ISO 9001 vs ISO 13485 or both? A QMS for a Design and Development Company

E

eileenr

#1
Hello,
I am just out of college and have just started my first quality role. I am creating a QMS for a design and development company. Initially I was going for ISO 13485 certification as the product in development is a medical device. However, it has been suggested that I get certification for both ISO 9001 and ISO 13485. The clients are quality naive and I was concerned about the continuous improvement element, however, I will be including a CAPA procedure so that should cover that, and internal audits will be performed, there are no customers as of yet.

I have noted that most companies implement ISO 9001 followed by ISO 13485 and not the reverse.

Any advice would be appreciated.

Furthermore, on the scope of certification would you just go for design and development or would you include manufacture and sales although they are down the line a bit.

Keep in mind I am a new graduate with little experience!!!!:)
 
Elsmar Forum Sponsor
#3
Hello,
I am just out of college and have just started my first quality role. <snip>
Welcome to the Cove eileenr ~~~
When you do all that is required for ISO13485, you can get the ISO9001 almost for free, both in your QMS implementation and QMS certification. Talk to your CB how they can do it for you most economically.
Your scope for a QMS is something that you are already doing and have evidences of the same. Likewise the scope enhancement can be done at a later date, once you have done something more, like the manufacture and sales. You get certified after you DO and not for your thoughts down the pipeline.
 
Last edited:

DannyK

Trusted Information Resource
#4
Hello,
I am just out of college and have just started my first quality role. <snip>
Before deciding on whether to implement ISO 9001 or ISO 13485, it is important to find out the classification of the medical devices in the regions that you want to sell the medical device. For example if you are interested in selling these devices in USA, then a quality system based on 21 CFR 820 may be required. For Canada, you require ISO 13485:2003 and CMDR part 1 requirements for class II, III & IV medical devices.
 
F

frank M

#5
Don't you have to add continuous improvement and customer satisfaction processes to your QMS? These go beyond 13485 requirements of meeting customer requirements and maintaining effectiveness of QMS.
 
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