ISO 9001:2008 ISO/TS 16949:2009 ISO 14001:2004

New edition of ISO 9004 maps out the path forward to "sustained success"

2009-12-01T06:40:00.000-08:00

The just-published new edition of ISO 9004 provides organizations with a model for "sustained success" in today's complex, demanding, and ever-changing environment.

ISO 9004:2009, Managing for the sustained success of an organization – A quality management approach, is the third edition of the standard first published in 1987. It is intended to support the achievement of sustained success by any organization, regardless of size, type or activity, by a quality management approach.

Bob Alisic, leader of the task group responsible for the ISO 9004:2009 comments: "While the goal is initially to ensure the production of 'good' products and services, leading to the achievement of customer satisfaction, the longer-term purpose is to ensure the economic survival of the organization. The new edition gives guidance on how an organization should adopt a systematic approach to achieve this."

ISO 9004:2009 provides guidance for the continual improvement of an organization's overall performance, efficiency and effectiveness based on a process-based approach. It focuses on meeting the needs and expectations of customers and other relevant parties, over the long term, and in a balanced way.

Compared to ISO 9001:2008 which ensures quality management of products and services, while enhancing customer satisfaction, ISO 9004:2009 provides a broader perspective of quality management, particularly for performance improvement. It will prove useful to organizations whose top management wishes to move beyond ISO 9001, in pursuit of ongoing improvement, measured through the satisfaction of customers and other stakeholders.

ISO 9004:2009 allows organizations to enhance the quality of product and service delivery to their customers by promoting self-assessment as an important tool to enable organizations to:

Benchmark their level of maturity, covering leadership, strategy, management system, resources and processes
Identify their strengths and weaknesses
Identify opportunities for either improvements or innovation, or both.

The self-assessment tool may become a key element during the strategic planning processes in any organization.

Jose Dominguez, a leader of the ISO 9001 task group comments: "The objectives of customer satisfaction and product quality are extended in ISO 9004:2009 to include the satisfaction of interested parties and the performance of the organization. The combination of ISO 9001 and ISO 9004 will allow you to get the most of your quality system.”

ISO 9004:2009 replaces ISO 9004:2000. It makes substantial changes to its structure and contents of the earlier edition based on eight years’ experience of implementing the standard worldwide and introduces changes intended to improve consistency with ISO 9001 and other management system standards. An example of an important (maybe the most important one) change in the structure of ISO 9004 is that the “body” of the standard starts with the chapter giving guidance on how to manage an organization aiming for sustained success and not how to build a quality management system.

Although ISO 9004:2009 complements ISO 9001:2008 (and vice versa), it can also be used independently. It is not intended for third-party certification, regulatory, or contractual use, nor as a guide to the implementation of ISO 9001:2008. To help users get the best out of the standard, an annex gives a clause-by-clause correspondence between ISO 9001:2008 and ISO 9004:2009.

Data from : www.iso.org/iso/pressrelease.htm?refid=Ref12

Latest ISO 9001 edition and draft of next ISO 9004 edition included on CD compilation of generic ISO 9000 standards

2009-10-27T09:55:00.000-07:00

ISO 9001:2008, the latest edition of the world's most widely used quality management standard, is included on a newly launched CD collection of the generic standards in the ISO 9000 family.

ISO 9000 Quality management Order the CD-ROM The ISO Standards collection – ISO 9000 Quality management on CD contains 18 standards (including one draft and two technical corrigendums).

The collection includes ISO 9001:2008, the latest edition of the standard that establishes the requirements for a quality management system and which can be used for certification by organizations that wish to have their conformity to the standard verified by an independent auditor. At the end of 2007, at least 951 486 certificates of conformity to the previous edition, ISO 9001:2000, had been issued in 175 countries and economies.

Also included on the CD is the Draft International Standard, ISO/DIS 9004, Managing for the sustained success of an organization – A quality management approach.

These are complemented by the rest of the comprehensive family of generic standards developed by ISO technical committee ISO/TC 176, Quality management and quality assurance. "Generic" means that the same standard can be applied by any organization, large or small, whatever its product or service, in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. The other standards address:

Fundamentals and vocabulary
Performance improvements
Quality plans
Projects
Configuration management
Measurement processes and measuring equipment
System documentation
Realizing financial and economic benefits
Training
The selection and use of consultants
Quality and/or environmental management systems auditing
Complaints handling
Codes of conduct for customer satisfaction
Dispute resolution.

The ISO Standards Collection – ISO 9000 Quality management on CD (ISBN 978-92-67-01173-8) includes all the above documents in both English and French. It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 308 Swiss francs, through th ISO Store or by contacting the Marketing & Communication department (see right-hand column).

hltp://www.iso.org/iso/pressrelease.htm?refid=Ref1236

New edition of ISO/TS 16949 quality specification for automotive industry supply chain

2009-07-28T07:33:00.000-07:00

ISO has just published a new edition of ISO/TS 16949:2009, which specifies quality system requirements for suppliers in the automotive sector.

ISO/TS 16949:2009, Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations, replaces the 2002 edition which has been used by the major automotive manufacturers to approve more than 35 000 organizations worldwide that produce and supply parts for the sector.

The review of ISO/TS 16949:2002 resulting in the 2009 edition was carried out by the International Automotive Task Force (IATF) and ISO technical committee ISO/TC 176, Quality management and quality assurance. The generalized implementation of ISO/TS 16949 quality management systems by automotive suppliers is seen as an opportunity to improve quality while reducing costs.

ISO Secretary-General Rob Steele commented: "With the global nature of the automotive industry quality management systems based on ISO/TS 16949:2009 throughout the supply chain will serve to streamline operations, and thus help organizations cut costs while improving efficiency. The publication of ISO/TS 16949 will assist the sector and to reassure consumers and ensure significant benefits for automotive suppliers amid the challenges facing the industry."

The new document aims at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. Incorporating the requirements of ISO 9001:2008, ISO/TS 16949:2009 also includes detailed, sector-specific requirements for employee competence, awareness and training, design and development, production and service provision, control of monitoring and measuring devices, and measurement, analysis and improvement.

Joe Bransky, a member of the International Automotive Task Force (IATF) comments: “In today's lean manufacturing environment, huge contingency stocks of inventory have given way to just-in-time logistics and delivery. The foundation of certainty that ISO/TS 16949:2009 provides in terms of improved productivity, quality, and delivery in the supply-chain, is probably more essential than ever.”

The 2009 edition results from the amendment of ISO/TS 16949:2002 to ensure its compatibility with the requirements of ISO 9001:2008, Quality management systems – Requirements. There are no essential changes to the technical requirements. The modifications relate mainly to the management requirements in the document to reflect the content of ISO 9001:2008, and those that are intended to improve consistency with the environmental management system standard, ISO 14001:2004.

Up to the end of December 2008, at least 39,300 ISO/TS 16949:2002 certificates had been issued in 81 countries and economies. This represents a 12 % increase over 2007.

The IATF has set a transition period of 120 days from date of publication of the new edition – 15 June – for organizations to comply with the standard's requirements. The details of the plan are given in a communiqué by the IATF Oversight Certification Body

ISO/TS 16949:2009 was prepared by the International Automotive Task Force (IATF), with the support of ISO technical committee ISO/TC 176, which is responsible for the ISO 9000 family of quality management standards.

ISO/TS 16949:2009, Quality management systems – Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations, is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 136 Swiss francs, through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

http://www.iso.org/iso/pressrelease.htm?refid=Ref1234

First step for ISO standard on recall of unsafe products

2009-06-15T06:19:00.000-07:00

The first meeting of the ISO project committee that will develop an International Standard providing a code of good practice for establishing, implementing and managing efficient, flexible and responsive consumer product recall programmes including corrective actions, took place in May 2009, in Kuala Lumpur, Malaysia.

ISO/PC 240, Product recall, decided on a publication target of 2012 for the new standard (ISO 10393). ISO/PC 240 also resolved to harmonize efforts with other ISO committees developing standards for consumer product safety (ISO/PC 243), anti-counterfeiting (ISO/PC 246) and combatting fraud (ISO/TC 247).

The committee extended a call for interested parties wishing to participate (through the ISO member of their respective country). Currently, about 12 countries participate in ISO/PC 240, and an additional four have observer status. Among its members, Canada, Japan, Malaysia, Republic of Korea and South Africa were present at the first meeting.

ISO/PC 240, Product recall was established following an initiative of ISO/COPOLCO, the ISO Committee on consumer policy, which noted that ineffective product recalls of damaged or unsafe products have resulted in millions of people being injured – sometimes fatally – or becoming ill.

“A market-oriented International Standard on product recall will help to protect consumers and users from fatalities, injuries and financial loss caused by flawed products, but it will also help businesses to save time and money and reduce related legal risks” said the Canadian representative, Mr. Doug Geralde, Director of Corporate Audits and Investigations, Canadian Standards Association.

“This standard is particularly relevant in today’s market context where products routinely cross borders, but uneven and inconsistent approaches in policies and procedures pose significant challenges for global recalls,” Mr. Geralde added.

The International Standard will help organizations to plan and execute timely and cost effective product recalls following design flaws, manufacturing defects, or inadequate warning labels or instructions – whether the products are still in the manufacturer’s or distributor’s inventory or retail shelves or in the hands of consumers. It will also provide guidance on corrective actions, including repair, placement, re-purchase and public notice, helping organizations to minimize legal risks, and contributing to customer satisfaction and loyalty.

The work of ISO/PC 240 will apply to consumer products, including electrical and gas household appliances. The projected standard will be useful for manufacturers, retailers, importers, testing organizations, providers of third party recall services, legal firms, government regulators and consumers/safety organizations.

The Kuala Lumpur meeting was hosted by the Department of Standards Malaysia (DSM), ISO member for the country, who provides the secretariat of the committee. ISO/PC 240’s next meeting will be held in November 2009.

Information by : http://www.iso.org/iso/pressrelease.htm?refid=Ref1227

ISO and the environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO,s portfolio

- but enviroment-related standardization is far from being a new departure for ISO.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in 1993. This followed ISO's successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207, and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.

This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

New ISO standard will help national libraries to evaluate their performance

2009-05-07T08:07:00.000-07:00

National libraries have special responsibilities for the cultural heritage of their country. A new ISO Technical Report that defines performance indicators for national libraries will help them to optimize effectiveness and efficiency in fulfilling these tasks.

ISO/TR 28118:2009, Information and documentation – Performance indicators for national libraries, establishes the performance indicators that are relevant to the special tasks and services of national libraries. These services include the collection and preservation of the national documentary heritage, the publication of a national bibliography, and a leading role in international cooperation. Therefore, the indicators address topics like the following:

Coverage of the national imprint (= all documents – print and electronic – published in a country)
Speed and comprehensiveness of the national bibliography
Efforts to preserve the national documentary heritage
International involvement of the library.

The Technical Report provides standardized terminology and definitions for data to be used in the performance indicators. Furthermore, it contains concise descriptions of the performance indicators, of the collection and the analysis of data needed, and of examples where the performance indicators have been used. It also describes what types of services or activities would benefit most from using the individual performance indicator as well as limitations to its application.

The performance indicators in this Technical Report facilitate achievement of the main objectives of national libraries:

Building the national collection
Making the collection accessible
Preserving the collection
Offering reference services
Building potentials for development
Managing efficiently.

Dr. Roswitha Poll, leader of the ISO group of experts that developed the report, comments: "National libraries play an important role in providing and ensuring permanent access to the knowledge and culture of the past and present and have special tasks and services compared to other libraries. ISO/TR 28118:2009 will help them assess and improve the performance of their public service mission. "

The Technical Report does not describe performance indicators for the collection of Internet resources, although this may be added to the next edition. However, it includes an annex giving a preliminary overview of methods and quality issues for this activity.

ISO/TR 28118:2009, Information and documentation – Performance indicators for national libraries, was developed by ISO technical committee ISO/TC 46, Information and documentation, subcommittee SC 8, Quality – Statistics and performance evaluation. It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 192 Swiss francs, through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

Information from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1222

Recent Changes Regarding Iso/ts 16949 (odak Danismanlik Ve Egitim)

2009-05-03T08:16:00.000-07:00

Two of the core tool manuals (namely FMEA and APQP) were revised in late 2008 and took effect as of 01.11.2008

FMEA

Main changes:

Identifying the team and assigning responsibilities
Defining the scope
Link between existing controls and “occurance and detection indices”
Prioritisation of actions
Severity, occurance and detection evaluation criteria
Sample forms
Link between DFMEA and PFMEA
“Process Step/Function – Requirement – Potential Failure Mode” analysis for PFMEA
“Item – Function – Requirement – Failure Mode”analysis for DFMEA
Methods to identify the potential effects (for PFMEA)

APQP

Main changes :

Minor changes to inputs and outputs of APQP phases
“Control plan methodology” fully in-line with ISO/TS 16949 requirements

The changes regarding automotive certification are not limited to core tools.

Upon the release of ISO 9001:2008 in November 2008, ISO/TS 16949:2002 is subject to revision once again. The proposed specification is called ISO/TS 16949:2009 and is expected to be released in the first quarter of 2009.Additionally, "Rules for

Achieving IATF Recognition" was also revised in late 2008.

Issues clarified and/or revised :

The types of audits which require Stage 1 visit
Actions to be taken in case of “major findings” in surveillance audits
Deadlines to clear the findings at re-certification audits
Audit scope versus “subscriber/non-subscriber” customer
The cases which require notification of the organization by the certification body
Visit deadlines per surveillance visit frequency
Details regarding on-site visit day calculations
The rules regarding time and responsibility assignments for audit teams with more than one auditor
The shall statement regarding the use of a different audit team per each audit cycle (should statement in former revision)
The rules regarding auditing of process performances and customer specific requirements
The content of “improvement potential”
The rules regarding termination of an audit before completion
Content and extent of corrective and preventive actions to clear audit findings
The types of audits which require an audit plan
Scope and content of Stage 1 audits
Rules regarding transfer audits
Decertification process details
(the word “audit” is used to represent “3rd party audits” in the above listing)

Article Source: http://www.articlesbase.com/automotive-articles/recent-changes-regarding-isots-16949-odak-danismanlik-ve-egitim-745532.html

ISO standard for access panels aims to increase effectiveness of market, opinion and social research

2009-04-25T09:47:00.000-07:00

Access panels are becoming a key tool of market, opinion and social research. A new ISO standard will support this evolution by providing definitions and requirements to increase the quality and efficiency of access panels as well as providing internationally harmonized criteria to facilitate comparison of the results of access panels worldwide.

Whereas people are often reluctant to respond to research questionnaires or calls due to lack of time or concerns about security and privacy, access panels provide an innovative solution for driving market, opinion and social research forward.
Composed of a representative set of individuals who accept to complete questionnaires on various subjects, access panels often involve incentives and take advantage of the latest technology to extend their outreach. As such they can efficiently attract thousands, even millions of respondents from around the world at a cost lower than other conventional strategies.

ISO 26362:2009, Access panels in market, opinion and social research – Vocabulary and service requirements, provides definitions and guidelines for good practice, tackling issues such as recruitment, validation of identity, size and profile of panels. Its application will help address any limitations and exploit their potential to the fullest. The standard can also be used to evaluate access panels and assess their quality.

