Medical Electronics
Certifying medical device quality management systems with ISO 13485
By Dr. Itoro Udofia, director, medical health service at TÜV SÜD, a global product testing and certification organisation
P
erhaps more than any other type of manufactured product, the quality of medical devices has a direct impact on their effectiveness as well as the safety of patients, users and, where appropriate, other persons. For these reasons, most national regulatory schemes require manufacturers and suppliers of medical devices to establish an internal quality management system that has been independently audited and verified. Medical devices manufactured or supplied by organisations without a verified quality management system are routinely denied legal entry into major markets, usually resulting in extended delays in gaining access and lost revenue opportunities.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses
36 October 2023
the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. Originally developed in the 1990s, the revised standard (ISO 13485:2016) was published on 1st March 2016. The standard details requirements for a quality management system that meets both customer requirements and regulations in the UK, European Union (EU), Canada and other major jurisdictions around the world. Although ISO 13485 is similar in scope and intent to ISO 9001, it also includes additional quality management system requirements specifically appropriate to an organisation involved in one or more stages of the medical device life cycle. As a result, ISO 9001 certification is generally not an acceptable substitute for certification to the requirements of ISO 13485.
Components in Electronics
Process validation
ISO 13485 stipulates validation of manufacturing processes for medical devices, where the resulting process output cannot be or is not verified by subsequent monitoring or measurement. This entails activities that are not only limited to the validation of the manufacturing process itself, but may also include equipment qualification, computer system validation and test method validation. When carrying out process validation activities, additional points to consider include statistical sampling plans, process monitoring, validation change control and good documentation practice. Manufacturers of medical devices should also note that the requirements on process validations are not limited to their own premises but also apply to processes conducted offsite by suppliers.
Prior to undertaking any validation activities, thorough planning is essential. Validation will include Installation Qualification (IQ) for equipment and machines, as well as Operational Qualification (OQ) and Performance Qualification (PQ) for the manufacturing process. It must be emphasised that additional process- and/ or product specific requirements must be considered. This includes but is not limited to sterilisation and sterile packaging processes where PQ also includes challenging of process tolerances and limits.
Documented procedures describing the approach for process validation are a requirement of ISO 13485. Beyond listing the definitions used, this documentation should describe responsibilities and delineate authorities. The different elements of process validation and the
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