When developing and implementing a QMS, quality managers often ask themselves these questions:
- Is this procedure mandatory?
- Do I need to maintain those records?
- What are the documents required by ISO 9001?
It is manager's job to establish and implement controls and ensure there is continual improvement. In the absence of specific guidance in performance standards (required procedures, records, or schedules) it is essential that management be able to demonstrate conformance to requirements.
It is especially important when preparing for the audit (both internal and external).
It is a good practice to maintain Quality Manual and Quality Standard procedures as documented information.
More on Auditing for control and improvement - in the corresponding article by J.P.Russel
ISO 9001:2015 Documents and Templates collection
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