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Encyclopedia > Quality management system

A quality management system (QMS) is a system that outlines the policies and procedures necessary to improve and control the various processes that will ultimately lead to improved business performance. One of their purposes is quality control in manufacturing. In engineering and manufacturing, quality control and quality engineering are involved in developing systems which ensure that products or services are designed and produced to meet or exceed customer requirements and expectations. ... To meet Wikipedias quality standards, this article or section may require cleanup. ...


Although it may seem obvious that quality systems are necessary, many small or start-up companies function, or attempt to function, with only some areas covered. A survey performed in 1988 indicates the breadth of the systems established within the biopharmaceutical industry. The table below summarizes the systems and the percentages of the respondent companies that had established these systems. The age of the company and the industry had some effect on the extensiveness of the quality function activities . It is clear that testing is the primary emphasis. This supports the observation that testing or QC is perceived, at least in the beginning, as the emphasis of the quality function.


In manufacturing industries, statistical process control is a vitally important methodology used to control quality. This is important in the Six Sigma quality management scheme, pioneered by Motorola. Statistical process control (SPC) is a method for achieving quality control in manufacturing processes. ... This article or section is not written in the formal tone expected of an encyclopedia article. ... Motorola (NYSE: MOT) is an American international communications company based in Schaumburg, Illinois, a Chicago suburb. ...

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Concept of quality - historical background

The concept of quality evolved from inspection, measurement, and testing, which had been in practice for many, many years. Long ago, an artist or a sculptor took pride in his work and as a result always tried to excel in what was created. Mass production systems brought the concept of inspection by someone other than the craftsman in the first half of the 20th century.


Application of statistical control came later as a result of World War production methods. Quality management systems are the outgrowth of work done by W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named. William Edwards Deming (October 14, 1900 - December 20, 1993) was an American statistician, college professor, author, and lecturer widely credited with improving production in the United States during World War II. However, Deming is perhaps best known for his work in Japan; where from 1950 onward he taught top management... For Wikipedia statistics, see m:Statistics Statistics is the science and practice of developing human knowledge through the use of empirical data expressed in quantitative form. ... The Deming prize was originally designed to reward Japanese companies for major advances in quality improvement. ... For the Talib Kweli album Quality (album) Quality can refer to a. ...


Quality, as a profession and the managerial process associated with the quality function, was introduced during the second-half of the 20th century, and has evolved since then. No other profession has seen as many changes as the quality profession.


The quality profession grew from simple control, to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession.

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Current good manufacturing practice

According to current Good Manufacturing Practice (GMP), medical device manufacturers should use good judgment when developing their quality system and apply those sections of the Food and Drug Administration (FDA) Quality System (QS) Regulation that are applicable to their specific products and operations, 21 CFR 820.5 of the QS regulation. Operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements. Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs). ... // European Definition COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices defines a ‘medical device’ as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human... This article or section is in need of attention from an expert on the subject. ...


FDA has identified in the QS regulation the essential elements that a quality system shall embody for design, production and distribution, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling.


Drug manufactures are regulated under a different section of the CFR: 21 CFR 211. The term CFR, when used by itself, can refer to: Campaign finance reform Căile Ferate Române, the state railway of Romania the United States Code of Federal Regulations the Council on Foreign Relations the incoterm Cost and Freight Certified first responder This page concerning a three-letter acronym...

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Quality management organizations and awards

The International Organization for Standardization's ISO 9000 series describes standards for a QMS addressing the processes surrounding the design, development and delivery of a general product or service. Organisations can participate in a continuing certification process to demonstrate their compliance with the standard. The International Organization for Standardization (ISO) is an international standard-setting body composed of representatives from national standards bodies. ... ISO 9001 certification of a fish wholesaler at the Tsukiji fish market ISO 9000 is a family of ISO (the International Organization for Standardization) standards for quality management systems. ... Design, usually considered in the context of the applied arts, engineering, architecture, and other such creative endeavours, is used as both a noun and a verb. ... In business and engineering, new product development is the complete process of bringing a new product to market. ... In economics and marketing, a service is the non-material equivalent of a good. ...


The Malcolm Baldrige National Quality Award is a competition to identify and recognise top-quality U.S. companies. This model addresses a broadly based range of quality criteria, including commercial success and corporate leadership. Once an organisation has won the award it has to wait several years before being eligible to apply again. The Malcolm Baldrige National Quality Award is given by the United States National Institute of Standards and Technology. ...


The European Foundation for Quality Management's EFQM Excellence Model supports an award scheme similar to the Malcom Baldrige Award for European companies. Categories: Possible copyright violations ... EFQM stands for European Foundation for Quality Management. ...


In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organisations that have displayed outstanding performance in the areas of Quality and Workplace Wellness, and have met the Institute's criteria with documented overall achievements and results.


The Alliance for Performance Excellence is a network of state, local, and international organizations that use the Malcolm Baldrige National Quality Award criteria and model at the grassroots level to improve the performance of local organizations and economies. NetworkforExcellence.org is the Alliance web site; browsers can find Alliance members in their state and get the latest news and events from the Baldrige community. The Malcolm Baldrige National Quality Award is given by the United States National Institute of Standards and Technology. ...


Nishant

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References

ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline

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See also

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This is a list of articles on general management and strategic management topics. ... Quality Assurance (or QA) covers all activities from design, development, production, installation, servicing and documentation. ...

External links


  Results from FactBites:
 
Quality management system - Wikipedia, the free encyclopedia (879 words)
Quality management systems are the outgrowth of work done by W.
Quality, as a profession and the managerial process associated with the quality function, was introduced during the second-half of the 20th century, and has evolved since then.
In Canada, the National Quality Institute presents the 'Canada Awards for Excellence' on an annual basis to organisations that have displayed outstanding performance in the areas of Quality and Workplace Wellness, and have met the Institute's criteria with documented overall achievements and results.
Quality management - Wikipedia, the free encyclopedia (497 words)
Quality management is a method for ensuring that all the activities necessary to design, develop and implement a product or service are effective and efficient with respect to the system and its performance.
The Quality Management System standards created by ISO are meant to certify the processes and the system of an organization and not the product or service itself.
The most elaborated and accepted concept of quality management is the model of the EFQM Excellence Model.
  More results at FactBites »

 
 

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