March 29, 2023

ISO 13485: Design & Development Obligations of Contract Manufacturers

As a general rule, a contract manufacturer who doesn’t perform any design and development for the subject device is thereby not required to have design and development in the scope of that contract manufacturer’s ISO 13485 certificate.  So its certificate scope statement would be something like, “The contract manufacturing of ABC widget devices“, whereas the original manufacturer’s certificate scope would be something like, “The design and manufacture of…”.  As a general rule, the OEM, rather than the contract manufacturer, is ultimately accountable and responsible for design and development in this kind of scenario.

But if the contractor performs / leads any design and development operations, then that could trigger the need for design to be included in its QMS and certificate depending on the nature of those operations.  In such cases, different ISO registrars might have varying interpretations about how they want the certificate scope statement to read; accordingly, consulting the particular ISO registrar(s) involved is a good idea in my opinion regarding borderline scenarios.