The ISO-13485 is an international quality management system (QMS) standard defined for the medical device industry.  It is therefore important for manufacturers of semiconductor devices used in medical electronics to get certified to the ISO-13485 in order to secure and maintain global business. Created by the International Organization for Standardization (ISO), the ISO-13485:2003 borrowed the structure of the ISO-9001:2000.

The benefits of registration to ISO-13485 include: 1) international recognition of compliance with the FDA Quality System Regulations and unique medical industry standards, facilitating global business; 2) a more efficient, cost-effective, and stable organization; 3) improved process, product, and service quality; and 4) better documentation of existing processes.

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-9001:2000. 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.