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ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
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.
These included those related to the production or processing of goods typically regulated by nations and other global jurisdictions, to ensure that unique elements pertaining to public health and safety are integrated into these Quality Management Systems. ISO 13485 specifies Quality Management System requirements for organizations involved in ...
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.
The international standard ISO 9000:2015 (Title: Quality management systems - fundamentals and vocabulary) defines the term in chapter 3.5.3 as a "set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives".
ISO 10008:2013 Quality management – Customer satisfaction – Guidelines for business-to-consumer electronic commerce transactions; ISO 10012:2003 Measurement management systems – Requirements for measurement processes and measuring equipment; ISO/TR 10013:2001 Guidelines for quality management system documentation; ISO 10014:2006 Quality ...
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ISO 1 – ISO 1999; ISO 2000 – ISO 2999; ISO 3000 – ISO 4999; ISO 5000 – ISO 7999; ... Code of Conduct; Developers; Statistics; Cookie statement; Mobile view ...