Current Medical Device under 9001 Excluded from future ISO 13485

D

Dasani

#1
This is my first post.

I work for a small contract manufacturer accredited to ISO 9001. 60% of our CURRENT business would fit the description of medical devices. These CURRENT medical device customers only require ISO 9001:2000. The balance is mixed industries.

We have a potential NEW medical device customer that is requesting ISO 13485 certification for the sub assemblies that we would manufacture. We have had a couple of gap audits. If we continue to proceed with 13485 certification, could our CURRENT medical device customers be excluded since they only require 9001?

We need to evaluate our resource requirements should we continue with 13485 and the risk analysis that would be required for our current business.

Thanks in advance for your help.
 
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Al Rosen

Leader
Super Moderator
#2
This is my first post.

I work for a small contract manufacturer accredited to ISO 9001. 60% of our CURRENT business would fit the description of medical devices. These CURRENT medical device customers only require ISO 9001:2000. The balance is mixed industries.

We have a potential NEW medical device customer that is requesting ISO 13485 certification for the sub assemblies that we would manufacture. We have had a couple of gap audits. If we continue to proceed with 13485 certification, could our CURRENT medical device customers be excluded since they only require 9001?

We need to evaluate our resource requirements should we continue with 13485 and the risk analysis that would be required for our current business.

Thanks in advance for your help.
By "excluded" do you mean not meet the ISO13485 requirements?

This is just my opinion. They're not medical devices unless you market them. So, since and your customers are not requiring ISO13485 and your not marketing them, I think you can exclude the 13485 requirements from those customers products as long as you have both Certs.
 

DannyK

Trusted Information Resource
#3
Hi,

Excluding the other medical devices could be performed if your scope is specific to the devices that apply.

Will you be manufacturing the product before you get registered?

If yes, you may have no issues.

If no, you have to determine how you will show conformance to the specific medical device requirements in ISO 13485.

Danny
 

Helmut Jilling

Auditor / Consultant
#4
This is my first post.

I work for a small contract manufacturer accredited to ISO 9001. 60% of our CURRENT business would fit the description of medical devices. These CURRENT medical device customers only require ISO 9001:2000. The balance is mixed industries.

We have a potential NEW medical device customer that is requesting ISO 13485 certification for the sub assemblies that we would manufacture. We have had a couple of gap audits. If we continue to proceed with 13485 certification, could our CURRENT medical device customers be excluded since they only require 9001?

We need to evaluate our resource requirements should we continue with 13485 and the risk analysis that would be required for our current business.

Thanks in advance for your help.

I don't audit under 13485, but whether you "exclude" the remaining products from 13485 or not, may not change the costs or resources much, if at all, should it? They are already covered under ISO 9001. It would just switch the line, wouldn't it?
 
L

Laughing Pierre

#5
I don't see that there is a problem.

If your scope of certification is worded adequately none of your customers will be excluded. The scope for ISO 13485 is not product specific (unlike MDD). So, if your scope is stated as something reasonably general like "Sub-contract manufacture and test of electrical and electro-mechanical medical devices, including procurement and kitting" (or whatever your areas of activity are) all of your medical device customers will benefit from the implementation of your 13485 system. Moreover you will be able to target new medical device customers and use the 13485 certification as an additional advantage to using your services.

By the way, I work as a consultant in the UK and one of my client companies sounds very similar to yours. They have been certified to 13485 (or its predecessor since about 1995.
 
R

Roland Cooke

#6
There is nothing to stop you requesting an ISO13485 scope that is limited to just that product range (that you provide a critical subcontract service for).

But I would ask why bother to not include the other products you are involved with? It shouldn't cost any more, and you should probably have everything in place already. If you don't, you are probably deficient where you won't want to be.

If you are still concerned (i.e. about fialing the audit), simply apply for the limited scope, then request an extension to cover all the other products to be done at the first surveillance.
 

somashekar

Leader
Admin
#7
This is my first post.

I work for a small contract manufacturer accredited to ISO 9001. 60% of our CURRENT business would fit the description of medical devices. These CURRENT medical device customers only require ISO 9001:2000. The balance is mixed industries.

We have a potential NEW medical device customer that is requesting ISO 13485 certification for the sub assemblies that we would manufacture. We have had a couple of gap audits. If we continue to proceed with 13485 certification, could our CURRENT medical device customers be excluded since they only require 9001?

We need to evaluate our resource requirements should we continue with 13485 and the risk analysis that would be required for our current business.

Thanks in advance for your help.
Suggest you cover all medical devices in your 13485 scope and keep the non medical under the 9001. It helps. What you do now is for the future. So wish you have a better future and apply the requirements of 13485 across all your medical products for good maturity. I am from a similar industry and happy doing this way.
Good luck.
 
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