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  • Does a company need to be ISO certified to present a Quality Manual?

    Hello, I'm trying to put together a quality manual. does the company have to be ISO certified to present a quality manual? Do you all have staff that specialize in pipe, valves, and fittings?
  • Audits and MDR - Internal Audit Requirements

    Hi, my question is the requirements for internal audit. Can we conduct it in house using your internal audit package? Or does the internal auditor have to be a professional/approved auditor. Currently we are using an external consultant but if we can do it ourselves, that would be great. Thank you!

  • ISO 9001:2015 Scope

    I understand "the organization shall consider the products and services" when developing the Scope (4.3) but is it a requirement that all customer facing products and services have to be included in the scope? Thus that product/service would not be included in the Certification.

  • ISO 9001:2015 and the Accounting department

    For ISO 9001-2015 does this standard covers for the whole organization which include accounts department? If yes which all ISO clause we need to use for accounts department?

  • Who should prepare the Quality System documentation?

    I want to know who usually should do the documentation work for a quality system? QC officer or internal auditor?  I want to know the position that prepare these ISO documents.
  • 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.

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