Referencing ISO 9001:2015 clause for Audit

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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
If I understand what you are asking, you would have to tell us the specific audit finding(s).
 
#3
Hi Marc,

Thank you for replying. Please can you tell me if the finding was related to,
1) Procedure not being updated with current process on procedure.
2) Required Checklist referenced in procedure not filled in - no evidence provided.
3) Incorrect document numbers in procedure.
 
#4
Are these the findings of the auditor? Is this an internal audit? Which process was being audited? It's impossible to related to any specific requirement of ISO 9001 without knowing more.
 

Minda

Starting to get Involved
#5
Are you referencing a 9001 clause to an internal audit finding, or did you have an external audit that resulted in findings that are not tied to a 9001 clause?

For internal audits I follow this formula:
<insert document or standard name and version/revision> states in <section identification information>: "<quote the standard here>". During an internal audit of <identify the process audited> it was found that <list your finding here>. This is supported by the following objective evidence:
*<item 1>
*<item 2>
...so on and so forth.

If you have findings from an external audit that are not tied to a standard or document then I feel that is poor practice on the part of your auditor. Either way, more background information is needed in order for someone on the boards to answer your question properly.
 

Randy

Super Moderator
#6
Most likely 7.5.2 Creating and updating, it's what I've been referencing and nothings been kicked back or complained about yet
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#7
I agree with Randy for #1 and #3, but #2 sounds like a process control issue or maybe failure to keep documented information - that would reference the process the checklist was used for. What process was it?
 

dsanabria

Quite Involved in Discussions
#8
Hi,

Please can someone help me with Referencing ISO 9001:2015 clause for specific Audit Findings
Can you copy / paste the non conformance - Presently, you are asking for is to help you with everything that an auditor will find - not possible, so if you copy / paste the NCR (internal / external) we can provide feedback...

Waiting for your response... :))
 
#9
Hi AndyN, Please see below for non-conformances.
Non-conformances: Findings

1. No evidence provided to show that NPI Checklist referenced in procedure, Document Number 031000194 was completed for DSD 4137 project.
2. No Evidence provided for Stage Gate referenced as Point 6 in procedure.
· Product Review – procedure stipulates meeting must be held with relevant teams to get consensus on whether to proceed to the next phase. Production Readiness Review for DSD 4137 Project, document number: 117000027 also have record that the Product Review was not approved.
· Production Readiness Review – Although meeting was held to complete Production Readiness Review checklist for DSD 4137 project, many action items on document number: 117000027 were left open and not closed out. No evidence of Production Readiness signoff as the document is still on Preliminary status.
3. The procedure for Project Asset Management is not being followed. There is no evidence to show that the identification, logging and tracking of project assets takes place for both customer and other project assets. No evidence was found for the tracking of DSD 4137 project tooling using the existing Project Asset Tracking list process.
4. The Asset Tracking register referenced on Document Number: 030000421 is not filled in. Project Asset tracking also does not done on Enterprise Project Management (EPM) system as stated on procedure.
 

dsanabria

Quite Involved in Discussions
#10
Were this finding from a customers or an internal audits - they don't look like they were written from a third party - CB auditor.

If they are internal or customers then they look like opportunities for improvements.
 
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