ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000and to improve compatibility with ISO 14001:2004.

ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008.

No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact ontheir current interpretation of ISO 9001:2000, as changes may be necessary to their QMS.

In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001, Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments.

In relation to the development of ISO 9001:2008 user needs were identified from the following:

  • the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
  • feedback from the ISO/TC 176/Working Group on “Interpretations”
  • the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004” by ISO/TC 176/SC 2/WG 18 and similar national surveys.

The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users. The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of theamendment in deciding which changes should be included, and to assist in the verification of drafts against theidentified user needs. The following decision making principles were applied:

  • No changes with high impact would be incorporated into the standard;
  • Changes with medium impact would only be incorporated when they provided a correspondingly medium or highbenefit to users of the standard;
  • Even where a change was low impact, it had to be justified by the benefits it delivered to users, before beingincorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

  • No changes or minimum changes on user documents, including records
  • No changes or minimum changes to existing processes of the organization
  • No additional training required or minimal training required
  • No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

  • Provides clarity
  • Increases compatibility with ISO 14001.
  • Maintains consistency with ISO 9000 family of standards.
  • Improves translatability.

The ultimate conclusion from the latest revision of the ISO 9001 standard:

No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008,users of the former version will need to take into consideration whether the clarifications introduced have an impact ontheir current interpretation of ISO 9001:2000, as changes may be necessary to their QMSNo new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008,users of the former version will need to take into consideration whether the clarifications introduced have an impact ontheir current interpretation of ISO 9001:2000, as changes may be necessary to their QMS.

Source: ISO/TC 176/SC 2/N836