Quality News

According to a joint announcement by the ISO (International Organization for Standardization) and the IAF (International Accreditation Forum), the two organizations have agreed to an implementation plan for a smooth migration to ISO 9001:2008.

1. Certification to ISO 9001:2008 will only be issued after publication of ISO 9001:2008 and after a routine surveillance audit or re-certification audit against ISO 9001:2008.
2. One year after publication of ISO 9001:2008, all certifications issued (new certifications and re-certifications) must be to ISO 9001:2008.
3. Two years after publication of ISO 9001:2008, existing ISO 9001:2000 certifications will not be valid.

This transition plan is possible because ISO and IAF have agreed that ISO 9001:2008 introduces no new requirements. The revised quality standard only introduces clarifications to the existing requirements with minor revisions to improve consistency with ISO 14001:2004, the environmental standard.



The revisions to ISO 9001:2000 are described below – deleted text is indicated by strikethroughs – new text is underlined and shown in standard font – text from the standard is shown in italic font to distinguish them from our comments. Most of the text in ISO 9001:2000 has not been affected by ISO 9001:2008.

0.1 General

In this section of the Introduction, ISO 9001:2008 adds “business environment” to the list of factors that influence the design and implementation of a quality management system.

The design and implementation of an organization’s quality management system is influenced by

• its business environment, changes in that environment, or risks associated with that environment,
• its varying needs,
• its particular objectives,
• the products it provides provided, – the processes it employs employed, and
• its the size and organizational structure of the organization.

ISO 9001:2008 changes “regulatory” to “statutory and regulatory” and clarifies that the Customer, statutory and regulatory requirements are those applicable to the product.

This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory, and regulatory requirements applicable to the product, and the organization’s own requirements.

0.2 Process Approach

ISO 9001:2008 focuses on “determine” linked activities rather than “identify” linked activities to clarify that a Process can be an activity or set of activities.

For an organization to function effectively, it has to identify determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.



The definition of Process Approach has been clarified by adding text:

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“.

Read more here http://www.quality-control-plan.com/changes-to-iso-9001-2000.htm