transition (between standards or revisions to a standard)

  1. F

    MDR ISO 13485 for Class I sw/hw company to be class II due dates

    Hi, There has been debate about the date we can no longer sell out product in the EU and need to be MDR and ISO 13485 certified. We are currently a Hw/SW device class I self-certified. When will that certification be no longer recognized? 2020, 2022, 2024. I've see multi-dates and wanted...
  2. C

    Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016

    Hello Everyone, Our company is the legal manufacturer for some reagent kits and related instruments for IVD. We will be having the re certification for ISO 13485:2016, as we only had surveillance audit after the transition and we are not sure if we have sufficient updates on the documentation...
  3. Marcelo Antunes

    Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

    Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Continue reading...
  4. Marcelo Antunes

    Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485

    FDA Reveals Vision for the Transition to ISO 13485 FDA Reveals Vision for the Transition to ISO 13485 | RAPS
  5. Marc

    Jennifer's "Some observations about the upgrades" from June 2018

    Read Jennifer's comments/thoughts here: Some observations about the upgrades – Conway Business Services LLC Quick excerpt: "People are still reading too much into the standard."
  6. O

    IEC 60601-1-2 4th edition transition deadline Dec 31 2018

    Hi all, 60601-1-2 is transitioning to 4th edition and will be implemented from Jan 1 2019. Are the old products which are already approved under 3rd edition can still continue without transitioning to 4th edition? Or all the products, no matter what, if they don't have certification to 4th...
  7. Q

    Transition and recertification at the same time?

    Hello cove members Ive seen like "offers" in this link. NSF-ISR will be performing your upgrade audit as a recertification audit, this means that once successfully completed, and any resulted cars are closed, we will be able to...
  8. P

    How To Transition From AS9100c to AS9100 Rev. D

    Good afternoon. I have visited Elsmar for many years and used the valuable tools offered to improve my work experiences and those of the people around me. I hoping for more assistance and words of wisdom today as well. I have been the Quality Manager for 5.5 years here at a small machine shop...
  9. F

    IATF 16949:2016 transition audit - Internal Audit Closures

    Dear all, shall all ncr's arised during the internal audit be closed before the transition audit performed by a CB take place? More specific, we performed a full internal audit acc. IATF two months before the transition audit, still not all ncr's are closed. How to interpredte transition rule 4...
  10. W

    AS9120A to AS9120B transition

    Good afternoon everyone, New to the site. So much information. I work for a Aerospace Dist. company who has transition from AS9120A to AS9120B just over a month ago. Looks like we got hit with a couple findings and I (an ex QA manager) have been appointed to take lead in correcting the...
  11. Lancaster

    Transition date to IEC 60601-1-11:2015

    Hi, I am hoping someone may be able to help me out with the following: I am trying to understand A. the transition/application date in Europe, Australia and USA from 6060-1-11:2010 to 60601-1-11:2015 B. a high level over view of the changes between the two. Any info that someone could...
  12. Q

    Surveillance Audit of 2008 before Transition Audit to ISO 9001:2015

    Hello all, My company is currently certified to ISO 9001:2008, certificate is valid till Sept. 2018 with a surveillance audit due this March. We worked on implementing ISO 9001:2015 and want to go for a transition audit directly this month but the registrar is saying that they dont have...
  13. B

    Going into IATF 16949 transition without Internal Audits

    I've recently joined the company and am working on transition prep, a big concern is that the internal audit schedule has not been adhered to in a big way. I raised an internal non conformance, devised a new plan and started up the audits, however there is still a massive gap. I am new to...
  14. pammesue

    We have done NOTHING toward the ISO 9001 transition

    As usual, my company has done NOTHING to move forward with the ISO 9001 transition. I need to hire someone to rewrite my manual/procedures to be in compliance and lead us in the risk assessment etc. Do our internal auditor training and take care of doing the first wave of internal audits...
  15. O

    ISO 9001:2015 Transition Internal Audit completion thread

    Question about the internal audit program requirements for transition prep. We audit all topics on a 1, 2, or 3, year interval based on a risk assessment approach. All audits have been done in the last three years. IMO opinion, most audit topics can be argued to have not be affected by the...
  16. R

    Transitioning to ISO 13485:2016 from EN ISO 13485:2012

    Hello All, I have inherited a QMS system that was created and released in September 2014 to 13485 at that time. I am in the process of conforming to 2016 and I have been told that my old system which was acceptable during the last audit has to be completely revised. My source is saying that...
  17. R

    Communication of CSR's throughout the organization and who they apply to

    Went through transition audit IATF received 2 minors, one being communication of CSR's throughout the organization and who they apply to. I was thinking a matrix of the standard against each CSR requirement and who they would apply to within the organization. Does anyone have any thoughts or...
  18. T

    ISO 9001:2008 to 2015 transition - How much work to change?

    I've finally got top management to start looking at transition. That means I've been told to do it, well that's how it feels. We're a small company that's been certified to 9001 for over ten years without any NC. Well a handful of little ones that got cleared before the auditor was able to write...
  19. R

    ISO 9001:2015 Transition Quality Manual Update - Redundant Content

    Still working on updating our Quality Manual to 9001:2015. As I have been working I have found that many of our procedures seem to be somewhat redundant compared to the Policy section of our manual. I think this update is going to allow for quite a few of our old procedures to be removed from...
  20. G

    Upkeep of ISO 9001:2008 during Transition TO ISO 9001:2015

    We are a small machine shop and have applied to transfer our 9001 certification to another body. We are in the process of transitioning to 2015, the new documents have been rolled out, new audit schedule etc. They have advised us that a transfer audit will need to be carried out for the 2008...
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