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.