1 Introduction

The industry-independent QM system according to the standard series DIN EN ISO 9000 ff. Is equally well suited for manufacturers, service providers, institutions, software developers and suppliers, but especially for:

• Suppliers whose customers demand or will demand a QM system in the near future, such as the automotive industry and public sector clients.
• Healthcare companies and institutions' (hospitals, nursing homes, etc.) for which a QM scheme is required by law.
• Manufacturer of products, where quality defects can lead to high liability risks (product liability law).
• Companies that manufacture products for which a CE mark is required by European directives.
• The following QM specifications are in use for Automotive Suppliers beyond ISO 9001:2008:
  • Germany: VDA 6.1, VDA 6.2, VDA 6.4
  • USA: QS-9000
  • worldwide: ISO/TS 16949 (as overarching worldwide standard)
• A separate QM standard is required for medical device manufacturers: EN ISO 13485:2003.

Introduction of a QM system

A QM system is introduced according to the following procedure:

1. Beginning of the introduction of the QM system by management decision
2. Name of a QM representative
3. Clarification of the question of whether to engage an external consultant. If so, contact consultants and get information about funding opportunities
4. Creation of a project plan with timelines and steps
5. Early information and involvement of employees
6. Formulating a quality policy with your own quality goals
7. Analysis and definition of processes
8. Determining interfaces between the processes
9. Definition of responsibilities (roles)
10. Determining the type of documentation — if necessary, creation of procedural and work instructions
11. Creating a QM manual
12. Introduction and qualification of employees
13. Implementation of internal audits
14. Certification
15. Selection of a certifier

Checklist

The following checklist is used to introduce quality management according to the ISO 9001-2015 standard.