New edition of DIN EN ISO 13485 published
On 1 August 2016, the new DIN EN ISO 13485:2016 has entered into force. The transition period for the previous version DIN EN ISO 13485:2012 ends on 31 March 2019.
Find below some important new aspects you should consider when upgrading your quality management system to the new standard:
- The scope of the standard has been extended to outsourced processes meaning that all parties involved in the life-cycle of a medical device can apply this standard. Suppliers and external service providers can even be bound by contract to act accordingly. The standard explicitly states that processes performed by external parties must be monitored, maintained and controlled by the organisation.
- The term "medical device family" has been introduced meaning that under defined conditions it is possible to evaluate a group of medical devices with similar characteristics instead of just one single device.
- Emphasis has been put on adherance to regulatory requirements meaning any legal requirements regarding the performance and safety of a medical device.
- The requirements on documentation have been extended. Amongst others, the manufacturer must maintain a medical device file and design and development files for his medical device or device family.
- Any software applied within the QM system and for processes related to the medical device must be validated.
- Emphasis is put on a risk-based approach for controlling processes.
- Additional monitoring requirements refer to complaint handling and reporting to regulatory authorities.
Annex B shows the correspondence between DIN EN ISO 13485:2016 and ISO 9001.
We are happy to support you in upgrading your system to the new standard.
Please contact Ulrike Weißflog, , T. +49 3722 7323-840