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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 Quality Management System standards created by ISO are meant for certification of the processes and management arrangements of an organization, not the product or service itself. The ISO 9000 family of standards do not set out requirements for product or service approval.
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 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.
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.
SCADA. v. t. e. Total quality management ( TQM) is an organization-wide effort to "install and make a permanent climate where employees continuously improve their ability to provide on demand products and services that customers will find of particular value." [ 1] Total emphasizes that departments in addition to production (for example sales ...
Quality engineering. Quality engineering is the discipline of engineering concerned with the principles and practice of product and service quality assurance and control. [ 1] In software development, it is the management, development, operation and maintenance of IT systems and enterprise architectures with high quality standard. [ 2][ 3][ 4]
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