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I have a few questions in regards to 13485. Please find them below:
In the guidelines, it is not clear when you need cleanroom facilities destined in FDA / GMP guidelines.
This ISO always refers to "medical device manufacturers." XYZ and numerous other independent service providers do NOT manufacture, but we repair and maintain medical equipment. In your nomenclature, "service provision" is always coupled with "production." How does a service-only provider gain ISO13485 certification exclusive of the manufacturing provisions? Is this ISO even appropriate given that XYZ is NOT a manufacturer? We are in the early stages of seeking counsel on the project, and we want to get it right.
I purchased the documents toolkit for 13485 and 14971, but I notice there is no Quality Agreement template in it for our vendors. Do you have one of those?
So to make a long story short, we are basically promised more work if we have ISO 13485 on our belt. In reading the standard I find that it really doesn’t apply to us. We do not do any sterilization, assembly, servicing, design, installation, particular requirements of implantable devices, CFR regulations, special labeling and traceability for medical devices. We do have a Clean Room where we mold medical products that has compliant procedures, risk assessments and so forth.
XYZ is a small rubber molding manufacturer (33 people) certified to ISO9001:2015 with the exclusion of Design. We manufacture for the Government, Aerospace, Military, Commercial and Medical fields. We manufacture small o-rings and core seals to medical manufacturer that typically ships in bulk with no major requirements such as CFA, FDA, labeling, etc.
So my question, is it a norm for a manufacturer to be ISO 9001 certified with an emphasis on ISO 13485? Getting ISO 13485 with so many exclusions or at least half of the standard doesn’t seem right.
For class III medical devices, looking for guidance to understand what are the responsibilities of a distributor having a full process, from storage and delivery to clinical use activities such as user training and proctoring. this will help me to write a proper quality agreement.