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3rd Party Supplier Audit in China: ISO 13485 & 21 CFR 820

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Lindy, Apr 17, 2019 at 3:51 PM.

  1. Lindy

    Lindy Member

    Jan 10, 2018
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    Hello everyone.

    I was wondering if anybody could recommend a good company that can perform an on-site audit in China to ISO 13485 and 21 CFR 820 requirements.

    My company wants to use a medical device manufacturer (for class 1 devices) that is located in China. I was scheduled to travel to China earlier this year to perform the on-site audit, however my company's legal department decided against allowing me and another employee travel to China amid the growing tensions between our two countries.

    After requesting procedures in preparation of the audit I thought I'd be going on earlier this year, I found some discrepancies and concerns. It could be a translation issue, however I would not be comfortable approving this supplier without an on-site audit.

    An audit via Skype isn't ideal since there is a 12-hour time difference. Therefore, the next possible way to perform this audit is by hiring a 3rd party to perform it on our behalf. I want to make sure we use a good company and I'm hoping for any recommendations.

    Thank you!
  2. John C. Abnet

    John C. Abnet Well-Known Member

    May 23, 2017
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    Good day Lindy;
    Apologies in advance that I can't answer your specific question.

    I can, however, be "that guy" and point out an error that is more than semantical. Since your organization is intending to audit a potential supplier (external provider), the audit is actually a "2nd party" and not a 3rd party audit. A 3rd party audit is one conducted by an entity with no direct vested interest (i.e. a registrar).

    Apologies again for being "that guy" but this is worth pointing out.

    Best of luck in arranging your audit.

    Be well.
    Andy Nichols likes this.

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