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ISO 9000 Documentation Requirements

There are 2 types of requirements for procedures and work instructions.
I. Specific procedures required by the standard.
These are the procedures that the standard says you must have documented. They include:

  • Document Control
  • Control of Quality Records
  • Internal Audits
  • Control of Nonconforming Product
  • Corrective Action
  • Preventive Action

II. Procedures, work instructions, quality plans and related documentation required to ensure control of your processes.

Your organization is responsible for determining the other documentation you need to have to control your processes. A guideline used for determining where documentation is a necessary control is to ask several different people how they perform the process. If the answers are different, you need more control and documentation is one way of getting that control. If the people answer the same, you may not need a procedure.

Other documentation required by the standard:

  • Quality Manual
  • Quality Policy
  • Quality Objectives
  • Quality Records
For more guidance, see "Guidance on the Documentation Requirements of ISO 9001:2008" provided by ISO

 

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