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Old 13th January 2018, 09:32 AM
AndyN's Avatar

Total Posts: 9,129
Let Me Help You Re: ISO 9001 2015 Documentation for Engineering and Design

In Reply to Parent Post by cferrer View Post

Hello Everyone,

Could you help clear out my confusion about where do the different design documents such as sizing arrangements, mathematical calculations, dimensioning, configurations overview concept documents, etc. , fall within the pyramid hierarchy of documents of a QMS (i.e. Policy, Procedures, Instructions, forms, records...).

And how about the knowledge-base? where does this fall under. We have a repository of technical descriptions and guidelines. Are this considered procedures, forms, instructions?

Thanks in advance

Chris: You are labouring under an old model. ISO 9001 never required such a structure, despite the fact that it became commonly used. Furthermore, this structure ended up CREATING the problem you are wrestling with - trying to pigeon hole documents document classifications totally artificially.

Similarly, unless there's a compelling reason for you to do this, your quality manual should only be like a "quick-start" guide, like you'd get with a new item of electrical equipment (not like the full blown user manual you also get)

I'd avoid creating a monster you'll have to feed from now and for ever...

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