ISO 9001:2000

4.2.2 Quality Manual

Change: ADDITIONAL Requirements
Procedure Required: YES (Quality Manual)
Record(s) Required: NONE

Comments:
This section clearly specifies detailed requirements for the quality manual to include:

a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

4.2.2a
The scope of the quality system means listing all of the facilities that the quality system covers (e.g., all operations located in the United States, except for California), product lines (or families), services (general), and any exclusions (e.g., ISO 9001:2000, section 7.3 "Design and Development", is excluded because the organization does not design product).

4.2.2b
If the required procedures (ref. ISO 9001:2000, section 4.2.1c & 4.2.1d) are not included in the quality manual, then the quality manual must contain a reference to those procedures (e.g., procedure name, number, hyperlink or other form of specific identification allowing it to be readily identified).

4.2.2c
The requirement for the quality manual to contain "a description of the interaction between the processes of the quality management system" is a highly ambiguous and extremely subjective requirement (i.e, auditors either don't know what this means or have widely varying interpretations of its meaning).

Guidance:

4.2.2a
I suggest stating the quality policy and quality objectives in the Quality Manual (ref. sections 5.3 & 5.4.1 for more detail)

4.2.2b
I have always suggested that quality manuals paraphrase each section of the most appropriate standard used (e.g., ISO 9001:2000). I have had several auditors who disagree with this approach tell me that they didn't "like" my quality manual, but I have never received a noncompliance or observation for taking this course.  Those quality professionals who disagree with me on this topic generally believe that the quality manual should be unique to the company and written in ones own words. In my experience, the majority of quality manuals written in ones own words are poorly written and much more difficult to verify as being compliant with a standard. Supporting my position, I have noted that those organizations who attempt to write their quality manuals in their own words often receive multiple noncompliances against their quality manual.

4.2.2c
This new requirement has become a furtile ground for auditors to wage lengthy discussions / debates (regardless of how you address the requirement). Quite often, simply duplicating the simple Plan-Do-Act-Cycle (as described in ISO 9001:2000, section 0.2 "Process Approach") within your quality manual linking each phase in the cycle to the processes of "your" quality management system will satisfy the auditor. Another popular approach is to create detailed functional flow charts. However, I prefer a high level functional graphic - as shown below: