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  • 1.  Retention Period for Training record

    This message was posted by a user wishing to remain anonymous
    Posted 31-May-2017 09:20
    This message was posted by a user wishing to remain anonymous

    Hi all,
    I would like to know what is the retention period for QMS training record, especially for ISO 13485?

    Thanks!


  • 2.  RE: Retention Period for Training record

    Posted 31-May-2017 10:17
    Edited by Kevin Randall 31-May-2017 10:25
    Revising/paraphrasing to protect ISO 13485 copyright and to add FDA requirement:

    ISO 13485:2003 clause 4.2.4 /ISO 13485:2016 clause 4.2.5:  For the lifetime of the device as defined by your firm, but not less than two years from the product release date, or as specified by regulatory requirements.

    FDA 21 CFR 820.180(b): For a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------

    Original Message


  • 3.  RE: Retention Period for Training record

    Posted 01-Jun-2017 09:01
    My company and most companies I've worked for go for the duration of employment plus 5 years. You could also say the duration of employment plus the lifetime of the device.


    ------------------------------
    Keri Froese RAC
    Quality Assurance Manager
    Spartan Bioscience
    Dunrobin ON
    Canada
    ------------------------------

    Original Message


  • 4.  RE: Retention Period for Training record

    This message was posted by a user wishing to remain anonymous
    Posted 02-Jun-2017 09:07
    This message was posted by a user wishing to remain anonymous

    Hi Kevin and Keri,
    Thank for the input. This is very helpful.

    Original Message


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