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A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both and deals with quality and sustainability and their integration.
The ISO 9000 family is a set of international standards for quality management systems. It was developed in March 1987 by International Organization for Standardization. The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. The standards were designed to fit into an integrated management system. The ISO refers to the set of standards as a "family", bringing together the standard for quality management systems and a set of "supporting standards", and their presentation as a family facilitates their integrated application within an organisation. ISO 9000 deals with the fundamentals and vocabulary of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. A companion document, ISO/TS 9002, provides guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.
The ISO 14000 family is a set of international standards for environment management systems. It was developed in March 1996 by International Organization for Standardization. The goal of these standards is to help organizations (a) minimize how their operations negatively affect the environment ; (b) comply with applicable laws, regulations, and other environmentally oriented requirements; and (c) continually improve in the above. The standards were designed to fit into an integrated management system.
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization's operations. For instance, a quality management system enables organizations to improve their quality performance, an environmental management system enables organizations to improve their environmental performance, and an occupational health and safety management system enables organizations to improve their occupational health and safety performance, can be run in an integrated management system.
SAE International is a global professional association and standards organization based in Warrendale, Pennsylvania, United States. Formerly the Society of Automotive Engineers, the organization adopted its current name in 2006 to reflect both its international membership and the increased scope of its activities beyond automotive engineering and the automotive industry to include aerospace and other transport industries, as well as commercial vehicles including autonomous vehicles such as self-driving cars, trucks, surface vessels, drones, and related technologies.
ABET , formerly known as the Accreditation Board for Engineering and Technology, Inc., is a non-governmental accreditation organization for post-secondary programs in engineering, engineering technology, computing, and applied and natural sciences.
Quality management ensures that an organization, product or service consistently functions well. It has four main components: quality planning, quality assurance, quality control, and quality improvement. Quality management is focused both on product and service quality and the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines quality. It is a written or unwritten commitment to a known or unknown consumer in the market. Quality can be defined as how well the product performs its intended function.
Aero Space 9100 is an international standard for aerospace management systems that is a widely adopted and standardized quality management system for the aerospace sector. It was developed in March 1999 by Society of Automotive Engineers. The goal of the standard is to provide for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the aerospace industry supply chain and assembly process. The standard was designed to fit into an integrated management system.
International Automotive Task Force 16949 is an international standard for automotive management systems that is a widely adopted and standardized quality management system for the automotive sector. It was released in 1999 by International Organization for Standardization based on ISO 9001, and the first edition was published in June 1999 as ISO/TS 16949:1999. IATF 16949:2016 replaced ISO/TS 16949 in October 2016 by International Automotive Task Force. The goal of the standard is to provide for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and assembly process. The standard was designed to fit into an integrated management system.
ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
In business, engineering, and manufacturing, quality – or high quality – has a pragmatic interpretation as the non-inferiority or superiority of something ; it is also defined as being suitable for the intended purpose while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable. In such ways, the subjectivity of quality is rendered objective via operational definitions and measured with metrics such as proxy measures.
TL 9000 is a quality management system standard designed by the QuEST Forum in 1998. It was created to focus on supply chain directives throughout the international telecommunications industry, including the USA. As with IATF 16949 for the automotive industry and AS9100 for the aerospace industry, TL 9000 specializes the generic ISO 9001 standard to meet the needs of one industrial sector, which for TL 9000 is the information and communications technology (ICT) sector—extending from service providers through ICT equipment manufacturers through the suppliers and contractors and subcontractors that provide electronic components, software components and services to those ICT equipment manufacturers.
In quality management, a nonconformity is a deviation from a specification, a standard, or an expectation. Nonconformities or nonconformance can be classified in seriousness multiple ways, though a typical classification scheme may have three to four levels, including critical, serious, major, and minor.
ISO 26262, titled "Road vehicles – Functional safety", is an international standard for functional safety of electrical and/or electronic systems that are installed in serial production road vehicles, defined by the International Organization for Standardization (ISO) in 2011, and revised in 2018.
A First Article Inspection (FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report. The FAI process usually consists of fully testing and inspecting either the first part produced by the new process or a sample from the first batch of parts. First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete. If the manufacturer doesn't have the in-house capability or if the purchaser requests, the first article inspection may be conducted by an approved subcontract supplier such as a dimensional inspection/metrology laboratory.
ISO 10007 "Quality management — Guidelines for configuration management" is the ISO standard that gives guidance on the use of configuration management within an organization. "It is applicable to the support of products from concept to disposal." The standard was originally published in 1995, and was updated in 2003 and 2017. Its guidance is specifically recommended for meeting "the product identification and traceability requirements" introduced in ISO 9001:2015 and AS9100 Rev D.
Nigel Howard Croft is a globally recognized authority on quality management and conformity assessment. He retired as Chairman of the ISO Joint Technical Coordination Group for Management System Standards in December 2023 after serving a three-year term, having been appointed by ISO's Technical Management Board in December 2020. During his tenure, he coordinated the deployment of the ISO London Declaration on Climate Action into all ISO Management System Standards, requiring organizations that implement these standards to determine the extent to which climate change can affect their results and the ways in which their activities can have a impact on climate change. This can then lead to the implementation of risk-based adaptation and mitigation strategies. Dr Croft was previously Chair of the ISO Technical Committee TC 176/SC 2 from February 2010 until December 2018, with overall responsibility for the ISO 9001 standard, used worldwide as a basis for certification of quality management systems, and the ISO 9004 guidelines standard aimed at improving organisational performance, among others. In 2019 and 2020 he led the revision of "Annex SL" of the ISO Directives, that forms the basis for over 40 management system standards including those on environmental management, Occupational Health and Safety, Information Security, Anti-bribery, Food Safety, Artificial Intelligence and many more.
DQS Holding GmbH based in Frankfurt am Main is the holding company of the worldwide DQS Group. The group provides assessments and certifications of management systems and processes of any type.
The Allied Quality Assurance Publications (AQAP) are standards for quality assurance systems developed by NATO.
References
- ↑ "AS 9000". Texas International Engineering Consultants. 2010. Retrieved December 15, 2012.
- ↑ Poksinska, Bozena; Dahlgaard, Jens Jörn; Antoni, Marc (2002). "The state of ISO 9000 certification: A study of Swedish organizations". The TQM Magazine. 14 (5): 297. doi:10.1108/09544780210439734.
- ↑ "Audits in the Aerospace Industries" (PDF). eoq.org. 2011. Retrieved December 15, 2012.
- ↑ "ISO 9001:2000". Magnetic Radiation. 2008. Archived from the original on July 9, 2013. Retrieved December 15, 2012.