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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 ...
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 ...
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.
ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but require the laboratory to justify using a particular method. In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant ...
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.
ISO 1 – ISO 1999. ISO 2000 – ISO 2999. ISO 3000 – ISO 4999. ISO 5000 – ISO 7999. ISO 8000 – ISO 9999. ISO 10000 – ISO 11999. ISO 12000 – ISO 13999. ISO 14000 – ISO 15999. ISO 16000 – ISO 17999.
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