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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] It is expressed as the organizational goals and aspirations, policies, processes, documented ...
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 not only on product and service quality, but also on the means to achieve it.
The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. [1] ISO 9000 deals with the fundamentals and ...
Software Quality Management ( SQM) is a management process that aims to develop and manage the quality of software in such a way so as to best ensure that the product meets the quality standards expected by the customer while also meeting any necessary regulatory and developer requirements, if any. [1] [2] [3] Software quality managers require ...
ISO 13485. ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Quality assurance. Quality assurance ( QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product (s) delivered to customer (s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer.
t. e. Six Sigma ( 6σ) is a set of techniques and tools for process improvement. It was introduced by American engineer Bill Smith while working at Motorola in 1986. [1] [2] Six Sigma strategies seek to improve manufacturing quality by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes.
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001 .
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