Quality management standard
A quality management standard describes which requirements the management system of an organization - be it a company or an authority - must meet in order to meet a certain standard in the implementation of quality management . It can serve both informative for the implementation within a company and as evidence of certain standards towards third parties. Evidence is provided by a certification process with subsequent issuance of a temporary certificate by independent certification bodies .
The German-language editions of these standards have the same content, depending on the country as DIN (Germany, bilingual German and English), ÖNORM (Austria, monolingual or bilingual German and English) or SN (Switzerland, trilingual German, English and French) standards (see European standard (EN) ).
The international edition is also available in Spanish and Russian. The English version is also available as a "Redline", here all changes to the previous standard are highlighted in color.
ISO 9000 ff.
With the series of standards EN ISO 9000 ff. Are standards created to document the principles of quality management measures. Together they form a coherent set of standards for quality management systems that are intended to facilitate mutual understanding at national and international level.
Each product (including any service) is subject to different requirements and is therefore only individual quality assurance to generate measures. Quality management systems, on the other hand, are not product-oriented and are therefore structured individually depending on the industry and the specific products and / or services as well as contracts with customers.
The successful management and operation of an organization requires that it be managed and directed in a systematic and clear manner. One path to success can be to establish and maintain a management system that is geared towards continuous improvement in performance by taking into account the needs of all interested parties. Leading and directing an organization includes quality management in addition to other management disciplines.
The EN ISO 9000: 2000 ff. Standards are fundamentally process-oriented . The predecessor standards ISO 9000: 1994 ff. Defined 20 elements of quality management that corresponded to the standard processes of the manufacturing industry from development through production and assembly to customer service , so that the structure of the predecessor standard made it difficult to transfer it to service companies, for example, as there were no analog ones Process names.
Creation of the ISO 9000 series of standards
In 1979 the British Standards Institution (BSI) established the first standard for quality management systems with BS 5750, which is considered the forerunner of the ISO 9000 series. In 1987 ISO 8402 was introduced, which was replaced by the ISO 9000 series of standards in 2000. From this series, ISO 9001 has now become one of the most widely accepted standards in quality management. According to the International Organization for Standardization (ISO), by the end of 2009 over 1 million certificates based on the ISO 9001 standard had been issued in over 170 countries. In 2012 around 51,000 organizations in Germany had this type of certification.
Contents of the ISO 9000 series of standards
EN ISO 9000
|DIN EN ISO 9000|
|title||Quality management systems - basics and terms (ISO 9000: 2015)|
|Brief description:||Terms for quality management systems in German and English|
This standard defines the basics and terms for quality management systems. The fundamentals of quality management systems and the terms used in the EN ISO 9000 ff series of standards are explained. In addition, the eight principles of quality management were listed in Chapter 0.2, which have only been the "Seven Principles of Quality Management" since the 2015 revision (since the 2018 revision, reference has also been made to the principles of ISO 9000: 2015 in ISO 9004).
- customer focus
- Responsibility of leadership
- Involvement of the people involved
- Process-oriented approach and (formerly independent) system-oriented management approach
- Continuous improvement
- Factual decision-making approach
- Supplier relationships for mutual benefit
The European standard ISO 9000: 2000 was published in three official versions in English, German and French. The process-oriented approach of quality management is also explained, based on the Deming circle named after William Edwards Deming (English also Deming Cycle or PDCA ).
ISO 9000: 2005 was revised and then published as edition ISO 9000: 2015-11.
EN ISO 9001
|DIN EN ISO 9001|
|title||Quality management systems - requirements (ISO 9001: 2015)|
|Brief description:||Requirements for the certification of quality management systems in German and English|
EN ISO 9001 defines the minimum requirements for a quality management system (QM system) that an organization has to meet in order to be able to provide products and services that meet customer expectations and any official requirements. At the same time, the management system should be subject to a continuous improvement process.
