M
mr.mike
I've been reviewing some opinions as to the definition of a "critical" subcontractor, but am still a bit fuzzy here.
One person suggested that it is only "critical" if it's the only company that can supply the item/service?
Or, more often used is the phrase "anything that would affect product quality or risk". I'm guessing this is the definition to go by, but it's still pretty vague, as pretty much ANY company supplying components to us would "affect product quality".
Here is an example:
- We have sourced a company to supply the custom-made (based on our CAD models) plastic components.
- If this company were to, for example, leave prodruding burrs in the plastic components, this would certainly affect the end-product quality, and pose a potential (albeit minor) risk to end users.
- So, would such a component supplier be deemed "critical"?
....if so, then really, ALL of our component suppliers would be considered critical.
The reason this is so important to clarify is that our NB is requesting that the critical subcontractors be ISO13485 certified. This would be very difficult, as most of the components are generic (not MD specific), and so most of the companies have ISO9001, but not ISO13485.
I hope someone can set me straight here...
MM
P.S. There was an older thread (2001) on this topic, but there didn't seem to be any concensus reached. Also, when I replied to it the system suggested I create a new thread seeing as that one was so old...
One person suggested that it is only "critical" if it's the only company that can supply the item/service?
Or, more often used is the phrase "anything that would affect product quality or risk". I'm guessing this is the definition to go by, but it's still pretty vague, as pretty much ANY company supplying components to us would "affect product quality".
Here is an example:
- We have sourced a company to supply the custom-made (based on our CAD models) plastic components.
- If this company were to, for example, leave prodruding burrs in the plastic components, this would certainly affect the end-product quality, and pose a potential (albeit minor) risk to end users.
- So, would such a component supplier be deemed "critical"?
....if so, then really, ALL of our component suppliers would be considered critical.
The reason this is so important to clarify is that our NB is requesting that the critical subcontractors be ISO13485 certified. This would be very difficult, as most of the components are generic (not MD specific), and so most of the companies have ISO9001, but not ISO13485.
I hope someone can set me straight here...
MM
P.S. There was an older thread (2001) on this topic, but there didn't seem to be any concensus reached. Also, when I replied to it the system suggested I create a new thread seeing as that one was so old...