QUALITY SYSTEMS

We are able to develop, implement and manage Quality Management Systems complying with ISO 13485:2003 and pride ourselves on the effectiveness of the quality management systems that we develop.

Our experience with ISO 13485 enables us to help clients with:

Designing and implementing ISO 13485:2003

Preparing a gap analysis and plan for upgrading from:

ISO 13485:1996 (EN 46001)

ISO 13488:1996 (EN 46002)

ISO 9000:2000 -ISO 9000:1994