Application of Risk Management - ISO 14971 for a Tooling Manufacturer

[Bud S.]

This might not be the correct location for this but please understand, I am reasonably new to Elsmar.
I have been asked by a friend to give his small company a little guidance toward ISO 13485 implementation and eventual certification.
I have led several facilities to 9001:2000 certification and figured I could help my friend before his company spent a bundle on consultants.
Now for my question: While I find it easy to help them with most of their documentation and preparation, I'm stuck on Risk Management. They DO NOT manufacture any medical products. They make tooling (for injection molders). They were asked by a couple of their customers to be certified 13485 because the customers make medical products with the tooling (molds/dies) my friends company designs and builds. How extensive must they be in Risk Management if most of it "does not apply"??

Thank you,
Bud S.

 

[Ajit Basrur]

any answers for Bud's question ?

 

[somashekar]

This might not be the correct location for this but please understand, I am reasonably new to Elsmar.
I have been asked by a friend to give his small company a little guidance toward ISO 13485 implementation and eventual certification.
I have led several facilities to 9001:2000 certification and figured I could help my friend before his company spent a bundle on consultants.
Now for my question: While I find it easy to help them with most of their documentation and preparation, I'm stuck on Risk Management. They DO NOT manufacture any medical products. They make tooling (for injection molders). They were asked by a couple of their customers to be certified 13485 because the customers make medical products with the tooling (molds/dies) my friends company designs and builds. How extensive must they be in Risk Management if most of it "does not apply"??

Thank you,
Bud S.

OK., while I have reservations about 13485 for such an organization, perhaps the customers drive this from the CMDCAS view point as I guess. Now coming to the point of risk management, a good process FMEA should answer the requirement. Can this make you more comfortable .... The FMEA ?

 

[jkuil]

First of all, ISO 13485 only applies to manufacturers of medical devices and not to their suppliers. And especially when they make tooling, they are way of the scope of ISO 13485. It is adequate to have ISO 9001, in which you seem experienced. You have to comply with the latest revision which is ISO 9001:2008.

For risk management, that would only apply to their manufacturing process. Again ISO 14971 is the risk management standard applicable to medical devices and does not apply to a tooling manufacturer. It is good reading though, because it helps you understand that risk management is more than a FMEA. Risks should be managed thoughout the life-time of a product.

 

[Bud S.]

Many thanks to you. While it is true that 9001:2008 would be sufficicient for them at this time, I am led to believe their customers will be wanting them to do some molding of subcomponents which will later be used in medical device assemblies. While this is not yet the case, it is a probable activity in the future.

I think I will simply try to figure out a way to set up an in-process inspection format for them in Excel and recommend they read up on Risk MAnagement somewhere.

As for FMEA, I don't know how to steer them into that. Fmea is not used in most of the companies I've helped through ISO 9001:2008 certification. I have always thought that to be more for automotive parts manufacturing.

Thanks again,
Bud S.

 

[Roland Cooke]

First of all, ISO 13485 only applies to manufacturers of medical devices and not to their suppliers.

This is a dangerous statement.

Sterilization facilities, plastic component molders, electronic equipment assemblers, cleanroom packaging companies, translation agencies, regulatory consultancies all (can) hold ISO13485. None of these organizations makes or markets a medical device. Many would not be in business without holding ISO13485.

That said, I would agree that a tooling manufacturer is indeed too far down the food chain to warrant specifically holding ISO13485.

 

[Bud S.]

Thank you Mr. Cooke.

While 13485 is almost a mirror of 9001:2008 it is a bit over the top for a tooling manufacturer. I am guessing that the customers do drive this from a CMDCAS viewpoint as one respondant suggested. Also, there is the probability that they will be asked to mold, or assemble some medical subcompomants in the not-to-distant future.
I will confer again with their chosen registrar to be certain.

As a quality professional, I am always pleased to see a company work toward a viable QMS.

Many thanks to you and all who have responded in this thread.

Respectfully,
Bud S.

 

[Ajit Basrur]

This is a dangerous statement.

Sterilization facilities, plastic component molders, electronic equipment assemblers, cleanroom packaging companies, translation agencies, regulatory consultancies all (can) hold ISO13485. None of these organizations makes or markets a medical device. Many would not be in business without holding ISO13485.

That said, I would agree that a tooling manufacturer is indeed too far down the food chain to warrant specifically holding ISO13485.

I do not think this is true - ISO 13485 is only applicable for medical device manufacturers and not to plastic component manufacturers (that go into medical device) or molders. Having said this, yes, if the system is aligned towards the ISO 13485 requirements, it would be easy for them to do business with device manufacturers.

 

[Roland Cooke]

ISO13485

0.1 "....and provision of related services".

 

[Ajit Basrur]

ISO13485

0.1 "....and provision of related services".

This is the root of discussion now