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Greetings, brand new here, hoping someone can offer useful opinions on the applicability of section 6.4 to the provision of service of medical devices.
Specifically, our business is sales and service of several medical devices (hospital CSSD sterilizers and washers, O.R. tables and lights) and we're now in the midst of preparing for certification against 13485 (we've had 9001 for almost a decade). I am our company's QM.
While I understand that the term product in this standard can -- key word -- apply to [the provision of] service, I interpret section 6.4 to be intended for medical device manufacturers.
Our ISO advisor is construing this section to apply to us providing service as well, with the 'product' referred to in "...the quality of the product" under (a) being 'the provision of service'. Further, she construes the 'contaminated product' referred to in (d) to include our personnel (as a part of "service").
I'm afraid I feel these are both mis-interpretations, not to mention far-fetched. FYI, while we have a fair amount of control over our employees' behavior in the hospital environment and train to ensure that they are 'gowned and bootied' and do not enter the hospital ill, we otherwise have no control whatsoever over the environments in which we provide service (always in-house at the hospital).
Any thoughts on this? I'd appreciate whatever anyone might have to offer, in agreement or not! I'd like to agree with our consultant as after all, we're paying her for her expertise, but honestly in these two cases so far I simply can't see it.
Thanks very much!
Specifically, our business is sales and service of several medical devices (hospital CSSD sterilizers and washers, O.R. tables and lights) and we're now in the midst of preparing for certification against 13485 (we've had 9001 for almost a decade). I am our company's QM.
While I understand that the term product in this standard can -- key word -- apply to [the provision of] service, I interpret section 6.4 to be intended for medical device manufacturers.
Our ISO advisor is construing this section to apply to us providing service as well, with the 'product' referred to in "...the quality of the product" under (a) being 'the provision of service'. Further, she construes the 'contaminated product' referred to in (d) to include our personnel (as a part of "service").
I'm afraid I feel these are both mis-interpretations, not to mention far-fetched. FYI, while we have a fair amount of control over our employees' behavior in the hospital environment and train to ensure that they are 'gowned and bootied' and do not enter the hospital ill, we otherwise have no control whatsoever over the environments in which we provide service (always in-house at the hospital).
Any thoughts on this? I'd appreciate whatever anyone might have to offer, in agreement or not! I'd like to agree with our consultant as after all, we're paying her for her expertise, but honestly in these two cases so far I simply can't see it.
Thanks very much!
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