“ISO 26362 will encourage potential clients to take advantage of this innovative way of carrying out research, which is best suited to modern needs. It will also help researchers make the most of their resources to achieve consistent results” says Erich Wiegand, Convenor of the ISO working group on access panels and leader of the project.

The standard provides a lot more than just the bare minimum requirements for good research practice and adopts a flexible approach to ensure its applicability in all countries.

ISO 26362 will be used by organizations and professionals who own and/or use any type of access panels for market, opinion and social research, whether online (internet) or offline (telephone, face-to-face, etc.).

Mr. Wiegand adds “By helping to eliminate misunderstandings between organizations that order research and those that carry it out for them, as well as providing information that will help to improve customer satisfaction for goods and services, International Standards for market, opinion and social research are among the most productive ways for the industry to improve its effectiveness and market relevance.”

The standard is based on and should be used in conjunction with the more generic ISO 20252:2006, Market, opinion and social research – Vocabulary and service requirements.

Article by : http://www.iso.org/iso/pressrelease.htm?refid=Ref1211

New CD collection of ISO/IEC standards and guides for testing laboratories and inspection bodies

2009-04-14T07:58:00.000-07:00

A new CD is available containing all ISO/IEC International Standards and Guides for testing laboratories and inspection bodies.

ISO/IEC Pack: Conformity assessment Laboratories and inspection bodies

Testing is a major conformity assessment activity and also provides the basis for other conformity assessment processes such as product certification and inspection. Conformity assessment is the process used to demonstrate that products, services, materials, management systems, personnel and organizations meet specified requirements.

ISO Secretary-General Rob Steele comments: "It has been estimated that standards and related conformity assessment activities have an impact on about 80 % of world commodity trade, which gives an idea of the importance of the conformity assessment standards and guides developed by ISO and its partner, the International Electrotechnical Commission."

The ISO/IEC Pack:Conformity assessment – Laboratories and inspection bodies, contains 10 standards and guides (plus a corrigendum). They include the general requirements for laboratories in order for them to be considered competent to carry out testing, calibration and sampling. These criteria are contained in ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories. An estimated 40 000 laboratories worldwide are accredited to ISO/IEC 17025.

Inspection bodies examine a huge range of products and processes, installations and plants. The overall aim is to reduce risk to the buyer and consumer of the item being inspected. As many laboratories also operate inspection activities, the CD also includes ISO/IEC 17020:1998, General requirements for the operation of various types of bodies performing inspection activities.

The use of ISO/IEC standards and guides on conformity assessment procedures allows for harmonization of good practice-based processes throughout the world. This not only facilitates international trade between countries, but also facilitates trade within countries giving the purchaser of the product or service confidence that it meets the requirements. The standards and guides in the new ISO/IEC Pack have been developed by ISO/CASCO , the ISO policy development committee on conformity assessment.

The CD, ISO/IEC Pack: Conformity assessment: Laboratories and inspection bodies (bilingual – English and French; ISBN 978-92-67-01169-1) is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 742 Swiss francs, through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

Information from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1212

New ISO standard for building escape and evacuation plans is a potential life saver

2009-04-08T08:25:00.000-07:00

A new ISO standard will help to ensure that when fire breaks out in a building, occupants trying to evacuate the premises are not left scratching their heads trying to understand escape plans and signs.

ISO 23601:2009, Safety identification – Escape and evacuation plan signs, establishes design principles for displayed escape plans that provide information vital to fire safety, escape, evacuation and rescue of a facility's occupants.

The purpose of escape plans is to help people orient themselves in relation to the planned escape route. In this way, the escape plan complements the facility's safety exit guidance system. These plans, which may be displayed as signs in work places and in public areas, may also be used by fire, rescue and medical teams, as well as by intervention forces in the case of terrorist attack.

The standard has been developed because there is a need to harmonize on an international scale a system of communicating escape routes in facilities that relies as little as possible on the use of words to get the message through. With an increasingly mobile world population and ever-greater opportunities for international trade, graphical symbols are an essential tool for concisely conveying messages to users independently of language. Where safety signs are concerned, ease and speed of recognition are vital to help save people from injury and death.

ISO 23601 is based on the safety signs, colour codes and design requirements of

ISO 7010:2003, Graphical symbols – Safety colours and safety signs – Safety signs. It establishes a common method of illustrating the position of the viewer in relation to designated escape routes leading to emergency exits and the location of fire safety and emergency equipment close to escape routes. It covers the following:

Design requirements
Size of plan elements
Content and representation
Materials
Installation and location
Inspection and revision.

Continued growth in international trade, travel and mobility of labour requires a common method of conveying this important safety information to the occupants of facilities. The use of ISO 23601:2009 is expected to reduce risk by providing a means of improved training and education and to reduce possible confusion in times of emergency.

ISO 23601:2009 was developed by ISO technical committee ISO/TC 145, Graphical symbols, subcommittee SC 2, Safety identification, signs, shapes, symbols and colours.

It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 80 Swiss francs, through the ISO Store or by contacting the Marketing & Communication department (see right-hand column

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1207

ISO launches online tutorial on consumer participation in standards development

2009-04-05T08:20:00.000-07:00

ISO has just launched a user-friendly, interactive tutorial on its Web site on consumers and standardization, explaining what consumers can gain from International Standards and how standards benefit from consumer input.

Consumers and standards: partnership for a better world is a convenient, stand-alone distance learning tutorial which will be useful for any person who is relatively new to the world of standardization and consumer policy. This module will also be helpful to seasoned professionals from consumer organizations and standards bodies as a review of concepts and a repository of ideas and background sources.

The aim of Consumers and standards is to provide the user with a basic understanding of what standards are and what they do, and explain how consumers can participate in standards development and why they should do so. It also demonstrates how standards can improve goods and services for consumers, using specific examples.

This module was produced as part of an ongoing joint programme of the ISO Committee on consumer policy (ISO/COPOLCO) and the ISO Committee on developing country matters (ISO/DEVCO) to promote consumer participation in standardization, with support of the Swedish International Development Cooperation Agency (SIDA). Consumers International, a liaison organization to ISO/COPOLCO, also participated actively in its development.

ISO Secretary-General Rob Steele comments: "Consumers are often the end users of goods and services influenced by ISO standards. They value such characteristics as safety, quality, ease of use and interoperability which standards help to ensure. For over 30 years, ISO has benefited from the views of consumer representatives who have identified new areas for standardization, such as services and social responsibility and who have participated in technical committees producing standards that influence consumer products. This tutorial will help both to broaden and intensify consumer participation in developing ISO standards by providing the basic tools and references needed to understand and take an active part in the partnership with ISO."

Consumers and standards is designed to be used by representatives of consumer organizations, standards bodies or other types of organization, both from developing and developed countries. The module includes a glossary of terms and definitions, selected useful reference materials and a short description of these materials. Furthermore, the module is easy to navigate, and text can be magnified for easy access by the visually impaired. An interactive review quiz at the end of each section will help the user review concepts. An embedded feedback form is also available for comments and suggestions.

The module will take about a half-day to complete; its four-section format gives the user flexibility to complete the module in several sessions, if desired. The four sections address the following themes:

Standards in our world
How standards benefit consumers
Ensuring that consumers have their say in standards-writing
What are consumers’ interests and how does ISO address them?

This tool, available in English and in French, is accessible directly in bilingual format from the "Consumers" section on ISO's Web site and from the "Publications and products" section. It is also available on a CD-ROM (ISBN 978-92-67-01172-1) on request (contact sales@iso.org) .

Information by : http://www.iso.org/iso/pressrelease.htm?refid=Ref1206

Iso Certification: What it is and What You Can Expect

2009-03-09T08:26:00.000-07:00

Obtaining an ISO certification is often a huge part of many organization's goals. ISO certification is an indication of high standards in terms of products and services. It's also the mark of excellence for many companies, a sign that they take their responsibilities very seriously. If your organization is aiming to have an ISO certification before the year ends, here are things you need to know about the process:

What is an ISO certification?
Many people are confused with what the acronym ISO stands for. Actually, it stands for a lot of different things, depending on the language of the country. A rough translation, however, would be 'International Organization for Standardization'. To make it more generic and avoid confusion across countries, the founders of the system decided on ISO, which is sourced from the Greek term 'isos', a word that means 'equal'.

In order to obtain an ISO certification, organizations have to apply by undergoing a series of procedures and implementing a system based on the standards set for the specific ISO standard they want to attain.

An ISO certification is actually an issued document that functions as an assurance that the organization's management system has been audited and verified and has indeed passed the requirements of the standard. The auditing and verification is performed by an independent third party which has the appropriate authorization to do so. The independent third party is also referred to as an accreditation body.

What to expect during ISO certification
An organization's ISO certification relies on its performance as assessed during auditing. Auditing is done two ways: one is by internal auditors (members or employees of the organization who have been especially trained to perform the job) and the other is by an independent accreditation body.

During the auditing, the organization applying for ISO certification provides samples of its procedures, processes, products, services and other documents that show proof of the company's functions and related activities. If there are problems or non-compliances, these are detailed in a list, which are then presented to the management. Related corrective measures are then implemented.

Correcting these problems is critical because if an organization fails to do so or at least to show proof that it does not really require a request for action, then they may not be issued an ISO certification.

Should there be multiple business sites, such as those located at different geographical areas, an ISO certification will have to be applied for and issued independently for each.

Article Source: http://www.articlesbase.com/business-articles/iso-certification-what-it-is-and-what-you-can-expect-732233.html
How long is an ISO certification valid?
An ISO certification has to be renewed regularly. Very often, the time period is 3 years or depending on the recommendation of the accreditation body.

ISO/TS 16949:2009 Transition (odak Danismanlik Ve Egitim)

2009-03-09T08:20:00.000-07:00

As a result of harmonisation efforts regarding the supplier quality management system requirements, ISO/TS 16949:1999 (based on ISO 9001:1994)was first released in 1999. The aim was to form a globally recognized automotive sector requirements document.

In March 2002, the revised version of ISO/TS 16949 (based on ISO 9001:2000) was released. Suppliers which were registered to OEM requirements (such as QS-9000:1998, VDA 6.1) were subject to respective deadlines to ugrade to ISO/TS 16949:2002.

Upon the release of ISO 9001:2008 in November 2008, ISO/TS 16949:2002 is subject to revision once again. The proposed specification is called ISO/TS 16949:2009 and is expected to be released in the first quarter of 2009.
ISO/TS 16949:2009 will be based on ISO 9001:2008. Similar to the case of ISO 9001 revision, ISO/TS 16949:2009 will not introduce new or changed requirements (shall statements).

The revised text of ISO/TS 16949:2009 will need to be implemented no later than 120 days after the release of the specification.

The existing ISO/TS 16949:2002 certificates will remain valid for the certification life.

The organizations are allowed to request the replacement of their existing certificates to ISO/TS 16949:2009 certificates at the surveillance audits, while it is not mandatory.

The changes regarding automotive certification are not limited to ISO 9001:2008 transition.

Two of the core tools (namely FMEA and APQP) were revised in late 2008. Additionally, "Rules for Achieving IATF Recognition" was also revised in late 2008.
Highlights of these changes can be found in respective issues of OdakInfo newsletter (an electronic newsletter regarding automotive certification) released by Odak Consulting - Savas Kutdemir.

Article Source: http://www.articlesbase.com/automotive-articles/isots-169492009-transition-odak-danismanlik-ve-egitim-738242.html

New ISO standard will facilitate implementation of ISO 14000 series in 12 languages

2009-03-08T10:09:00.000-07:00

A newly revised ISO standard will facilitate even further the application of the ISO 14000 series on environmental management. By establishing a common vocabulary, the standard will ensure the effectiveness of communication, key for the implementation and operation of environmental management systems (EMS).

This third edition of ISO 14050:2009, Environmental management – Vocabulary has been fully updated to include the latest developments in the field. The standard now provides clear and concise definitions of all concepts and terms used throughout the ISO 14000 series in the three official ISO languages, English, French and Russian, as well as in Arabic and Spanish. The standard also provides equivalent terms in Dutch, Finnish, German, Italian, Norwegian, Portuguese and Swedish.

An ISO survey published last year showed that up to the end of 2007 at least 154 572 certificates of compliance with ISO 14001:2004 (requirements for environmental management systems) had been issued in 148 countries. Commenting on these results, Håvard Hjulstad, Convenor of the ISO/TC 207 Terminology Coordination Group which developed the standard, said “Given the global context, and the extent of the application of the ISO 14000 standards, it is clear now more than ever that ISO 14050 is crucial for ensuring that all the users of these standards are on the same page, no matter where in the world they are.”

Mr. Hjulstad added, “ISO 14050 will clarify any doubts that users of the ISO 14000 series may have concerning terminology and concepts, which is particularly important given the key role communication plays in the standards. By helping to maintain consistency, the ISO 14050 will also be very helpful to developers of standards, in particular those working on translations.”

Currently there are 21 published standards in the ISO 14000 series. ISO 14001 and ISO 14004 provide requirements and guidelines for establishing an EMS. The rest address specific environmental aspects including labeling, product design, performance evaluation, greenhouse gases, life cycle assessment, communication, and auditing. ISO 14050 compiles the terms in all these standards in one practical document.

ISO 14050:2008, Environmental management – Vocabulary, was developed by ISO technical committee ISO/TC 207, Environmental management. It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 238 Swiss francs, through the ISO Store or by contacting the Marketing & Communication department

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1204

ISO-conforming RFID tags for freight containers ready for the worst

2009-03-08T09:51:00.000-07:00

A new ISO technical specification will help to ensure the functioning of radio frequency identification (RFID) tags on freight containers despite the harsh environments they may be subjected to during transport by sea, road and rail.

ISO/TS 10891:2009, Freight containers – Radio frequency identification (RFID) – Licence plate tag, provides specifications and test methods for RFID devices used for automatic identification of freight containers in supply chains.

This tag is a permanently affixed, read-only tag containing limited data relating only to physical identification and description of the container to which it is affixed. This tag is required to last the lifetime of its associated container.

The purpose of ISO/TS 10891 is to optimise the efficiency of equipment control systems including the optional usage of electronic seals in conformity with the ISO 18185 series.
ISO/TS 10891:2009 establishes:

A set of requirements for container tags which allow the transfer of information from a container to automatic processing systems by electronic means

A data coding system for container identification and container related information which resides within a container tag

A data coding system for the electronic transfer of both container identification and container related information from container tags to automatic data processing systems

The description of data to be included in container tags for transmission to automatic data processing systems

Performance criteria necessary to ensure consistent and reliable operation of container tags within the international transportation community

The physical location of container tags on containers

Features to inhibit malicious or unintentional alteration and/or deletion of the information content of container tags when installed on a freight container.

Mr Frank Nachbar, leader of the ISO committee which developed the standard comments: "Containerization has reduced the time and cost of moving goods across the oceans to market and it has greatly reduced pilferage and theft in the transportation of goods, as well as leading to enormous improvements in the safety and health of transportation workers. ISO/TS 10891 will help container manufacturers, the shipping industry, customs, terminal operators, rail operators and container depot operators to achieve optimal benefits from using RFID to improve efficiency, speed up operations and enhance security in the handling and transport of freight containers."

