Total Quality Management - Allmed & ISO 13485
The International Standard specifies requirements for a Quality Management System to ensure that medical products are manufactured to the right specification for safe intended use every time.
An organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer and applicable regulatory requirements.
During 2016 important changes were approved from International Regulatory agencies:
- revised version of ISO 13485:2016
- new Medical Device Regulation 745/2017
- MEDDEV 2.7/1 Rev.4 about Clinical Evaluation
In addition, the MDSAP Certification unifying several different areas, has been codified and will be effective early 2019.
Allmed is proud to report that some 2.5 years pre deadline, the process to become compliant is already underway.
As a first step, we are updating the Quality Management System (QMS) of our plants to the new ISO 13485:2016.
In line with our ‘Total Quality Management Policy’, all Allmed functions are involved at different stages in the product life-cycle, from Research & Development to Post-sales, in a fully integrated system.
Consequently, during the summer a team comprising Quality, R&D, Sales and Marketing, and Operations met in London for an interactive week of training held by BSI on the new ISO 13845.
It was a very successful week and our thanks go to BSI for their efforts in bringing Allmed up to speed on the new regulatory requirements.