Posts Tagged ‘quality manual’

The ISO 9001 Quality Manual – how useful is it?

Friday, March 6th, 2009

It is always amazing to see how many small companies construct a lengthy quality manual and then question whether or not it provides any real value. Unfortunately, this scenario is more common than it should be and the question is quite valid – how useful is it?

The first thing that an organization should realize when constructing a quality manual is that there is no single prescribed way for it to look. The requirements are plainly stated in ISO 9001:2008 clause 4.2.2. According to the “Introduction and support package: Guidance on the documentation requirements of ISO 9001:2008″ (Document: ISO/TC 176/SC 2/N525R2) created by ISO Techincal Committee 176:

Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS (Quality Management System).

A small organization may find it appropriate to include the description, processes and methods of its entire QMS within a single manual, including all the documented procedures required by the standard.

Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.”

Nowhere in the standard or in the guidance document does it state that the organization must regurgitate the standard and replace the word “shall” with some type of term as “we do…”.

The best quality manuals are always written specifically for the company (NOT templates) and contain the scope of the manual, reference or inclusion of procedures and SIMPLE, employee-friendly process descriptions that clearly show the sequence and interaction of key company processes.

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