ISO 13485 certification and consultation

2 Replies

ISO 13485 certification and consultation

Posted by Tyler Tsugita on Jan 4, 2019 10:25 am

Hello Everybody

My company (9001/17100 certified) is now in the process of investigating certification in 13485 (Med Device). We are a language services provider, so our connection to medical devices is in the translation/localization of documentation, applications, etc. We have no hand in any manufacturing aspects. With that, I was wondering if anyone here had undergone certification for 13845 as a services provider, rather than a manufacturer?

We are trying to ensure this process is as efficient and effective as possible, so any known resources would be superlative. Thank you all.


Re: ISO 13485 certification and consultation

Posted by Imran Rana on Jan 8, 2019 1:49 pm

As i have observed, ISO 13485;2016 is more advantageous for technical processes than the service operations where ISO 9001 certification will suffice. However, there is a good book "ISO 13485:2016 A Complete Guide to Quality Management in the Medical Device Industry" , i have found this helpful in my certification projects This may help you providing additional guidance on the subject. (especially pages 110-113).

Re: ISO 13485 certification and consultation

Posted by Stephanie Gaulding on Jan 9, 2019 8:43 am

Hi Tyler,

I am a consultant in the industry (worked for several organizations in support of their ISO 13485 certification) and have seen some medical device service providers, such as your company would be, obtain an ISO 13485 certification in addition to ISO 9001 and other relevent ISO certifications. Since you aren't a manufacturer of medical devices, some of the ISO 13485 standard would not be applicable. Unfortunately, I'm not sure you'll find a resource specific to your situation, but Imran mentioned a book that would help on interpretation and application of the standard in his post. I would recommend that your company start with a detailed review of the standard and identify clauses that are applicable to the service that you provide and those that are not applicable to your work - paying particular attention to clauses 7 and 8. There are likely many of these that are not applicable to your translation service as they are geared at device design and manufacturing. Once you have the applicable clauses, I'd do a gap analysis of your current QMS against the 13485 requirements you've identified as applicable. That would quickly tell you how much work may be required, if any, to support obtaining certification to the ISO 13485 standard.

Feel free to reach out if you want to chat about this further.

Hope this helps!

Stephanie Gaulding, CQA, CPGP, Chair-Elect Human Development & Leadership Division and Principal Consultant @ DPS Group