May 2, 2008: Our clients have asked many questions on how the upcoming changes to ISO 9001 may impact their management systems. To answer these questions, a team of Intertek’s lead auditors and technical experts reviewed the latest draft of ISO 9001 (ISO/DIS 9001:2008) and, drawing on their extensive knowledge of ISO 9001:2000, have prepared a set of responses. Download ISO 9001 Revision: Your Questions Answered now!

February 1, 2008: The following is an overview of the coming changes to the current version of ISO 9001:2000.  The next version of this standard should be published at the end of 2008, or the beginning of 2009 at the latest.

At the present moment, it is expected that all ISO 9001:2000-based standards, such as ISO/TS 16949 and the AS9100 series of standards, will be amended accordingly.  However, it is to be noted that ISO 13485 will not be.

The following list provides a clear indication that no significant changes to requirements are expected.  This amendment is primarily for clarification and ease of use.  It is therefore expected that the transition to this version of the standard will not require any extra audit time.  It is also expected that certified clients will have a period of 12 to 18 months to make the transition to the requirements of the new version of the standard.

This summary is based on the DIS (Draft International Standard) version of the standard.  It will be updated, as deemed necessary, upon publication of the FDIS (Final Draft International Standard) and the IS (International Standard) versions of the document.

The changes can be summarized as follows:

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

Clause 1.1 (Scope - General)
Clarification that product also includes intermediate product. 
Explanation regarding statutory, regulatory and legal requirements.

Clause 4.1 (General requirements)
Addition of a note to clarify outsourced processes as well as the types of control that may be applied to such processes.

Clause 4.2.1 (Documentation requirements - General)
Clarification that QMS documentation also includes records. 
Clarification that one document may include the requirements of one or more procedures, and that the requirements of one procedure may be covered by more than one document.

Clause 4.2.3 (Control of documents)
Clarification regarding the documents of external origin that need to be controlled.

Clause 5.5.2 (Management representative)
Clarifies that this person must be a member of the organization’s own management.

Clause 6.2.2 (Competence, training and awareness)
Now requires the organization to ensure that necessary competence has been achieved.

Clause 6.4 (Work environment)
A note has been added to clarify the term work environment.

Clause 7.2.1 (Determination of requirements related to the product)
Clarifies that post-delivery activities may include actions under warranty provisions, contractual obligations such as maintenance services and supplementary services such as recycling or final disposal.

Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification, and validation have distinct purposes but 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)
Clarifies that information needed for production and service provision may include preservation of the product.

Clause 7.5.4 (Customer property)
A note has been added to specify that personal data should be considered customer property.

Clause 7.5.5 (Preservation of product)
Clarification that preservation of the product relates to the maintenance of conformity to requirements.

Clause 7.6 (Now retitled Control of monitoring and measuring equipment)
Addition of a note related to the confirmation of computer software used as monitoring and measuring equipment.

Clause 8.2.1 (Customer satisfaction)
Note added to provide examples of how customer satisfaction data could be collected.

Clause 8.2.2 (Internal audit)
Editorial changes to clarify this requirement of the standard.

Clause 8.2.3 (Monitoring and measurement of processes)
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.  

Clause 8.2.4 (Monitoring and measurement of product)
Clarification that the release of the product relates to the delivery to the customer.