Book 1
Book 1
23
Audit Dates: 26th & 27th Oct.2023
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2S Qualified 28
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18
16
14
12 10
10
8
6
2 2 3
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24-Dec
ISO 9001 mandatory documents and records
Here is the quality documents list you need to produce if you want to be compliant with ISO 9001:2015. (Please n
Besides this quality documentation list, here are the mandatory records:
*Note that records marked with * are only mandatory in cases when the relevant clause is not excluded
Diagram displaying the mandatory documents and records for ISO 9001
Non-mandatory documents
There are numerous non-mandatory documents that can be used for ISO 9001 implementation. However, these n
What must be documented
Procedure for determining context of the organization and interested parties
So, to resume, we have listed the most frequently asked questions about ISO 9001 documentation requirements
So, this is it – it might seem like a lot to write, but once you do it, you will have all the aspects of quality managem
Dejan Kosutic
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Suggested reading
New approach to document and record control in ISO 9001:2015
Advisera Mark HammarMark Hammar
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One of the first things to do when implementing a Quality Management System...
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November 10, 2015
With the amount of emphasis put on relevant interested parties in the release...
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nt with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant proce
mplementation. However, these non-mandatory documents are the most commonly used:
ISO 9001 reference
clauses 4.1 and 4.2
clause 6.1
clauses 7.1.2, 7.2 and 7.3
clause 7.1.5
clause 7.5
clause 8.2
clause 8.3
clause 8.5
clause 8.5.4
clauses 8.7 and 10.2
clause 9.1.2
clause 9.2
clause 9.3
SO 9001?
001:2015 does not have any required procedures. The organization needs to determine which procedures are needed within the QMS s
h ISO 9001?
to be kept, unless the specific requirement is excluded from the Quality Management System in the scope document.
re in ISO 9001:2015?
r, organizations may need to include them to ensure that processes occur as planned.
create one in response to a customer requirement, or as a way to compile the four mandatory documents of the QMS – scope, quality p
ope document.
nts of the QMS – scope, quality policy, quality objectives, and supplier selection criteria – into one document.