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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]
[1] [2] Quality policy management is a strategic item. [3] Section 5.2 of the ISO 9001:2015 standard requires a written, well-defined quality policy that is communicated and understood within an organization. Section 5.2 also sets out some of the requirements for quality policies. [4]
The ISO 9000 family is a set of international standards for quality management systems.It was developed in March 1987 by International Organization for Standardization.The goal of these standards is to help organizations ensure that they meet customer and other stakeholder needs within the statutory and regulatory requirements related to a product or service.
ISO created Quality Management System (QMS) [31] 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.
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] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
The company-wide quality approach places an emphasis on four aspects (enshrined in standards such as ISO 9001): [28] Elements such as controls, job management, adequate processes, performance and integrity criteria, and identification of records; Competence such as knowledge, skills, experiences, qualifications
ISO/TS 9002:2016 Quality management systems – Guidelines for the application of ISO 9001:2015; ISO 9004:2018 Managing for the sustained success of an organization – A quality management approach; ISO/TR 9007:1987 Information processing systems - Concepts and terminology for the conceptual schema and the information base
New employees use an SOP to answer questions without having to interrupt supervisors to ask how an operation is performed. The international quality standard ISO 9001 essentially requires the determination of processes (documented as standard operating procedures) used in any manufacturing process that could affect the quality of the product. [6]
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