Although the process-oriented approach was introduced with the 2000 revision, there were considerable problems in its implementation. This should be made easier by the revision. In addition, the standard calls for a more risk-based approach. A formal QM manual will no longer be necessary if the organization provides appropriate documentation in another way. There will also no longer have to be a “senior management representative” in the formal sense.
The current EN ISO 9001 was last revised in 2015 (EN ISO 9001: 2015-09). Titled as an "amendment", it is not a major change, but mostly clarifications (for example through the choice of words "legal and regulatory requirements", definition of "outsourced process", choice of words "competence" instead of "training", introduction of the term "risk") “In the introduction).
Based on EN ISO 9001, IATF 16949 exists for series production in the automotive industry . Compared to EN ISO 9001, it places more extensive requirements on the quality management system.
Revision of ISO 9001: 2015
In 2012 the ISO member bodies decided on a formal global review of ISO 9001. A majority of those questioned voted for a revision of the standard. The new version of the standard was adopted in November 2015. Certification bodies usually grant a three-year transition period within which the QM systems must be converted to the new revision.
The structure of the new revision is based on the basic structure for management system standards ( high level structure ) specified in the ISO directives and therefore now has 10 instead of 8 chapters.
|1||scope of application|
|4th||Context of the organization|
|4.1||Understand the organization and its context|
|4.2||Understand the needs and expectations of interested parties|
|4.3||Establishing the scope of the quality management system|
|4.4||Quality management system and its processes|
|5.1||Leadership and commitment|
|5.3||Roles, responsibilities and authorities in the organization|
|6th||Planning for the quality management system|
|6.1||Measures for dealing with risks and opportunities|
|6.2||Quality goals and planning to achieve them|
|6.3||Planning of changes|
|7.1.4||Environment for carrying out processes|
|7.1.5||Monitoring and measurement resources|
|7.1.6||Knowledge of the organization|
|7.5.2||Creation and updating|
|7.5.3||Control of documented information|
|8.1||Operational planning and control|
|8.2||Requirements for products and services|
|8.2.1||Communication with customers|
|8.2.2||Determine requirements related to products and services|
|8.2.3||Review of requirements related to products and services|
|8.2.4||Changes in requirements related to products and services|
|8.3||Development of products and services|
|8.3.4||Control measures for development|
|8.4||Control of externally provided processes, products and services|
|8.4.2||Type and scope of control|
|8.4.3||Information for external providers|
|8.5||Production and service delivery|
|8.5.1||Control of production and service provision|
|8.5.2||Labelling and traceability|
|8.5.3||Property of customers or external providers|
|8.5.6||Monitoring of changes|
|8.6||Release of products and services|
|8.7||Control of non-compliant process results, products and services|
|9||Evaluation of performance|
|9.1||Monitoring, measurement, analysis and evaluation|
|9.1.3||Analysis and assessment|
|9.3.2||Inputs for management review|
|9.3.3||Results of the management review|
|10.2||Non-conformity and corrective action|
The 'High Level Structure', which has now also been implemented for ISO 9001: 2015, is based on the PDCA cycle ; the following standard chapters can be assigned to the cycle:
|phase||Chapter number and title||Supplement (in ISO 9001)|
1: Area of application |
2: Normative references
4: The environment of the organization |
5: Leadership behavior
|To 4: Interested parties or stakeholders and their expectations|
7: Provision of funds, support |
|to 8: Production or service provision|
|C heck||9: Assessment of performance|
|A ct||10: improvement|
EN ISO 9004
|DIN EN ISO 9004|
|title||Leading and steering for the sustainable success of an organization - A quality management approach|
|Brief description:||Quality management system efficiency|
EN ISO 9004 provides guidelines that consider both the effectiveness and the efficiency of the quality management system. This contains instructions for aligning a company towards Total Quality Management (TQM) , but is not a certification or contractual basis.
Instead, it can be used as a guide to self-assessment. In the appendix there are lists that give specific information about the "maturity levels" for the individual requirements (maturity level 1 represents the minimum requirements, maturity level 3 should be achieved by an ISO 9001-certified company and maturity level 5 is based on the top performance in the respective sector ).
