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Non-medical device is in the ISO 13485 audit scope?

L

luloo117117

#1
#1
Hello,

One question: our company, a medical device company, makes medical and non-medical products. We are applying ISO 13485 now, but not sure our non-medical products should also comply with our quality system and are audited by BSI auditor too?

Thanks

Leon
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
#2
In as far as the product is not part of the scope of your certification then it should not be audited. However, it may be listed on your certificate as well and then BSI can and should audit it.
:bigwave:
 
H

harry

Super Moderator
#3
#3
luloo117117 said:
Hello,

One question: our company, a medical device company, makes medical and non-medical products. We are applying ISO 13485 now, but not sure our non-medical products should also comply with our quality system and are audited by BSI auditor too?

Thanks

Leon
Click to expand...
Discuss and seek advice from your CB.
 
Y

yodon

Staff member
Super Moderator
#4
#4
We're in a bit of a similar boat. We have a single quality system for all the work we do - including medical and commercial. In our quality system, we define projects that are either fully in scope (13485) or not. For those that are not in scope, we define what aspects of the quality system apply. For example, no matter what we do, we control our documents the same way. Thus, Document Control applies to all projects. We have a matrix in our quality system that lays out what the various project types must comply with in the system.

When we are audited, the auditor asks for evidence of compliance from the various project types. (We also keep a table listing each project and what type it is).

Very straight forward and clear to the auditor. Hope that helps. This is just OUR approach. The recommendation by harry to discuss with your CB is sound.
 
R

Roland Cooke

#5
#5
ISO13485 can apply to related activities, not just devices. Sterilization companies, component manufacturers, translation companies, Authorised Reps etc can also hold ISO13485..

Possibly what you want to consider is additional registration to ISO9001, for any activities that fall outside of ISO13485.
(Some registrars would charge for this which might make it an unviable option. SGS doesn't charge, just fyi).
 
somashekar

somashekar

Staff member
Super Moderator
#6
#6
luloo117117 said:
Hello,

One question: our company, a medical device company, makes medical and non-medical products. We are applying ISO 13485 now, but not sure our non-medical products should also comply with our quality system and are audited by BSI auditor too?

Thanks

Leon
Click to expand...
Hii...
We have been successful in clearly defining in the scope, the products covered under the ISO 13485 QMS and the ISO 9001 QMS. During the audit process, the same has been considered and audited and certified. This is done after discussions had with our certifying body. So I am sure you can have a clear way of doing this when you define the scope well in your level I document itself....
Good Luck...
 
M

MIREGMGR

#7
#7
Per the present revision of MDD, some products that are used in a medical context are PPDs instead of medical devices.

It seems obvious that a medical device company that markets surgical facemasks needs a quality system to control that activity. 13485 should work that way.

It's not directly relevant to 13485, of course, but my understanding is that the FDA regards surgical facemasks as personal protective devices rather than medical devices, but nonetheless considers them to be within its purview and governed by the QSR.
 
R

Roland Cooke

#8
#8
Your product only needs to be regulated as a medical device in any of the countries you intend to market for your ISO13485 scope to include it.
 
R

rthompson

Starting to get Involved
#9
#9
yodon said:
We're in a bit of a similar boat. We have a single quality system for all the work we do - including medical and commercial. In our quality system, we define projects that are either fully in scope (13485) or not. For those that are not in scope, we define what aspects of the quality system apply. For example, no matter what we do, we control our documents the same way. Thus, Document Control applies to all projects. We have a matrix in our quality system that lays out what the various project types must comply with in the system.

When we are audited, the auditor asks for evidence of compliance from the various project types. (We also keep a table listing each project and what type it is).

Very straight forward and clear to the auditor. Hope that helps. This is just OUR approach. The recommendation by harry to discuss with your CB is sound.
Click to expand...
Yodon, Would you be willing to provide an example of your matrix? Much thanks.
 
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