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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 ]
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 13485 specifies Quality Management System requirements for organizations involved in the design and manufacture of medical devices to demonstrate the ability to meet relevant regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and ...
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. The words "verification" and ...
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.
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212 (ISO/TC 212).
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
This is not an isolated process, but a combination of all interacting business processes which affect the quality performance of a firm. A key requirement of IATF 16949:2016 is the fulfillment of customer-specific requirements, set up by the automotive manufacturer in addition to the quality management system of their suppliers.