While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. Though it is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard, in contrast to the automotive sector's ISO/TS 16949, where only firms with an active request for quotation, or on the bid list, of an International Automotive Task Force supply chain manufacturer can seek registration.
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