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.