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Minimum documentation requirements for ISO9001

Another common question I am asked when implementing a Quality Management System (QMS) for customers is “What are the minimum requirements?”. Not a question I particularly like as no system I implement does the bare minimum to scrape accreditation. In the long term, in my humble opinion, you need a system that meets the requirements of the standard - yes, but also something that adds value to the organisation. If a system is “just more bureaucracy” then it’s probably not appropriate for the organisation, or top management commitment is not present.

If you pick up a copy of the ISO9001 standard, any clause that says, “must be retained as documented information” means an auditor will want to see a document that meets the requirements of the standard. There are several clauses of ISO9001:2015 that MUST have documented information, here are a few:

  • 4.3 Scope of the Quality Management System
  • 5.2 Policy
  • 6.2 Quality Objectives
  • 8.4 Control of externally provided processes, products and services
  • 10.2 Nonconformity and corrective action

There are lots of these if you read the standard itself, but if you are looking to only do the bare minimum my advice is -  don’t! Even if the standard does not say “must be documented” some auditors (including myself I am not ashamed to say) will argue that unless areas of the QMS are documented then how can staff follow them?

Remember that with a QMS that are often 4 types of documents:

Quality Policy: this is often a small set of statements in relation to quality and your organisational objectives.

Quality Manual: I must stress that this is not a requirement but often organisations choose to have a quality manual to collate several quality documents such as management commitment, awareness programme, internal audit and so on.

Procedures/Work instructions: What your organisation does, what the inputs and outputs are from each department/process/procedure and how they all fit together. Who is responsible and accountable and what to do when stuff goes wrong.

Finally, Records. When your staff/contractors/work buddies are working they will produce forms, paperwork and emails etc when doing their day to day jobs. 

So, I hope you found that useful, if you want more information why not give me a call?

 

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