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.
In measurement technology and metrology, calibration is the comparison of measurement values delivered by a device under test with those of a calibration standard of known accuracy. Such a standard could be another measurement device of known accuracy, a device generating the quantity to be measured such as a voltage, a sound tone, or a physical artifact, such as a meter ruler.
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation. Testing is often either logical testing or physical testing. The test procedures may involve other criteria from mathematical testing or chemical testing. Beyond simple conformance, other requirements for efficiency, interoperability, or compliance may apply. Conformance testing may be undertaken by the producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification, the products or services may then be advertised as being certified in compliance with the referred technical standard. Manufacturers and suppliers of products and services rely on such certification including listing on the certification body's website, to assure quality to the end user and that competing suppliers are on the same level.
The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) which help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service. 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. ISO/TS 9002 offers guidelines for the application of ISO 9001. ISO 9004 gives guidance on achieving sustained organizational success.
The ISO 14000 family of standards by the International Organization for Standardization (ISO) relate to environmental management that exists 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.
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a shift left since it focuses on quality efforts earlier in product development and production and on avoiding defects in the first place rather than correcting them after the fact.
An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the item or activity is in line with these targets, often with a Standard Inspection Procedure in place to ensure consistent checking. Inspections are usually non-destructive.
In the context of software engineering, software quality refers to two related but distinct notions:
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.
Software quality assurance (SQA) is a means and practice of monitoring all software engineering processes, methods, and work products to ensure compliance against defined standards. It may include ensuring conformance to standards or models, such as ISO/IEC 9126, SPICE or CMMI.
The International Organization of Legal Metrology, is an intergovernmental organisation that was created in 1955 to promote the global harmonisation of the legal metrology procedures that underpin and facilitate international trade.
Certification is part of testing, inspection and certification and the provision by an independent body of written assurance that the product, service or system in question meets specific requirements. It is the formal attestation or confirmation of certain characteristics of an object, person, or organization. This confirmation is often, but not always, provided by some form of external review, education, assessment, or audit. Accreditation is a specific organization's process of certification. According to the U.S. National Council on Measurement in Education, a certification test is a credentialing test used to determine whether individuals are knowledgeable enough in a given occupational area to be labeled "competent to practice" in that area.
The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
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.
The South African National Accreditation System (SANAS) is the official laboratory accreditation body for South Africa. Founded in 1996, SANAS is headquartered in Pretoria, South Africa. SANAS accreditation certificates are a formal recognition by the Government of South Africa that an organisation is competent to perform specific tasks.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
EN 15038 is a withdrawn quality standard developed especially for translation services providers. The EN 15038 standard ensured the consistent quality of the service. In 2015, CEN withdrew EN 15038 and adopted ISO 17100 as a European standard.
ISO 28000:2022, Security and resilience – Security management systems – Requirements, is a management system standard published by International Organization for Standardization (ISO) that specifies requirements for a security management system including aspects relevant to the supply chain.
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.
The Annex SL is a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written. The aim of Annex SL is to enhance the consistency and alignment of MSS by providing a unifying and agreed-upon high level structure, identical core text and common terms and core definitions. The aim being that all ISO Type A MSS are aligned and the compatibility of these standards is enhanced.