The EN ISO 9004 rather represents the "management design" (a management model and not a separate management system). The concrete implementation of EN ISO 9004 largely corresponds to the EFQM model , which is not a standard, but a comprehensive holistic quality management system in the sense of Total -Quality Management (TQM) and z. B. includes the logging of quality checks and quality controls.
With the December 2009 issue date, there is a new version of EN ISO 9004 with the title “Guiding and steering for the sustainable success of an organization - A quality management approach”.
The division into chapters corresponds roughly to the structure of the old ISO 9001: 2008 and therefore unfortunately not the high level structure.
|3.2||Environment of an organization|
|4th||Leading and steering for the sustainable success of an organization|
|4.3||The environment of the organization|
|4.4||Interested parties, needs and expectations|
|5||Strategy and politics|
|5.2||Conception of strategy and politics|
|5.3||Implementation of strategy and policy|
|5.3.2||Processes and procedures|
|5.4||Communication of strategy and politics|
|6th||Management of resources|
|6.3.3||Involvement and motivation of employees|
|6.4||Suppliers and partners|
|6.4.2||Selection, evaluation and improvement of the capabilities of suppliers and partners|
|6.7||Knowledge, information and technology|
|7.2||Process planning and control|
|7.3||Process responsibility and authority|
|8th||Monitoring, measurement, analysis and evaluation|
|8.3.2||Crucial performance indicators|
|8.5||Evaluation of the information obtained through monitoring, measurement and analysis|
|9||Improvement, innovation and learning|
|Appendix A.||Self-assessment tool|
|A3||Self-assessment of key elements|
|A4||Detailed self-assessment of the individual elements|
|A5||Use the self-assessment tools|
|A6||Results of self-assessment and planning of improvements and innovations|
|Appendix B.||Quality management principles|
|B2||1st principle: customer orientation|
|B3||2nd principle: leadership|
|B4||3rd principle: involvement of employees|
|B5||4th principle: process-oriented approach|
|B6||5th principle: system-oriented management approach|
|B7||6th principle: continuous improvement|
|B8||7th principle: factual approach to decision making|
|B9||8. Principle: supplier relationships for mutual benefit|
|Appendix C.||Correspondences between ISO 9004: 2009 and ISO 9001: 2008|
DIN EN ISO 19011
|DIN EN ISO 19011|
|title||Guide to auditing management systems|
|Brief description:||Guide to auditing management systems|
This standard provides guidance on the implementation of audit principles , the management of audit programs and the implementation of audits for quality and environmental management systems. It also gives instructions on how to qualify auditors. It can be used for internal and external audits.
EN ISO / IEC 17021
|DIN EN ISO / IEC 17021|
|title||Conformity assessment - requirements for bodies that audit and certify management systems|
This standard contains requirements for bodies that audit and certify management systems.
Three areas can be highlighted for the importance of introducing ISO 9000: market strategy , safeguarding the future and legal aspects. It is important that the standards themselves have no legal character; rather, the management systems are certified on a voluntary basis by a body that is accredited for this task . In application of the EU regulations, there is only one national (central) accreditation body in each EU country, which accredits the certification bodies. This procedure is intended to ensure a reliable implementation of the requirements specified by the standards.
In Germany, the Regulation (EC) No that was by the law on the accreditation body under Article 4, paragraph 1. 765/2008 German accreditation body with the task mortgaged . With this name, the legal text means the sole right to confirm and approve the competence of the certifying bodies, i.e. to accredit .
In Switzerland, this task is carried out by the Swiss Accreditation Service (SAS).
Market strategic importance
From a market strategy point of view, a certificate is used to prove the standard of its processes and products or services to a company. For manufacturers , suppliers and large international companies, the certificate can be seen as mandatory in order to even get orders of a certain size.