ISO/TS 10891:2009, Freight containers – Radio frequency identification (RFID) – Licence plate tag, was developed by ISO technical committee ISO/TC 104, Freight containers, subcommittee SC 4, Identification and communication. It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 86 Swiss francs, through the ISO Store or by contacting the Marketing & Communication department.

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1205

Trainsition to ISO 9001:2008 by Walk Rally

2009-02-19T05:52:00.000-08:00

หลักการและเหตุผล

ระบบบริหารคุณภาพ (ISO 9001:2008) เป็นส่วนหนึ่งของการแสดงให้เห็นถึงศึกยภาพขององค์กรที่มีมาตรฐานการทำงานที่ชัดเจน การดำเนินงานที่เทียบเท่าและเป็นที่ยอมรับในระดับสากล บุคลากรซึ่งเป็นทรัพยากรที่มีคุณค่ายิ่งสำหรับองค์การ จำเป็นต้องได้รับการพัฒนาให้มีความรู้ ความเข้าใจกับระบบการบริหารต่างๆ ที่องค์กรดำเนินการ เพื่อให้มีความสามารถในการทำงาน และการทำงานร่วมกันได้อย่างมีประสิทธิภาพ

การจัดฝึกอบรมหลักสูตร "Trainsition to ISO 9001:2008 by Walk Rally" เป็น การอบรมในรูปของการทำกิจกรรมกลุ่ม เป็นรูปแบบของการเรียนรู้คู่กับความสนุกสนาน ซึ่งจะช่วยเสริมสร้างให้บุคลากรได้มีความเข้าใจในการนำระบบบริหารคุณภาพไปประยุกต์เพื่อให้มีระบบการทำงานที่ได้มาตรฐาน อีกทั้งยังส่งเสริมหลักในการทำงานร่วมกันเป็นทีม ได้เรียนรู้ตนเองและเพื่อนร่วมงาน อันจะมีส่วนทำให้มีการพัฒนาระบบบริหารคุณภาพภายในองค์กรดียิ่งๆขึ้นไป

ISO 9001:2008 Walk Rally คืออะไร

ISO 9001:2008 Walk Rally คือ กิจกรรมที่กำหนดให้มีการเดินอย่างเป็นกลุ่มในแต่ละทีม โดยเดินไปตามแผนที่ที่กำหนดให้เดิน และเป็นไปตามกติกา เพื่อค้นหาปริศนารวมถึงหมากกลที่ซ่อนอยู่ตามจุดต่างๆ และนำพาเข้าสู่เส้นชัยในเวลาที่เหมาะสมกิจกรรม Walk Rally นี้ เป็นกิจกรรมที่คิดค้นขึ้นมาเพื่อให้ผู้เข้าร่วมกิจกรรมได้ทบทวนและทำความเข้าใจในการเปลี่ยนแปลงข้อกำหนดของ ISO 9001:2000 เป็น ISO 9001:2008 และเข้าใจระบบเอกสารในองค์กร การตรวจติดตามผลการดำเนินงาน และเพื่อให้บุคลากรได้มีจิตสำนึกในการทำงานร่วมกัน ส่งเสริมให้มีการใช้ความคิดและแสดงความคิดเห็นร่วมกันอย่างเต็มที่ บนพื้นฐานแห่งความเป็นจริงในการทำงานและที่สำคัญคือ ผู้ปฏิบัติงานสามารถเรียนรู้การทำงานเป็นทีมได้ด้วยตนเอง"Trainsiton to ISO 9001:2008 by Walk Rally" จึงเป็นหลักสูตรการฝึกอบรมในรูปแบบกิจกรรมที่อาศัยตัวเราเป็นครูสอนตัวของเราเอง ให้เกิดการเรียนรู้และการตีความในข้อกำหนดและการประยุกต์ใช้ในการปฏิบัติจริงได้เป็นอย่างดี

วัตถุประสงค์ของหลักสูตร Trainsition to ISO 9001:2008 by Walk Rally

1. เพื่อเป็นการทบทวนและทำความเข้าใจในข้อกำหนด ISO 9001:2008
2. เพื่อให้เข้าใจถึงลักษณะการทำงานโดยมุ่งเน้นที่กระบวนการ (Process Approach)
3. เพื่อให้เป็นคนยอมรับฟังความคิดเห็นของผู้อื่น และเป็นคนมีเหตุมีผล
4. เพื่อให้เป็นคนช่างสังเกต และละเอียดรอบคอบ
5. เพื่อให้เป็นคนที่ซื่อสัตย์และรับผิดชอบ
6. เพื่อให้เป็นคนที่มีการวางแผนในการทำงาน
7. เพื่อให้เป็นคนที่มีมนุษยสัมพันธ์
8. เพื่อให้มีสุขภาพร่างกายแข็งแรง
9. เพื่อเสริมสร้างทัศนคติที่ดีและแรงจูงใจในการทำงาน

ขั้นตอนในการจัดกิจกรรมแบ่งออกเป็น 3 ขั้นตอน

1. ภาควิชาการ การทบทวนความรู้เกี่ยวกับระบบบริหารคุณภาพ ISO 9001:2008
2. ภาคกิจกรรม การดำเนินกิจกรรม Walk Rally
3. ภาคประเมินผล การสรุปประเมินผลในภาคปฏิบัติ

ประโยชน์ที่ได้รับจากกิจกรรม Walk Rally

ประโยชน์ส่วนตัว
1. ทำให้มีความเข้าใจในข้อกำหนดของ ISO 9001:2008 และผลของการเปลียนแปลง
2. ทำให้เข้าใจการทำงานที่มุ่งเน้นกระบวนการ โครงสร้างเอกสาร การตรวจติดตามผลการ ดำเนินงาน และการนำไปประยุกต์ใช้ในการปฏิบัติงานจริง
3. ทำให้เป็นคนละเอียดรอบคอบ และช่างสังเกต
4. ทำให้เป็นคนมีเหตุมีผลและยอมรับฟังความคิดเห็นผู้อื่น
5. ทำให้เป็นคนตรงต่อเวลา และรู้จักรักษาเวลา
6. ทำให้เป็นคนมองเห็นข้อบกพร่องของตนเอง เพื่อนำไปปรับปรุง
7. ทำให้เป็นผู้มีมนุษยสัมพันธ์
8. ทำให้รู้จักการทำงานร่วมกัน
9. ทำให้สุขภาพร่างกายแข็งแรง

ประโยชน์ต่อการทำงาน
1. ทำให้มีความเข้าใจในข้อกำหนดของ ISO 9001:2008 และผลของการเปลี่ยนแปลง
2. ทำให้รู้จักการทำงานเป็นทีม โดยเรียนรู้ที่จะรับผิดชอบร่วมกัน ร่วมกันใช้ความคิด ฟังเหตุผลและความคิดของกันและกัน รวมทั้งรู้จักแก้ไขปัญหาร่วมกัน
3. ทำให้มีความรับผิดชอบต่อหน้าที่ และมีการปฏิบัติตามกฎระเบียบอย่างเคร่งครัด เพราะ Walk Rally เรื่องกฎ กติกา มีความสำคัญมาก
4. รู้จักมีการพิจารณาอย่างถี่ถ้วนและมีการวางแผนการทำงานก่อนการลงมือปฏิบัติจริง
5. ทำให้มีความละเอียดรอบคอบในการทำงาน
6. ได้สร้างความสัมพันธ์อันดี สร้างความรักสามัคคีระหว่างเพื่อนร่วมงานทุกระดับชั้นและทุกวัย ซึ่ง จะก่อให้เกิดความเข้าใจซึ่งกันและกัน
7. ทำให้เป็นผู้ที่มีมนุษยสัมพันธ์ในการทำงาน
8. ทำให้รู้จักคุณค่าแห่งการทักทายผู้อื่น
9. ทำให้มีแนวความคิดในการทำงานและการดำเนินชีวิตที่ถูกต้องและเป็นคนดีมีคุณธรรม

สนใจสอบถามรายเลียดเพิ่มเติมได้ที่ คุณทวีศักดิ์, คุณณัฐฐา, คุณพรชัย หมายเลขโทรศัพท์ 02-7458325-6

Iso 9001:2008 - Hidden Business Opportunities. an Opportunity to Reenergize Your Qms and to Outperform Your Competition

2009-01-11T06:39:00.000-08:00

The ISO 9001:2000 Standard has been revised after eight years. And the buzz is rapidly reaching a crescendo. We continue to receive numerous emails and phone calls regarding the impact of the new release. First, let me dispel any anxiety about the November 15, 2008 official “2008” release. There are no new requirements. The changes are largely interpretive, and focus on terminology clarifications. The changes to the ISO 9001 amendment, however, will have considerable benefit.

As a back drop, keep in mind that ISO 9001 is not just an International Standard for a Quality Management System. It is the world’s most recognized business management standard. And it makes a strong business case. It focuses attention on leadership, business planning, organizational business processes, your customers (internal and external), measurement and reporting, and continual improvement. That translates to improved business results and a sustainable competitive advantage.

Transitioning to ISO 9001:2008

The International Organization of for Standardization and the International Accreditation Forum have agreed to a smooth transition. Both standards will remain current for two years—until November 15, 2010. Registration of conformity to ISO 9001:2008 will be issued from November 15 on, and after a routine registrar surveillance audit, or a recertification audit against the new version. Also, as of November 15, 2009, all new registrations and recertifications must be to ISO 9001:2008.

Two years after publication of ISO 9001:2008 (November 15, 2010), any certifications that are still to ISO 9001:2000 will no longer be valid. This means that currently certified organizations in “surveillance mode” in 2008-2009 have until November 15, 2010 to be successfully certified to ISO 9001:2008. We recommend a proactive approach. If you can win in your marketplace every day—why put it off?

Overview of the Changes

The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action. But bear in mind, no “shalls” (requirements) were added or removed.

Examples of select changes include: In an attempt to clarify the term “outsourcing,” notes were added that require the organization to identify processes (and the control of these) to be completed by an external party. With respect to documentation, the changes focus on improving the compatibility between ISO 9001 and ISO 14001.

The only significant addition to the management representative sub clause was to require that the MR be a member of the organization’s management team. This means a contracted person could serve in this role as long as he or she is also considered part of management. The management representative does not have to be full-time.

With regard to competence of employees, a note was added to make training more pervasive throughout the organization. Training applies to all employees directly or indirectly responsible for delivering a service or producing a product (everyone that is part of the quality chain). A complete listing of changes can be found in Annex B (Table B.1) of the Standard. Also, note that there is better alignment with ISO 14001:2004.

Potential Danger and Hidden Opportunities

The Chinese character for crisis consists of two parts—potential danger and hidden opportunities. Clearly, the amended release does not suggest a crisis, and the hidden opportunities far outnumber any potential danger. So, if you are anxious—don’t be. That said, perhaps the greatest potential danger is to dismiss this release, and to rationalize that there is no work to be done.

Even though there are minor changes, hidden opportunities abound. This is the ideal time to be proactive, and to reenergize your quality (business) management system. Ask yourself: Is your QMS integrated with your organization’s vision, mission and values? Are your quality objectives aligned with your organization’s business objectives? Have you considered the needs of your customers in developing your objectives? Are you using a balanced scorecard to evaluate performance (key performance indicators)?

You could drill down further and ask: How are you measuring “the voice of the customer?” Are your document and record control processes effective? Are your preventive and corrective action processes effective? Do you have an effective root cause analysis methodology? Do you have an effective organization-wide training plan? How do you evaluate the competence of your employees? Are you measuring the cost of quality, and driving waste and inefficiency out of your business?

The Path Forward

This pragmatic path forward can be used as a guide to craft a game plan during the transition. It stresses the basic steps that your organization should consider, regardless of the maturity of your QMS.
Obtain a copy of the ISO 9001:2008 Standard. Copies can be purchased from your national standards body ANSI in the United States at (www.ansi.org), the International Organization for Standardization (www.iso.org), or from the American Society for Quality (www.asq.org).
Review Annex B, and familiarize yourself with the changes to the Standard. This Annex (Table B.1) identifies the text changes between the 2000 and 2008 versions. It’s a must read.
Discuss the transition requirements with your registrar. Remember you have two years to make the transition. We recommend transitioning sooner than later. This is no time to procrastinate.
Determine whether the changes impact your organization. If nothing else, it will give you and your management team a better understanding of the nuances and underlying reasons for the change.
Use this opportunity to reenergize your QMS. Remember, “ISO” is a fundamental business model, and it is the foundation from which to build a competitive, customer-centric enterprise.
Schedule a meeting with your ISO Business Partner (consulting firm) to assist you with taking your QMS to the next level. Along the way, you should also explore ways to leverage your certificate to accelerate growth of sales.

Article Source: http://www.articlesbase.com/business-articles/iso-90012008-hidden-business-opportunities-an-opportunity-to-reenergize-your-qms-and-to-outperform-your-competition-700001.html

New ISO Technical Report for safer manufacturing and handling of nanomaterials

2009-01-07T06:42:00.000-08:00

The field of nanotechnologies is advancing rapidly and is expected to impact virtually every facet of global industry and society. International standardization contributes to realizing the potential of this technology for the betterment and sustainability of the world through economic development, improving the quality of life, and for improving and protecting public health and the environment.

ISO has just published new ISO/TR 12885:2008, Health and safety practices in occupational settings relevant to nanotechnologies, which focuses on the manufacture and use of engineered nanomaterials. The Technical Report is based on current information about nanotechnologies, including characterization, health effects, exposure assessments, and control practices.
Broadly applicable across a range of nanomaterials and applications, the Technical Report provides advice for companies, researchers, workers and other people to prevent adverse health and safety consequences during the production, handling, use and disposal of manufactured nanomaterials.

Dr. Peter Hatto, Chair of ISO technical committee ISO/TC 229, Nanotechnologies, comments: "The introduction of new engineered nanomaterials into the workplace raises questions concerning occupational safety and health that should be addressed, as appropriate, by international standards. While such standards are being developed, it is important, through ISO/TR 12885:2008, to assemble and make available to users, useful knowledge on occupational safety and health practices in the context of nanotechnologies."

The Technical Report will be revised and updated and new safety standards will be developed as knowledge increases and experience is gained in the course of technological advance.
ISO/TR 12885:2008, Health and safety practices in occupational settings relevant to nanotechnologies, was developed by ISO/TC 229, Nanotechnologies.

It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from ISO Central Secretariat, price 176 Swiss francs through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

ISO launches second edition of award for higher education in standardization

2008-12-23T05:26:00.000-08:00

ISO (International Organization for Standardization) is inviting entries for the second edition of its award to encourage and recognize successful programmes in higher education on standardization.

The ISO Award for Higher Education in Standardization aims to raise awareness of the importance of standardization worldwide by supporting institutions of higher education that have developed and implemented successful programmes related to standardization as a tool to access world markets, transfer technology and promote good business practice and sustainable development.

The award comprises a certificate of appreciation and a cash prize of 15 000 Swiss francs. It is co-sponsored by ISO and the Japanese Industrial Standards Committee (JISC), the ISO member for Japan.

