ISO 9001 Quality Manual

Your ISO 9001 Quality Manual is the top tier document for your Quality Management system (QMS).

Write the Quality Manual so a customer can read it. Many customers will ask for a copy of the manual. They want to ensure that you have addressed all the critical quality management systems. If there are product complaints, customers may refer to your manual to understand your quality systems.

ISO auditors start with your quality manual to understand your systems. They will ask many questions about the statements you make in the manual. The ISO 9001 Quality Manual needs to be factual and summarize your systems.

What must you include in your Quality Assurance Manual?

Designate the list of the key procedures
Describe the Scope
Outline your document structure
Justify any exclusions.
Document the Quality Policy
Process Interaction Chart
State who is the management representative

Scope

The scope of the manual describes why the manual is written. In case of ISO 9001, the scope could be:

The policies written within this manual conform to ISO 9001. The manual supports our company scope of making widgets. The manual describes the quality management systems deployed at our company.

Make sure the QA manual follows your documentation system.

Exclusions

Only clauses from product realization can be excluded from your quality management system. For example Customer Property Control does not apply to many companies

So If there is a section from product realization that does not apply to your business, you can take exclusion to this in the manual. Provide a justification on the exclusion within the QA manual. During a ISO 9001 audit, the auditor will need verbal reasoning for the exclusion.

Quality Policy

When crafting your Quality Policy, think about these items.

The eight principles of the ISO 9001 standard
Continuous improvement
Product requirements
Quality objectives
How do you continuously improve?
What are your quality principles?
Quality strategies
Does it align with your corporate mission?
Customer satisfaction
Supplier relationships

Representative

The management representative ensures the adequacy of the quality management systems. The management representative is the main contact for the ISO auditor.

Your QA manual may separate individual clauses to a specific person. For example Design and development may be the responsibility of the Research Engineering Manager.

Key Elements

I recommend you go through each section of the Main and Key Elements. For each section in the QA Manual, provide a summary and document the supporting procedure. If there is no supporting procedure than address that section fully in the QA Manual.

If you would like to review a completed ISO 9001 Quality Manual please send me an email.

Process Interaction Chart

A process interaction chart shows the inputs and outputs between your managment systems. Please subscribe to QA-Solutions E-zine to see an example of the process interaction chart

Applications That Drive Improvement
Robert Broughton
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USA
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