ISO 13485:2016 provides a practical foundation for manufacturers to address regulations and responsibilities as well as demonstrating their commitment to safety and quality. As a quality management system standard, it is not product specific, but covers processes relevant to the production of medical devices and related services.
Legal market access for products is essential for medical device manufacturers. National regulations often require ISO 13485:2016 as part of the approval process for medical devices.
Related standard
- ISO 13485:2016 – Medical devices – A practical guide. This is an implementation guide authored by technical experts of ISO/TC 210 and published by the International Organization for Standardization (ISO). The handbook guides organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485.
- ISO 14971 - Application of risk management to medical devices. This standard specifies a procedure for manufacturers to identify hazards associated with medical devices and accessories and how to estimate and evaluate, control and monitor the identified risks as well as control effectiveness.
- ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems. This standard applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.
Benefits of ISO 13485:2016 Certification
- Enables access to global medical device markets
- Improves product safety and reliability
- Ensures regulatory compliance
- Reduces risk of product recalls
- Strengthens customer confidence
- Provides a structured approach to continuous improvement
- Helps prepare for MDSAP audits
