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iso 13485:2016

  1. Ann Hannan
    Thread

    Hello from Virginia - not new to Quality Systems

    Found this place because I was looking for more information about people who work from home and how it might relate to the IATF 16949 explanation...
    Thread by: Ann Hannan, Aug 31, 2022, 1 replies, in forum: New Member Introductions
  2. Praveen Gunasekaran
    Thread

    Does ISO 9001:2015 require CSV

    Hi my organization is a ISO 13485 and ISO 9001 certified, we have certain product lines that are fully under ISO 13485. Some products line are...
    Thread by: Praveen Gunasekaran, Aug 10, 2022, 9 replies, in forum: ISO 9001:2015 - Quality Management Systems
  3. Kamil
    Thread

    Clean Room Environments Specifications

    Hello All, What should temperature, humudity and pressure parameters be for cleanroom class 3, class 4 and class 5, and what could be the source...
    Thread by: Kamil, Feb 22, 2021, 1 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  4. Lindy
    Thread

    ISO 13485:2016 Procedures in China

    Hi everyone, I'm hoping somebody has some experience performing on-site supplier audits in China. Last year I performed my first on-site audit...
    Thread by: Lindy, Nov 4, 2019, 1 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  5. MarkMeer
    Thread

    Does requirement to validate QMS software rule-out cloud-based apps?

    Curious: The just-released ISO 13485:2016 will require vigilance regarding validation of QMS software. I'm wondering to what degree this would...
    Thread by: MarkMeer, Feb 29, 2016, 16 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
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