The nomination of candidates must be made by 16 February 2009 to the ISO Secretary-General by the national standards institutes that make up ISO's worldwide membership. The deadline for the subsequent receipt of documented applications for the award is 4 May 2009. The award selection committee consists of eminent personalities from international organizations for education, from academia, the economic sphere and the media.

"Knowledge of the benefits that international standardization can bring is not only important for young people who may one day participate in developing ISO standards," ISO Secretary-General Alan Bryden commented, "but for future managers, engineers and lawyers, as well as political and social leaders.

"This is because the international community is increasingly turning to ISO to develop standards that serve as practical tools to address the facilitation of trade on wolrd markets as well as global challenges such as, climate change, sustainable development, food and water, energy efficiency and the dissemination of innovation."

The second edition of The ISO Award will be presented in September 2009, at the ISO General Assembly in Cape Town, South Africa. The winning submission, as well as those of the runners-up, receive widespread exposure through publication in ISO Focus magazine and on the ISO Web site.

The winner of the inaugural award in 2007 was China Jiliang University, People's Republic of China, which was one of six finalists. The other educational institutions were from Egypt, France, Republic of Korea, Japan and the Netherlands.

ISO is the world’s leading developer of voluntary, consensus-based International Standards. There are more than 17 400 current ISO standards and related documents that specify the requirements for state-of-the-art products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice.

Article source by : http://www.iso.org/iso/pressrelease.htm?refid=Ref1183

Iso 9001:2008: Guidance on Documentation Requirements

2008-12-21T06:22:00.000-08:00

The ISO 9001:2008 standard is meant to be generic and applicable to all kinds of organizations. Therefore, organizations from both the public and private sectors, including non-governmental organizations can benefit from the ISO 9001 quality management system model, regardless of whether they are small, medium or large organizations. The immediate benefit that can be realized from the implementation of ISO 9001 is the collective alignment of the activities of internal processes that are focused towards the enhancement of customer satisfaction, which in turn will result in many other benefits, whether internal or external. The magnitude of these benefits are determined by how effective the processes are in achieving its objectives.

ISO 9001:2008 is not focused on the amount of documentation that must be established for the quality management system. The main objectives of an organization’s documentation are to provide a basis for communication of information, evidence of conformity and knowledge sharing. Clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”. Clause 4.2.1 General of the ISO 9001:2008 standard explains that the quality management system documentation shall include:

Documented statements of a quality policy and quality objectives;
Quality manual;
Documented procedures required by this International Standard;
Documents needed by the organization to ensure the effective planning, operation and control of its processes, and
Records required by this International Standard.

The procedures that are required to be documented are:
Clause 4.2.3 Control of documents
Clause 4.2.4 Control of records
Clause 8.2.2 Internal audit
Clause 8.3 Control of nonconforming product
Clause 8.5.2 Corrective action
Clause 8.5.3 Preventive action

For an organization who wishes to optimise its quality management system's documentation, it is sufficient to maintain these six procedures only. Other processes need only to have records that provide evidence of implementation, conformance and effectiveness. Quality records may come in various forms, such as meeting minutes, filled-up forms, reports, technical drawings, tags, et cetera.

The main purpose of the quality management system is its effectiveness in meeting customer requirements. Although ISO 9001 gives much flexibility to the documentation aspect of the quality management system, it is still supportive in nature. It is not the focal point.

Article Source: http://www.articlesbase.com/management-articles/iso-90012008-guidance-on-documentation-requirements-674035.html

ISO signs updated MoU with IAF and ILAC to strengthen cooperation

2008-12-16T06:53:00.000-08:00

ISO has signed an updated Memordandum of Understanding (MoU) with the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) strengthening their cooperation on accreditation.

The MoU, signed on 27 October 2008, updates an MoU reached in 2004. The new agreement provides the three organizations with a mechanism to collaborate with each other at the strategic and planning levels, in addition to the work already being carried out at the technical level.

Accreditation is the formal recognition by a specialized body – an accreditation body – that a certification body, an inspection body or a testing laboratory is competent to perform its activities. It is an important and recognized option for generating confidence in international trade. It involves the evaluation and recognition of operators involved in testing, calibration and inspection, as well as in assessing the conformity of products, services, management systems and personal competence, based on International Standards and Guides developed by ISO and its partner, the International Electrotechnical Commission (IEC). Today, there are approximately 40 000 laboratories accredited to ISO/IEC 17025.

IAF and ILAC are international groupings of national accreditation bodies and both cooperate with ISO/IEC in developing conformity assessments documents within the ISO Committee on conformity assessment, ISO/CASCO. The MoU confirms ISO/CASCO as the primary body within ISO for the interface with the international accreditation community.

In addition, the MoU will continue to consolidate practices that are largely already implemented by ISO, IAF and ILAC and enable ISO to better manage and monitor the relationships of its various components with the international accreditation community.

It provides an ongoing mechanism for technical cooperation between ISO and international accreditors in order to contribute to the development and subsequent implementation of ISO/IEC Standards and Guides.

The MoU's main implementation methods include involvement in each other's technical work, the continuation of the Joint Working Group that considers policy and operational issues within accreditation as they arise, and the confirmation of complaint exchange procedures to ensure action is undertaken by one or more of the relevant organizations. The Joint Working Group includes representation by the IEC Conformity Assessment Board and ISO technical committee ISO/TC 176, which is responsible for the widely implemented ISO 9000 family of standards for quality management. Approximately one million accredited certificates of conformity to the ISO 9001 standard have been issued to organizations in 175 countries.

http://www.iso.org/iso/pressrelease.htm?refid=Ref1187

New ISO standard tackles recyclability of earth-moving machinery

2008-12-11T06:25:00.000-08:00

Over the years, earth-moving machinery reaching the end of its useful life has significantly contributed to the total volume of waste needing to be treated or disposed of. For this reason, end-of-life recycling has today become a market requirement and an integral phase of a machine’s life cycle.

To ensure environmentally sound treatment of a machine and all its components when the time comes, it is essential that eventual recovery issues are already taken into account during the design phase, along with safety, emissions, fuel consumption and other design considerations.

ISO 16714:2008, Earth-moving machinery – Recyclability and recoverability – Terminology and calculation method, will provide manufacturers with a much needed and internationally agreed tool to evaluate the ability and potential of new machines to be recovered and/or recycled.

The standard is applicable to machinery designed to perform excavation, loading, transportation, drilling, spreading, compacting or trenching of earth, rock and other materials, as defined in ISO 6165:2006, Earth-moving machinery – Basic types – Identification and terms and definitions.

The specified method of calculation is based on four main stages reflecting the typical treatment of end-of-life machines. As noted by Mr. Nobukazu Kotake, Chair of ISO/TC 127/SC 3, “ISO 16714 will help manufacturers to calculate the reuse and recycling percentage of machines, their components and materials before they are put on the market. Dismantlers and recyclers will also find this standard useful to help identify what parts of a machine are recoverable, with a view to recycling or reusing the materials or components for new applications.”
ISO 16714: 2008 was developed by subcommittee SC 3, Machine characteristics, electrical and electronic systems, operation and maintenance, of technical committee ISO/TC127, Earth-moving machinery.

The outstanding achievements and international expertise of ISO/TC 127 were publicly recognized in October, when the technical committee was presented with the 2008 edition of the Lawrence D. Eicher Leadership Award at the 31st ISO General Assembly in Dubai, United Arab Emirates. Every year, the award provides recognition for superior performance by one of ISO's standards development groups.

ISO 16714:2008, Earth-moving machinery – Recyclability and recoverability – Terminology and calculation method, is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from the ISO Central Secretariat, price 64 Swiss francs, through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1186

ไม่มีอะไรใหม่ใน ISO 9001:2008 จริงหรือ

2008-12-07T04:20:00.000-08:00

ในที่สุดมาตรฐาน ISO 9001 ฉบับใหม่ก็ถูกประกาศใช้อย่างเป็นทางการเมื่อวันที่ 15 พฤศจิกายน 2551 หลายท่านอาจยังไม่ทราบว่าการเปลี่ยนแปลงในครั้งนี้มีส่วนใดบ้าง มากหรือน้อยแค่ไหน ดังนั้นวันนี้เราจะมาแบ่งปัน ความรู้ที่ได้จากการอ่านข้อกำหนดของ ISO 9001:2008 กัน ว่าจะเหมือนหรือต่างจาก ISO 9001:2000 อย่างไร

ก่อนอื่นผมขอสรุปเหตุผลของการเปลี่ยนแปลงสั้นๆ ให้ท่านทราบกันก่อน ว่าทำไมถึงเปลี่ยนมาเป็นฉบับ 2008

เพื่อให้เกิดความชัดเจนมากขึ้น ไม่ต้องเสียเวลามาตีความกัน เท่าที่รู้มาฉบับนี้จะเพิ่มการอธิบายความหมายใน Note หลายข้อกำหนด
ให้มีความสอดคล้องต้องกันกับ ISO 14001:2004 เช่น ในข้อ 6.2.2 จากเดิม “Competence awareness and training” เปลี่ยนให้สอดคล้องเป็น “Competence training and awareness” ไม่เชื่อกลับไปดู
ข้อความไหนอ่านแล้วต้องตีความกันเยอะ ก็เลยร้อยเรียงถ้อยคำมันใหม่ให้เข้าใจง่ายขึ้น แต่ประเด็นการปฏิบัติยังเหมือนเดิม

แนวทางของมาตรฐาน ISO 9001:2008 นั้นยังคงยึดหลักการ Process Approach ซึ่งเน้นการบริหารงานแบบ PDCA (Plan-Do-Check-Action) ในแต่ละกระบวนการ

การเปลี่ยนแปลงในครั้งนี้ ไม่มีการเพิ่ม หรือลดข้อกำหนดแต่อย่างใด การเปลี่ยนแปลงส่วนใหญ่เป็นการเพิ่ม Note เพื่ออธิบายความหมายให้เข้าใจยิ่งขึ้น ลดการตีความหรือถกเถียงกันระหว่างผู้ตรวจประเมินกับผู้ถูกตรวจ มีการเปลี่ยนแปลงคำศัพท์ ให้เข้าใจง่ายขึ้น แต่ก็ไม่รู้ว่าจะง่ายสำหรับผู้ที่ไม่เข้าใจภาษาอังกฤษอย่างลึกซึ้ง อย่างผมคนหนึ่งที่เห็นแล้วก็บอกว่า ในภาษาแม่มันอาจจะคนละความหมาย แต่ในทางปฏิบัติก็ปฏิบัติเหมือนกัน เช่น การเปลี่ยนคำว่า "identify" เป็น "determine" และอีกประการหนึ่งที่มีการเปลี่ยนแปลงคือ การเรียงร้อยถ้อยคำใหม่ ตัดข้อความท้ายประโยค มาเป็นต้นประโยค ตัดข้อความต้นประโยคไปไว้ท้ายประโยค อะไรทำนองนี้ สุดท้ายก็ปฏิบัติเหมือนเดิม

ส่วนที่มีการเปลี่ยนแปลงและเห็นได้ชัดว่าแตกต่างจาก ISO 9001:2000 ก็คือ การกำหนดให้ QMR หรือ MR (Quality Management Representative) ต้องเป็นคนในองค์กร จะจ้าง QMR มืออาชีพหรือชั่วคราวคงไม่ได้แล้ว แต่เรื่องแบบนี้ หากองค์กรใดจะหลบเลี่ยงก็ทำได้

จะเห็นได้ว่า ISO 9001:2008 มีการเปลี่ยนแปลงในเชิงภาษา การเขียน การเรียบเรียง การใช้ถ้อยคำ ส่วนการปฏิบัติยังคงไม่มีอะไรเปลี่ยนแปลงมากนัก หาก CB ของคุณตรวจเข้มอยู่แล้ว รับรองได้ว่าไม่ต้องทำอะไรเพิ่มแน่นอน

ISO/IEC standard provides common international framework for RFID frequencies

2008-12-06T05:56:00.000-08:00

In the context of growing adoption of radio frequency identification (RFID), particularly in open supply chain applications and the concurrent development of innovative products and services, the International Standard ISO/IEC 18000-1 has been revised.

ISO/IEC 18000-1:2008, Information technology – Radio frequency identification for item management – Reference architecture and definition of parameters to be standardized, defines the generic architecture concepts in which item identification may be commonly required within the logistics and supply chain and defines the parameters that need to be determined in any standardized air interface definition in the subsequent parts of ISO/IEC 18000.

All parts of ISO/IEC 18000 provide the specific values for definition of the air interface parameters for a particular frequency/type of air interface from which compliance (or non-compliance) with Part 1 of ISO/IEC 18000 can be established.
ISO/IEC 18000-1:2008 also gives examples of conceptual architectures in which these air interfaces are often to be utilized. It provides parameter definitions for communications protocols within a common framework for internationally useable frequencies for RFID.

It also provides reference information in respect of patents that have been declared to the developers of ISO/IEC 18000 as pertinent and provides reference addresses in respect of regulations under which ISO/IEC 18000 must operate.

Charles Biss, Chair of Joint Technical Committee JTC1, Information technology, subcommittee SC 31 Automatic identification and data capture technique, which developed the series of standards observes: “Logistics, supply and distribution systems are an indispensable part of modern society. The market interest in unique permanent identification of supply chain items has dramatically increased and additional standards are under development by SC 31 to accommodate market sectors and supply chain items."

ISO/IEC 18000-1:2008, Information technology – Radio frequency identification for item management – Reference architecture and definition of parameters to be standardized, was developed by the joint technical committee ISO/IEC JTC 1, Information technology, subcommittee SC 31, Automatic identification and data capture techniques, working group WG 4, Radio frequency identification for item management.

It is available from ISO national member institutes (see the complete list with contact details). It may also be obtained directly from ISO Central Secretariat, price 146 Swiss francs through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1184

ISO 9001:2008 Upgrading - online service

2008-11-27T05:53:00.000-08:00

Now you can upgrade your ISO 9001 Documentation to meet requirements of NEW version of the standard with out leaving your desk.

How It Works?

Email us soft copy of your ISO 9001:2000 Documents in EDITABLE text format (e.g Microsoft WORD or EXCEL files). We will amend and email back your documents to meet the requirements of new version of the standard ISO 9001:2008. For more Information visit our web site http://www.musa-group.com/ISO/ISO9K/iso9Kupgradeonline_1.html

How long it takes to upgrade?

If you send us your ISO 9001:2000 Documents in EDITABLE text format (e.g Microsoft WORD or EXCEL files, it takes 7 (Seven) working days to revise and send back your documents. Count 7 days from the date you have sent the complete set of documents and payment.

From which country we can use this online upgrading service?

You can use this online service from any country or region or part of the world.

Is it possible to interact or communicate or talk with the consultant who is handling our project?

Yes, you can interact or communicate or talk with the consultant through phone, fax, email or chat on msn or yahoo or skype.

We do not have editable text files for our ISO 9001 documents, we only have printed copy, can we still use this online upgrading service?

Yes, you can use our online upgrading service if you only have printed copies. You can send us scanned copies as pdf or tiff files or courier your printed copies to us. But there will be additional charges to convert your pdf or tiff files or printed copies to Microsoft WORD or EXCEL files). Contact us through email or phone or fax for a quotation.

