ISO 9001 vs. 13485 - What are the differences between ISO 9001 and ISO 13485

[QE]

Dear Coves

At work we are told by management that the quality systems will be changing in the near future. From ISO 13485 to a process based ISO 9000.

Can some one point out the pros and cons between the two ?

-QE

[Randy]

If you are under 13485 you already meet 9001

13485 is more stringent and specifically for medical device just as TS 16969 is for automotive and AS 9100 is for aerospace...basically all the same and you don't have to do anything special or different to conform to 9001, it's a done deal

[Marc]

Also see this oldie but goodie:

Differences - ISO 13485 - Requirements in Addition to ISO 9001

[Sidney Vianna]

There are a couple of requirements in ISO 9001 that are not included in ISO 13485: monitoring of customer satisfaction and continual improvement. So, strictly speaking, conformance to ISO 13485 makes you very close to ISO 9001, but not 100%.

[DannyK]

There are many more requirements for documented procedures with ISO 13485:2003. Since you are dealing with medical devices, there are expectations that your system will be more robust.
Regulatory requirements play a major role with ISO 13485:2003.

[AndyN]

In Reply to Parent Post by Sidney Vianna

There are a couple of requirements in ISO 9001 that are not included in ISO 13485: monitoring of customer satisfaction and continual improvement. So, strictly speaking, conformance to ISO 13485 makes you very close to ISO 9001, but not 100%.

Thanks for that very salient, and often overlooked, point, Sidney!

[Marc]

In Reply to Parent Post by DannyK

<snip> Regulatory requirements play a major role with ISO 13485 <snip>

Can you be more specific?

[somashekar]

In Reply to Parent Post by Marc

Can you be more specific?

Just pitching in, while DannyK would write back ...
By your 13485 QMS if you are to respect
FDA requirement (your medical devices may be getting into USA) or
MDD / IVD requirements (your medical devices may be getting into EU) or
CMDR requirements (your medical devices may be geting into Canada) or
the respective regions regulatory requirements wherever your medical devices will be entering the market
These requirements becomes a part of your QMS activities, and they get to be mentioned in your QMS documentation, and addressed accordingly. These will be audited by you in internal audits and by the CB or NB etc etc.