ISO 9001 - Understanding ISO 9001 Requirements

4.2.2 Quality Manual

Establish and maintain a quality manual & include:

a)The scope of the QMS including details of and justification for any exclusions

b)The documented procedures (or references to them)

c)A description of interaction between QMS processes

Key Explanation Points and Tips:

ÞThe quality manual is a special type of document that describes your QMS. Besides describing your QMS, your quality manual could provide information on organizational background and capabilities. It may be used by customers, regulatory bodies, suppliers and company personnel for a variety of purposes. There are many acceptable ways to document your quality manual.

ÞYou must define the scope of your QMS in your quality manual. Your QMS scope should include - facilities (manufacturing and support locations), products, processes, Quality Management and other standards, etc. Customers will want to know the extent of your capabilities and the Registrar will want to determine the time and effort needed to audit your organization.

ÞProvide details of any clause exclusions from your scope, e.g. 7.3 Product Design and Development, and justification for it. You must justify all exclusions and remember, exclusions can only be made from clause 7.

ÞYou have flexibility in whether or not to include your procedures and lower level documentation with your quality manual or organize them in some other fashion. You may include all or some of your procedures in your Quality Manual or reference them to your Quality Manual. Keep a listing or index at the front or back of your Manual showing the complete list of your procedures whether included or referenced.

ÞThe practicality of all this would depend, of course, on the size of your organization, complexity of products and processes; competency of personnel, media used for documentation (hard copy versus computerized); ease of use and understanding by personnel; etc. So go ahead and organize your documentation to facilitate ease of use; availability and maintainability.

ÞYour quality manual must include a description of the interaction of your QMS processes. This was discussed above under clause 4.1

ÞAs a controlled document (see 4.2.1), the quality manual is subject to all of the controls in clause 4.2.3.



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