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<bookshelf src="Quality Handbook" /> | <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: | 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. | ||
== <span class="mw-headline">Introduction of a QM system</span> == | ==<span class="mw-headline">Introduction of a QM system</span>== | ||
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 [ | #Analysis and definition of [[IMS:Process descriptions|Process descriptions]] | ||
# Determining interfaces between the processes | #Determining interfaces between the processes | ||
# Definition of [ | #Definition of [[IMS:Role definitions|Role definitions]] | ||
# Determining the type of documentation — if necessary, creation of procedural and work instructions | #Determining the type of documentation — 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 [ | #Implementation of internal [[IMS:Audit reports|Audits]] | ||
# Certification | #Certification | ||
# Selection of a certifier | #Selection of a certifier | ||
== <span class="mw-headline">Checklist</span> == | ==<span class="mw-headline">Checklist</span> == | ||
The following [ | The following [[Media:Checklist-ISO-9001-2015_English.xls|checklist]] is used to introduce quality management according to the ISO 9001-2015 standard. | ||
Latest revision as of 12:54, 2 December 2021
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 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
- Certification
- Selection of a certifier
Checklist
The following checklist is used to introduce quality management according to the ISO 9001-2015 standard.