Securing the future
The introduction of a good QMS helps a company to develop its own potential. A QMS that meets the requirements of the series of standards is thus a way of designing and managing a company in a future-proof manner - despite the change and the resulting changed framework conditions and requirements.
From a legal point of view, only the EN ISO 13485 standards for medical products, as well as the ISO 9000 ff. Series of standards for all other products, are accepted as the sole certification basis by all national standardization and certification bodies in the EU and largely worldwide. These standards thus provide a legal basis that is of great importance, especially for international companies. This is a key argument in favor of certification of a company, especially when it comes to product liability.
The following standards have been withdrawn:
- EN ISO 8402: 1994
contained “Quality Management and Quality Assurance - Terms” and defined the basic terms for the quality concept, as they should be used for products and services, for the preparation and application of quality standards and for mutual understanding in international communication. It was withdrawn in December 2000 and replaced by EN ISO 9000: 2001 (now EN ISO 9000: 2005).
- EN ISO 9001: 2008
was withdrawn in November 2015 and replaced by EN ISO 9001: 2015.
- EN ISO 9000: 2000
was withdrawn in December 2005 and replaced by EN ISO 9000: 2005.
- EN ISO 9002: 1994
only looked at part of the process of creating a product by only focusing on production and assembly, i.e. the areas in which suppliers performed their sub-tasks. With the revision of the series of standards for quality management (ISO 9000ff) in 2000, this standard lost its validity. In a transition period until the end of 2003 there were still certificates according to this standard.
- EN ISO 9003: 1994
made statements about quality assurance in the area of responsibility, error correction and other things. This standard is applicable between the supplier and the buyer if the supplier has a proven quality assurance system. With the revision of the series of standards for quality management (ISO 9000ff) in 2000, this standard lost its validity. In a transition period until the end of 2003 there were still certificates according to this standard. Curiously, this standard is still valid in medical technology. Since there is still no successor standard for EN 46003: 1999 analogous to EN ISO 13485: 2003, EN ISO 9003: 1994 can still be used as a basis for certification in this branch.
- QS 9000
QS 9000 was a quality standard that was jointly developed by the automobile manufacturers General Motors, Chrysler and Ford. It was used in the automotive industry from 1994. The standard was divided into three sections.
- Part 1: ISO 9001 with some extensions for requirements in the automotive industry.
- Part 2: Additional requirements that have been adopted by the three automobile manufacturers mentioned.
- Part 3: System requirements that are specific to individual manufacturers.
On December 14, 2006, all three parts were withdrawn. The QS 9000 has been replaced by ISO 9001 and ISO / TS 16949. The ISO / TS 16949 was replaced by the IATF 16949 in 2016.
Implementation within the operational framework
When introducing a quality management system according to EN ISO 9001 in an organization, the development can be divided into one of three phases.
- Companies that are about to introduce a quality management system;
- Companies in the introductory phase shortly before certification and
- Companies that are already certified and continue to follow this system.
For companies that already have a QM system, but want to convert it for ISO certification, the existing system must be broken down into individual processes and process descriptions, the individual processes must be checked for up-to-dateness, appropriateness, plausibility and necessity, and finally the processes must be checked for new ones Design principles are reassembled.
There are a number of industry-specific standards and other specifications for quality management, some of which are written as supplementary standards to ISO 9001 or as guidelines.
