Who are we ?

We are the ISO Subcommittee for Quality Systems. We are responsible for the development of

ISO 9001 Quality management systems – Requirements

the most widely used International Standard in the world.

In addition, we produce the key ISO 9004 standard which provides guidelines for organizations who wish to go beyond ISO 9001, as well as other guidance standards such as ISO 10005, ISO 10006 and ISO 10007.

 

                        ISO 9001 Systematic Review - Path forward

The systematic review (SR) of ISO 9001 closed on 2nd December and indicated 36 members in favour of confirming the standard (unchanged) and 32 in favour of revising it.

 

ISO permits a committee 6 months after the close of an SR in which to announce its decision on the action to be taken on a standard. In addition ISO permits that after a detailed analysis of the results of the SR, and taking into account other inputs, another interpretation than indicated by the majority of national standards bodies responses to the review may be more appropriate.  

 

The ISO 9001 User Survey closed on 31st December, and the results of the survey are currently being processed by ISO/TC 176/SC 2/TG5.

 

A meeting of the ISO/TC 176/SC 2 "Strategic Planning and Operations Task Group" (SPOTG) will be held in March. SC2/TG5 will present the results of thee survey to that meeting, along with other inputs, including:

  • the TC176 work on Future Quality Concepts
  • the TC 176 work on Brand Integrity
  • the work of the ISO 9001 Auditing Practices Group
  • the interpretations issued on ISO 9001
  • the revision of Annex SL
  • the WG24 Project Review report on the development of ISO 9001:2015

The SPOTG will review the SR results along with these inputs, before making a recommendation on what action to take on ISO 9001.

 

The SPOTG's recommendation will then be circulated for a one month ballot of SC2's members, closing on 1st May.

 

If the SPOTG's recommendation is for a revision or amendment and is approved, then SC2/TG5 will create an initial draft of a Design Specification for the revision, while a new Working Group (WG) is constituted to undertake the revision/amendment work.

 

The Design Specification will then be transferred to the new WG for review and amendment, prior to being circulated for a one month ballot in SC2 (around June/July). Once the Design Specification has been approved, the new WG will then be able to start drafting the revision/amendment to the standard. The revision/amendment process could take up to 3 years to complete.

 

In contrast, if the SPOTG's recommendation is for confirmation, and this is approved, then no further action will be planned for ISO 9001 in the immediate future.

Our vision is:

  • That our products should be recognized and respected worldwide, and used by organizations as an integral component of sustainable development initiatives.

Our mission is:

  • To develop, maintain and support a portfolio of products that enable organizations to improve their performance and to benefit from the implementation of a robust quality management system.
  • To establish generic quality management system requirements that provide the foundations to build confidence in products and services delivered throughout the supply chain to organizations and people worldwide.
  • To provide guidance and support, where needed, to ensure the continued credibility of our products.

Our products

 

Please use the "Projects" tab at the top if this page to find further information on the products that are currently being developed or are under revision.

Guidance on ISO 9001

The following links will take you to supporting documents to help you in your use of the standard

Auditing to ISO 9001

Do you need advice about auditing to ISO 9001 ?

A key standard you should refer to is ISO 19011:2018 Guidelines for auditing management systems.

In addition a number of guidance papers on the auditing of quality management systems can be found on the website of the ISO 9001 Auditing Practices Group. These have been developed by an informal group of quality management system experts, auditors and practitioners from ISO/TC 176 and the International Accreditation Forum.

Also note that ISO/IEC 17021-3: 2017 Conformity assessment -- Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems  may help you.

Interpretations of ISO 9001

ISO provides an interpretations service for its member bodies, to resolve any identified ambiguities in the standard.

Regrettably this is NOT a service that is available for individual users of the standard. If you, as a user, have a query on the standard you should contact to your national standards body or liaison organization in the first instance, to seek advice on resolving it.

As it is an official process, that involves developing consensus among the members of ISO/TC 176/SC 2 to agree on any proposed interpretation, a quick response cannot be expected.

The listing of formally approved interpretations is available to download.

Member bodies should refer to the Guidance on the interpretations process and apply for an interpretation using The "Request for an Interpretation" form.

Related ISO pages

Our page on ISO.org

The page for ISO/TC 176

The web page for ISO's journal 'ISOfocus'

What is "certification" to management system standards?

ISO Survey of certification to management system standards, including ISO 9001

Who develops ISO standards?

Want to get involved?

Standards are developed by the people who need them – that could mean you. Technical committees include experts from both standards and industry and these experts are put forward by ISO’s national members. If you want to help shape future standards in your field, contact your national member

Mr Charles Corrie (UK)
Mr Charles Corrie (UK)
Secretary ISO/TC 176/SC 2