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

Wes Bucey

Quite Involved in Discussions
#11
Re: can't get no... satisfaction

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.
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.
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..........!!
I suspect the entire issue is related to Sidney's comment ISO 13485 specifically omits "continual improvement" as it seems to mirror ISO 2001 9001-2000.

I also suspect the auditor may have the impression from the phrasing you use and the number of times you refer to customer satisfaction that you are not concentrating enough on conforming to the basic tenet of making a good product [and considering "ideas for improvement" as new products] because ISO 13485 is slanted toward the "harmonization" between and among various regulatory bodies of governments and those folks tend to be more comfortable with folks who follow the recipe versus "creative cooks."

Since we have not reviewed the documents in question to make our own several appraisals of the sufficiency or lack, then you should pursue the course of bucking the story up to the management level of the CB -

Caution:
Do NOT pose this as a recalcitrant or inflexible auditor, but a potential or probable misunderstanding which needs a third party to clarify. Every auditor is not a specialist in communicating and some certainly need a reality check that their communication skills need improving, even if the products under ISO 13485 do not.
 
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s.parakos

#12
Re: can't get no... satisfaction

I agree with Wes that there may be a communication issue with your auditor.

They possibly are concerned more with where you are using the phrase "Customer Satisfaction" rather then the phrase itself. For example if your documentation implies that "Customer Satisfaction" is the main yardstick for measuring quality, I could see where the auditor may have an objection.

Simon
 
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D.Scott

#13
Re: Can't get no... satisfaction - Auditor wants me to get rid of 'Satisfaction' from

First, let me say welcome to the posting side of the Cove. I look forward to more interesting posts from you.

I think you have already received the definitive answers to your question from Sidney and Coury. I agree with the answers and information they supplied.

I would like to offer an additional thought for you. Keep in mind that this was a pre-assessment. The auditor is certainly well aware that although he is not allowed to consult, he will be obliged to review evidence of meeting the standards of "Customer Satisfaction" you are setting for yourself by including it in your QMS. Although you are free to include what you like in your own manual, it may be to your advantage to review the instances where you might have created an additional burden. Customer Service or continual improvement can certainly be mentioned in a philosophical sense but you can also back yourself into a situation where you will have to monitor and document your progress.

I agree, the system is yours, not the auditor's. You can put in anything extra you want. The others here have given you good information.

I like to take an auditor miscommunication/dispute/whatever one step further. I try to imagine what result would be left if didn't assume he was an idiot or that he was trying to micro manage my system. What are the other possibilities and/or end results if I considered his comment in another context. Auditors are not allowed to consult, however there is no rule stating an auditor is not allowed to make us think..

Please don't go to the CB with the issue until you are positive that it really is an issue. Sometimes, believe it or not, auditors may be trying to help.

Dave
 
#14
Re: Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfact

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.

Does it matter if it's a pre-assessment or anything else? If a CB auditor is making this kind of comment it doesn't sound like being helpful, 'consulting' or a misunderstanding either! It sounds like a person who's only thinking strict compliance to the ISO requirements!

When I was a consultant, I heard way too many of these kinds of comments to be good for a) clients sanity and b) the CB business as a whole.

If the auditor "didn't mean that", then they need to be perceptive enough to see what reactions such comments cause. Isn't that what 19011 is about (in part)?
 

Doug Tropf

Quite Involved in Discussions
#15
Re: Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfact

5.2 of 13485 (Customer Focus) states, "Top Management shall ensure that customer requirements are determined and are met". Sounds like a good definition for "customer satisfaction" to me.
 
#16
Re: Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfact

If I may....

There may be an alternative view. It just might be possible that the auditor is trying to tell you something. Perhaps the way things are written, there is no way you can achieve your customer satisfactions goals. He may be suggesting you get rid of it because it is not required, and there is evidence that it will only become a snare, trapping you by your own documentation.

If that is the case, he probably should have told you, but he might be afraid that would be consulting, and by just telling you to get rid of it, he is not crossing the consulting line.

Just a thought.

Anyways, welcome to the cove. :bigwave:
 
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Phil Fields

#17
Re: Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfact

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:
Rob,
If you remove the word satisfaction, will your system address customer satisfaction, even if you do not call it that?

How does your system address 13485 8.2.1?

Our Quality Manual addresses 8.2.1 with the word Satisfaction in the heading, but Satisfaction is not used in the body of the text. Customer satisfaction can be derived by the information gathered in the feed back stage.

Phil
 
R

Roland Cooke

#18
Re: Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfact

The reason that "customer satisfaction" is not included within 13485 is that it is not a regulatory requirement that your customers are happy, only that they are being safely and effectively treated by your medical device. :)

It is entirely appropriate to also include customer satisfaction (and continuous improvement for that matter) within your QMS.


As DB pointed out, this could be a communication error. No auditor is perfect, but I would be fairly surprised if this basic issue wasn't understood. Then again, very little astonishes me in this job anymore! :D
 
R

RickT

#19
Re: Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfact

There is a lot of great advice in all the responses, all of which support your desire to maintain the phrase "customer satisfaction".
Your company is in a growth phase and a particular concern is entering a new market (Canada) that may well be quite different form those you are now in. Surely customer satisfaction must be front and centre of that objective and if not, do you really think it will succeed? Is that not what a QMS is all about (see 5.2 and 8.2.1, etc.)?
I will first assume customer satisfaction gets significant attention in both you Quality and Business objectives. Next I will assume you have clear definition of how you will both determine that satisfaction and measure it. Finally are these aspects really understood by all employees?
That being the case, go for it, but as everyone has said, be positive and keep confrontation out of discussions with the Auditor (& CB if that becomes necessary).
 
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rob_heg

#20
Re: Auditor wants me to get rid of 'Satisfaction' from QM - Can't get no... satisfact

I want to thank everybody for all the great advice. You people are all so wonderful. I wanted to clarify that I do like my auditor. I know that is irrelevant, but I just thought I would mention it.

After assimilating all the great input about including satisfaction, I have decided to limit the scope to Feedback only, using the info to gauge whether our product is safe and effective.

I wont have much of a chance to be active on this thread until after my Stage 1 assessment in a couple weeks, as I have a lot to prepare between now and then. Thanks again to everyone!
 
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