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Quality Objectives 5.4.1 - KPI SOP - ISO 13485 Audit Observations

A

Achemd

#1
Ok, so I am filling in to clean up ISO13485 observations and this is the observation "No SOP was available to review describing measurement of KPI/Quality indicators". It is listed under %.4.1 Quality Objectives.

Now - we have Quality objectives listed in our manual. They are correct, there is no SOP. Do we need one? Can someone share for a rough outline? How do I get away without one?

Thanks
:thanx:
 
Elsmar Forum Sponsor
C

Chance

#2
Re: Quality objectives 5.4.1 - KPI SOP

Does SOP for reviewing KPI's listed somewhere in your internal procedures? There is no such requirement in ISO 9001 I don't know about ISO 13485. Is there?

Also, that is only an observation, you are not required to respond. It is up to your organization (or you are in-charge) to decide whether having one would benefit the organization.

I hope this helps.
 
A

Achemd

#3
Re: Quality objectives 5.4.1 - KPI SOP

No, we did not state that we would have a SOP. Oh, and sorry we received a minor non-conformity for not having one.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#4
Re: Quality objectives 5.4.1 - KPI SOP

Ok, so I am filling in to clean up ISO13485 observations and this is the observation "No SOP was available to review describing measurement of KPI/Quality indicators". It is listed under %.4.1 Quality Objectives.

Now - we have Quality objectives listed in our manual. They are correct, there is no SOP. Do we need one? Can someone share for a rough outline? How do I get away without one?

Thanks
:thanx:
It should remain an observation or an opportunity for improvement, unless you have no other way of revealing what your critical objectives or goals are, but the finding should not dictate the "lack of an SOP" as evidence of nonconformity. Do you have a copy of ISO 13485? There should be no documentation requirements under 5.4.1, but that does not release your organization from the responsibility to make sure objectives are at least established at all relevant functions and levels within your organization, and are consistent with your quality policy.

Brian :rolleyes:
 
Last edited:
A

Achemd

#5
Re: Quality objectives 5.4.1 - KPI SOP

Thanks, that is what I thought, but started to doubt myself.......
 
I

isoalchemist

#6
Re: Quality objectives 5.4.1 - KPI SOP

:2cents: Just exploring here after having a similar discussion with an auditor. I agree the standard does not require an SOP, but could they have been looking for evidence that the objectives were reviewed during a Management Review? I had quickly written up the minutes of the MR and was not as expansive on the Quality Objective discussions as the auditor would want and got into a similar sounding discussion.

As usual I think the auditor is wrong, but.....:2cents:
 
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