ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related
services to such organizations.
The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to stage 2
This second assessment determines the effectiveness of the system and seeks to confirm that the management system is implemented and operational
At this point in the process we review any corrective action taken to address findings raised at stage 1 & 2. Certification may be recommended
The organisation’s file are reviewed by an independent and impartial panel and the certifxication decision is made
Successful certification is communicated to the client. Certificates are issued