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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 ...
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 ...
Quality control. 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]
Verification and validation. Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. [1] These are critical components of a quality management system such as ISO 9000.
Quality audit. 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 .
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.
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 third edition of ISO 14971 was published in December 2019 and supersedes the second edition of ISO 14971. [6] Specifically, ISO 14971 is a nine-part standard which first establishes a framework for risk analysis, evaluation, control, and review, and also specifies a procedure for review and monitoring during production and post-production.