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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 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 processes]]
            
            #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]]
(3 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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