- ISO 10006 guidelines for quality management in projects
- ISO / TR 10013 Guide for the documentation of the quality management system
- ISO 10014 Quality Management Systems - Guide to Achieving Financial and Economic Benefits
- ISO 13485 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
- ISO / TR 14969 Quality assurance systems - Medical devices - Instructions for the application of ISO 13485
- ISO 15189 Medical Laboratories - Special requirements for quality and competence
- ISO 15378 Primary packaging for pharmaceuticals - Special requirements for the application of ISO 9001: 2000 according to Good Manufacturing Practice ( GMP )
- ISO 16106 Packaging - Packaging for the transport of dangerous goods - Dangerous goods packaging, IBCs and large packagings - Guide for the application of ISO
- IATF 16949 Quality Management Systems - Special requirements when using ISO 9001: 2008 for series and spare parts production in the automotive industry
- ISO / IEC 17025 General requirements for the competence of testing and calibration laboratories
- ISO 17100 Translation Services - Service Requirements
- ISO 18295 quality management system with special requirements for call centers
- ISO / IEC 19796-1 Information technology - Learning, education and training - Quality management, assurance and metrics - Part 1: General approach
- ISO / TS 29001 Petroleum, petrochemical and natural gas industries - Area-specific quality management systems - Requirements for organizations for product and service provision
- ISO 29990 Learning Services for Education and Training - Basic Requirements for Service Providers
- ISO / IEC 80079-34 Hazardous Areas - Use of Quality Management Systems
- ISO / IEC 90003 Software and Systems Engineering - Guidelines for the application of ISO 9001: 2000 to software
- EN 9100 , AS 9100 Aerospace - Quality Management Systems - Requirements (based on ISO 9001: 2000) and Quality Systems
- EN 12507 Transportation Services - Guide to the application of EN ISO 9001: 2000 to road and rail freight, warehousing and distribution industries
- EN 12798 Quality management for transport - Transport by road, rail and inland waterways - Requirements of the quality management system to supplement EN ISO 9001 with regard to the safety of the transport of dangerous goods
- EN 15224 Healthcare Services - Quality Management Systems - Guide to the Application of EN ISO 9001: 2008
- EN 15358 Solid recovered fuels - Quality management systems - Particular requirements for use in the production of solid recovered fuels
- CEN / TR 15592 Health care services - Quality management systems - Guide for the application of EN ISO 9004: 2000 to health care services to improve performance
- KTQ requirements for health care facilities, especially hospitals
- VDA 6.1 regulations of the German automotive industry - QM system audit -
- VDA 6.2 regulations of the German automotive industry - services -
- VDA 6.4 set of rules of the German automotive industry - production equipment production -
- E DIN VDE 0753-4: Application rules for procedures for chronic extracorporeal renal replacement therapy - quality management in dialysis facilities
- PAS 1037 Requirements for quality management systems in business-oriented education and training organizations: QM STAGE MODEL
- S 9000 rules of the North American automotive industry ( valid until December 14, 2006, afterwards upgrade to ISO / TS 16949: 2002 required )
- TL 9000 QuEST - Quality Excellence for Suppliers of Telecommunications
- IRIS ( Railway Standard ) International Railway Industry Standard - requirements for the quality management system of the suppliers of railway system manufacturers
- ISAS BC-9001 International Quality Management Standard for the Media Industry - Requirements for the Quality Management System of Broadcasting Organizations
- Official ISO documentation in English (downloads are subject to a charge)
- QS 9000 history
- NA 147 Standards Committee Quality Management, Statistics and Certification Bases (NQSZ)
- Instructions for use for ISO9001: 2008
- Assistance in choosing a certification body
- DIN Verlag (= Beuth); ISO 9001: 2015 .
- ISO 8402: 1994 Quality management and quality assurance - Vocabulary. International Organization for Standardization, accessed August 17, 2017 .
- The ISO Survey of certifications 2009 . 18th edition (2010), ISBN 978-92-67-10535-2 .
- Klaus Petrick, Frank Graichen: 25 years of ISO 9001: the road to success for a system standard . In: quality and reliability . 57th vol., No. 3, 2012, pp. 26-28.
- DIN EN ISO 9000: 2000-12, section 0.2.
- Frank Bünting, Thomas Votsmeier, Ronald Menacher, Leo Stühler: "QM becomes a matter for the boss!" in QZ - quality and reliability 7/2014.
- "Quality Manager (TÜV)"; Training documents from TÜV Süd Akademie; 2017.
- ISO 19011: 2011, German version, p. 8.
- AkkStelleG .
- DAkkS .