What are the documents we need to send?

You need to send the following documents for us to completely upgrade:

Quality Policy Statements

Quality Objectives

Quality Manual

Quality Procedures

Standard Work Instructions / Standard Work Methods (if any)

Work Quality Plans (if any)

Process Flow Charts (if any)

Material Quality Plans (if any)

Inspection and test Plan (if any)

QA / QC plans (if any)

Standard Forms

Our ISO 9001 is integrated with OHSAS 18001, can we still use this online upgrading service?

Yes, integrated ISO 9001 & OHSAS 18001 documents can be upgrded. Pay for both Standards and send the payment receipt numbers and the integrated ISO 9001 & OHSAS 18001 documents.

Our ISO 9001 is integrated with ISO 14001 or other standards, can we still use this online upgrading service?

Yes, We can upgrade the ISO 9001 part on your integrated Management system Documents. Pay only for ISO 9001 upgrading and send the payment receipt number and the Integrated Management system Documents

Article Source: http://www.articlesbase.com/management-articles/iso-90012008-upgrading-on-line-637493.html

ISO publishes new edition of ISO 9001 quality management system standard

2008-11-14T05:11:00.000-08:00

ISO today published ISO 9001:2008, the latest edition of the International Standard used by organizations in 175 countries as the framework for their quality management systems (QMS).

ISO 9001:2008, Quality management system – Requirements, is the fourth edition of the standard first published in 1987 and which has become the global benchmark for providing assurance about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.

ISO 9001:2008 contains no new requirements compared to the 2000 edition, which it replaces. It provides clarifications to the existing requirements of ISO 9001:2000 based on eight years’ experience of implementing the standard worldwide and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.

All ISO standards – currently more than 17 400 – are periodically reviewed. Several factors combine to render a standard out of date, such as technological evolution, new methods and materials, new quality and safety requirements, or questions of interpretation and application. To take account of such factors and to ensure that ISO standards are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a decision taken to confirm, withdraw or revise the documents.

ISO/TC 176, which is responsible for the ISO 9000 family, unites expertise from 80 participating countries and 19 international or regional organizations, plus other technical committees. The review of ISO 9001 resulting in the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176.

This review has benefited from a number of inputs, including the following: a justification study against the criteria of ISO Guide 72:2001, Guidelines for the justification and development of management system standards; feedback from the ISO/TC 176 interpretations process; a two-year systematic review of ISO 9001:2000 within ISO/TC 176/SC2; a worldwide user survey carried out by ISO/TC 176/SC 2, and further data from national surveys.

ISO Secretary-General Alan Bryden commented: “The revised ISO 9001 results from a structured process giving weight to the needs of users and to the likely impacts and benefits of the revisions. ISO 9001:2008 is therefore the outcome of a rigorous examination confirming its fitness for use as the international benchmark for quality management.”

ISO/TC 176/SC 2 has also developed an introduction and support package of documents explaining what the differences are between ISO 9001:2008 and the year 2000 version, why and what they mean for users. These documents are available on the ISO Web site.

Although certification of conformity to ISO 9001 is not a requirement of the standard, it is frequently used in both public and private sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts. Up to the end of December 2007, at least 951 486 ISO 9001:2000 certificates had been issued in 175 countries and economies.

ISO (which does not itself carry out certification) and the International Accreditation Forum (IAF) have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008. The details of the plan are given in a joint communiqué by the two organizations which is available on the ISO Web site.

ISO 9001:2008, Quality management system – Requirements, costs 114 Swiss francs and is available from ISO national member institutes (see the complete list with contact details) and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1180

ISO helps make design work for more people

2008-11-14T04:58:00.000-08:00

ISO has released a report that will help make products, services and environments more accessible to older persons and those with disabilities.

The new ISO technical report, Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities (ISO/TR22411:2008), offers technical information, data and ergonomic know-how for design that addresses the needs of these often overlooked members of the population.

It builds on the contribution already made in this area by ISO/IEC Guide 71:2001, aimed mainly at experts and government bodies working in the field of standardization. Standards exist for almost every product or service used by human beings. The new technical report can also be used by manufacturers, designers, service providers, educators and others.

Each of the report's design considerations or recommendations is based on ergonomic principles necessary for making accessible products, services and environments encountered in all aspects of daily life, as well as in the consumer market.

Accessible design extends standard design to persons with some type of performance limitation. Its purpose is to maximize the number of people who can readily use a product, building or service. This can be achieved either by designing products, services and environments that are readily usable by most users without any modification, or by making products or services adaptable to different users (adapting user interfaces), or by means of standardized interfaces compatible with special products for persons with disabilities.

The issue of the accessibility of products, services and environments has become more important with the increasing percentage of older persons in the world’s population and the high prevalence of disability or limitations in this demographic group as expressed in the UN Convention on the rights of persons with disabilities.

Georg Krämer, chair of the ISO committee that authored the report comments: “Products, services and the places where people live, work and play should be designed to be accessible for the widest range of the population, including those with special requirements.

“This report will help a greater number of individuals to become involved in social activities without the restrictions often imposed by age or disability. The economic benefit is that products developed using accessible design will be able to be purchased by a wider range of people, including older persons and those with disabilities, who are now a significant proportion of consumers with buying power.”

ISO/TR 22411:2008, Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities, was developed by ISO technical committee ISO/TC 159, Ergonomics, Working Group (WG 2), Ergonomics for persons with special requirements.

It costs 230 Swiss francs and is also available from ISO national member institutes (see the complete list with contact details) and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1179

The ISO Survey - 2007 shows ISO management systems standards implemented in 175 countries

2008-11-14T04:48:00.000-08:00

The ISO Survey of Certifications – 2007 reveals certification activity around one or more of ISO's management system standards in 175 countries, up from 170 in 2006 – "a clear demonstration", according to the survey, " that they have become essential tools of the world economy".

ISO Secretary-General Alan Bryden comments: "The survey illustrates in a very concrete manner the extent to which ISO management system standards are meeting the organization's strategic objective of 'global relevance' – in other words, adding value for the organizations that use them all over the world."
The principal findings of the survey are as follows:

ISO 9001:2000 (quality management)

Up to the end of December 2007, at least 951 486 ISO 9001:2000 certificates had been issued in 175 countries and economies. The 2007 total represents an increase of 54 557 (+ 6 %) over 2006, when the total was 896 929 in 170 countries and economies. Services again accounted for 32 % of all certificates issued.

The increase appears much smaller than in 2006 (+16 %) and according to the survey several factors may have combined to produce this result:

The 2007 survey data collection methodology was strongly re-focused on obtaining figures from primary sources, the certification bodies that actually issue certificates, to reduce the increased possibility of error inherent in obtaining data from secondary sources (accreditation bodies and databases). This has resulted in the totals for several countries being revised downwards.
Certification activity slowed down in anticipation of the forthcoming new edition of ISO 9001, with organizations adopting a "wait and see" attitude, as many did in the run-up to the 2000 edition.
The market for certification is maturing in certain countries where this activity began early on.
The continuing growth of sector- or activity-specific editions of ISO 9001 reduces the number of certifications to the generic standard.
The trend for organizations to replace multiple-site certificates by one certificate covering all sites continues, although its extent is difficult to quantify, and also reduces the number of certificates.

ISO 14001:2004 (environmental management)

Up to the end of December 2007, at least 154 572 certificates had been issued in 148 countries and economies. The 2006 total represents an increase of 26 361 (+ 21 %) over 2006, when the total was 128 211 in 140 countries and economies. The service sectors accounted for 29 % of certificates issued, up from 27 % in 2006.

ISO/TS 16949:2002 (quality management for automotive suppliers)

Up to the end of December 2007, at least 35 198 ISO/TS 16949:2002 certificates had been issued in 81 countries and economies. The 2007 total represents an increase of 7 199 (+ 26 %) over 2006 when the total was 27 999 certificates in 78 countries and economies.

ISO 13485:2003 (quality management for medical devices)

Up to the end of December 2007, at least 12 985 ISO 13485:2003 certificates had been issued in 84 countries and economies. The 2007 total represents an increase of 4 959 (+ 62 %) over 2006 when the total was 8 026 in 81 countries and economies.

ISO/IEC 27001:2005 (information security management)

At the end of December 2007, at least 7 732 ISO/IEC 27001:2005 certificates had been issued in 70 countries and economies. The 2007 total represents an increase of 1 935 (+ 33 %) over 2006 when the total was 5 797 in 64 countries and economies. Service sector organizations accounted for 90 % of the certificates issued.

The survey results continue to shed light on the evolution of the global economy, with newly emerging economies such as China, India, Brazil and the Russian Federation appearing among the leading countries for totals of certificates issued, or growth during 2007. Countries other than the established industrialized economies showing intensive certification actitivity include Bulgaria, the Czech Republic, the Republic of Korea, Mexico, Poland, Romania, Thailand and Turkey.
More information

ISO makes available the principal findings of the survey free of charge on the ISO Web site. More information, including industry sector breakdowns, can be found in The ISO Survey of Certifications – 2007, which is a combined brochure and CD costing 48 Swiss francs. It is available from ISO national member institutes (see the complete list with contact details) and from the ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department (see Sales enquiries, right-hand column).

Data from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1178

ISO launches video clip: "The ISO 9000 family – Global management standards"

2008-11-05T05:48:00.000-08:00

With the publication of ISO 9001:2008 imminent, ISO has just launched a video clip in which users share their perspectives of earlier ISO 9001 editions and other standards in the ISO 9000 family which has become the global benchmark for qualtiy management systems

The ISO 9000 family – Global management standards takes the form of a fictional television business news report on ISO 9000 in which real users speak from their personal experience in the varied contexts of multinational industry, a humanitarian aid organization and a police department, which ISO says underlines the combination of flexibility, efficiency and effectiveness of the ISO 9000 approach.

ISO Secretary-General Alan Bryden comments: "Whenever the ISO 9000 family is evoked, the emphasis is usually on ISO 9001 certification. This video is refreshing because the users emphasize the importance and benefits of ISO 9000 aspects such as management commitment, metrics, customer focus, continual improvement, knowledge transfer, cost savings and the eight quality management principles."
The video includes interviews with ISO 9000 users from: the international oil and gas industry; the Cambodia Trust, a humanitarian aid organization with headquarters in the United Kingdom, and the Phoenix Police Department, Arizona, USA.

The ISO 9000 family is developed and maintained by ISO technical committee ISO/TC 176, Quality management and quality assurance.

The ISO 9000 family – Global management standards can be downloaded free of charge from ISO's Web site. It is also available (English only) in high resolution on DVD in PAL (ISBN 978-92-67-10485-0) and NTSC (ISBN 978-92-67-10486-7) versions for being shown in conference settings. The DVD version is also free, although postage and handling will be charged. It is available from from ISO national member institutes (see the complete list with contact details) and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

The video concept was created by Communication Services, ISO Central Secretariat (ISO/CS). Post-production by Communication and Information services (ISO/CS) and Taurus Studio (sound), Geneva, Switzerland (www.taurus-studio.com). Production input by Trueworld Communications, United Kingdom (www.trueworld.media.officelive.com).

http://www.youtube.com/watch?v=GdUPyUlKrAQ

Source by:http://www.iso.org/iso/pressrelease.htm?refid=Ref1174

New ISO standard gives recommendations for care of optical discs

2008-11-04T05:16:00.000-08:00

A new International Standard establishes general principles and gives recommendations for the care and handling of digital optical discs during use with a view to maximizing their effective life.

ISO 18938:2008, Imaging materials – Optical discs – Care and handling for extended storage, applies to the families of compact disc (CD), digital versatile disc (DVD), high definition digital versatile disc (HD DVD), Blu-ray disc (BD), and any hybrids of these families, as well as each type of disc within a family, e.g. injection moulded [read-only memory (ROM)], dye-layer [recordable (R)] and phase change [rewriteable (RW), random access memory (RAM)] technologies.
Optical discs are widely used for the recording and storage of information. Their popularity has led to wide availability and made them the medium of choice for numerous applications. The advantages are many: information is recorded in digital format that not only provides high storage density, but also allows duplication without information loss, offers ease of data manipulation and facilitates transmission.

The medium is of tremendous benefit for audio usage since it permits uninterrupted playback for long periods of time. Further, information in a disc format can be accessed very quickly.

However, as with other media there are concerns about the life expectancy of recorded information on optical discs which, like paper records, photographic film and magnetic tape, can be subject to both damage and decay.

Mr. Ted Sheldon, Committee member of ISO/TC 42, Photography, which developed the new standard, makes the point: “In addition to storage conditions, the proper care and handling of optical discs is vital to prolonged disc life. Faulty handling, packing and transporting techniques and methods can cause physical damage to the discs and their recorded content. Extending the longevity of optical discs requires appropriate handling methods. Following these recommendations promotes their physical integrity and increases their effective life.”

ISO 18938:2008 addresses the issues of physical integrity of the medium necessary to preserve access to the recorded data. These include:

use and handling environments, including pollutants, temperature and humidity and light exposure

contamination concerns

inspection

cleaning and maintenance, including cleaning methods and frequency

transportation

disasters, including water, fire, construction and post-disaster procedures

staff training

Although some of the recommendations in ISO 18938:2008, such as staff training programmes, apply specifically to large-scale usage, the basics of all recommendations are intended for any circumstances where the desired result is long-term use of the medium, whether archival, commercial or personal.

The effective life of optical disks can also be increased or decreased significantly depending upon the conditions under which they are stored. Storage recommendations are given in ISO 18925:2008, Imaging materials – Optical disc media – Storage practices.

ISO 18938:2008, Imaging materials – Optical discs – Care and handling for extended storage, was prepared by ISO/TC 42, Photography. It costs 108 Swiss francs and is available from ISO national member institutes (see the

complete list with contact details) and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).

Resourse from : http://www.iso.org/iso/pressrelease.htm?refid=Ref1175

Advancing public-private partnership for e-business standards

2008-10-14T06:20:00.000-07:00

An international conference on the key role of International Standards in enabling e-business was organized by ISO, IEC, ITU-T, OASIS, UN/ECE-UN/CEFACT and UPU* and supported by the e-business MoU Management Group** held on 18-19 September 2008 in Geneva, Switzerland.

In the context of e-business (i.e. the use of information technology to support business processes), standards are indispensable tools to capture, process and exchange data, ensure inter-operability, support security of data handling and financial transactions, promote good practices and facilitate customer-supplier relations. Considering the global reach of Internet, International Standards are particularly relevant. Their development and use involve both the public and private sectors.

The public-private partnerships that advance the standards, technical specifications and recommendations associated with e-business are motivated by many specific goals both within and across borders, such as:

national competitiveness,
effectiveness in regulatory controls,
reducing trade barriers,
fostering market entry by small and medium-sized enterprises (SMEs), and
facilitating growth in developing and transition economies.

In his opening address, Mr Howard Mason, Chair of the e-business Memorandum of Understanding Management Group, on behalf of Marek Belka, Executive Secretary of the United Nations Economic Commission for Europe (UN/ECE), introduced the partner organizations and highlighted the objectives of the workshop.

