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.

Bijlagen

Overleg