I am working for a small company accredited to ISO 13485. Until this point, all of our products have been final, end-user products. All of our existing quality procedures, including a risk management checklist and FMEA, assume a final end-user product (as does ISO 14971).
We are going to supply a sub-component to be integrated into another company's product. The client company will be responsible for safety testing, regulatory approvals and risk management, although we will be supporting these activities as required.
Within our current procedures, the risk analysis would seem to be the most problematic, since it is directly mandated by ISO 13485. It seems to be impossible to evaluate risk without detailed knowledge of the end product's intended use, which we don't have full access to in this case. And it would seem to be a duplication of effort since the manufacturer of the end product is responsible for this in any case.
Since we are not going to be ultimately responsible for some of these activities, I am wondering whether we should revise our procedures so that certain products can be excluded from the scope of ISO 13485.
Alternately, I am wondering what sort of risk analysis can be done with incomplete knowledge of the full context of the end use of the component we're designing.
I know answers have been posted which touch on these issues, but I'm particularly interested in knowing what sort of language would go into our procedures to allow the exclusion of certain products from the full ISO 13485 process. I am assuming that the procedure for excluding a product would be covered in the Quality Manual as given by 4.2.2 (a): "the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2)". I have seen a post in this forum (which I'm not currently able to link to) which implies that a product could be excluded from the scope of ISO13485, but what criteria would typically allow this and how would such an exclusion typically be handled by quality system procedures?
Would an exclusion be justified as a matter of holding, in certain cases, that "regulatory requirements permit exclusions of design and development controls" (in section 1.2)? Can this clause be applicable on a product-by-product basis? Does anyone work with a quality manual which allows specific products to be excluded from the full ISO 13485 process?
Any thoughts from anyone who has considered this issue before would be most appreciated.
We are going to supply a sub-component to be integrated into another company's product. The client company will be responsible for safety testing, regulatory approvals and risk management, although we will be supporting these activities as required.
Within our current procedures, the risk analysis would seem to be the most problematic, since it is directly mandated by ISO 13485. It seems to be impossible to evaluate risk without detailed knowledge of the end product's intended use, which we don't have full access to in this case. And it would seem to be a duplication of effort since the manufacturer of the end product is responsible for this in any case.
Since we are not going to be ultimately responsible for some of these activities, I am wondering whether we should revise our procedures so that certain products can be excluded from the scope of ISO 13485.
Alternately, I am wondering what sort of risk analysis can be done with incomplete knowledge of the full context of the end use of the component we're designing.
I know answers have been posted which touch on these issues, but I'm particularly interested in knowing what sort of language would go into our procedures to allow the exclusion of certain products from the full ISO 13485 process. I am assuming that the procedure for excluding a product would be covered in the Quality Manual as given by 4.2.2 (a): "the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2)". I have seen a post in this forum (which I'm not currently able to link to) which implies that a product could be excluded from the scope of ISO13485, but what criteria would typically allow this and how would such an exclusion typically be handled by quality system procedures?
Would an exclusion be justified as a matter of holding, in certain cases, that "regulatory requirements permit exclusions of design and development controls" (in section 1.2)? Can this clause be applicable on a product-by-product basis? Does anyone work with a quality manual which allows specific products to be excluded from the full ISO 13485 process?
Any thoughts from anyone who has considered this issue before would be most appreciated.