Application of Risk Management - ISO 14971 for a Tooling Manufacturer

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Ajit Basrur

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#12
Then how to decide what comes under "related services" - is there any guidance from ISO. I tried to look into ISO 14969 but could not find any.

My feeling is that since ISO 13485 is only for medical devices, this QMS is not applicable when your "related service" is not a device per se ie. if a tool is manufactured for a medical device, the tool in itself isnt a device and thus ISO 13485 is not applicale. Likewise, when you mold some plastic parts of a device, that part not being a device, does not fall under ISO 13485.

Am I right in inferring this ?
 
R

Roland Cooke

#13
No, that's not right.

The services offered by plastic molding companies are a critical element of the industry.

As well as pumping out critical components for manufacturers of finishes medical devices, many of these subcontractors also offer design, assembly, packaging and (out-outsourced) sterilization.
They will need to incorporate recall procedures, risk management etc etc.
To all intents and purposes they are medical device companies, just with less clinical interface.

And a very large proportion of these companies hold ISO13485 (just open any trade magazine). A finished medical device manufacturer will actively seek out such suppliers.


Now I'll admit I'm biased (it's the product I sell after all! ;)), but I would hold that both the suppliers* and the finished device manufacturers are generally extremely happy with the whole system. It provides visibility, security, and improvement over time.


*not just plastic molders, see my above post
 
R

Roland Cooke

#15
I don't think a definition is really required. If a potential client can make a case for registration, we would listen.

So offhand I would suggest that a mold tool maker wouldn't really qualify, but if such a client was able to make a decent case that he provided a service to the finished medical device industry, even indirectly*, that would be fine by me.


*c.f. a sterilization service provider is often one or two levels away
 
J

Juan Dude

#16
[FONT=Arial,Bold][FONT=Arial,Bold][FONT=Arial,Bold][FONT=Arial,Bold]3 Terms and definitions[/FONT][/FONT] [/FONT]

[FONT=Arial,Bold][FONT=Arial,Bold][FONT=Arial,Bold]--------(snip)------[/FONT] [/FONT][/FONT]​

[FONT=Arial,Bold][FONT=Arial,Bold]Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to related services as supplied by the organization.

[/FONT][/FONT][/FONT]
As aready mentioned, the real question is what falls under the "related services" definition.
 
J

Juan Dude

#18
Returning to the original poster's question I'm afraid it's difficult to give good advice regarding such a broad question, my best advice for now is to read the GHTF guidance for the Implementation of risk management principles and activities within a Quality Management System available here: GHTF guidance.

Hope it helps.
 
B

Bud S.

#19
As before, I extend many thanks to all of you.

We have gone beyond the word "only" to describe companies which can show cause to certify to 13485.

All of the thoughts and guidance have been put to use and I would consider this case closed.

Bud S.
 
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