ISO 13485 Requirements

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	03.04.2014 10:15:03
Modified:	08.03.2015 06:09:04

Diagram Elements :

3 Terms and definitions

Compliance :Compliance

Annex ZB.2 Relationship with Annex II of MDD 93/42/EEC

8 Measurement, analysis and improvement

7 Product realization

6 Resource management

5 Management responsibilities

4 Quality management system