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  1. Kishnu Vaarma ROSS
    Post

    ISO 13485

    Hi Andy, firstly thanks a mil for all the advices and guidance you've shared in this forums.. its really amazing help to the rest of us! There's...
    Post by: Kishnu Vaarma ROSS, Nov 14, 2022 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  2. Kishnu Vaarma ROSS
    Post

    ISO 13485

    Thank you for your feedback! much appreciated :)
    Post by: Kishnu Vaarma ROSS, Nov 10, 2022 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  3. Kishnu Vaarma ROSS
    Thread

    ISO 13485

    Hi, my company is due to have its Stage 1 certification audit coming January. My question is that whilst the QMS and its associated procedures are...
    Thread by: Kishnu Vaarma ROSS, Nov 3, 2022, 3 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  4. Kishnu Vaarma ROSS
    Post

    ISO 9001 and ISO 13485

    In terms of its clauses, for example : Clause 4 talks about QMS : can I just state, for this clause it is fulfilled and validated from QMS...
    Post by: Kishnu Vaarma ROSS, Aug 23, 2022 in forum: ISO 9001:2015 - Quality Management Systems
  5. Kishnu Vaarma ROSS
    Post

    ISO 9001 and ISO 13485

    I dont quite follow your statement there?
    Post by: Kishnu Vaarma ROSS, Aug 23, 2022 in forum: ISO 9001:2015 - Quality Management Systems
  6. Kishnu Vaarma ROSS
    Post

    ISO 9001 and ISO 13485

    Hi, I am now currently developing the QMS for ISO13485, integrated from our HQ QMS. Question is can I just put in reference statement in the new...
    Post by: Kishnu Vaarma ROSS, Aug 23, 2022 in forum: ISO 9001:2015 - Quality Management Systems
  7. Kishnu Vaarma ROSS
    Post

    ISO 9001 and ISO 13485

    Hi, This is my plan, since the company as a group is certified ISO 9001, I am planning to create a new QMS for the subsidiary company and have it...
    Post by: Kishnu Vaarma ROSS, Aug 15, 2022 in forum: ISO 9001:2015 - Quality Management Systems
  8. Kishnu Vaarma ROSS
    Post

    ISO 9001 and ISO 13485

    Super stuff! Thanks John! Have a great one!
    Post by: Kishnu Vaarma ROSS, Aug 12, 2022 in forum: ISO 9001:2015 - Quality Management Systems
  9. Kishnu Vaarma ROSS
    Post

    ISO 9001 and ISO 13485

    Also, if I am to carry out the internal audit, should I have to go through the internal auditor training externally as part of staff competency...
    Post by: Kishnu Vaarma ROSS, Aug 12, 2022 in forum: ISO 9001:2015 - Quality Management Systems
  10. Kishnu Vaarma ROSS
    Post

    ISO 9001 and ISO 13485

    Hi Andy, so the best way forward is to carry out a gap analysis between the two : 1. Fill in the blanks to best reflect our new company ISO13485....
    Post by: Kishnu Vaarma ROSS, Aug 11, 2022 in forum: ISO 9001:2015 - Quality Management Systems
  11. Kishnu Vaarma ROSS
    Thread

    ISO 9001 and ISO 13485

    Hi distinguished members! I would really appreciate your expert advice on this matter that I find myself in. The current organisation is ISO...
    Thread by: Kishnu Vaarma ROSS, Aug 11, 2022, 15 replies, in forum: ISO 9001:2015 - Quality Management Systems
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