Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfaction

R

rob_heg

#1
Well after about a year of lurking, finally time to ask a question that the Search button does not seem to lead to a good answer.

First of all, thanks Marc for an invaluable resource. By far the best on the interwebs.

We are a company of 6, and 18 months ago I did not know what ISO or QMS was. I was in charge of eCommerce, among several other things. Then we decided we were ready to go into Canada, and that is when I started learning all those cool acronyms. :read:

So the road to 13485 under CMDCAS began, as I donned my new QA Manager hat. We bought a 13485 QM template, and spent countless hours modifying to mirror what we do.

18 months later...... Last week was the pre-assessment.

The auditor wants me to get rid of every instance of the word "satisfaction" from my QM, because 13485 does not require satisfaction. The reason I left it in there is because I thought...well, I still want my customers satisfied.

I am curious to your thoughts on this, and what I should replace
QOP-82 Feedback and Customer Satisfaction with, if anything.

:thanx:
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
Re: can't get no... satisfaction

Is this a third Party (Certification Body) that is saying this? If so, I would politely tell them that it is none of their business if I reflect customer satisfaction, even though it is not required.

If this is an Internal Audit, then I would look at this as a possible improvement to be discussed with the Powers to be.

You designed the system (documentation) not the third party auditor from a Certification Body. They are required to verify that the system is in compliance with the requirements of the standard, and that is where their Scope should remain, in my opinion.
 
R

rob_heg

#3
Re: can't get no... satisfaction

Thanks Coury

Yes it is 3rd party. Deep down, I agree with your advice, but we are just a desperate little guy trying to expand our market, and I want to avoid bumping heads.... I fear that will just make things harder.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#4
Re: can't get no... satisfaction

Thanks Coury

Yes it is 3rd party. Deep down, I agree with your advice, but we are just a desperate little guy trying to expand our market, and I want to avoid bumping heads.... I fear that will just make things harder.
You should have no fear here. It is your company and the organization determines the needs. The Auditor has nothing to say about that, and if they did...I would talk to their Powers to be and explain my concern.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Re: can't get no... satisfaction

The auditor wants me to get rid of every instance of the word "satisfaction" from my QM, because 13485 does not require satisfaction. The reason I left it in there is because I thought...well, I still want my customers satisfied.
Do not, I repeat, do not let the auditor win this stupid battle. Sometimes I wonder if we should have a minimum IQ requirement for management system auditors. I suspect we would get rid of a good percentage of morons out there, who pretend to be auditors.

While ISO 13485 focuses on product regulatory compliance and deletes monitoring of customer satisfaction, as well as continual improvement from the ISO 9001 baseline, it obviously does not prohibit you to monitor your customer satisfaction nor continually improve your product, processes and system.

Just because ISO 13485 does not require you to be concerned with profits, it does not mean that you, as an organization, should not focus on profitability.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#6
Re: can't get no... satisfaction

Do not, I repeat, do not let the auditor win this stupid battle.
How true this is.

Just something else that might be interesting...I had a similar but different issue with my Registrar. See this Post

Just don't back down and do not be afraid.
 
Last edited:
R

rob_heg

#7
Re: can't get no... satisfaction

Ok, I'll muster the courage. Shouldn't be no big deal as long as I am humble and respectful. Thanks for the replies.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Re: can't get no... satisfaction

Ok, I'll muster the courage. Shouldn't be no big deal as long as I am humble and respectful. Thanks for the replies.
Keep us appraised. And like Coury mentioned, if the individual is inflexible on his/her stance concerning this, you should escalate the issue to your CB's management. If you allow your system to be hijacked by an auditor's whim from the get go, the relationship will be very asymmetrical.
 
#10
Re: can't get no... satisfaction

Please also do yourself and the CB a favo(u)r - if the auditor is inflexible, don't contest any non-conformity with the CB, which is merely adressing the symptom. Tell the CB management what the real issue is - the inflexibility of the auditor.

If you do this, they will have to address the person and their behaviours, not simply regrade or remove the NC, only to have the auditor go on, blissfully unaware that their attitude is getting the CB a bad name.

I've seen this happen too many times, and like all corrective actions, it needs a clear and correct problem definition. After all, if it wasn't for the auditor, the NC wouldn't exist..........!!
 
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