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Old 12th January 2018, 12:44 PM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,624
Lightbulb Re: ISO 9001 2015 Documentation for Engineering and Design

Quote:
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
Chris,

I understand your desire for a rigorous hierarchy of documents commonly found in hard copy parts of documented management systems. The structure made the management system easier for users to navigate and find exactly what they needed.

That structure with its document coding scheme made hard copy systems easier to administer too.

But with electronic procedures and their hyperlinks to instructions, forms and tools we are seeing more and more that every doc is controlled as part of its parent procedure.

Be careful to separately control design inputs and outputs as records that may be tied to each project. Indeed, each drawing is controlled as a project document until it is superseded or updated to become the “as built” or project record

So, let’s take a look at the docs you identified:

- sizing arrangements - serves as a project instruction before becoming a record unless standardized across your practice when it would be controlled as an instruction

- mathematical calculations - record

- dimensioning - normally standardized practice-wide, so an instruction

- configurations overview (concept documents) is an output of the conceptual design stage before it becomes a record as detailed construction drawings take over.

Your knowledge base is a reference library and its documents (records really) are not subject to revision control. Again, today’s search engine savvy users prefer keywords in place of hierarchy.

John
Thanks to John Broomfield for your informative Post and/or Attachment!

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