ISO 9000

A quality management standard describes the requirements that must comply with the management system of a company to meet a certain standard in the implementation of quality management. It can serve both informative for the implementation within a company as well as for detecting certain standards to third parties. The proof is provided by a certification process followed by the issue of a temporary certificate by independent certification bodies.

4.1 Market Strategic importance
4.2 Securing the Future
4.3 Legal significance

ISO 9000

With the series of standards EN ISO 9000 standards have been created to document the principles of quality management measures. Together they form a coherent set of standards for quality management systems that will facilitate mutual understanding at national and international level.

Each product (including any service) is subject to other specific requirements and is therefore produce only individual quality assurance measures. Quality management systems, however, are not product -oriented and therefore dependent on the industry and the specific products and / or services and contracts individually constructed with customers.

Successful performance and operating an organization requires that it is led and guided in a systematic and clear way. A path to success can achieve and maintain a management system be, that is geared towards continual improvement in performance by taking into account the needs of all interested parties. Managing an organization and directing includes, among other management disciplines and quality management.

The standards EN ISO 9000:2000 ff are basically constructed in a process-oriented. The previous standards ISO 9000:1994 ff defined 20 elements of quality management, which corresponded to the standard processes in the manufacturing industry from development to production and assembly to customer service, so that the structure of the previous edition, for example, made it difficult to transfer to service companies as there is no analog processes names were.

Emergence of the ISO 9000 series

In 1979, the BSI -founded with the BS 5750 the first standard for quality management systems, which as a precursor to the ISO 9000 series is considered. On the base of 1987, the ISO 9000 series of standards has been introduced and recognized internationally. From this series, the ISO 9001 has now become one of the most widely accepted standards in quality management. According to the International Organization for Standardization (ISO) over 1 million certificates were issued based on the ISO 9001 standard internationally in over 170 countries by the end of 2009. In Germany, approximately 51,000 organizations have such a certification.

Contents of the ISO 9000 series of standards

EN ISO 9000

This standard defines basic principles and concepts for quality management systems. Explains the fundamentals of quality management systems and the terms used in the 9000 series of standards EN ISO. The European standard ISO 9000:2000 was published in three official versions in English, German and French. Also, the process-oriented approach of quality management is explained, based on the named after William Edwards Deming Deming ( Deming Cycle or PDCA also engl. ).

The ISO 9000:2000 has been revised in 2005 to uniform concepts and definitions for ISO 9001:2000 and ISO 19011:2002 expanded and published as ISO 9000:2005 in December 2005.

EN ISO 9001

EN ISO 9001 specifies the minimum requirements for a quality management system ( QM system), where an organization has to meet in order to provide products and services which meet customer expectations as well as any regulatory requirements. At the same time, the management system should be subject to a process of continuous improvement.

The eight principles of quality management are:

The introduction of a quality management system is a strategic decision for an organization. If an organization wants to become more responsive to their clients in order to gain competitive advantage, it has a coat with this standard with which they can dress themselves. The standard only specifies a certain frame, which is much broader in scope than the previous norms.

The process-oriented approach based on the four main processes of an organization, which transforms an input into an output. The standard considers these processes ( processes ) and compares the target specifications ( plans ) with the actual values . In case of deviations improvements and changes are defined and planned. Do - - Check - Thus the cycle plan includes Act, also called the PDCA cycle.

The eight main chapters of the standard are:

( Ch.1 -3 contain Preface and general information )
Chapter 4: Quality Management System 4.1 General requirements
4.2 Documentation requirements ( documented requirements, quality manual, quality control of documents, control of records )

5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review

6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment

7.1 Planning of product realization
7.2 Customer-related processes
7.3 Development (this point can be excluded from a certification )
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices

8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement

The current EN ISO 9001 was last revised in 2008 ( EN ISO 9001:2008). As the " Amendment" dubs, it involves no major change, but mostly for clarification ( for example through choice of words " statutory and regulatory requirements ," definition " outsourced process " choice of words "competence" instead of the term " training " Introduction " risk " in the Introduction)

Based exist on the EN ISO 9001 for the series production of the automotive industry, the ISO / TS 16949. Compared with the EN ISO 9001 puts more stringent requirements for the quality management system.

EN ISO 9004

The EN ISO 9004 A guide explaining who considers both the effectiveness and the efficiency of the quality management system. It contains instructions for aligning a company towards Total Quality Management ( TQM), but is no certification or contractual basis. The EN ISO 9004 is more of the " management style " (and no own management system ) represents the concrete implementation of EN ISO 9004 is the EFQM model. It is not a norm but a comprehensive holistic quality management system within the meaning of Total Quality Management ( TQM), which for example includes the logging of quality tests and quality controls.

With Issue Date December 2009 at a recasting of EN ISO 9004, entitled " Managing for the sustained success of an organization - A quality management approach " before.

EN ISO 19011

This standard provides guidance on the implementation of audit principles, management of audit programs, and to conduct audits for quality and environmental management systems. It also provides guidance on the qualification of auditors. It is applicable for internal and external audits.

EN ISO / IEC 17021

This standard contains requirements for bodies providing audit and certification of management systems.

Importance

Three areas can be used for the importance of the introduction of ISO 9000 to offer: market strategy, future security and legal aspects. It is significant that the standards themselves have no legal character, but rather the management systems are certified on a voluntary basis by an accredited body for this task. In application of EU rules only exist in each country, each national ( central ) accreditation body which accredits certification bodies. This procedure is a reliable version of the limits established by the standards specifications are secured.

In Germany, the Regulation ( EC) No 765/2008 mortgaged the German accreditation body with the task by the Law on the accreditation body in accordance with Article 4, paragraph 1. The text of the law means by this term the sole right to confirm the certifying bodies and to allow, so to accredit.

