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Equipment SOPs

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nomi P, Jan 28, 2016.

  1. Nomi P

    Nomi P New Member

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    Is there a regulatory requirement (either ISO 13485 or FDA CFR) to have a written SOP/work instruction for each piece of laboratory equipment, available in the immediate vicinity of the equipment in the lab? Or is it enough to have a scanned copy of the manufacturer's "Quick Start" guide (or equivalent) nearby? Currently our company has a combination of in-house written "mini IFUs" for equipment, and scanned copies of the manufacturers' quick start guides. I would like to find out if this is acceptable, or if these mini IFUs for equipment need to be standardized/controlled. Thanks!
     
  2. yodon

    yodon Active Member

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    The intent of the regulations is to ensure that you consistently make the product that you verified (i.e., the manufactured product will meet the specifications). If there is an opportunity to use the equipment in a way that could jeopardize those goals, you should have some way to ensure that can't happen. Do your operators use the mini IFUs? Do they maybe use hand-marked-up copies (worst case!!)? If they need them to ensure the processes are carried out consistently, then you should control them. If they don't use them at all, you should purge them (presuming there's no opportunity for deviation as a result).

    If you do control them, you'll need to ensure you know to whom they are distributed. Same with the manufacturer's quick start guide. If it's needed then you should control it and know where copies are distributed.
     

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