ISO 9000

ISO 9000
Name	ISO 9000
Status	Published
Started	1987
Organization	International Organization for Standardization
Base standard	Quality management systems

ISO 9000 is a set of international standards for quality management systems intended to help organizations ensure that they meet customer and regulatory requirements. The series provides vocabulary, fundamentals, and principles for quality management, and is maintained by a network of national bodies, technical committees, and experts from standards organizations. Major stakeholders include multinational corporations, certification bodies, regulators, professional associations, and academic institutions involved in industrial management.

Overview

The ISO 9000 family is administered by the International Organization for Standardization International Organization for Standardization, with technical development led by committee ISO/TC 176 and subcommittees that draw experts from national bodies such as British Standards Institution, American National Standards Institute, Deutsches Institut für Normung, Association Française de Normalisation, Standards Australia, Standards New Zealand, Canadian Standards Association, Japanese Industrial Standards Committee, China National Institute of Standardization, Bureau of Indian Standards, Instituto Nacional de Tecnología Industrial and DIN. Major corporations and groups participating have included Siemens, General Electric, Toyota, IBM, Ford Motor Company, Shell plc, Boeing, Rolls-Royce Holdings, Nestlé, Procter & Gamble, Unilever, Samsung, LG Corporation, Hitachi, Honeywell, Intel Corporation, Microsoft Corporation, Apple Inc., Caterpillar Inc., Volkswagen, Airbus, ABB Group, Schneider Electric, 3M Company, Dow Chemical Company, BASF SE, Johnson & Johnson, GlaxoSmithKline, Pfizer, Roche, Novartis, Siemens Healthineers, Medtronic, Philips, Canon Inc., Sony Corporation, Hyundai Motor Company, Nokia, Ericsson, Vestas Wind Systems, EDF Group, Enel, and BP plc.

History and development

Development began in the 1970s and culminated with the first publication in 1987, influenced by national standards such as BS 5750 and management thinkers associated with W. Edwards Deming, Joseph M. Juran, Philip B. Crosby, Armand V. Feigenbaum, Kaoru Ishikawa and practices from Toyota Production System. Revisions occurred in 1994, 2000, 2008, and 2015, reflecting shifts advocated by bodies like ISO/TC 176/SC 2 and standards committees in European Committee for Standardization, International Electrotechnical Commission, World Trade Organization, Organisation for Economic Co-operation and Development, and professional groups such as American Society for Quality, Chartered Quality Institute, Project Management Institute, Institute of Electrical and Electronics Engineers, International Accreditation Forum and International Laboratory Accreditation Cooperation.

Principles and concepts

Fundamental concepts embedded in the family draw upon quality management principles credited to figures and movements linked to W. Edwards Deming, Joseph M. Juran, Kaoru Ishikawa, Genichi Taguchi, Shigeo Shingo, Eliyahu M. Goldratt, Peter Drucker, Frederick Winslow Taylor, Henry Ford, Herbert Simon, Norbert Wiener, H. James Harrington, Kenichi Ohmae, Michael Porter, Clayton Christensen, C. K. Prahalad, Igor Ansoff, Armand V. Feigenbaum, Donald Schon, Richard Industrial Standards Association and institutions like Harvard Business School, Stanford University, Massachusetts Institute of Technology, INSEAD, London Business School, Wharton School, IMD Business School and Kellogg School of Management. Core themes include customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management, paralleling methodologies used in Six Sigma, Lean manufacturing, Total Quality Management, Kaizen, Just-in-Time manufacturing, Value Stream Mapping, Design for Six Sigma, and risk approaches from Failure Mode and Effects Analysis.

Standards within the ISO 9000 family

The family comprises multiple deliverables and standards produced by committees such as ISO/TC 176. Notable documents include vocabulary and fundamentals provided in foundational standards and guidance analogous to sector-specific standards like ISO 13485, ISO/TS 16949, AS9100, ISO 14001, ISO 45001, ISO 27001, ISO 22000, ISO 20000-1, ISO 31000, ISO 50001, ISO 45001, ISO 17025, ISO 15189, ISO 10002, ISO 10004, ISO 29001, ISO/IEC 17021, ISO/IEC 27002, ISO/TC 176/SC 1, ISO/TC 176/SC 2, CEN, ETSI, IETF, IEC. The family interoperates with regulatory frameworks like Food and Drug Administration, European Medicines Agency, Federal Aviation Administration, European Union, United States Department of Defense, National Institute of Standards and Technology, World Health Organization and sector consortia such as Aerospace Industries Association and Automotive Industry Action Group.

Certification and implementation

Organizations pursue certification through accredited bodies overseen by accreditation organizations such as International Accreditation Forum, European Cooperation for Accreditation, National Accreditation Board for Certification Bodies, United Kingdom Accreditation Service, Deutsche Akkreditierungsstelle, American National Accreditation Board, Japan Accreditation Board, China National Accreditation Service for Conformity Assessment and Standards Council of Canada. Implementation programs draw on consultants, training providers, and software vendors including SAP SE, Oracle Corporation, Microsoft Corporation (Azure), Salesforce, Siemens PLM Software, PTC Inc., Dassault Systèmes, Autodesk, IBM, Atlassian, ServiceNow, Infor and professional service firms like Deloitte, PricewaterhouseCoopers, Ernst & Young, KPMG, McKinsey & Company, Boston Consulting Group, Accenture, Capgemini, Bain & Company.

Criticism and limitations

Critiques originate from academics, industry analysts, and trade groups including voices at London School of Economics, University of Cambridge, University of Oxford, University of Manchester, INSEAD, MIT Sloan School of Management, Harvard Kennedy School, OECD, European Parliament, United Nations Conference on Trade and Development, Trade Union Congress, Confederation of British Industry, American Chamber of Commerce, Business Roundtable and investigative reporting by outlets like The Economist, Financial Times, The Wall Street Journal, New York Times, Le Monde, Der Spiegel, Nikkei Asian Review and The Guardian. Common criticisms cite administrative burden, checkbox compliance, cost to small enterprises, variability among certification bodies, and limited proof of performance improvement in studies from World Bank, International Monetary Fund, Asian Development Bank and academic journals such as Harvard Business Review, Journal of Operations Management, Quality Management Journal, International Journal of Production Economics.

Impact and global adoption

The standards have been adopted by public and private organizations across regions including European Union, United States, People's Republic of China, India, Japan, Brazil, Canada, Australia, New Zealand, South Africa, Russia, Mexico, Argentina, Chile, Colombia, Vietnam, Thailand, Malaysia, Singapore, Indonesia, Philippines, South Korea, Taiwan, Turkey, Saudi Arabia, United Arab Emirates, Israel, Egypt, Morocco, Kenya, Nigeria, Ethiopia, Ghana, Peru, Bolivia, Paraguay, Uruguay, Venezuela, Poland, Czech Republic, Hungary, Romania, Bulgaria, Greece, Portugal, Spain, Italy, France, Germany, Netherlands, Belgium, Switzerland, Sweden, Norway, Denmark, Finland, Iceland, Ireland', Luxembourg and multinational development programs run by World Bank Group, United Nations Development Programme, United Nations Industrial Development Organization, Asian Development Bank, African Development Bank and Inter-American Development Bank. Adoption has influenced procurement rules at organizations such as United Nations, European Commission, World Health Organization, North Atlantic Treaty Organization, World Trade Organization and large buyers in automotive industry, aerospace industry, pharmaceutical industry, construction industry and information technology industry.

Category:International standards