We manufacture machines that are not subject to FDA oversight. However, our customers use them in an FDA regulated environment. Would our becoming ISO 13485 compliant benefit our customers more than an ISO 9001 certification?
Yes, because ISO 13485 is made strictly for the manufacturer of medical devices. ISO 13485 allows a company to demonstrate that it consistently meets customer's needs, medical device regulatory requirements and complies with local legislation. It is, in certain points, related to ISO 9001, but ISO 13485 emphasizes areas such as risk management, the work environment, and medical device documentation and reporting.