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ISO 9001 states that the Quality Management System requirements of the standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides, however, ISO has also published separate standards which specify Quality Management System requirements for specific industries.
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.
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 International Organization for Standardization (ISO / ˈ aɪ s oʊ /; [3] French: Organisation internationale de normalisation; Russian: Международная организация по стандартизации) is an independent, non-governmental, international standard development organization composed of representatives from the national standards organizations of member ...
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/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.
Quality inspector in a Volkseigener Betrieb sewing machine parts factory in Dresden, East Germany, 1977. 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]
ISO 21500, Guidance on Project Management, is an international standard developed by the International Organization for Standardization, or ISO starting in 2007 and released in 2012. It was intended to provide generic guidance, explain core principles and what constitutes good practice in project management. [ 1 ]