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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 #Beginning of the introduction of the QM system by management decision
        
        
        # Name #Name of a QM representative
        
        
        # Clarification #Clarification of the question of whether to engage an external consultant. If so, contact consultants and get information about funding opportunities
        
        
        # Creation #Creation of a project plan with timelines and steps
        
        
        # Early #Early information and involvement of employees
        
        
        # Formulating #Formulating a quality policy with your own quality goals
        
        
        # Analysis #Analysis and definition of [[QM:Process Descriptions| processes]]
        
        
        # Determining #Determining interfaces between the processes
        
        
        # Definition #Definition of [[QM:Role Descriptions | responsibilities (roles)]]
        
        
        # Determining #Determining the type of documentation &mdash; if necessary, creation of procedural and work instructions
        
        
        # Creating #Creating a QM manual
        
        
        # Introduction #Introduction and qualification of employees
        
        
        # Implementation #Implementation of internal [[QM:Audits | audits]]
        
        
        # Certification
            
            
        #Certification
            
            
        #Selection of a certifier
        
        
        
        
        
            
            == ==Checklist ==
        
        The following checklist[[Media:Checklist-ISO-9001-2015 English.xls|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]]
(2 intermediate revisions by one other user not shown)
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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:
 
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.
+
*'''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.
+
*'''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).
+
*'''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.
+
*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:
+
*The following QM specifications are in use for '''Automotive Suppliers''' beyond ISO 9001:2008:
−
** Germany: VDA 6.1, VDA 6.2, VDA 6.4
+
**Germany: VDA 6.1, VDA 6.2, VDA 6.4
−
** USA: QS-9000
+
**USA: QS-9000
−
** worldwide: ISO/TS 16949 (as overarching worldwide standard)
+
**worldwide: ISO/TS 16949 (as overarching worldwide standard)
−
* A separate QM standard is required for medical device manufacturers: EN ISO 13485:2003.
+
*A separate QM standard is required for medical device manufacturers: EN ISO 13485:2003.
  
−
== Introduction of a QM system ==
+
==Introduction of a QM system==
 
A QM system is introduced according to the following procedure:
 
A QM system is introduced according to the following procedure:
  
−
# Beginning of the introduction of the QM system by management decision
+
#Beginning of the introduction of the QM system by management decision
−
# Name of a QM representative
+
#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
+
#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
+
#Creation of a project plan with timelines and steps
−
# Early information and involvement of employees
+
#Early information and involvement of employees
−
# Formulating a quality policy with your own quality goals
+
#Formulating a quality policy with your own quality goals
−
# 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
−
# Introduction and qualification of employees
+
#Introduction and qualification of employees
−
# Implementation of internal [[QM:Audits | audits]]
+
#Implementation of internal [[QM:Audits | audits]]
−
# Certification
+
#Certification
 
#Selection of a certifier
 
#Selection of a certifier
  
 +
==Checklist==
 +
The following [[Media:Checklist-ISO-9001-2015 English.xls|checklist]] is used to introduce quality management according to the ISO 9001-2015 standard. 
  
−
== 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]]
 
[[Category:Wiki Software]]
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