More Changes in ISO/DIS 9001:2008

In the last newsletter, I previewed the requirement changes in the ISO/DIS 9001:2008 standard. However, the changes planned for Edition 4 of ISO 9001 weren’t limited to clauses 4 through 8.

0.1 General

ISO 9001:2000 states, “The design and implementation of an organization’s quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed, and the size and structure of the organization.”

The following factors are added to the list by ISO/DIS 9001:2008, “influenced by: its business environment, changes in that environment, or risks associated with that environment; ” 

Later in section 0.1, ISO 9001:2000 states the standard is used, “to assess the organization’s ability to meet customer, regulatory, and the organization’s own requirements.”

ISO/DIS 9001:2008 changes “regulatory” to “statutory and regulatory requirements applicable to the product.” 

0.2 Process Approach

In this section, ISO/DIS 9001:2008 has modified the definition of the process approach by adding “to produce the desired outcome” to the text below:

“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”.”

0.3 Relationship with ISO 9004

The planned revision to ISO 9004:2000 is expected to be issued in 2009 with extensive changes, including a new clause structure that no longer matches that of ISO 9001. As a result, it will no longer forms a “consistent pair” with ISO 9001.

In anticipation of that change, ISO/DIS 9001:2008 no longer refers to the two standards as having, “similar structures in order to assist their application as a consistent pair.” 

This section adds that an objective of the ISO 9004 guidance is to manage for the“sustainable success” of an organization. And, instead of saying ISO 9004 is a guide to“move beyond the requirements of ISO 9001”, it now says ISO 9004 is a guide to“extend the benefits of ISO 9001.”

ISO 9001:2000 states ISO 9004 should be used to pursue “continual improvement of performance”, but ISO/DIS 9001:2008 has reworded it to pursue “systematic and continual improvement of the organization’s overall performance”. 

0.4 Compatibility with Other Management Systems

The change at this section was to refer to ISO 14001:2004 instead of ISO 14001:1996.

1. Scope
1.1 General

This section still explains that ISO 9001 specifies requirements for a quality management system. It refers to the product meeting customer and applicable regulatory requirements, as well as, enhancing customer satisfaction by assuring conformity to customer and applicable regulatory requirements.

ISO/DIS 9001:2008 has changed the two uses of “regulatory” to “statutory and regulatory”.

The Note at this section used to say the term “product” applied only to the product intended for, or required by, a customer. ISO /DIS 9001:2008 has expanded the Note to read “or required by, a customer or the product realization processes.” It goes on to add, “This applies to any intended output resulting from product realization processes, including purchasing.

A second Note has been added to explain that, “Statutory and regulatory requirements may be expressed as legal requirements.”

1.2 Application

ISO 9001:2000 states that any exclusions cannot affect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. ISO/DIS 9001:2008 replaces “regulatory” with “statutory and regulatory”.

2. Normative Reference

Although the text at this section has been significantly reduced, the key change is to reference ISO 9000:2005 instead of the old ISO 9000:2000.

3. Terms and Definitions

The change at this section was to drop the explanation of the supply chain terms, including that “supplier” replaced “subcontractor” and “organization” replacing “supplier”. The explanation was needed when making the transition from ISO 9001:1994 to ISO 9001:2000, but not now.

Annex A

Table A.1 in the Annex was revised to show the correspondence of ISO/DIS 9001:2008 clauses with ISO 14001:2004 (instead of ISO 14001:1996). Table A.2 shows the reverse correspondence, from ISO 14001:2004 clauses to ISO/DIS 9001:2008 clauses.

The old Annex B that showed the correspondence of ISO 9001:2000 and ISO 9001:1994 has been dropped since the clause structure of ISO 9001:2000 and ISO/DIS 9001:2008 are the same.

Bibliography

The bibliography has been updated with the latest versions of standards, and in a few cases, references to new standards, e.g., ISO 10002:2004 on complaint handling, ISO 10019:2005 on the selection and use of consultants, and IEC 61160:2006 on design reviews.