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Difference between revisions of "QM:Introduction"

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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[edit | edit source]

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[edit | edit source]

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

<bookshelf src="Book:Quality Handbook" />
        
        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:
        
        
        
        # 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 [[QM:Process Descriptions| Processes]]
        
        # Determining interfaces between the processes
        
        # Definition of [[QM: role descriptions Role Descriptions | responsibilities (roles)]]
        
        # Determining the type of documentation &mdash; if necessary, creation of procedural and work instructions
        
        # Creating a QM manual
        
        # Introduction and qualification of employees
        
        # Implementation of internal [[QM:Audits | audits]]
        
        # Certification
        
        #Selection of a certifier
        
        
        
        
        
        == Checklist ==
        
        The following checklist is used to introduce quality management according to the ISO 9001-2015 standard [[Media:Checklist-ISO-9001-2015_English.xls|checklist]].  
        
        [[Category:Wiki Software]]
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# Analysis and definition of [[QM:Process Descriptions| Processes]]
 
# Analysis and definition of [[QM:Process Descriptions| Processes]]
 
# Determining interfaces between the processes
 
# Determining interfaces between the processes
−
# Definition of [[QM: role descriptions | responsibilities (roles)]]
+
# Definition of [[QM:Role Descriptions | responsibilities (roles)]]
 
# Determining the type of documentation &mdash; if necessary, creation of procedural and work instructions
 
# Determining the type of documentation &mdash; if necessary, creation of procedural and work instructions
 
# Creating a QM manual
 
# Creating a QM manual
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