4.2.1 General

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	06.03.2014 11:23:51
Modified:	17.09.2019 10:36:40

Diagram Elements :

Create DMRs and MMRs

Match business processes against compliance checklist

Determine legally required and relevant business processes

Publish QMS

Define and publish quality policy

Define measurable quality objectives in unison with quality policy

4.2.1 File for each type or model of medical device

4.2.1 a) The QMS shall include a quality policy and quality objectives

4.2.1 b) The QMS shall include quality manual

4.2.1 c) The QMS shall include documented procedures

4.2.1 e) The QMS documentation shall include records required

4.2.1 f) The QMS shall include other documentation specified by national or regional regulations

4.2.1 d) Ensure the effective planning, operation and control of its processes