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ISO 9001 - Expert Advice Community

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  • ISO 9001:2015 and health care organization

    I work as Quality Manager for a Home healthcare Organization in India and would appreciate some clarity on the following:

  • Questions regarding Management Representative

    1. In what extents, a QMR must have to qualify?

  • Risks and opportunities and Leadership requiremnets

    My organization is ISO 9001:2008 certified organization and QMS is already in place.

  • ISO 9001:2015 requirements and clasues

    I hope you can help me as I have been studying the standard for quite some time now.

  • What % of companies have already transitioned to ISO 9001:2015?

    I was trying to do research to understand what % of companies have already transitioned to the 2015 standard? Top management is asking because we have completed the transition in the US but still need to do so in Europe. I would love some educated guesses or data that I could supply to them.

  • Certification audit findings

    In stage one Audit what we should find as auditor ? Some say just write a report on observation but do not address it as a non-conformity.

  • Document control

    In regards to Document Control, can people check out native copies of the documents from the document library? My way of thinking is that the library is the controlled environment, and it is only the re-submissions and revisions that needs to be controlled again. People checking out natives, does not have a negative impact, unless changes are made and the document does not become controlled. I think my organisation is a lot more mature than our staff to do that.

  • Evidencing organizational knowledge

    Regarding organizational knowledge evidence. What evidence of org knowledge will be checked by auditor?

  • FMEA and addressing opportunities in ISO 9001

    Failure Mode Effect Analysis and Control Plan are used in automotive world, in order to control the risks, however the opportunities how can we addressed, is it enough to do with a continuous improvement? your comments will be appreciated, thanks.

  • HACCP and hierarchy of documents

    Pls let me know in 4 levels of documents, where does HACCP manual falls..
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