The two-day conference fostered a better understanding of public-private partnerships through which stakeholders collaborate in relation to e-business standards, focusing attention on:

implementation of existing standards and related benefits,
priority issues to be addressed by different stakeholders and related needs for e-business standards,
further steps that might be taken to significantly enhance recent achievements and work in progress as well as to address emerging new requirements.

During the conference, keynote presentations from Roland Berger, the Swatch group and DHL, provided insight on major e-business trends, with focus on supply chain integration and logistics. They underlined that private and public sector investment in these areas is substantial and will continue to increase in the coming years. They provided an overview of the major challenges (i.e. interoperability, rationalization of business processes, involvement of SMEs) and emphasized the essential role that standards have in addressing them.

Business cases from various sectors both in private and public areas such as e-trade, defence and the retail trade provided examples of the use of standards to support global supply chains. They demonstrated how the effective use of standards leads to changes in the way business is done, generating significant return on investment.

Public and private sector organizations which described their use of e-business standards included the following:, the Ministry of Communication and Technology of India, the Ministry of Finance of the Netherland, UPU, ABN AMRO, SITPRO, UNeDocs, and GS1.

Through the conference interactive sessions, participants underlined that an impressive set of standards is already available to support implementation of e-business solutions in a broad variety of fields. They noted, however, that more information on guidance to standards implementation is needed to help users.

They also advocated the importance of more coordinated efforts involving standards developing organizations and standards users to address priorities and to promote support of international standards by technology vendors.

Thanking all the participants of the conference, Alan Bryden, ISO Secretary-General concluded with three key actions to sum up the workshop recommendations for standardizers: “ensure interoperability, develop communication and promote implementation".

http://www.iso.org/iso/pressrelease.htm?refid=Ref1162

Iso 9001 Documents Control - Elements and Requirements

2008-09-25T06:48:00.000-07:00

The ISO 9001 standard is caring for us. It cares for us from several angles. One of these cares regards our documentation. The standard requires that we will document by all means.But it also cares that we won't get confused and mix up different documents from different sources. Therefore it requires all documents to be controlled. This is not a recommendation but a requirement. You must control your documents. In order to achieve documents control you must maintain a method. This method must be one of the organizations quality procedures and it should be called "Documents Control". In this procedure you must refer to the next line of issues.

Types of recordsAt first, you must define what documents this procedure would include. Documents can be working procedures, diagrams, technical specifications, price quotes etc. In order not to "swirl" around too many documents, let's make it clear. Let's define what a document is: Communication of information, evidence for correspondence, sharing of any kind of knowledge, approved documents. Someone within the organization must supervise all documents and see that they are suitable for working before they are released.The reason is to prevent any faults where unsuitable documents are being used or information that is classified is handed to wrong bodies. It is required to define for whom it is authorized and when must he approve any document. Who is responsible? The same one who is responsible for the information documented. It must be part of his job description. There are situations that more than one function would be needed to approve one document. It happens when more than one process is documented on one document.

Updated documentsThis requirement assures that always the last version is the version in use - and not an older. Therefore you must define a method for maintaining updated version and elimination of older versions. How would one know what is the last version? Usually organizations manage a list of editions and updates for documents. You can manage the document itself. But most important, it is required to indicate the document itself as the last edition. This way, any employee that would use the document, would be sure that he holds the last edition. Of course, don't forget to document the method.It is also required to define what to do with the old versions that are now not updated. How do you handle them? Are they to be destroyed, archived etc. Managing editions must include: Date of last update, The reason for the update, The function who demanded the update, The function that authorized the update.
Although the ISO 9001 standard doesn't require these requirements specifically, it would help you to achieve its basic requirements. Of course you would use what is suitable for your organization. Today there is a lot of document management softwares. These software, naturally qualify for the standard requirements but it is recommended to review anyone before purchasing.

Availability and distribution of documentsThis is an un separated part of the last requirement. Defining the availability and distribution of documents must include the following:User authorization - to which it is authorized to use the document, the location of the document - where must the document be kept before and after use. Most of today's process management systems (such as ERP or CRM systems) provide documents control relevant to the process they handle. They present the user with a screen (a screen on a computer system is a document like any other document) with defined information to input. Most of these systems also has authorization module installed. But when systems like the ones mentioned do not exist in the organization, it must provide with his employees the relevant updated documents. That means the latest editions. In order to ensure that, the standard require a documented method. How to obtain that?

Well, it depends on your organization and his substructures.

Identification of documentsAny document (internal or external) must be identified somehow. Any internal document must have a name, serial number, catalogue number or whatever. Somehow to define it. The ISO 9001 standard requires that you maintain a method to achieve identification. The identification must include the numbering, coding or however you decided to identify it. But it is required to document the method. You must also include location of documents. How one can trace the document. for example customer's files are scanned to the computer or stored in some closet. The final purpose of all this is to achieve control of the documents - any employee, once he looks at a document or trying to trace a document, would know where to approach: a department, a process, some function or any kind of identification relevant to your organization. If we look again at process management systems, then it is much simpler. Any document in those systems is identified by a number of some kind, produced by the system. The number is given according to some internal method. In this case you must not document this method but mention it in the procedure that these specific documents are managed. In case there are documents that are manually managed you must document the method. All this also applies for external documents. Any documentation that arrives from outside (with presumption that it is a document as defined) is included in the ISO 9001 standard requirement. In this case you must specify what is to do with these documents and where one can trace them in the hour of need. For example, where to file the documents. Again, you define the method according to your organization's nature.

Documents removalYou must define a method for documents removal for any reason: un updated, out of use, etc. the method must include what is it to do with the document and who is responsible, once it is out of use. For example, removing old documents from the organization's server for no further use or removing old forms from the offices that no one would use them again. Some of this things sound trivial and they are, but still this is a ISO 9001 standard requirement..

Summary:The ISO 9001 standard requires that we document all sorts of our documents. It also requires that we would not confuse all kinds of documents from different sources. Therefore we must define a method for documents control. This is not a recommendation but a requirement. The method must be presented as a documented procedure. The documented procedure would be called "Documents control". You must include a definition of documents within the method - what is a document. All documents must be approved before use. The purpose is to verify that the documents are suitable for work. All documents must be updated. You must define a method to ensure the use of updated documents only. The method should include management documents editions and documents indications. All documents must be identified. The organization must specify a method for documents identification. The purpose is that any employee would know which document he holds or where to trace it. It is also required to manage availability and distribution of documents. You must verify that the documents that are distributed to the employees are the correct ones. You must define a method for documents removal. When and why to remove documents and in whose responsibility.

Article Source: http://www.articlesbase.com/management-articles/iso-9001-documents-control-elements-and-requirements-475097.html

The Audit's Results and Report - the True Story, According to the Iso 9001 Standard Requirements

2008-09-24T07:14:00.000-07:00

The internal audit chapter is included under chapter 8.2 - Monitoring and measurement (it's been said before on our web site already). When performing an audit you are monitoring processes. You sample a process and validate that it is done according to prior requirements. Once you stumble upon nonconformity, a process that was performed not according to a requirement, you must mention it in the audit report. But this is not the end of your story.

In this article we will review the ISO 9001 requirements for conducting the internal audit with reference to the ISO 19011 Standard "Guidelines for auditing quality management systems". ISO 19011 provides guidance in order to achieve the ISO 9001 requirements for internal audit. Actually it is suitable for the environmental management system requirements for internal audits as well, but for now, we will focus on the ISO 9001 requirements only.

The ISO 9001 Standard requires that the management would bear the responsible for the audit's results. The management will assure that any nonconformity revealed during the audit would be removed without any delays. The removal than would be verified and validated. Harsh requirements! Well, they have a point. The ISO 9001 Standard requires the management's responsibility for implementing the Standard's requirements. In fact, a whole chapter was dedicated to the matter (chapter 5 management responsibility , very clear). One aspect of the required responsibility is to assure the minimum as possible of nonconformities. Nonconformities can be revealed during audits. The relation is clear. The management becomes responsible for the audit's results. Actually the revised ISO 9001:2008 Specifically requires that the management would ensure corrective action to nonconformities revealed during audits.

All of the above are nice and well written over and over again. We are sure that most of you heard it already throughout audits (internal and external). But the big question is how to maintain? Well, that's why we are here for. We will explain it in plain English and suggest solutions. If you would have further questions you may send them to us via this page.

The audit main goal is to give a status report. The tactic of an audit (external or internal) is to evaluate the organization's performances with reference to the requirements. In plain words, it is required from your organization to maintain several activities. The audit evaluates whether the activities are performed and how well they are performed.

When you reveal nonconformities, those nonconformities should be applied to a controled process. The purpose is to verify that the nonconformities are removed. The main activity during the audit is sampling and documenting. The auditor samples processes and documents the results. But this activity is divided into several stages that take place during the audit. Let's review them.

An opening meeting:

In this meeting the management meets the auditor. In this meeting usually the auditor documents some general details and information about the organization:

Which units are being audited

Which are the persons involved during the audit and what is their role

How many employees working in the audited organization

The the main products of the organization

Special events that occurred lately within the organization that might affect the product or the processes

The purpose is to gather information that can shed light on the audit's report. This part is very important.

The next one is an informal advice!! Sometime the organization can't compete with its requirements for various reasons that are or not depended on the organization's ability to compete. It happens a lot. This is perfectly normal. But this is the time to explain why. If you know that some of the requirements are not fulfilled and there is a good reason, reveal it and explain exactly why, before the auditor sample the process and gets angry...

An opening meeting is not mandatory within internal audits. But it is within external audits. In this meeting the auditor should publish his schedules for the audit. Actually, the schedules should be published a week or so before the audit, allowing the relevant parties to prepare themselves. But in the opening meeting the auditor should declare the schedules again. Just to be polite.

And now the audit begins!

Ohhh! Stay calm! We are used to say: whatever happens, act as if it is normal! Another informal advice. Please erase the last comment from the protocol.

The main activity during the audit should be sampling. The auditor must sample the processes in order to determine whether the process was performed according to prior requirements... or not. Samples can occur as:

Records of processes

Documentations of any kind such as working instructions, quality plans or standard requirements

Records of Knowledge and employees trainings

Compliant product handling according to defined requirements

Any process that was sampled must be documented. The auditor must describe specifically what he had observed and document it. The documentation must indicate whether it is according to the requirements or not. The requirements can be such as:

A working procedures requirement

A quality plan

Customers' requirements

A Standard requirements (not only ISO 9001 but any other Standard applicable)

A legal or regulatory requirement.

The ISO 9001 Standard requires a procedure specifying how the internal audit should be performed within the organization - one of the Quality procedures required by the ISO 9001 Standard. This is not a recommendation but a requirement. You must document it and maintain it. That means that it's not enough to document the procedure, you must also prove that you follow what you define and actually perform it , perform a quality management activities for internal audits (chapter 8.2.2). It's not easy being an auditor. It also not so easy to maintain all of the above without some help.

The audit's findings

The documentation, during the audit, should include details about the processes sampled. The auditor should supply as much details as he can. These are the audit's findings. For example, if he samples a construction plan, he should document:

Who is the customer

The planer

Which employee is responsible

The date of the plan

The plan's status

The version or edition of the plan

This way, anyone who reads the report, has as much information as possible. The purpose is to make the picture clear. Remember who is assigned to read this report; the top management. They might seem far from the processes but once they hold the audit's report they would be highly interested in any details written. Any sampled process leads to the audit's results. Is or not according to the specific relevant requirement, these results, later are stated.

The audit's results

Any finding during the audit should be indicated as three states:

Conformity: the process sampled was according to the relevant requirement , the audit's criteria

Opportunity for improvement (OFI): the organization may or may not adopt this opportunity

Non conformity: the process sampled, was not according to the requirements, the audit's criteria

Now' we are getting to the most thrilling part - The nonconformities! Nonconformities may be documented three times during the audit.

First time, within the audit's report along with the audit's findings. We can also refer it as the report itself.

Second time, where it is suitable, as nonconformities. Any audit report should bear at the end a summary of the nonconformities.

Third time, as a corrective action.

The report's summit
any audit's report must have a summit. The auditor should concentrate all the non conformities and opportunities for improvement and present them together. The purpose is to go over them during the next audit and to review the treatment and to verify that all nonconformities are closed.

In the next stage the organization must eliminate the nonconformities. Nonconformity was revealed - the organization must introduce it into a controlled process in order to eliminate it. The auditor should also determine the time frame for conducting any corrective action. Want to know more about this subject? Turn to this section about the old famous CAPA. But the principle is very simple:

The organization should prove to the auditor that a corrective action was taken over any nonconformity (revealed during the audit) within the time frame that was scheduled.

The organization must prove closing these nonconformities by the next audit.

Summary:

The ISO 9001 Standard requires that the management would bear the responsible for the audit's results.

The audit's main goal is to give a status report. The tactic of an audit (external or internal) is to evaluate the organization's performances with reference to prior requirements.

The main activity during the audit is sampling processes and documenting the findings.

An opening meeting - the purpose is to gather information that can shed light on the audit's report. This part is very important.

The auditor must sample the processes in order to determine whether the process was performed according to prior requirements.

The auditor must describe specifically what he had observed and document it.

Any finding during the audit should be indicated as three states: Conformity, opportunity for improvement or Conformity

The auditor should concentrate all the non conformities and opportunities for improvement and present them together.

The organization must eliminate the nonconformities.

The auditor should determine the time frame for conducting a corrective action.

Implementation of accredited certification to ISO 9001:2008

2008-09-05T07:12:00.000-07:00

ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001:2008, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services.

ISO 9001:2008 does not contain any new requirements

They have recognized that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001:2004
The agreed implementation plan in relation to accredited certification is therefore the following:

Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or recertification audit against ISO 9001:2008.

Validity of certifications to ISO 9001:2000

One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or recertifications) shall be to ISO 9001:2008.

Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

ISO and IAF announce schedule for implementation of accredited certification to ISO 9001:2008

2008-08-26T07:35:00.000-07:00

ISO (International Organization for Standardization) and the IAF (International Accreditation Forum) have agreed on an implementation plan to ensure a smooth transition of accredited certification to ISO 9001:2008, the latest version of the world's most widely used standard for quality management systems (QMS). The details of the plan are given in the joint communiqué by the two organizations which appears below.

Like all of ISO's more than 17 000 standards, ISO 9001 is periodically reviewed to ensure that it is maintained at the state of the art and a decision taken to confirm, withdraw or revise the document.

ISO 9001:2008, which is due to be published before the end of the year, will replace the year 2000 version of the standard which is implemented by both business and public sector organizations in 170 countries. Although certification is not a requirement of the standard, the QMS of about one million organizations have been audited and certified by independent certification bodies (also known in some countries as registration bodies) to ISO 9001:2000.
ISO 9001 certification is frequently used in both private and public sectors to increase confidence in the products and services provided by certified organizations, between partners in business-to-business relations, in the selection of suppliers in supply chains and in the right to tender for procurement contracts.

ISO is the developer and publisher of ISO 9001, but does not itself carry out auditing and certification. These services are performed independently of ISO by certification bodies. ISO does not control such bodies, but does develop voluntary International Standards to encourage good practice in their activities on a worldwide basis. For example, ISO/IEC 17021:2006 specifies the requirements for bodies providing auditing and certification of management systems.

