Is this Quality Policy acceptable in the context of ISO 13485?

SGquality

Quite Involved in Discussions
#1
In one of the supplier audits, I came across the quality policy for ISO 13485 as -

"The employees of xxxx are dedicated to the continual improvement of the xxxx quality system in order to ensure that our products meet or exceed customer expectations"

When I raised for a nonconformance as it didnot meet the requirements of section 5.3 of the ISO 13485 standard, the supplier called their certification body to confirm and stranegely, the CB also defended the quality policy per ISO/TS 14969 interpretation.

Pls let me know if that quality policy is acceptable per ISO 13485 as ISO 13485 is not about continual improvement and meeting customer expectations ?
 
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harry

Super Moderator
#3
Re: Is this Quality Policy okay ?

........................ Pls let me know if that quality policy is acceptable per ISO 13485 as ISO 13485 is not about continual improvement and meeting customer expectations ?
Do you expect your injection moulder to continuously improve on the quality of parts that they supplied? I think you have to understand where each stand in the supply chain.

Policies are very broad statements that are not easily nailed! As Jane mentioned, tell us why you don't think it meets requirements.
 

SGquality

Quite Involved in Discussions
#4
Re: Is this Quality Policy okay ?

Can I ask why you don't think it meets requirements?
This policy looks abosultely fine from ISO 9001 perspective but from an ISO 13485 standard requirement, it doesnot include a commitment to comply with requirements and to maintain the effectiveness of the qms.

ISO 13485 is all about meeting regulatory requirements and that is not stated in the policy.

Your thoughts pl.
 

Kales Veggie

People: The Vital Few
#5
In one of the supplier audits, I came across the quality policy for ISO 13485 as -

"The employees of xxxx are dedicated to the continual improvement of the xxxx quality system in order to ensure that our products meet or exceed customer expectations"

When I raised for a nonconformance as it didnot meet the requirements of section 5.3 of the ISO 13485 standard, the supplier called their certification body to confirm and stranegely, the CB also defended the quality policy per ISO/TS 14969 interpretation.

Pls let me know if that quality policy is acceptable per ISO 13485 as ISO 13485 is not about continual improvement and meeting customer expectations ?
So, what if I say that the customer expectation is that the organization meets the requirements, then the policy is just fine.
 
J

JaneB

#6
I agree with Kales AND the supplier's certification body.

As a customer, my absolute minimum 'expectations' would be that my suppliers meet requirements, which means mine and any regulatory ones that apply.

Your reservation seems like splitting hairs. Is there a point to it?

Is there actually any problem with the supplier, other than that you dislike the exact wording of their policy? Because arguing about something as broad as their policy - which is acceptable to them and to their CB - seems like a relatively pointless exercise that is extremely unlikely to add anything positive to the business relationship.
 

harry

Super Moderator
#7
Re: Is this Quality Policy okay ?

..................... "The employees of xxxx are dedicated to the continual improvement of the xxxx quality system in order to ensure that our products meet or exceed customer expectations" .....................
................., it doesnot include a commitment to comply with requirements and to maintain the effectiveness of the qms.

ISO 13485 is all about meeting regulatory requirements and that is not stated in the policy. ..........................
There is already a commitment to continual improvement of the QMS and all that you mentioned should be found directly or indirectly (through audit for instance) therein. As the others had implied, moved on for it does not add value to either you or them.
 

sagai

Quite Involved in Discussions
#8
Re: Is this Quality Policy okay ?

I have the same recollection that improvement was unfortunately castrated from 13485, on the other hand i really do not see the reason to hang on it, i would be delighted and impressed with their statement.
However the question mark remains how they actually accommodate this vision!
I have just heard a proverb saying the vision without execution is a hallucination :)
Cheers!
 

SGquality

Quite Involved in Discussions
#9
Thanks for all responses.

Do not get me wrong ... our relationship is great and we have a great partnership. The wording of the Quality Policy is just to be sure that they are in full agreement with the section 5 of of the ISO 13485 standard.
 

somashekar

Staff member
Super Moderator
#10
Thanks for all responses.

Do not get me wrong ... our relationship is great and we have a great partnership. The wording of the Quality Policy is just to be sure that they are in full agreement with the section 5 of of the ISO 13485 standard.
The quality policy falls short of meeting the requirements set in the ISO13485.
 
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