Thursday, March 10, 2011

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

Figure 1 - Implementation timetable for ISO 9001:2008, for all user groups




Figure 1 - Implementation timetable for ISO 9001:2008, for all user groups

To benefit from the clarifications introduced into ISO 9001:2008, users (from all user groups) should note the recommendations given in the table below. Recommendations for specific user groups are given in section 4.2 further down.

Get acquainted with the new edition of the standard. Use Annex B in ISO 9001:2008 to facilitate identification of the clarifications

Was your former interpretation of ISO 9001:2000 different from the clarifications provided by ISO 9001:2008 ?
If not, communicate to both internal and external parties the conclusion and results of your implementation of ISO 9001:2008.

If yes, determine the impact of the clarifications of the new version on your current use of ISO 9001 and plan any necessary remedial actions.
Use the Plan-Do-Check-Act methodology to manage the implementation of your remedial actions, but keep in mind the timeframe provided in Figure 1.

Note that the actions may need to vary according to your user group (see 4.2 below).


4.2 Guidance for specific user groups
These recommendations complement the generic guidance to all user groups given in section 3.0 above.

4.2.1 Organizations using ISO 9001:2000

a) Current users
Organisations that are already certified to ISO 9001:2000 should contact their certification/registration bodies (CB/RB) to agree a programme for analysing the clarifications in ISO 9001:2008 in relation to their individual quality management systems and for upgrading their certificates.

Certified organizations should bear in mind that ISO 9001:2000 certificates have the same status as new ISO 9001:2008 certificates during the co-existence period.

Organizations in the process of certification to ISO 9001:2000 should change to using ISO 9001:2008 and apply for certification to it.

b) New users
New users should start by using ISO 9001:2008.

c) Industry Sector Schemes
Users of specific sector schemes are recommended to refer to the organization that is responsible that sector scheme’, e.g. for:
• ISO/TS 16 949 refer to the IATF,
• TL 9000 refer to the QuEST Forum
• AS 9000/ EN 9100 refer to the IAQG


4.2.2 National Standards Bodies

Information regarding the 2008 edition of ISO 9001 should be communicated to standard users, in a timely manner, by the national standards bodies (NSBs). It is recommended that NSB actions be synchronized with the information flows from ISO and ISO/TC 176.

NSBs are responsible, at a national level, for communicating the issues regarding the changes from ISO 9001:2000 to ISO 9001:2008 to all interested parties and for providing translations of the new edition of the standard in their national languages. It is recommended that they coordinate their communications regarding these issues with other local interested parties (for example: ABs, CB/RBs, professional quality associations, etc.).

Translation Issues - If a requirement for translation of the new standards exists, the translation process should be started as early as possible, in order to provide the equivalent national edition as soon as possible.

An NSB should analyse if there are interpretation problems in the national ISO 9001:2000 version due to former translation problems. In affirmative cases the NSB should carry out an extensive translation of the standard. If interpretation divergences still remain, the NSB is recommended to apply for clarification to the “ISO/TC 176 Interpretations Working Group” using the established “Interpretations” process.

If an NSB has no translation problem with its version of ISO 9001:2000 it can use Annex B to ISO 9001:2008 as a quick guide for preparing its translation of the standard.


4.2.4 Accreditation Bodies

ABs should refer to the joint IAF-ISO communiqué for the implementation of accredited certification to ISO 9001:2008 (see 4.1 above).


4.2.5 Certification Bodies

CBs should refer to the joint IAF-ISO communiqué for the implementation of accredited certification to ISO 9001:2008 (see 4.1 above).

CBs should remember that certificates of conformity to ISO 9001:2008 and/or its national equivalent adoptions can only be issued after the official publication of the amended standard.

It is important that accredited certification bodies ensure that their auditors are aware of the clarifications introduced in ISO 9001:2008, and their implications, prior to conducting audits to that standard.


4.2.6 Training Bodies and Consultants

All trainers and consultants should be aware of the clarifications in ISO 9001:2008. All training bodies and consultants are recommended to determine the need for updating training programs and documentation, or any other changes necessary, to the services they provide.


5.0 FREQUENTLY ASKED QUESTIONS

While this Implementation Guidance provides recommendations on a number of issues facing the different user groups during the co-existence period, it does not address more general questions about the ISO 9000 standards. Instead ISO/TC 176/SC 2 has prepared a set of frequently asked questions (FAQs) to provide such advice.

It is expected that the FAQs will be updated on a more regular basis than this Implementation Guidance. For the latest version of the FAQs, reference should be made to the open access web site at www.iso.org/tc176/sc2


6.0 AUTHENTICITY OF INFORMATION REGARDING ISO 9001:2008

The first point of contact for information regarding the requirements of ISO 9001:2008 should be your National Standards Body (for a listing of ISO’s member National Standards Bodies, see www.iso.org/iso/about/iso_members.htm).

Other recommended sources of information are:

• ISO’s web site www.iso.org provides general information regarding ISO 9001:2008 and the ISO 9004 revision programme (as well as details of its member National Standards Bodies).

• The ISO/TC176 web site www.tc176.org provides more specific information on the structure and work programme of ISO/TC176, and on the formal “interpretations” issued on ISO 9001

• The ISO/TC176/SC2 web site, www.iso.org/tc176/sc2 provides detailed information on the ISO 9001/9004 revision program, updated on a regular basis.
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1 comment:

anand said...

iso ts 16949 Consultants:
Based on ISO 9001, the first edition of ISO/TS 16949:2009 was published in March 2002 as ISO/TS 16949:2002. ISO/TS 16949 was introduced by the Technical committee of ISO and IATF (International Automotive Task Force) with an aim to develop the quality management system.

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