QC Audits and Product Audits in a Service Provider

  • Thread starter Workability_Explorer
  • Start date
W

Workability_Explorer

#1
Have you conducted product audit (service provided-operation) with previously prepared checklist, that kind of checklist is a template with constant points to be checked wherever you audit the same area you will check the same points.
Some call this Product Audit while others call it QC Audit!

If yes do you consider this type of audit is in comply with 8.2.2 clause of ISO 9001:2008?
what do you call this type of audit?
Where you may identify OFI in such audit?
 
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J

Joanb

#2
Re: QC Audit/Product Audit

My company does Internal Quality System Audits with prepared checklists that we created to address all of the FDA regulations for medical devices which we manufacturer. We are not ISO certified. :bigwave:
 
#3
Re: QC Audit/Product Audit

Have you conducted product audit (service provided-operation) with previously prepared checklist, that kind of checklist is a template with constant points to be checked wherever you audit the same area you will check the same points.
Some call this Product Audit while others call it QC Audit!

If yes do you consider this type of audit is in comply with 8.2.2 clause of ISO 9001:2008?
what do you call this type of audit?
Where you may identify OFI in such audit?
Such audits will NOT meet the requirements of ISO 9001, because they are not QMS audits, by their very nature. It is an expectation that ISO 9001 8.2.2 audits will be based on process(es) or systems, not product or QC activities. It will result in a MAJOR non-conformity.
 
D

DrM2u

#4
I have conducted product audits both on finished products ready to ship (aka dock audits) and while in process (reffered to as QC audits). A prepared or standard checksheet helps with the audit to ensure that all aspects of the product (material, dimensions, preservation, storage, etc) are covered, but is not mandatory for a versed auditor. Like Andy said, such product audits no not meet the requirements of ISO 9001 8.2.2 on their own; however they could be considered part of the QMS audit by the organization. Product audits could be considered as part of the product realization process validation and/or verification. This is just my opinion.
 
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