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  1. ValeriaGar
    Thread

    What do you think about remote audit during the COVID pandemic?

    How demanding are auditors during remote audits? How do you prepare for this type of audit? Do you send the material to the auditor or do you just...
    Thread by: ValeriaGar, Oct 6, 2021, 4 replies, in forum: ISO 19011 - Auditing Management Systems Guidelines
  2. ValeriaGar
    Post

    What do you think about Remote Audit during COVID 19?

    Hello John. I thought similarly to you, but I wanted to hear someone else's opinion. However, 30% is a pretty big percentage which I didn’t...
    Post by: ValeriaGar, Dec 28, 2020 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  3. ValeriaGar
    Thread

    What do you think about Remote Audit during COVID 19?

    Due to the current situation, we all switched to remote work, audit, etc. How effective do you think this way of auditing is? We know that the...
    Thread by: ValeriaGar, Dec 22, 2020, 6 replies, in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  4. ValeriaGar
    Post

    How much work to get to 13485 from ISO 9001:2015?

    I just wanted to say that it can help and speed up. I'm not saying it solves all the problems. It is easier to organize the documentation, there...
    Post by: ValeriaGar, Nov 4, 2020 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  5. ValeriaGar
    Post

    How much work to get to 13485 from ISO 9001:2015?

    If you want to implement the standard as soon as possible, then there is a software solution for you that will make your job much easier and...
    Post by: ValeriaGar, Nov 3, 2020 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  6. ValeriaGar
    Post

    Understanding the difference between ISO 13485 and 21 CFR 820

    Both are important today because companies usually choose the American and European markets. Study the standard well before starting the...
    Post by: ValeriaGar, Nov 3, 2020 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  7. ValeriaGar
    Post

    How to get ISO 13485

    Hi everyone, I agree you should start with the standard, but not only the purchase but also to understand it well. Believe me, it's not that...
    Post by: ValeriaGar, Nov 3, 2020 in forum: ISO 13485 and ISO 14969 – Medical Devices QMS
  8. ValeriaGar
    Post

    New to ISO 9001? What frustrates you about the standard?

    Thank you John. I think we can change that mindset (of certain companies) if we, as managers, work hard on it. We need to explain why something is...
    Post by: ValeriaGar, Nov 2, 2020 in forum: ISO 9001:2015 - Quality Management Systems
  9. ValeriaGar
    Post

    New to ISO 9001? What frustrates you about the standard?

    Hi everyone. When the company I work for now started implementing QMS, they were all frustrated because they didn’t know much about the standard...
    Post by: ValeriaGar, Oct 27, 2020 in forum: ISO 9001:2015 - Quality Management Systems
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