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.
1.1. Introduction of a QM system
A QM system is introduced according to the following procedure:
- Beginning of the introduction of the QM system by management decision
- Name of a QM representative
- Clarification of the question of whether to engage an external consultant. If so, contact consultants and get information about funding opportunities
- Creation of a project plan with timelines and steps
- Early information and involvement of employees
- Formulating a quality policy with your own quality goals
- Analysis and definition of Process descriptions
- Determining interfaces between the processes
- Definition of Role definitions
- Determining the type of documentation — if necessary, creation of procedural and work instructions
- Creating a QM manual
- Introduction and qualification of employees
- Implementation of internal Audits
- Selection of a certifier
The following checklist is used to introduce quality management according to the ISO 9001-2015 standard.