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ISO 9001 - Expert Advice Community



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  • How to assess all Vendors/Suppliers (8.4)

    My company have many Suppliers (about 1000 company). How can I assess and audit them according to 8.4 ISO 9001?

    It's very hard to do that!!! Please advise me.

  • ISO 9001 - Company's organization log

    I came from a company that was ISO 13485 certified and there, as doc control, I maintained a form log that designated form numbers to all forms used within the organization. I have since moved on to a new company that retains only an ISO 9001 certification, but my question is, is it necessary to still retain this kind of specificity to the forms used? For example, should the company's organization log contain a form number and revision, and have a log as to when it was created and by whom? Or is it alright to have it posted without any of that identity as a free standing document? I ask this because as I perform an internal audit on a give process, I find myself needing to reference their org chart, but am hazy as to how controlled it needs to be. Does this make sense? Please advise.

  • Concerns with performing an internal audit

    Auditing to the Standard is one thing, but advice on auditing the key processes is more difficult.  How do I evaluate the key processes for full compliance and for usefulness?

  • Subsidiary Response to Supplier Survey When Only Parent Company is ISO Certified

    Our site is not currently ISO certified but our parent company is (we were recently acquired, we provide similar products).  It is not clear to me how to best and accurately respond to the supplier survey questions as it relates to Inspections by regulatory bodies and our QMS. The parent company has been audited by regulatory bodies against the QMS that we are not fully integrated into (working on it) but the site has been added to the Quality Manual Scope.  My thought is to simply respond as our own entity with the company name and make sure to specify on a note that this site is not certified.  Is that the best approach?

  • Legal Documents for Railway Station

    Please guide what legal documents are required for the re-certification audit for iso 9001 & iso 14001 standards provided to Railway Station.

  • ISO 9001:2015 Clause 6.2.2.

    I have a question on ISO 9001:2015 Cl.6.2.2." When planning how to achieve its quality objectives, the organization shall determine: e) how the results will be evaluated". What is meant by that?

  • ISO 9001 to Software companies

    Does ISO 9001 internal Audit course work for Software company

  • Air Traffic Control Technology

    "I was exploring ISO 9001 and I noted a reference to aerospace additions in AS9100. 

    Our Company is ISO9001 certified, but we have interest in the procurement of Air Traffic Control Technology.

    The only question at the moment as we specify ISO 9001 for suppliers should we also reference AS9100?"


  • The difference between QMS and TQM

    Please is there any difference between QMS and TQM. Its sort of confusing to me. Appreciate any clarification

  • KPIs to measure results

    I just want to know how I can factor in the KPIs to measure my results in accordance with clause 9... Performance evaluation and 10. Improvements.

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