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Business process to aid consistent product fitness
the general topic of quality management

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 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. 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.

The International Standard for Quality management (ISO 9001:2015) adopts a number of management principles, that can be used by top management to guide their organizations towards improved performance.

The social scientist Bettina Warzecha (2017) describes the central concepts of Quality Management (QM), such as e. g. process orientation, controllability, and zero defects as modern myths. She alleges that zero error processes and the associated illusion of controllability involve the epistemological problem of self referentiality. The emphasis on the processes in QM also ignores the artificiality and thus arbitrariness of the difference between structure and process. Above all, the complexity of management cannot be reduced to standardized (mathematical) procedures. According to her, the risks and negative side effects of QM are usually greater than the benefits (see also brand eins, 2010).

The International Organization for Standardization (ISO) is an independent non governmental coalition representing 165 countries through their national standards bodies. ISO brings together experts to share knowledge and develop voluntary, consensus based international commercial, industrial and technical standards. ISO created Quality Management System (QMS) standards in 1987. They were the ISO 9000:1987 series of standards comprising ISO 9001:1987, ISO 9002:1987 and ISO 9003:1987; which were applicable in different types of industries, based on the type of activity or process: designing, production or service delivery. The standards are reviewed every few years by the International Organization for Standardization. The version in 1994 was called the ISO 9000:1994 series; consisting of the ISO 9001:1994, 9002:1994 and 9003:1994 versions. A major revision was published in the year 2000 and the series was called ISO 9000:2000 series. The ISO 9002 and 9003 standards were integrated into one single certifiable standard: ISO 9001:2000. After December 2003, organizations holding ISO 9002 or 9003 standards had to complete a transition to the new standard. ISO released a minor revision, ISO 9001:2008 on 14 October 2008. It contains no new requirements. Many of the changes were to improve consistency in grammar, facilitating translation of the standard into other languages for use by over 950,000 certified organization in the 175 countries (as at Dec 2007) that use the standard. The ISO 9004:2009 document gives guidelines for performance improvement over and above the basic standard (ISO 9001:2000). This standard provides a measurement framework for improved quality management, similar to and based upon the measurement framework for process assessment. The last major revision was published 15 September 2015. This change adopted the High Level Structure, contained in ISO Directive 1 Annex SL, for the first time. The Quality Management System standards created by ISO are meant for certification of the processes and management arrangements of an organization, not the product or service itself. The ISO 9000 family of standards do not set out requirements for product or service approval. Instead, ISO 9001 requires that product or service requirements are agreed between the organization and its customers, and that the organization manages its business processes to achieve these agreed requirements. ISO 9001 states that the Quality Management System requirements of the standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides, however, ISO has also published a number of separate standards which specify Quality Management System requirements for specific industries, in many cases those involved in the production or processing of goods typically regulated by nations and other global jurisdictions, in order to ensure that unique elements pertaining to public health and safety are integrated into these Quality Management Systems. ISO 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices in order to demonstrate the ability to meet relevant regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e. g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system related services to such organizations. ISO has not published a standard in similar manner specifying Quality Management System requirements unique to the pharmaceutical industry for regulatory purposes, therefore compliance with ISO 9001 is typically utilized by organizations involved in the design and manufacture of pharmaceuticals. In 2005 ISO published ISO 22000 specifying the Food Safety Management System requirements for the food industry. This standard covers the values and principles of ISO 9000 and the HACCP standards. It gives one single integrated standard for the food industry, defining requirements for any organization in the food chain. Technical Standard TS 16949 defines requirements in addition to those in ISO 9001:2008 specifically for the automotive industry. ISO has a number of standards that support quality management. One group describes processes (including ISO/IEC 12207 and ISO/IEC 15288) and another describes process assessment and improvement ISO 15504.

Quality Improvement can be distinguished from Quality Control in that Quality Improvement is the purposeful change of a process to improve the reliability of achieving an outcome. Quality Control is the ongoing effort to maintain the integrity of a process to maintain the reliability of achieving an outcome. Quality Assurance is the planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements.