5.6 Manual Section Length


5.6 Manual Section Length

There is some correlation between the number of expanded SHALLS and the number of pages in a given manual's section, but it is a weak one. The actual number of words required in a section has more to do with the scope of the SHALL, although Section 7.0: Product Realization is generally the longest because so many topics are covered, followed by section 4.0: Quality Management System because of the need not only to describe the system's structure but to also define the policies related to document and records control. Here we have assumed that appropriate quality policy statements have been created for each SHALL. A paraphrased manual—essentially just a play back of the Standard—will have sections approximately equal to the played-back Standard.

A good example of the inherent lack of precision in such an estimate is to consider that for a service organization whose specialty is repair and calibration of test equipment, Section 7.6: Control of Monitoring and Measuring Devices can represent over 40% of the manual.

Sections 4.0 and 5.0 require some graphics in the form of charts and figures that also increase the number of pages in those sections, although appendixes can be used to decrease the explicit size of the section. A graphic for Clauses 7.3: Design and Development and 7.5.2: Validation of Processes for Production and Service Provision is common if the system is online.

Font size differences make a study of such relationships almost meaningless. Instead say what is necessary, regardless of length, and use a font large enough to be read with ease.




ISO 9001(c) 2000 Quality Management System Design
ISO 9001: 2000 Quality Management System Design
ISBN: 1580535267
EAN: 2147483647
Year: 2003
Pages: 155

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