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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 (ISO 9001:2015). [1]
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. [1] Quality management is focused both on product and service quality and the means to achieve it.
The seven basic tools of quality are a fixed set of visual exercises identified as being most helpful in troubleshooting issues related to quality. [1] They are called basic because they are suitable for people with little formal training in statistics and because they can be used to solve the vast majority of quality-related issues.
Quality inspector in a Volkseigener Betrieb sewing machine parts factory in Dresden, East Germany, 1977. Quality control (QC) is a process by which entities review the quality of all factors involved in production. ISO 9000 defines quality control as "a part of quality management focused on fulfilling quality requirements". [1]
When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process that both meets business and regulatory needs. [1]: "Decision Makers' Summary", [2]
Process decision program chart. A useful way of planning is to break down tasks into a hierarchy, using a tree diagram. The process decision program chart (PDPC) extends the tree diagram a couple of levels to identify risks and countermeasures for the bottom level tasks. Different shaped boxes are used to highlight risks and identify possible ...
During the 1980s, the concept of "company quality" with the focus on management and people came to the fore in the U.S. [22] It was considered that, if all departments approached quality with an open mind, success was possible if management led the quality improvement process. The company-wide quality approach places an emphasis on four aspects ...
Some see continual improvement processes as a meta-process for most management systems (such as business process management, quality management, project management, and program management). [3] W. Edwards Deming , a pioneer of the field, saw it as part of the 'system' whereby feedback from the process and customer were evaluated against ...