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QW Academy - What is ISO 13485?
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
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services and products can help you develop or improve your ISO
13485 quality management system.
today if you have questions about ISO 13485 quality management systems!