ISO 13485:2003 Standard defines requirements for a quality management system (QMS) used by the companies designing, manufacturing and distributing medical devices and associated services. The primary goal of the standard is to promote harmonization of regulatory requirements for medical device manufacturers. ISO 13485:2003 is based on ISO 9001 Standard. Due to specifics of the medical device manufacturing industry, it includes particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate for regulated industry. Often medical device manufacturers wish to establish compliance with both ISO 13485 and ISO 9001. Since these standards incorporate different requirements, companies that established an ISO 13485 QMS cannot claim conformity to ISO 9001 standard. To establish conformity to both standards, a company needs to ensure that their QMS addresses all requirements of ISO 13485 and ISO 9001 standards.

All requirements of ISO 13485:2003 are specific to companies designing, manufacturing or selling medical devices, regardless of the type or size of the business. Like in ISO 9001, if any requirements in Clause 7 of ISO 13485:2003 are not applicable because of the nature of the medical devices, the QMS does not need to include these requirements. The processes required by ISO 13485:2003, but which are not performed by the company, are still the responsibility of the organization and shall be addressed within company’s QMS. For example, if a company sub-contracts manufacturing or other activities, the company is still responsible for these processes. To ensure that these outsourced processes are in compliance with applicable requirements, a company may use supplier audits. Check our Products page to see how our services and products can help you develop or improve your ISO 13485 quality management system.

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