QUALITY MANAGEMENT SYSTEM: REQUIREMENTS FOR PRODUCTION OFMEDICAL DEVICES

Abstract

This article discusses the approach and methodology to implement the Quality Management System for manufacturer of Medical Devices. One of the most famous quality ‘gurus’ Jo Juran (1904-2008) stated, “Quality improvement is carried out on a project by project basis, and in no other way.” Since ‘implementation of a QMS conforming with ISO 13485’ can be viewed as quality improvement, Juran’s credo can be applied to the process.

There are some provisos. The project must be approved and driven by top management

who must accept that like any other project it will require resources i.e. the time of the

individuals involved to carry the whole thing through to completion. It’s no use going to a

busy member of staff with full time functional responsibilities and then just telling them to

take on the implementation project as well.

It is ideal if the top management identifies a project ‘champion’ from within their own

ranks to encourage, oversee and communicate progress, and smooth the way for the

project at his/her level. Top management also need to appoint a Project Leader who will

have responsibility for driving the project, appointing team members and members of any

specialist Working Groups.