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  • ISO 9001 Quality Inspection Records

    We have some standard quality inspection records.  Basically they are spreadsheets that have a checklist for each product we make where we verify our product meets specifications (for example, height, weight, etc) and then we mark down whether it’s passed or not. Do these inspection records need to be considered as controlled documents?  Do they need to be given a document number, revision level, and approval?  Do they need to be kept on the document control master list?

  • 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.

  • 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.

  • ISO 9001 and fertility centers

    Is ISO 9001 certificate valid for fertility centers?"

  • Integrating ISO 14001 & ISO 45001 into ISO 9001

    A client has iso 9001 and he needs implement iso 45001 & iso 14001. What documents I should to ask him and how we will give him implement those iso?