Actualités
02.10.2017
ISO 13485 version 2016 medical certification
Qualimatest has recertified its entire organization according to the new standards ISO 9001: 2015 and ISO 13485: 2016
After successfully passing the ISO 13485: 2012 certification in 2014, Qualimatest has been successfully recertified according to the 2016 version of ISO 13485.
ISO 13485 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) specifies the requirements of quality management systems (QMS) for the medical device industry, in particular:
- compliance with regulatory requirements
- mastery of special processes
- risk analysis throughout product development
- the organization of materiovigilance
- control of traceability
Michele Iarocci
Quality and Validations Manager
iarocci@qualimatest.ch
