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  • 1.  Retention for obsolete QMS procedures

    Posted 07-Apr-2018 11:24

    What is an appropriate retention period for obsolete quality system procedures? I cannot find anything specifically mentioning this.

    Should the retention period be tied to the life cycle of the devices that were manufactured while those procedures were current?

    Thanks



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    Travis Scott
    Rifton NY
    United States
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  • 2.  RE: Retention for obsolete QMS procedures

    Posted 10-Apr-2018 13:44
    Are you talking specifically QMS level documents and not documents used to manufacture the product.

    If that is the case then as I understand the reg's it is up to you as a company to define the period for at least one copy of the obsolete document must be kept.

    I am assuming that you are also taking about a hard copy? We use an electronic system therefore the clause is slightly redundant. That being said we still define it as 5 years after the life of the device just to be consistent.

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    Keri Froese RAC
    Quality Assurance Manager
    Ottawa ON
    Canada
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    Original Message


  • 3.  RE: Retention for obsolete QMS procedures

    Posted 10-Apr-2018 14:40

    ISO 13485:2003 Clause 4.2.3 requires, "The organization shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record, or as specified by relevant regulatory requirements".

    This means that if you use a procedure to populate a record, the retention period for the procedure must be at least as long as the resulting record.

    ISO 13485:2016 Clause 4.2.4 carries over the same requirement, "The organization shall define the period for which at least one copy of obsolete documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record, or as specified by applicable regulatory requirements".

    Notice that it drops the adjective "controlled" from the original phrase "obsolete controlled documents".

     

     



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


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