The Standard requires that you document the following:

1. Quality Manual
2. Quality Policy
3. Quality Objectives
4. Quality Records
5. Six Procedures
   1. Control of Documents (4.2.3)
   2. Control of Records (4.2.4)
   3. Internal Audit (8.2.2)
   4. Control of Nonconforming Product (8.3)
   5. Corrective Action (8.5.2)
   6. Preventive Action (8.5.3)

How Much Documentation Do You Need For Your ISO 9000 process?

Much depends on the size and complexity of your organization. You should have enough procedures to cover each section of the standard that applies to your business.

The ISO/IAF Guidelines says: “The auditee/auditor considers that each clause or sub-clause of ISO 9001 must be defined as a separate process“.

Do you purchase anything that could have an impact on meeting the customers’ requirements? Then you’ll need a Purchasing Procedure to describe section 7.4 – yet that isn’t “required”.

How do I set up my Documentation?

If you look at this pyramid, the lower the items are – the more specific they are to your business. The higher levels are dictated by the standard and are thus fairly common from one ISO 9001 company to the next.

• The Quality Manual describes the quality management system
• Procedure describe an ISO 9000 process (Purchasing)
• Work instructions describe an activity within a process (Creating a Purchase Order)
• Forms record the actions of an activity or process
  • NOTE: A record is a completed form,Table etc. that prove the action took place.

Related Posts

1. List of significant changes the 2008 revision brings to ISO 9001
2. What is a Quality Management System?
3. What is ISO 9001?
4. ISO 9000 Family of Standards
5. Internal Auditing — Turning negatives into positives

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