Related Research Articles
The International Organization for Standardization is an international standard-setting body composed of representatives from various national standards organizations.
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 (ISO9001:2015). 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 is 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.
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 of quality management systems (QMS) is a set of standards that helps organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals 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 fulfil.
Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use. Documentation can be provided on paper, online, or on digital or analog media, such as audio tape or CDs. Examples are user guides, white papers, online help, and quick-reference guides. Paper or hard-copy documentation has become less common. Documentation is often distributed via websites, software products, and other online applications.
An open standard is a standard that is publicly available and has various rights to use associated with it and may also have various properties of how it was designed. There is no single definition, and interpretations vary with usage.
Quality management ensures that an organization, product or service is consistent. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. 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. Thus, quality can be defined as fitness for intended use or, in other words, how well the product performs its intended function.
GOST refers to a set of technical standards maintained by the Euro-Asian Council for Standardization, Metrology and Certification (EASC), a regional standards organization operating under the auspices of the Commonwealth of Independent States (CIS).
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
Validation is 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:
ISO/TS 16949 is an ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain and production. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
A functional specification in systems engineering and software development is a document that specifies the functions that a system or component must perform.
In business, engineering, and manufacturing, quality has a pragmatic interpretation as the non-inferiority or superiority of something; it's also defined as being suitable for its intended 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.
A Publicly Available Specification or PAS is a standardization document that closely resembles a formal standard in structure and format but which has a different development model. The objective of a Publicly Available Specification is to speed up standardization. PASs are often produced in response to an urgent market need.
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard.
A technical standard is an established norm or requirement for a repeatable technical task. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes, and practices. In contrast, a custom, convention, company product, corporate standard, and so forth that becomes generally accepted and dominant is often called a de facto standard.
A first article inspection (FAI) is a design verification and design history file and a formal method of providing a reported measurement for each manufactured feature of a part or assembly. Typically the supplier performs the FAI and the purchaser reviews or approves the report. Another method is for both the supplier and purchaser perform the First Article on the ordered product. The evaluation report consists of assuring all the properties and features are compliant to its specifications, for example a drawing. Despite the name, the inspected article may not necessarily be the 'first' produced, but an item or random sample of parts from the first lot. First article inspection is typically called for in a purchase order contract between the producer and buyer of a manufactured article.
The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
ISO 50001Energy management systems - Requirements with guidance for use, is an international standard created by the International Organization for Standardization (ISO). The standard specifies the requirements for establishing, implementing, maintaining and improving an energy management system, whose purpose is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance, including energy efficiency, energy security, energy use and consumption.
References
- ↑ "Standards". Enterprise Singapore. Retrieved 6 October 2018.
- ↑ Standards Development
- ↑ USA Trade Department Report
- ↑ Singapore Standards eShop
