Why customer satisfaction is not appropriate regulatory objective in medical device?

[rangani_rj]

Hi All,

I am confused regarding what said at many places in ISO 13485 that customer satisfaction is not appropriate regulatory objective in medical device? Can somebody give example? I mean customer satisfaction may be considered as base value to any manufacturer?

And if above is right Should we delete that part (customer satisfaction) from quality policy?

Many thanks in advance...

 

[Bev D]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

can you quote the sections of 13485 that you are concerned with?

 

[Marc]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

<snip>And if above is right Should we delete that part (customer satisfaction) from quality policy? <snip>

You mention "regulatory objective" and "quality policy". What Bev said, but to add: If Customer Satisfaction is part of your Quality Policy, there is no reason to delete it just because it is not required by ISO 13485.

 

[somashekar]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

ISO 13485 aims at aligning the QMS in line with the regulatory requirements.
Just make sure that the quality objectives, continual improvements and customer satisfaction are not considered in isolation to the regulatory requirements.
The regulatory requirements thus forms the base line to be maintained.

 

[Bev D]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

remember the role of 13485 adn any human medical endeavor: first do no harm; second the things should do what it is intended to do; third for your organization to be a long term success supplier of the devie you need to satisfy your customers or they won't buy from you....13485 is focused primarily on teh first and second objectives...but it doesn't obviate customer satisfaction.

 

[MIREGMGR]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

When 13485's predecessor standards were split off from 9001 to create an international standard for medical device activities, US FDA's already-existing QSR was considered as an example. The QSR is built around a longstanding regulatory determination that there can be conflicts between FDA's goal of safety and effectiveness, and what the "customer" wants...whoever the customer may be, i.e. device user or patient, who in many instances have conflicting desires.

As an example: the patient might want the device to result in a procedure with no pain or discomfort at time of procedure or subsequently. The clinician / device user might want the device to be inexpensive and fast to use. The device maker's obligation to provide safety and effectiveness may conflict with provision of these customer desires. In 13485, that conflict is specifically recognized and addressed by removing the "customer satisfaction" primary goal.

If you choose to include "customer satisfaction" as a QMS goal, you must make clear that that goal is secondary to the primary goals. Your QMS must never cause customer satisfaction to be achieved instead of safety or effectiveness.

 

[Marcelo]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

MIREGMGR already hit the spot, and this is also the reason that continual improvement was removed.

Another example, the customer could want a cheap device which is unsafe, but due to regulatory requirements, the manufacturer cannot give them an unsafe device, even if they really want one!

 

[rangani_rj]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

can you quote the sections of 13485 that you are concerned with?

Particularly It is mentioned at Annex B, 5.2

 

[somashekar]

Re: Why customer satisfaction is not appropriate regulatory objective in medical devi

Particularly It is mentioned at Annex B, 5.2

Rightly pointed out, and rightly responded by all...
The "aim of enhancing customer satisfaction" which is from the ISO9001:2000, is not the customer focus as the ISO 13485 intends to communicate. The reason for difference is explained within the ISO 13485 column.
Regulatory first, customer next...