Certification bodies that wish to provide further confidence in their services may apply to be "accredited" as competent by an IAF recognized national accreditation body. ISO/IEC 17011:2004 specifies the requirements for carrying out such accreditation. IAF is an international association whose membership includes the national accreditation bodies of 49 economies.

ISO technical committee ISO/TC 176, Quality management and quality assurance, which is responsible for the ISO 9000 family of standards, is preparing a number of support documents explaining what the differences are between ISO 9001:2008 and the year 2000 version, why and what they mean for users. Once approved, these documents will be posted on the ISO Web site – probably in October 2008.

Sourse by : http://www.iso.org/iso/pressrelease.htm?refid=Ref1152

ISO/FDIS 9001 Quality management systems -- Requirements

2008-08-26T07:12:00.000-07:00

ISO 9001:2008 specifies requirements for a quality management system where an organization

needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

Sourse by:http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=46486

ISO 9001:2000 - Management Review Q&A

2008-08-18T07:22:00.000-07:00

Each month I get a number of inquiries, primarily from companies looking to become ISO 9001:2000 certified, on the subject (and the performance) of management reviews. As a result, I've decided to put together a simple Question and Answer (Q&A) session, based on the questions I'm most frequently asked:

Q1: Is a Management Review a formal meeting?

A1: A management review is appropriately named, as it's an opportunity for top management of an organization to review the performance of their organization's management system. It's more than just a meeting however, as a management review includes the collection, analysis and review of performance data, and any decisions and actions related to the results.

Q2: Can a management review be held remotely?

A2: With the technology that is currently available, there's no reason that telephone and web conferencing shouldn't be considered. Portions of the review can be performed remotely when it is not possible or cost effective to meet in person. Data can be collected and analyzed electronically, and the results communicated by email or other means.

Q3: Our organization is quite large and geographically dispersed. How can we perform a single management review?

A3: There's actually nothing in the standard that requires only one management review be performed. For a large organization, this review can be performed at individual levels (or locations) and then consolidated into a final review that is performed by executive management of the organization.

Q4: This is our first management review and we don't have much information to report. Can we still hold a management review?

A4: You have information to report; the problem is that you just don't have much data. This in itself is noteworthy, and should also be considered as an opportunity for improving the effectiveness of your quality management system under section 5.6.3 of the ISO 9001:2000 standard (Review Output).

Q5: What is the required interval for management reviews?

A5: The ISO 9001 standard doesn't specify any specific time frame, other than requiring these reviews to be performed at planned intervals. For a "new" program, I would recommend at least quarterly, and then adjusting the duration to possibly six months or even on an annual basis if this meets the needs of the organization. Personally, I would never go longer than a 12 mo. interval between reviews.

Q6: Prior to implementing ISO 9001:2000, our organization held monthly meetings to review the performance of our organization. While these meetings wouldn't meet the requirements of the ISO 9001 standard, they were of considerable value to us. Will this need to be changed?

A6: The answer is no. There's no reason to change what you're already doing, particularly if it works well for you. I would keep minutes for these meetings however, and use these as a source of review input for when the organization does hold a formal management review.

Q7: Section 5.4.1. of the ISO 9001:2000 standard requires that Quality Objectives are established at relevant functions and levels within the organization. Is the Management Review an appropriate time to address this?

A7: I personally recommend this. The management review is an ideal time to address your organization's performance towards meeting existing objectives, and for determining new or revised objectives for the upcoming review period.

Q8: What types of records do we need to maintain?

A8: You'll need to retain records that demonstrate the requirements of the ISO 9001 standard have been met. This should include, as applicable, meeting minutes (dates, attendees, location, agenda, etc.), objective evidence used as part of this review, and any decisions and actions that result (including responsibilities and timelines).

Mark Randig is the President and Founder of MAS Solutions LLC., a Houston Texas based consulting firm that specializes in helping companies achieve breakthrough performance by focusing on Quality Enhancement and Productivity Improvement.

To get your FREE copy of Mark's newsletter "The Quality Specialist", go to http://www.masquality.com

Article Source: http://EzineArticles.com/?expert=Mark_Randig

จับกระแส ISO 9001 ฉบับใหม่

2008-08-15T07:51:00.000-07:00

อ้างอิง สยามธุรกิจ : ฉบับที่ 838 ประจำวันที่ 20-10-2007 ถึง 23-10-2007จับกระแสการเปลี่ยนแปลง ISO 9001 ฉบับใหม่

จากโจทย์ขององค์กรมาตรฐานสากล (International Organization for Standardization ISO) ที่คณะกรรม การ TC 176 รับมาเรื่องการปรับเปลี่ยน มาตรฐาน ISO 9001:2000 ให้ทันตาม รอบเวลาที่ได้กำหนดไว้ทำให้เกิดการประชุม ณ กรุงปานามา เพื่อกำหนดกรอบงานตั้งแต่เมื่อสองปีที่ผ่านมา ผลงานของ TC 176 ที่ปรากฏออกมาเป็น ระยะๆ ตั้งแต่นั้นมาเริ่มเป็นรูปธรรมเมื่อ มีการออกมาตรฐาน ISO 9000 ฉบับปี ค.ศ. 2005 ตามมาด้วยการกำหนดเวลาคลอดของมาตรฐาน ISO 9001 และ ISO 9004 ฉบับใหม่ในปี 2008 ตลอดจนการกำหนดเป้าหมายของการออกฉบับต่อไปในปี ค.ศ. 2012 ซึ่ง ว่ากันว่าจะเป็นการเปลี่ยนแปลงกันขนานใหญ่

ณ ขณะนี้พอจะเห็นสมควรแก่เวลาที่เราจะหยิบยกเรื่องนี้มาคุยกันได้ซะทีว่าการเปลี่ยนแปลงของมาตรฐาน ISO 9001: 2000 ไปสู่ ISO 9001:2008 จะเป็นอย่างไร ก่อนอื่นต้องขออนุญาตเท้าความไป ที่ตัวมาตรฐานก่อนว่าชุดมาตรฐานนี้มี 3 ฉบับที่ถือว่าต้องใช้ร่วมกันคือ ISO 9000, ISO 9001 และ ISO 9004 โดยมีมาตร ฐานในกลุ่มเดียวกันอีกหลายฉบับที่ควรนำมาใช้ประกอบการพิจารณา เช่น ISO 19011 เป็นต้น มาตรฐาน ISO 9000:2005 ซึ่งมีการปรับเปลี่ยนไปก่อนหน้านี้แล้วมีรายละเอียดเน้นไปที่การอธิบายคำศัพท์ คำนิยาม ที่ใช้กับมาตรฐานกลุ่มนี้ ในขณะที่ข้อกำหนด ที่เราๆ ท่านๆ รู้จักกันดีจะเป็น ISO 9001: 2000 ซึ่งจะใช้สำหรับการตรวจประเมิน

ส่วน ISO 9004:2000 นั้น มีจุด มุ่งหมายให้องค์กรนำไปประยุกต์เพื่อปรับ ปรุงระบบบริหารจัดการให้ดียิ่งขึ้นกว่าเดิม ที่ผ่านมา เราอาจจะคุ้นเคยกับการเปลี่ยนมาตรฐานยกเป็นชุดพร้อมกันทั้งสามฉบับ คราวนี้จะได้เห็นรหัสท้ายที่ระบุปี ค.ศ. ที่ประกาศใช้ไม่พร้อมกันเวลาใช้งานก็อย่างงแล้วกัน

แนวทางของมาตรฐานทั้งสามฉบับ ใน ชุดของ ISO 9000 นั้นยึดหลักการ Process approach ซึ่งเปิดโอกาสให้องค์กรสามารถกำหนดและแสดงเห็นอย่างชัดเจนว่า มีกิจกรรมใดเกิดขึ้นบ้างในระบบบริหารขององค์กร กระบวนการที่ว่านี้ไม่ได้หมายความเฉพาะกระบวนการที่เกี่ยวข้องกับการผลิตหรือการบริการโดยตรง แต่เป็นกระบวนการ ที่ใช้ในระบบบริหารทั้งหมดซึ่งแน่นอนว่ามีงานของผู้บริหารองค์กรรวมอยู่ด้วย ผลของ กระบวนการจะถูกมาตรฐานเรียกว่าผลิต ภัณฑ์ทั้งหมด ดังนั้นผลิตภัณฑ์จึงไม่ได้ถูกจำกัดไว้เรียกเฉพาะสินค้าขององค์กรหรือบริการที่องค์กรมอบให้ลูกค้าเพียงอย่างเดียว การพิจารณากระบวนการหรือ Process approach นั้น มีผลให้มาตรฐานชุดนี้สามารถ นำไปประยุกต์ใช้กับองค์กรในธุรกิจใดก็ได้ รวมทั้งไม่จำกัดขนาดขององค์กรอีกด้วย ดังนั้นมาตรฐาน ISO 9001:2008 นี้จึงยึดหลักการ Process approach ไว้อย่างเหนียว แน่น นอกจากนี้ยังมีความพยายามของ TC 176 ที่จะประสานมาตรฐานกับ ISO 14001:2004 ด้วย จึงมีบางข้อกำหนดถูกทำให้มีรายละเอียดเดียวกัน

ช่วงของการปรับเปลี่ยนการรับรองจากมาตรฐาน ISO 9001:2000 ไปสู่ ISO 9001:2008 อาจไม่นานมากนัก ทั้งนี้เรายังต้องรอการตัดสินใจของ ISO ภายหลัง การประกาศใช้มาตรฐานฉบับใหม่อย่างเป็นทางการ ประมาณการกันว่าจะเป็นช่วง 18 ถึง 24 เดือน จากความมุ่งหมายของการที่จะเปลี่ยนแปลงมาตรฐานในครั้งนี้ที่ TC 176 ใช้หลักการ Low impact/High benefit การเปลี่ยนแปลงจึงถูกกำหนดด้วยเกณฑ์ ดังนี้

>> Low impact- ไม่มีการเพิ่มหรือลดข้อกำหนด- ไม่เปลี่ยนแปลงจุดมุ่งหมาย (Intent) ของข้อกำหนด- การเปลี่ยนแปลงต้องกระทบต่อผู้ใช้น้อยที่สุด (ผู้ใช้ได้แก่ AB, CB, องค์กรที่ได้รับรอง เป็นต้น)- ไม่มีความจำเป็นต้องมีการอบรมเพิ่มเติมแก่ผู้ใช้- อาจจำเป็นต้องแก้ไขเอกสารขององค์กรบางส่วน

>>High benefit- ให้ความชัดเจนในเรื่องของการตี ความและลดความสับสนด้านภาษา- แก้ไขจุดบกพร่องของมาตรฐานฉบับเดิม แก้ไขข้อความที่ขัดแย้งกันเองในระหว่าง ข้อกำหนด- แก้ไขข้อความที่ขัดแย้งกับมาตรฐานประกอบอื่น (ISO 9000 และ ISO 9004)- แก้ไขปัญหาที่มีผลต่อการแปลภาษา

4.1 ข้อกำหนดทั่วไปของระบบบริหาร คุณภาพ กระบวนการที่ดำเนินการโดยผู้ขาย (Outsourced process) ถูกเน้นย้ำให้องค์กร ต้องกำหนดแนวทางในการควบคุมกระบวน การเหล่านี้ อย่างไรก็ตามเจาะจงเฉพาะกระบวนการที่มีผลต่อความสอดคล้องต่อข้อ กำหนดและไม่ได้บังคับให้มีเอกสารแสดงการควบคุมกำกับไว้อย่างไรก็ดี การใช้ผู้ขายดำเนินการแทนองค์กรนั้นสามารถนำข้อกำหนดด้าน การจัดซื้อจัดจ้าง-7.4 ไปประยุกต์ใช้กับ ผู้ขายได้

4.2 ข้อกำหนดด้านเอกสาร ไม่มีการเปลี่ยนแปลงในเชิงของการเพิ่มลดเอกสารใดๆ การปรับปรุงมีเฉพาะในแง่ภาษาเพื่อให้ทราบว่าเอกสารกับบันทึกนั้นถือเป็นกลุ่มเดียวกัน เอกสารกับบันทึกจะแยกไว้แต่เพียงที่ข้อกำหนดบังคับให้มีกับส่วนที่องค์ กรกำหนดให้มีใช้กันเองตามความเหมาะสม นอกเหนือจากนี้มีการขยายความในหมาย เหตุเพื่อให้ทราบว่า เอกสารขั้นตอนการทำงาน (Procedure) ไม่ได้ถูกจำกัดด้วยจำนวนเล่ม ตัวอย่างเช่น ข้อกำหนดระบุให้มีขั้นตอนการทำงาน 6 เรื่องไม่ได้หมายความ ว่าต้องเขียนเป็น 6 เล่มแยกกัน

4.2.3 การควบคุมเอกสาร ถูกขยายความเฉพาะเอกสารจากภายนอกเพื่อให้เห็น เจตนาของข้อกำหนดว่าเอกสารจากภาย นอกที่ต้องควบคุมนั้นขึ้นอยู่กับว่าเอกสารนั้นมีความจำเป็นต่อระบบขององค์กร ไม่ใช่เอกสารที่รับมาจากภายนอกทั้งหมด

4.2.4 การควบคุมบันทึก มีการแก้ไขในเชิงภาษาศาสตร์เท่านั้น

Iso 9001 Documents Control - Elements and Requirements

2008-08-15T07:43:00.000-07:00

The ISO 9001 standard is caring for us. It cares for us from several angles. One of these cares regards our documentation. The standard requires that we will document by all means.But it also cares that we won't get confused and mix up different documents from different sources. Therefore it requires all documents to be controlled. This is not a recommendation but a requirement. You must control your documents. In order to achieve documents control you must maintain a method. This method must be one of the organizations quality procedures and it should be called "Documents Control". In this procedure you must refer to the next line of issues.

Types of recordsAt first, you must define what documents this procedure would include. Documents can be working procedures, diagrams, technical specifications, price quotes etc. In order not to "swirl" around too many documents, let's make it clear. Let's define what a document is: Communication of information, evidence for correspondence, sharing of any kind of knowledge, approved documents. Someone within the organization must supervise all documents and see that they are suitable for working before they are released.The reason is to prevent any faults where unsuitable documents are being used or information that is classified is handed to wrong bodies. It is required to define for whom it is authorized and when must he approve any document. Who is responsible? The same one who is responsible for the information documented. It must be part of his job description. There are situations that more than one function would be needed to approve one document. It happens when more than one process is documented on one document.

Updated documentsThis requirement assures that always the last version is the version in use - and not an older. Therefore you must define a method for maintaining updated version and elimination of older versions. How would one know what is the last version? Usually organizations manage a list of editions and updates for documents. You can manage the document itself. But most important, it is required to indicate the document itself as the last edition. This way, any employee that would use the document, would be sure that he holds the last edition. Of course, don't forget to document the method.It is also required to define what to do with the old versions that are now not updated. How do you handle them? Are they to be destroyed, archived etc. Managing editions must include: Date of last update, The reason for the update, The function who demanded the update, The function that authorized the update. Although the ISO 9001 standard doesn't require these requirements specifically, it would help you to achieve its basic requirements. Of course you would use what is suitable for your organization. Today there is a lot of document management softwares. These software, naturally qualify for the standard requirements but it is recommended to review anyone before purchasing.
Availability and distribution of documentsThis is an un separated part of the last requirement. Defining the availability and distribution of documents must include the following:User authorization - to which it is authorized to use the document, the location of the document - where must the document be kept before and after use. Most of today's process management systems (such as ERP or CRM systems) provide documents control relevant to the process they handle. They present the user with a screen (a screen on a computer system is a document like any other document) with defined information to input. Most of these systems also has authorization module installed. But when systems like the ones mentioned do not exist in the organization, it must provide with his employees the relevant updated documents. That means the latest editions. In order to ensure that, the standard require a documented method. How to obtain that? Well, it depends on your organization and his substructures.

