Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line

N

Nvenuto

#1
Hi there, I'm new to the forum and this is my first post. :bigwave:
I work for a company that designs and manufactures Research Products (for use in animals) and medical devices.
Our US office is ISO 13485 (and FDA) certified as they design and produce the human use devices. The Auckland office (where I am) has no certification, we design and manufacture the research products. We are looking into implementing either 9001 or 13485.
Even though the Auk office only does research products, in the (near) future we could be doing design for medical devices (but not manufacturing).
Due to our lack of resources (I?m it for the Quality department and new to the industry) I was wondering if it were possible to:

Design Control be ISO 13485 certified (applicable to our current research products and for future medical device design)
Manufacturing be ISO 9001 certified (since we will not do medical device manufacturing)

I?m in the process of carrying out a gap analysis, one for 9001 and one for 13485, and was thinking of putting the above forward as an option. But, I don?t even know if that?s ?acceptable? in the ISO industry.

Thanks for your input!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product lin

Hi there, I'm new to the forum and this is my first post. :bigwave:
I work for a company that designs and manufactures Research Products (for use in animals) and medical devices.
Our US office is ISO 13485 (and FDA) certified as they design and produce the human use devices. The Auckland office (where I am) has no certification, we design and manufacture the research products. We are looking into implementing either 9001 or 13485.
Even though the Auk office only does research products, in the (near) future we could be doing design for medical devices (but not manufacturing).
Due to our lack of resources (I?m it for the Quality department and new to the industry) I was wondering if it were possible to:

Design Control be ISO 13485 certified (applicable to our current research products and for future medical device design)
Manufacturing be ISO 9001 certified (since we will not do medical device manufacturing)

I?m in the process of carrying out a gap analysis, one for 9001 and one for 13485, and was thinking of putting the above forward as an option. But, I don?t even know if that?s ?acceptable? in the ISO industry.

Thanks for your input!
Hello and welcome to the Cove :bigwave:

AFAIK there's no option to be certified to ISO 13485 excluding everything BUT Design & Development (the opposite is possible sometimes).

IMO the most efficient solution for you is (assuming that you actually need certification, not just a QMS implementation) is to go for dual certification - ISO 9001+13485 - and exclude everything in ISO 13485 that is directly related to manufacturing medical devices.

Cheers,
Ronen.
 
N

Nvenuto

#3
Re: Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product lin

Hi Ronen,

A follow up question if you don't mind. So for the 9001 cert would we include everything except design control or are you recommending the whole system be 9001 compliant?

From what I have researched the main difference btwn 9001 and 13485 is the continuous improvement and customer satisfaction parts, so I guess if we structure our design control with 13485 in mind it should be a breeze to comply with 9001 product realization section. Is that a correct statement?
Thanks,
Natalia
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product lin

Hi Ronen,

A follow up question if you don't mind. So for the 9001 cert would we include everything except design control or are you recommending the whole system be 9001 compliant?

From what I have researched the main difference btwn 9001 and 13485 is the continuous improvement and customer satisfaction parts, so I guess if we structure our design control with 13485 in mind it should be a breeze to comply with 9001 product realization section. Is that a correct statement?
Thanks,
Natalia
Hi Natalia,

I wouldn't have excluded ISO 9001 D&D, because (you stated) you do design some products outside ISO 13485's scope: "we design and manufacture the research products" (=animal use). Are you concerned over some contradiction between the D&D sections in ISO 13485 and ISO 9001? Such contradictions (if any) are normally workable; if your CB auditor points out a residual "contradiction" during review/audit/certification, they are likely to either tell you exactly what you need to change to avoid it, or indirectly point you in the right direction towards compliance with both standards.

Yes, for the most part ISO 9001 reqs are a subset of ISO 13485 reqs. You have correctly identified the areas of biggest difference, IMO.

Cheers,
Ronen.
 
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