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ISO 9001 quality manual 4.2.2

 

 

 

 

The main difference in ISO 9001:2000 is that you do not need procedures to control the activities - instead you simply have to prove that you have met the requirements.

An ISO 9001 quality manual must describe:

>    the scope of the Quality Management System ie what's included in the Quality System

>   details and justification of any exclusions ie what's excluded

>   procedures (or make reference to them) procedures may be a separate set of documents  

>   a description of the interaction of the processes eg a flowchart of relevant business activities

See our quality manual products

IMPORTANT

Some exclusions are permitted but the exclusions are limited to the Product Realization requirements (ISO 9001:2000 Section 7).

Exclusions are only permitted where an element of Section 7 is genuinely not relevant to the company.

Quality manual writing tips:

- check this link to ISO 9000 history & terminology

- To pass a certification body audit, a quality management system must be an auditable entity.

- Just writing about it is not enough - the QMS must also be implemented

- Consider including the mandatory procedures in the quality manual

- Aim for minimal documentation

- Especially if you're a small business

- Start with the assumption that you're currently doing all (or most) of what ISO 9001 asks.

- Keep the documentation small and simple

Take a look at the public documents on the ISO 9000 committee site

 

Use ISONavigator with ISO 9001 or ISO 9004.

While every effort is made to ensure the accuracy of the information provided, you are solely responsible for deciding its relevance and applicability given your unique situation. No liability is accepted if you choose to act upon this information.

ISO 9000:2000 principles and ISO 9001:2000 requirements are indicated in
black. Guidance and interpretation is in green