Re: can't get no... satisfaction
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.
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.
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..........!!
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 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.
Last edited:

