Technology & Engineering
ISO 9000
ISO 9000 is a set of international standards for quality management systems. It provides guidelines and criteria for companies to ensure that their products and services consistently meet customer requirements and regulatory standards. Compliance with ISO 9000 can enhance a company's reputation, improve customer satisfaction, and increase operational efficiency.
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12 Key excerpts on "ISO 9000"
- Boris Mutafelija, Harvey Stromberg(Authors)
- 2008(Publication Date)
- Auerbach Publications(Publisher)
Chapter 4ISO Standards
Introduction
In this chapter we will summarize the content and structure of the following ISO standards for quality management, software engineering processes, systems engineering processes, and information technology service delivery:■ ISO 9001:2000,Quality management systems – Requirements (ISO 2000b)■ ISO 90003:2004,Guidelines for the application of ISO 9001:2000 to computer software (ISO 2004a)■ ISO 15288:2008,Systems and software engineering – System life cycle processes (ISO 2008a)■ ISO 12207:2008,Systems and software engineering – Software life cycle processes (ISO 2008b)■ ISO 20000:2005,Information technology – Service management (ISO 2005a)ISO, the International Organization for Standardization, was formed in the mid-1940s with the goal of unifying international industrial standards. ISO has published more than 16,000 standards, most of which are narrowly focused on specific technical criteria. In contrast to the bulk of ISO standards, ISO 9000:2000, Quality management systems – Fundamentals and vocabulary (ISO 2000a), probably the best known ISO standard, is a generalized standard for quality management systems. A quality management system defines the activities an organization performs to ensure that its products and services meet the needs and expectations of its customers. As such, ISO 9000 is intended to be applicable to organizations of all sizes and types, no matter what types of products and services those organizations provide.ISO 9000, shown in Figure 4.1
eBook - PDF- Ray Tricker(Author)
- 2012(Publication Date)
- Newnes(Publisher)
This standard applies to hardware and/or software products, where dependability characteristics are significant during the product's operation and maintenance phases. 3.6.5 ISO 9001, 9002 and 9003 ISO 9001, 9002 and 9003 are a series of quality system specifications containing details of the basic requirements for a two-party contract. They provide detailed guidance for external, contractual quality assurance and may be used in a contract to specify the quality-system requirements that are most appropriate to that particular product or service. These standards can also be used by a purchaser (i.e. non-contractually) to show whether a supplier operates an acceptable quality system. A more detailed description of these standards is given in Section 1.7. 3.7 ISO 9004 ISO 9004 (Ref. 8 -guidelines to the quality management and quality system elements) provides a basic set of rules for the development and implementation of quality systems according to product nature, market, manufacturing techniques, etc. The selection of suitable elements contained in this standard (and the extent to which these elements are adopted and applied by a company) depends on factors such as the nature of product, consumer requirements, the market being served and production processes. ISO 9004 also provides definitions of organization, company, customer and the requirements of society. It covers management responsibility and its application to quality policy, quality objectives and a quality system. ISO 9004 is subdivided into four subsections which are described below. 3.7. 1 ISO 9004/1 ISO 9004/1 (Ref. 9 -guide to quality management and quality system elements) covers organizational goals, customer requirements, risks, cost ISO 9000 47 and benefits. It includes sections on definitions, management responsibility and quality in marketing.
- Richard C. Fries(Author)
- 1998(Publication Date)
- CRC Press(Publisher)
Section 2 Quality Systems Chapter6 The ISO 9000 Series of Standards The ISO 9000 standards are a series of internationally accepted standards which specify a quality management system. They judge how well a business is run in delivering a consistent quality product. They deal with all aspects of a business and how controls are managed and improved. They describe a basic set of elements by which an organization can develop and implement a quality management system. Registration to the series of standards is accomplished through a third party audit, by a notified body, which must be approved by an international certification organization. Some examples of notified bodies are British Standards Institute (BSI), Lloyds, and Technischer Oberwachungs Verein (TDV). Registration to these standards ensures an organization, and those that do business with them, of an operating quality management system. The standards are important externally for several reasons. First, they serve as a benchmark for quality performance. Second, the European Community has adopted them as a quality standard. Third, major customers may require certification to one of the ISO 9000 standards as a requirement to conduct business. Fourth, certification may be required in order to process sales in Europe. The standards are important internally for several reasons. 62 Chapter 6 Certification establishes a quality system and employee understanding of quality systems. Certification creates active employee participation in establishing the quality system. Certification helps maintain quality improvement gains. Certification places the company on a level playing field with the competition. 6.1 Origin of the ISO 9000 Standards In 1979, Technical Committee 176 was formed as part of the International Organization for Standardization (ISO) in response to a formal proposal by the British Standard Institute.
No longer available |Learn moreTrade in Services
An Answer Book for Small and Medium-sized Exporters
- International Trade Centre(Author)
- 2001(Publication Date)
- United Nations Publications(Publisher)
The ISO 9000 standards first came out in 1987; they were revised for the first time in 1994 and for the second time in 2000. Standards are reviewed every five years to ensure that they are current and satisfy the needs of users. ISO 9000 is a starting point for understanding the standards, as it defines the fundamental terms used in the ISO 9000 family. ISO 9001 specifies the requirements for a quality management system through which a company can demonstrate its ability to provide products that fulfil customer requirements and applicable regulatory requirements; it also aims to enhance customer satisfaction. ISO 9004 provides guidance on continual improvement of the quality management system so that the needs and expectations of all interested parties are met. These parties include customers and end-users; company directors and staff; owners and investors; suppliers and partners; and society at large. ISO 9001 and ISO 9004 are a ‘consistent pair’ of standards that relate modern quality management to an organization’s processes and activities, and emphasize the promotion of continual improvement and achievement of customer satisfaction. ISO 9001, which focuses on the effectiveness of the quality management system in meeting customer requirements, is used for certification or for contractual agreements between suppliers and buyers. ISO 9004 cannot be used for certification as it does not prescribe requirements, but it does provide guidance for the continual improvement of an organization’s performance. ISO 9001 focuses on ‘effectiveness’, i.e. doing the right things, whereas ISO 9004 emphasizes both ‘effectiveness’ and ‘efficiency’, i.e. doing the right thing in the right way. The ISO 9000 quality management system is generic in nature and is applicable to all sectors, including services, and to organizations of all sizes, including the single entrepreneur.
eBook - ePubTotal Quality Management
Text, Cases, and Readings, Third Edition
- Joel E. Ross, Susan Perry(Authors)
- 2017(Publication Date)
- CRC Press(Publisher)
12 ISO 9000 AND ISO 14000:UNIVERSAL STANDARDS OF QUALITY Companies can comply with Europe’s standards — or stay home Business Week International standards had their origin in World War II when military allies needed to adopt some common units of measure and product specifications for munitions, vehicles, and military hardware. These later became known as MilSpecs. Even today, many standards are the descendants of these early standards. Industry followed the lead of the military, but industries in each country developed their own standards, and the result was incompatibility across boundaries. With the exception of ISO 9000 and ISO 14000, the majority of ISO standards are highly specifically documented agreements that contain technical specifications of other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics to ensure that material, products, processes, and services are fit for their purposes. The focus is on the product, and before ISO 9000 and ISO 14000, the ISO standards were principally of concern to engineers and other technical specialists. For example, standards for items such as bolts, nuts, screws, pins, and rivets are essential to keep products from falling apart but are of interest primarily to technical personnel. The science of quality control emerged as the technique to ensure that standards were met, and the technique was confined almost exclusively to manufacturing. During the 1970s and 1980s, quality control evolved from reactive (inspection-dominant) to proactive (system-oriented) organizations. 1 The focus changed the end result (the product) to the process by which it was produced. The theory behind this change was that if the process used to produce the product was developed and maintained properly, the product would be consistent and the quality could be improved. This, of course, is one of the main tenets of total quality management (TQM) as described in this book
eBook - PDFAutomotive Quality Systems Handbook
ISO/TS 16949:2002 Edition
- David Hoyle(Author)
- 2005(Publication Date)
- Butterworth-Heinemann(Publisher)
ISO 9000 is both an international standard and until December 2000 was a family of some 20 international standards. As a standard, ISO 9000 was divided into four parts with Part 1 providing guidelines on the selection and use of the other standards in the family. The family of standards included requirements for quality assurance and guidelines on quality management. Some might argue that none of these are in fact stan-dards in the sense of being quantifiable. The critics argue that the standards are too open to interpretation to be standards – anything that produces such a wide variation is surely an incapable process with one of its primary causes being a series of objectives that are not meas-urable. ISO/TS 16949:1999 was not a family of standards (ignoring the fact that it was a Technical Specification). Only ISO 8402 of the ISO 9000 family was invoked but this has changed with the new version. However, if we take a broader view of standards, any set of rules, rituals, requirements, quantities, targets or behaviours that have been agreed by a group of people could be deemed to be a standard. Therefore, by this definition, ISO 9000 is a stand-ard and yes ISO/TS 16949 is also a standard! An auto industry view The Society of Motor Manufactures and Traders (SMMT) conducted a study in 1995 of the relationship between ISO 9000 and product quality. An initial questionnaire was sent to 650 companies and 12 of these were selected for interview. The conclusion of the study was that “there was little evidence to suggest that ISO 9000 certification can give any indication of the actual quality performance of a company and also little evidence that it plays a significant part in determining the overall ability of a company to satisfy the needs of its customers”. Although now nearly 10 years old and 4 years after the launch of a complete revision of the standard, there is little to suggest that anything has significantly changed but clearly another study is urgently needed.
eBook - PDF- David Hoyle(Author)
- 2015(Publication Date)
- Butterworth-Heinemann(Publisher)
This book, however, only addresses one type of 18 Basic concepts quality system - that which is intended to meet ISO 9000. ISO 9000 focuses on the quality of the deliverable product or service alone, and not the efficacy of the organiza-tion which supplies it. There are standards which deal with QIP and TQM and a range of these and other related standards are given in Appendix C. Chapter 2 What is ISO 9000? ISO 9000 is a series of International Standards for Quality Systems. They specify requirements and recommendations for the design and assessment of a management system, the purpose of which is to ensure that suppliers provide products and services which satisfy specified requirements. These specified requirements may be specific customer requirements, where suppliers are contracted to supply certain products and services, or may be the requirements of a particular market, as determined by the supplier. ISO 9000 is not a product standard. It does not contain any requirements with which a product or service can comply. There are no product acceptance criteria in ISO 9000 so you can't inspect a product against the standard. You can, however, question whether a particular product has a certain record, an identity traceable to applicable drawings, inspection status etc. but any nonconformances are with the quality system not the product. The presence or absence of a record, a document or an inspection label does not alter the characteristics of a product. So where products are being advertised as meeting ISO 9000 or the national equivalent the consumer is being misled. ■ Products cannot meet ISO 9000; organizations can. The requirements and recommendations apply to the organizations that supply the product or service and hence affect the manner in which the products and services are designed, manufactured, installed etc.
eBook - PDFGMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines)
Regulations, Standards, and Guidelines
- Leonard Steinborn(Author)
- 2004(Publication Date)
- CRC Press(Publisher)
Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and nongovernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 9000-3 was prepared by Technical Committee ISOITC 176, Quality management and quality assurance , Subcommittee SC 2, Quality systems . This second edition cancels and replaces the first edition (ISO 9000-3:1991), which has been technically revised. ISO 9000 consists of the following parts, under the general title Quality management and quality assurance standards : Part 1: Guidelines for selection and use Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003 Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software Part 4: Guide to dependability programme management. Annexes A and B of this part of ISO 9000 are for information only. INTRODUCTION This part of ISO 9000 provides guidance in applying the requirements of ISO 9001:1994 where computer software design, development, installation and maintenance are an element of the business of a supplier: a) as part of a commercial contract with an external organization; b) as a product available for a market sector; c) in support of the business processes of the supplier; d) as software embedded in a hardware product.
eBook - PDF- Vincent K. Omachonu, Joel E. Ross(Authors)
- 2004(Publication Date)
- CRC Press(Publisher)
ISO 9000 353 Today the old ISO 9001, 1994 standard has ben replaced by ISO 9001, 2000. Similarly, the old ISO 9002, 1994 and ISO 9003, 1994 quality standards have been discontinued. Briefly, ISO 9000 is a guideline for selecting at which level (9001, 9002, or 9003) to be certified. ISO 9001, ISO 9002, and ISO 9003 are the guidelines for each specific level of certification. ISO 9004 is a management model. ISO 9000 certification is done on a site basis. In other words, a company cannot get an ISO 9000 certification that covers all sites and facilities of that company. The company must have each individual site and facility independently certified. Certification can be obtained at one of three different levels: 9001, 9002, or 9003. ISO 9001 certification is the most comprehensive level of certification in the series. Certification at this level requires conformance to all 20 functional areas of the standard. ISO 9002 certification requires conformance to 19 of the 20 functional areas. ISO 9003 requires conformance to 16 elements. The 20 functional areas of standards and which elements are required for each level of certification are listed in Table 20-2. Management Responsibility The commitment and involvement of top management are requirements for the success of any significant cultural or operational change. So it is with both the Baldrige and ISO 9000. The concern of ISO with manage-ment responsibility is reflected in the following series excerpts: 13 Quality policy. The supplier’s management shall define and document its policy and objectives for, and commitment to, quality. The supplier shall ensure that this policy is understood, implemented, and maintained at all levels in the organization. Management review. The quality system adopted to satisfy the requirement of the standard shall be reviewed at appropriate inter-vals by the supplier’s management to ensure its continuing suitability and effectiveness.
eBook - PDFMedical Device Safety
The Regulation of Medical Devices for Public Health and Safety
- G.R Higson(Author)
- 2001(Publication Date)
- CRC Press(Publisher)
Quality assurance today The growth of quality assurance Since the publication of the ISO 9000 series in 1987 the standards have been adopted as national standards in some 90 countries. The certification of manufacturers for compliance with the standards has grown into an industry: at the end of 1999, 343,643 ISO 9000 certificates had been issued (ISO 00a). A large number of organizations now offer certification/registration against the ISO standards. Many purchasing organizations (including manufacturers choosing component suppliers and sub-contractors) demand the possession of an appropriate ISO 9000 certificate. This growth in the use of, and reliance on, quality standards has, in the past few years, been inhibited to some degree by questions about the ability of these standards, which address systems to assure the satisfaction of products and by concerns about the competence of some of the certifying organizations and the consistency of operation of the large number of certifying bodies. The first of these concerns appears to stem from a lack of understanding of the standards and fear that they may not be properly applied. ISO 9002 and ISO 9003 have no design content and can only be used to ensure con-sistent manufacture of a design shown to be satisfactory by other means. ISO 9001 is intended to control both design and consistent manufacture. Sub-clause 4.4 defines a system which, if properly implemented , cannot fail to ensure that the final design meets the ‘design input’. The guidance on the application of ISO 9001, given in ISO 9000-2 (ISO 93) says that ‘design inputs are typically in the form of – product requirements specifications, and/or – product description with specifications relating to configuration, compo-sition, incorporated elements and other design features.’ 120 The place of quality systems
eBook - PDFHow to Audit ISO 9001:2015
A Handbook for Auditors
- Chad Kymal(Author)
- 2016(Publication Date)
- ASQ Quality Press(Publisher)
1 1 Introduction to ISO 9001:2015 HISTORY OF THE ISO 9001 STANDARDS ISO 9001 was initiated in 1987 with a primary focus on manufacturing. There were 20 require- ments, or clauses, each stand-alone, and it covered not only manufacturing, but also included requirements for purchasing, sales (contract review), and design. The 1994 revision of the standard was primarily just a continuation of the ISO 9001:1987 version of the standard, and the changes were incremental. In 2000, the standard made a radical change and became more of the standard it is today, that is, customer focused and process focused. Along with the customer and process orientation, the standard included requirements for customer satisfaction and continual improvement. In 2008, the standard underwent another mostly incremental change. While there were some significant changes, the authors of the standard (ISO/TC 176) explained that the majority of the changes were merely clarifications and interpretations of the original 2000 revision. In 2015, the standard is undergoing another radical change. “Radical change” is actually a mis- nomer. It has added business context, and incorporated not only customer expectations in setting objectives, but interested party expectations as well. Most importantly, it has taken on the concept of risk, which it defines as “effect of uncertainty.” The second major change in the 2015 revision is the reorganization of the standard into what ISO calls its high level structure (HLS) This HLS change, which altered the overall struc- ture of ISO 9001:2015 and of all ISO’s management system standards (MSS), will be covered in this chapter. Not only the structure of the standard has changed, but also its internal relationships in terms of the plan–do–check–act cycle, which will also be covered. This is a conceptual change from the old process model, incorporating context, interested party expectations, and risk.
eBook - ePub- Bruce Sherring-Lucas(Author)
- 2005(Publication Date)
- Routledge(Publisher)
The ISO 9000:2000 family of standards consists of three primary standards. These are:ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary (superseding ISO 8402:1994 ‘Quality Management and Quality Assurance – Vocabulary’ and ISO 9000–1:1994 ‘Quality Management and Quality Assurance Standards – Guidelines for selection and use’).Describes fundamentals of QMSs which forms the subject of the ISO 9000 family, and defines related terms.ISO 9001:2000 Quality Management Systems – Requirements (superseding ISO 9001:1994 ‘Quality Systems – Model for quality assurance in design, development, production, installation and servicing’, ISO 9002:1994 ‘Quality Systems – Model for quality assurance in production, installation and servicing’ and ISO 9003:1994 ‘Quality Systems – Model for quality assurance in final inspection and test’).Specifies the requirements for QMSs for use where an organisation’s capability to provide products that meet customer and applicable regulatory requirements needs to be demonstrated.Figure 5.7 The ISO 9001:2000 familyISO 9004:2000 Quality Management Systems – Guidelines for performance improvement (superseding ISO 9004–1:1994 ‘Quality Management and Quality System Elements – Guidelines).Provides guidance on QMSs, including the processes for continual improvement that will contribute to the satisfaction of an organisation’s customers and other interested parties. For completeness, a new standard has been written to assist auditing systems against ISO 9001:2000, this is:ISO 19011 Guidelines on auditing quality and environmental management systems
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