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ISO 13485:2003 - Medical Devices-Quality Management Systems

ISO 13485:2003 - Medical devices -- Quality management systems -- Requirements for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

ISO-13485:2003 basically consists of: 1) certain ISO-9001 requirements and 2) newly defined requirements catering specifically to the medical device industry. As such, ISO-13485 differs from ISO-9001 in certain ways, modifying or even excluding some of the latter's requirements. For instance, the ISO-13485 excludes the ISO-9001's requirements related to continual improvement because most medical device regulations require organizations to maintain their quality management systems, and not to improve on them. Thus, while ISO-9001emphasizes the importance of improving quality systems, ISO-13485 emphasizes the importance of maintaining them. ISO-9001 customer satisfaction requirements were also excluded because some of the committee members who worked on ISO-13485 found them to be too subjective.

Some key points adopted by the ISO-13485 include:

1) focus on meeting regulatory requirements; 2) focus on meeting customer requirements; 3) use of a 'process' approach; 4) maintenance of the effectiveness of quality management systems; and 5) maintenance of procedural documentation.

As mentioned, the ISO-13485 has special requirements that are not covered by ISO-9001:2008. These special requirements include both documentation and system/process requirements that cater to the medical device industry.

Aside from regulation-required documents, additional documentations required by ISO-13485 include those pertaining to:

1) responsibilities and authorities; 2) training procedures; 3) health, cleanliness, and clothing; 6) environmental conditions; 7) control of contaminated products; 8) risk management; 9) customer requirements; 10) design and development; 11) purchasing control, including purchase traceability and verification; 12) reference materials; 13) labeling and packaging; 14) installation and verification; 15) sterilization process validation; 16) preservation of product (including shelf life); and 17) measurement and monitoring. Special system/process requirements of the ISO-13485 include: 1) risk management systems; 2) clinical evaluations and trials; 3) product cleanliness and contamination controls; 4) requirements for implantable devices; 5) proper communication of advisory notices; and 6) additional research and development requirements.

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