ISO 13485 – Medical devices quality management
Demonstrate your ability to consistently meet customer and applicable regulatory requirements.
In the medical devices industry, safety and quality are non-negotiable. Regulatory requirements are increasing at every step of a product’s life cycle and public scrutiny is intensifying.
ISO 13485 is the internationally recognized industry-specific standard for quality management systems. It is designed and intended for organizations involved in related to design and development, production, installation, servicing and sales of medical devices. A certified organization proves its ability to provide medical devices and that related services consistently meet customer and applicable regulatory requirements.
What is ISO 13485
ISO 13485 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 as part of the approval process for medical devices.
- 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 becoming certified
While beneficial for any manufacturer, ISO 13485 implementation and certification is a very good starting point for companies seeking to enter the medical device industry. In particular, certified companies can:
- Improve ability to contract with larger companies;
- Improve internal processes and decision-making;
- Create a culture of continual improvement;
- Demonstrate commitment to safety and quality;
- Prove ability to meet customer and legislative requirements.