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ISO 13485 vs CFR 820

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by PoojaN, May 26, 2016.

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  1. PoojaN

    PoojaN New Member

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    So I'm a new grad who was just hired as my company's QA manager. We're a small company and classified as a initial distributor since we don't have manufacturing or device development. We already have 21 CFR 820 compliance but I'm trying to figure out how to get to ISO 13485. So I have questions. Broadly, I know what the major differences are but I'm wondering what some of the details are that I should look out for since there's so much overlap. Also, if we sell to foreign businesses do we need recall procedures?

    Since I'm very new at this, help is very much appreciated!
     
  2. Vintage Goose

    Vintage Goose Active Member

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    Hi, as you say there are many similarities between the QSR and ISO13485. However I would strongly recommend obtaining a copy of the new 13485 and performing a gap analysis.

    You need recall procedures to comply with the local regulation on the countries you sell to, as well as for the FDA.
     
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  3. MarkMeer

    MarkMeer Well-Known Member

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    I second Vintage Goose's advice: It's worth purchasing a copy of the standard so you can reference it yourself.

    Check out this thread for discussion on outlets for purchasing a copy.

    As for "how to get ISO 13485", are you seeking just to make your system compliant, or are you seeking formal certification? If the latter, there will be the additional cost of sourcing a certification body and having them conduct annual on-site audits...
     
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  4. PoojaN

    PoojaN New Member

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    From what I understand (this is my first week on the job) we're trying to get certified. We're trying to get into the international markets and some of these countries we're trying to break into require that we be ISO certified in order to be able to sell in their country.

    At this point, we're not prepared for an audit. There's a QS in place but like i mentioned, it's not ISO 13485 compliant

    Thank you both though for the advice
     
  5. Marc Smith

    Marc Smith Moderator

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    I'll third that. If you don't have a copy of the standards (and read and understand them) - Well, see my avatar - You are lost.
     

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