Identification of documentsAny document (internal or external) must be identified somehow. Any internal document must have a name, serial number, catalogue number or whatever. Somehow to define it. The ISO 9001 standard requires that you maintain a method to achieve identification. The identification must include the numbering, coding or however you decided to identify it. But it is required to document the method. You must also include location of documents. How one can trace the document. for example customer's files are scanned to the computer or stored in some closet. The final purpose of all this is to achieve control of the documents - any employee, once he looks at a document or trying to trace a document, would know where to approach: a department, a process, some function or any kind of identification relevant to your organization. If we look again at process management systems, then it is much simpler. Any document in those systems is identified by a number of some kind, produced by the system. The number is given according to some internal method. In this case you must not document this method but mention it in the procedure that these specific documents are managed. In case there are documents that are manually managed you must document the method. All this also applies for external documents. Any documentation that arrives from outside (with presumption that it is a document as defined) is included in the ISO 9001 standard requirement. In this case you must specify what is to do with these documents and where one can trace them in the hour of need. For example, where to file the documents.

Again, you define the method according to your organization's nature.
Documents removalYou must define a method for documents removal for any reason: un updated, out of use, etc. the method must include what is it to do with the document and who is responsible, once it is out of use. For example, removing old documents from the organization's server for no further use or removing old forms from the offices that no one would use them again. Some of this things sound trivial and they are, but still this is a ISO 9001 standard requirement..

Summary:The ISO 9001 standard requires that we document all sorts of our documents. It also requires that we would not confuse all kinds of documents from different sources. Therefore we must define a method for documents control. This is not a recommendation but a requirement. The method must be presented as a documented procedure. The documented procedure would be called "Documents control". You must include a definition of documents within the method - what is a document. All documents must be approved before use. The purpose is to verify that the documents are suitable for work. All documents must be updated. You must define a method to ensure the use of updated documents only. The method should include management documents editions and documents indications. All documents must be identified. The organization must specify a method for documents identification. The purpose is that any employee would know which document he holds or where to trace it. It is also required to manage availability and distribution of documents. You must verify that the documents that are distributed to the employees are the correct ones. You must define a method for documents removal. When and why to remove documents and in whose responsibility.

Article Source: http://www.articlesbase.com/management-articles/iso-9001-documents-control-elements-and-requirements-475097.html

Publication of new edition of ISO 9001 expected in October-November 2008

2008-08-04T08:40:00.000-07:00

A new edition of ISO 9001, the world's most widely used quality management system standard, is being submitted for voting as a Final Draft International Standard and, subject to formal approval by the ISO membership, the publication of the revised version should be in the October-November 2008 time frame.
The proposed ISO 9001:2008 does not introduce additional requirements compared to the last edition in 2000 and does not change the intent of ISO 9001:2000.

The draft International Standard was approved at the 19-23 May 2008 meeting of ISO technical committee ISO/TC 176, Quality management and quality assurance, held in Novi Sad, Serbia, and hosted by the Serbian national standards body, ISS. ISO 9001 will be circulated in July as a Final Draft International Standard, on which ISO's national member bodies as a whole may vote.

ISO 9001 provides the requirements for a quality management system (QMS), which is a framework for an organization to control its processes in order to achieve objectives including customer satisfaction, regulatory compliance and continual improvement. Organizations that implement the standard can choose to have their QMS independently certified as conforming to the requirements of ISO 9001, as means of increasing the confidence of their business partners, customers and regulators in their products and services.

Although certification is not compulsory, it is estimated that over one million ISO 9001 certificates have been issued to organizations in private and public sectors, in manufacturing and services, and in 170 countries. The new edition, however, will not require any specific reassessment for certification.

ISO 9001:2008 will be the fourth edition of the standard which was first published in 1987. The third edition, published in 2000, represented a thorough revision, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

ISO's rules for the development of standards require their periodic review to decide if they need revising, maintaining or withdrawing. Compared to the 2000 revision, ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It introduces clarifications to the requirements existing in ISO 9001:2000, based on user experience over the last eight years, and changes that are intended to improve further compatibility with the ISO 14001:2004 standard for environmental management systems.

To accompany the publication of the new versions, ISO is now working on implementation guidance for ISO 9001:2008, a reference table comparing and contrasting ISO 9001:2000 and ISO 9001:2008 and answers to Frequently Asked Questions. ISO is collaborating with the International Accreditation Forum (IAF) concerning accredited certification.

ISO 9001 is one of 17 standards (plus a corrigendum) developed by ISO/TC 176 on quality management supporting tools. These include ISO 9004:2000, Quality management systems – Guidelines for performance improvements, which is undergoing revision and expected to be published as a new edition in 2009.

Articles sourse : www.iso.org/iso/pressrelease.htm?refid=Ref1138

Iso 9001-2008 Vs. Iso 9001-2000 - the New Requirements and a Comparison Between Them

2008-07-31T08:51:00.000-07:00

Congratulations to all of us quality managers. We have a new standard. ISO 9001: 2008. This is really an exciting moment for quality managers. In order to celebrate this event in a way that only quality managers know how, I prepared here a comparison article between the ISO 9001:2000 and the new born ISO 9001:2008. I also included my comments regarding my experience and my perspective of things.

At the end of it I will summon the new requirements from the new ISO 9001:2008 standard.

Paragraph number 0.1 - Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.

My comment - Of course. The world is getting greener every day so they must remind you of the ISO 14001 standard. I believe and recommend to any organization that is needed of the ISO 14001 standard to implement also the 9001. There is a big correlation between these two. They actually help one another.

Paragraph number 1 - Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.

My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.

Paragraph number 2 - Normative reference - the ISO 9000 is now referred to ISO 9000:2005

Paragraph number 3 - Explanation about what is a customer and what is an organization and what is a supplier had been removed.

Paragraph number 4.1 - Clause a - The word "determine" is replacing the "identify". A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products.

My comment - Come on, like it wasn't obvious before....

Paragraph number 4.2.1 - Slight change of words but when you examine the change you realize the meaning is the same. Note2 was changed - a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document.

My comment - It's about time. A lot of headaches are vowed to be save. If your audit was one of the old school and demanded everything by the book - now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the demands.

Paragraph number 4.2.3 - A clarification that external documentation are the ones needed for the quality management system.

Paragraph number 5.1 - Clause a - the word "statutory" had been added.

Paragraph number 5.5.2 - An addition for a demand that the management representative would be a member of the organization's management.My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of forms and documentations for you to develop in order that the external consultants would be considered as a management representative.

Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting conformity to product requirements"

Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competence".

My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new.Clause c - you must ensure that the training is with competence rather than if it was an effective training.

My comment - On one hand it is an improvement. The training must be reviewed before. But I think it's not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before. Only time will tell...

Paragraph number 6.3 - Clause c - information systems are included. My comment - They are totally right!

Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine OHSAS 18001...

Paragraph number 7.1 - Clause c - measurement had been added to the activities.

Paragraph number 7.2.1 - Clause a - change of words - not of the meaning. Clause c- the word 'applicable' replaces 'related'. Clause d - change of words - not of meaning. A note has been added to explain what is the meaning of "post delivery activities".

My comment - I agree with the "post delivery activities" - it wasn't clear enough for my opinion.

Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.

Paragraph number 7.3.3- A change of wording. A note had been added clarifying what is included in "preservation of product".

Paragraph number 7.5.3 - A requirement added specifying that product traceability must be included throughout the product realization.My comment - That actually means that the product must be identifying not only on the shelves but also throughout the realization process.

Paragraph number 7.5.4 - A change of words to in the requirement to inform the customer of any problem regarding his property. The note had been amended that also personal data is included as customer's property.

Paragraph number 7.5.5 - A change of words: from "conformity of" to "in order to maintain conformity to requirements"

Paragraph number 7.6 - A change of words: from "devices" to "equipment" The reference to paragraph 7.2.1 had been removed. Clause c - from "be identified to enable the"to " identification to enable their"Changes in the notes: Note 1 - the reference to ISO 100012-2 had been removed. Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.

My comment - That means that from now on a computer that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone.

Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.

Paragraph number 8.2.2- Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken. The reference to the ISO 10011 is changed to ISO 19011.

Paragraph number 8.2.3 - A change of words: "to ensure conformity of the product" had been removed. A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.

Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.

Paragraph number 8.3 - An addition - Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.So, what are the new requirements of the new standard?

Statutory requirements are given scale as any other legal or customer's requirements.The statutory requirements are including the suppliers as well.A purchased process is just like any other product that the organization purchased.

If it's affecting the product it must be under the quality system.You may include two quality processes in one document and split one process to two documents.The management representative must be a member of the management.A requirement to ensure that trainings are suitable for the product in advance and not to check if the training was effective after it was taken.Information system in now officially considered as a substructure.Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.

Measuring is considered as one of the activities of product realization.The product must be identifying not only on the shelves but also throughout the realization process.The management is now responsible for preventive and corrective actions regarding nonconformities that were discovered during audit.The organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.

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Update on ISO 9001:2008

2008-07-27T08:11:00.000-07:00

Current status
Following a recent meeting of ISO’s Technical Committee TC176 in Helsinki, Finland, from June 11th – 15th 2007, publication of the new version of ISO 9001 has been brought forward from 2009 and is now scheduled to be published in August 2008. Experts representing over 70 ISO member bodies, met to discuss the comments received during circulation of the Committee Draft (“CD”) of the new standard, and concluded that in view of the very limited changes being proposed, the draft is now sufficiently mature to progress directly to the DIS (Draft International Standard) stage (see Figure 1 for an explanation of the various stages in the ISO standards development process).

The main changes being introduced into the new standard are as follows:

· Clause 0.2 (Process approach)
o Text added to emphasize the importance of processes being capable of achieving desired outputs

· Clause 1.1 (Scope)
o Clarification that “product” also includes intermediate product
o Explanation regarding statutory, regulatory and legal requirements

· Clause 4.1 (General requirements)
o Notes added to explain more about outsourcing
o Types of control that may be applied to outsourced processes
o Relationship to clause 7.4 (Purchasing)
o Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system

· Clause 4.2.1 (Documentation)
o Clarification that QMS documentation also includes records
o Documents required by the standard may be combined
o ISO 9001 requirements may be covered by more than one documented
procedure

· Clause 4.2.3 (Document control)
o Clarification that only external documents relevant to the QMS need to be
controlled

· Clause 4.2.4 (Records control)
o Editorial changes only (better alignment with ISO 14001)

· Clause 5.5.2 (Management rep)
o Clarifies that this must be a member of the organization’s own management

· Clause 6.2.1 (Human resources)
o Clarification that competence requirements are relevant for any personnel who
are involved in the operation of the quality management system

· Clause 6.3 (Infrastructure)
o Includes information systems as example

· Clause 6.4 (Work environment)
o Clarifies that this includes conditions under which work is performed and
includes, for example physical, environmental and other factors such as noise,
temperature, humidity, lighting, or weather

· Clause 7.2.1 (Customer related processes)
o Clarifies that post-delivery activities may include:
§ Actions under warranty provisions
§ Contractual obligations such as maintenance services
§ Supplementary services such as recycling or final disposal

· Clause 7.3.1 (Design & development planning)
o Clarifies that design and development review, verification and validation have
distinct purposes
o These may be conducted and recorded separately or in any combination as
suitable for the product and the organization

· Clause 7.3.3(Design & development outputs)
o Clarifies that information needed for production and service provision includes
preservation of the product

· Clause 7.5.4 (Customer property)
o Explains that both intellectual property and personal data should be considered
as customer property

· Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)
o Explanatory notes added regarding the use of computer software:
“Confirmation of the ability of computer software to satisfy the intended
application would typically include its verification and configuration management
to maintain its suitability for use.”

· Clause 8.2.1 (Customer satisfaction)
o Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports

· Clause 8.2.3 (Monitoring / Measurement of process)
o Note added to clarify that when deciding on appropriate methods, the
organization should consider impact on the conformity to product requirements
and on the effectiveness of the quality management system.

ISO 9001 - Design in Education

2008-06-12T07:23:00.000-07:00

By Mark Randig

I decided several articles ago that, instead of trying to address issues that I thought were important, I would focus on questions posed to me during the course of my consulting activities. Of these, one of my favorite questions to date is:
Can ISO 9001:2000 design and development criteria be applied to training and educational programs?

The answer is a definite yes. While the ISO 9001 design and development model is usually associated with manufacturing activities, it's important to realize that the intent of this criterion has much wider application. These requirements not only relate to the design of product, but the design of processes and services as well.

If we consider the design of training or educational programs, we find that the basic requirements specified in the ISO 9001 standard are by no means unique or foreign. In fact, these requirements can be applied quite easily to training and educational design, and are generally consistent with accepted design methodologies:

• Design Planning - includes project timelines, scope documents, and other information that defines the stages of design and development, design review, verification and validation activities, and design responsibilities.

• Interface Management - includes interested parties, such as the student, the learning institution, their instructors/teachers, representatives of industry, and even parents.

• Design Inputs - includes needs or requirements defined by the student, parents, institution, industry, state and other interested parties; technological developments, and feedback from past experiences could also be considered.

• Design Outputs - includes the resulting specifications that define the learning program. This covers learning objectives, course charts, instruction and/or lessons plans. Specifications for learning aids, equipment and/or materials needed, room requirements (e.g., room size, table size, number of chairs, etc.), and instructor qualification requirements would also fall into this category.

• Design Reviews - includes initial/kick-off meetings to review the design inputs, progress meetings to review the progression of the design to the design plan and final reviews to evaluate the completed program design for approval.

• Design Verification - includes the design reviews stated above, evaluation against similar programs and other activities.

• Design Validation - includes consideration of data obtained from pilot courses, course quizzes and exams, feedback from students (course critiques), feedback from employers and other interested parties including employers and industry.

• Change Control - includes control methods for reviewing and approving proposed changes to existing designs, as well as methods of interface management (such as involvement and notification of affected parties) and configuration control.

Needless to say, the examples above are not intended to be all-inclusive. The specific configuration and attributes of a design program should be based on the training or educational event being developed. Regardless of the specifics of the design program however, the basic framework laid out in the ISO 9001:2000 standard can be applied, and it can be used as an effective means of controlling the design and development process.

The answer is a definite yes.
Mark Randig is the President and Founder of MAS Solutions LLC., a Houston Texas based consulting firm that specializes in helping companies achieve breakthrough performance by focusing on Quality Enhancement and Productivity Improvement. To get your FREE copy of

Mark's newsletter "The Quality Specialist", go to http://www.masquality.com
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