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  • 1.  ISO 13485 Certification Audit

    Posted 10-Sep-2021 13:51
    What are other's experiences in terms of timelines from completion of an ISO 13485 audit to issuance of their certificate from their auditing organization?

    Sandra Veenstra
    Director- Quality Assurance and Regulatory Affairs
    Picomole Inc.


    Our commitment to quality saves lives.

    191 Halifax Street, Moncton, NB
    (506)855-2400 ext. 234 (office)
    (709)699-4972 (mobile)
    www.picomole.com





  • 2.  RE: ISO 13485 Certification Audit

    Posted 10-Sep-2021 16:24
    Edited by Lance Tovar 10-Sep-2021 16:30
    Hi Sandra,

    It depends on how the closing meeting goes with the Auditor.  For example, if you have a couple major findings, then the auditor will give your company 30 days to correct any NCs, in which, will delay your certification. Now, if you pass your audit, then the auditor generally takes about a week or so to write up the report and submit that to his/her registrar. Then, once they review the written report, they will issue your certification via mail, which can take up to a couple weeks.

    Now this has just been my experience... there are probably several people here with way more advise on the matter then what I was able to provide.

    Hope this Helps,
    Cheers!

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    Lance Tovar
    RA/QA Specialist
    Roy UT
    United States
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    Original Message


  • 3.  RE: ISO 13485 Certification Audit

    Posted 12-Sep-2021 07:56
    It takes typically one month after the corrective action plan is accepted. 

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    Ajit Basrur
    Worcester MA
    United States
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    Original Message


  • 4.  RE: ISO 13485 Certification Audit

    Posted 10-Sep-2021 17:54
    Hi Sandra,
    In my experience it's generally been a couple of months.

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    Hiral Dutia
    Regulatory Affairs Manager
    Third Pole Therapeutics
    Waltham, MA
    USA
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    Original Message


  • 5.  RE: ISO 13485 Certification Audit

    Posted 11-Sep-2021 01:42
    Edited by Aiste Simokaitiene 11-Sep-2021 01:43
    Hi Sandra,

    From my experiences after closing an audit Auditor gives you some time (usually up to 2 weeks) to plan your corrective actions and get auditors approval for it. This can take some time if approval wasn't reached from the first time but this time intervals depends mostly on you and your corrective actions plan.
    After corrective actions plan is acceptable for both sides, auditor pass his findings to reviewers and this is where the timeframe is getting very fuzzy and does not depend nor on you nor on auditor and can take about 1-3 months.

    Hope this helps

    Best wishes,

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    Aiste Simokaitiene
    Kaunas
    Lithuania
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    Original Message


  • 6.  RE: ISO 13485 Certification Audit

    Posted 11-Sep-2021 14:40
    Really depends on the Audit Organization or Notified Body and how loaded up that origanization's accrediation body is.  Could take anywhere from a couple weeks after the approved final report is passed on from the auditor (after all corrective actions are approved by the auditor - remember the accreditation body has a review committee that also is reviewing the audit package in many cases before issuing the certificate) to upwards of I have seen over 6 months later due to high workload at times.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


  • 7.  RE: ISO 13485 Certification Audit

    Posted 12-Sep-2021 08:02
    Good day Sandra,

    I have to comment along with Leo, it really depends if you are using a Notified Body (European certification only), Auditing Organisation (MDSAP certification only), or just a certification body to ISO 13485.  Also like to comment it also depends highly on the nonconformities which were identified because different bodies have different reviews or requirements for how these are addressed depending on the risk severity of the finding perceived by the auditor or by the reviewing team.  A certification body only can be a few weeks, whereas an NB or AO can indeed take months (to many months) to get the actual certificate.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 8.  RE: ISO 13485 Certification Audit

    Posted 13-Sep-2021 07:59
    Good Day Sandra,

    Our closing meeting was January 19, 2021 and our certificate was issued February 26, 2021.  We had no nonconformances.  During the closing meeting we were told to expect the certificate in 45 - 60 days if there were no concerns internally about the audit findings.

    Best of luck,

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    D Michelle Williams
    VP - Operations
    United States
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    Original Message


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