In Switzerland, this task is performed by the Swiss Accreditation Service (SAS).

Market of strategic importance

From a strategic perspective, market a certificate is used to prove a company standard processes and its products or services. For manufacturers, suppliers and large international companies, the certificate can be considered as mandatory in order to even get orders of a certain size.

Securing the Future

The introduction of a good QMS helps a company in the development of their own potential. A QMS that meets the requirements of the standard series, is thus a way a company - in spite of change and thereby changing conditions and requirements - to shape the future and steer.

Legal Significance

From a legal perspective, only EN ISO 13485 for medical devices as well as the ISO 9000 series of standards for all other products as the sole basis for certification of all national standardization and certification companies in the EU and widely accepted worldwide. In order for these standards provide a legal basis, which is just for international companies of great importance. This is an important argument, which speaks for the certification of a company, especially in product liability.

Withdrawn standards

The following standards have been withdrawn:

Contained "Quality management and quality assurance - Vocabulary " and defined the basic terms of the quality of design, how they should be applied to 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 ISO 9000:2005 ).

Was withdrawn in December 2005 and replaced by EN ISO 9000:2005.

Considered only a part of the product creation process, by only had production and assembly in view, so the areas in which suppliers fulfilled their tasks. This standard has lost with the revision of the standard series for quality management (ISO 9000 ) in 2000 to be valid. In a transition period until the end of 2003, there were certificates according to this standard.

Made statements on quality assurance in the area of responsibility, error correction, and more. This standard is applicable between suppliers and customers when an approved quality assurance system is at the supplier. This standard has lost with the revision of the standard series for quality management (ISO 9000 ) in 2000 to be valid. In a transition period until the end of 2003, there were certificates according to this standard. Curiously, this standard in medical technology continue to be valid. Since there are still similar to the EN ISO 13485:2003 any successor standard EN 46003:1999 for the EN ISO 9003:1994 can be further applied in this industry as a basis for certification.

QS 9000 was a quality standard that was jointly developed by automobile manufacturers General Motors, Chrysler and Ford. He was employed in 1994 in the automotive industry. 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 these three automakers.
Part 3: System requirements, which are specific to individual manufacturers.

On 14 December 2006, all three parts were withdrawn. The QS 9000 is now replaced by the ISO 9001 and ISO / TS 16949.

Implementation in the operational framework

With the introduction of a quality management system according to EN ISO 9001 in an organization development can be divided into one of three phases.

For companies that already have a quality management system, but this will change for an ISO certification, the existing system into individual processes and process descriptions must be disassembled, the individual processes of timeliness, adequacy, reasonableness and necessity are checked and finally the processes for new design principles are put back together.

Industry-specific standards

There are a number of industry standards and other specifications for quality management, which are partially written as a supplement to the standards EN ISO 9001:2008 or as a guide.

ISO 10006 guide quality management in projects
ISO / TR 10013 Guidelines for the documentation of the quality management system
ISO 10014 Quality management systems - Guidelines for achieving financial and economic benefits
ISO / TR 14969 Quality systems - Medical devices - Guidance on the application of ISO 13485
ISO 15189 Medical laboratories - Particular requirements for quality and competence
ISO 15378 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice ( GMP)
ISO / TS 16949 Quality management systems - Particular requirements for the application of ISO 9001:2008 for the series and spare part production in the automotive industry
ISO / IEC 17025 General requirements for the competence of testing and calibration laboratories
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 - Sector-specific quality management systems - Requirements for any organization for product and service delivery
ISO 29990 Learning services for the education and training - Basic requirements for service providers
ISO / IEC 90003 software and system engineering - Guidelines for the application of ISO 9001:2000 to computer software
EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes
EN ISO 16106 Packaging - Transport packaging for dangerous goods - Dangerous goods packagings, intermediate bulk containers (IBCs ) and large packagings - Guidelines for the application of ISO
EN 9100, AS 9100 Aerospace - Quality management systems - Requirements ( based on ISO 9001:2000 ) and Quality Systems
EN 12507 Transportation Services - Guidance on the application of EN ISO 9001:2000 to the road and rail freight, warehousing and distribution industry
PrEN 12798:1999 quality management for the transport - transport by road, rail and inland waterways - the quality management system requirements to supplement EN ISO 9001 with regard to safety in the transport of dangerous goods
EN 13980 Potentially explosive atmospheres - Application of quality systems
EN 15038 Translation Services - Service Requirements
EN 15224 services in health care - Quality management systems - Guidance on the application of EN ISO 9001:2000
EN 15838 quality management system with specific requirements for the call center specific conditions - first European industry norm for this area
PrCEN / TS 15358 Solid recovered fuels - Quality management systems - Particular requirements for the application in the production of solid recovered fuels
CEN / TR 15592 services in health care - Quality management systems - Guidelines for the application of EN ISO 9004:2000 to the services in health care to improve performance
KTQ requirements for health care facilities, especially hospitals
VDA 6.1 rules of the German automotive industry - QM system audit -
VDA 6.2 rules of the German Automotive Industry - Services -
VDA 6.4 rules of the German automotive industry - Production equipment manufacturing -
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 of organizations in the business-oriented education and training: QM STAGE MODEL
S 9000 ' rules of the North American automotive industry ( required valid to 14 December 2006, and thereafter upgrade to ISO / TS 16949:2002 )
IRIS ( railway standard ) International Railway Industry Standard - Management of the Quality Management System of the supplier of conveyor system manufacturers
ISAS BC- 9001 International Quality Management Standard for the media industry - requirements for the quality management system of broadcasting organizations

Tsukiji fish market ISO/TS 16949 EFQM Excellence Model TL 9000

242051