ISO 9001:2008 Revision Status

As of July 2008

The ISO/DIS 9001:2008 has been approved and the proposed standard is being submitted for voting as a Final Draft International Standard (FDIS). If the FDIS is approved as scheduled, the new edition should be published in the October-November 2008 time frame. The proposed ISO 9001:2008 does not introduce any additional requirements beyond the current ISO 9001:2000.

Most of the suggested changes are just word changes for improved clarity and more objective interpretation of the requirements, and changes that are intended to improve further compatibility with the ISO 14001:2004 environmental standard. The new edition, however, will not require any specific reassessment for certification.

Examples and nature of the proposed changes

4.1 General Requirements

Clause 4.1 a)

The word "Identify" has been replaced with "Determine", which implies more analysis and judgment than merely identifying the processes needed for the quality management system and their application throughout the organization.

Clause 4.1 e)

This requirement change indicates that processes are to be measured �where applicable�.

Clause 4.1 regarding outsourcing

The proposed change clarifies that specific controls are to be defined and applied, not just identified within the QMS.

The current Note under clause 4.1 has been expanded and two new Notes have been added. One of the new notes provides an explanation of what is considered an outsourced process and the second one identifies the factors influencing the control of an outsourced process.

4.2 Documentation Requirements
4.2.1 General

The requirement changes in 4.2.1 are basically just a restructuring of the sub-clauses c), d), and e).

4.2.3 Control of Documents

The proposed change in sub-clause (f) clarifies that only those external documents, that are necessary for the planning and operation of the quality management system, have to be identified and controlled.

4.2.4 Control of Records

The opening sentence for clause 4.2.4 has expanded from records being "maintained" to having them "controlled". Later in the clause it is proposed to reduce "retention time" to "retention".

Therefore, the proposed changes to clause 4 in the draft ISO 9001 are primarily clarifications for improved understanding of the existing requirements.

5.5.2 Management Representative

The proposed change in this clause clarifies the existing requirement to appoint a Management Representative who is a member of their own management team.

6. Resource Management
6.2 Human Resources
6.2.1 General

The proposed revision for this clause is from work affecting "product quality" to work affecting "conformity to product requirements". This change should not result in a new interpretation of the requirement. A new Note has also been proposed for clause 6.2.1 to explain that anyone working within the system may affect conformity to product requirements.

6.2.2 Competence, Training, and Awareness, and Training

It is proposed to change the clause title as above and also the sequence of requirements to match the same. The other proposed minor changes include changing �ensure the effectiveness of the actions taken� to �ensure that the necessary competence has been achieved�.

6.3 Infrastructure

The only proposed change under Infrastructure is to include "information systems" as an additional example of a supporting service.

6.4 Work Environment

The only proposed change to this clause is to add a Note to explain the term Work Environment by providing examples of work environment conditions for achieving product conformity.

7.1 Planning of Product Realization

The only proposed change to the text of clause 7.1 is the addition of "measurement" as one of the required activities to be determined during the planning of product realization.

7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product

The slight proposed change from "for delivery and post-delivery activities" to "for delivery, and for post-delivery activities" adds emphasis to post-delivery activities. In addition, a new Note, with examples of post-delivery activities, is proposed.

The proposed change from "related" to "applicable", for �statutory and regulatory requirements� shifts the meaning from determining legal requirements that are merely associated with the product to those that are relevant and can be applied to the product.

Similarly, for �any additional requirements� the word �determined� is proposed to be substituted by �considered necessary� thereby clarifying that the additional requirements aren't just determined, they are determined to be needed by the organization.

7.3 Design and Development
7.3.1 Design and Development Planning

The proposed new Note to be added to Clause 7.3.1.b explains that although review, verification, and validation have distinct goals, they can be carried out separately or in any combination.

7.3.3 Design and Development Outputs

The proposed change removes the unnecessary word, "provided". It also switches from "a form that enables verification" to "a form suitable for verification". Also the proposed new note reminds to include details for the preservation of product.

7.5 Production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision

An update will be posted soon.