ISO 13485

If an organisation is ISO 13485 certified, it has implemented a quality management system in line with these medical device requirements. This means its processes for ensuring the quality, safety and efficiency of medical devices have been assessed and recognised as reaching the high ISO standards.

ISO 13485:2016 is the most up-to-date version of this standard.

The current standard has significant changes from the previous version ISO 13485: 2003 and reflects the evolution of the medical device regulatory environment and the greater need for risk management and risk-based decision-making processes within the medical devices industry.

Requirements of ISO 13485 apply to organisations regardless of their size and type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services supplied by the organisation. The requirements may vary based upon the class of medical device, from a wheelchair to a pacemaker.

The processes required by this standard that applies to the organisation, but are not performed by the organisation, are the organisation’s responsibility and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable 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 regulatory requirements can provide alternative approaches to be addressed in the quality management system. It is the organisation’s responsibility to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

Certification for this ISO lasts for three years and is subject to mandatory audits to ensure compliance.