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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.
The system of concepts to support continuity of care, often referred to as ContSys, is an ISO and CEN standard (EN ISO 13940). [1] [2] Continuity of care is an organisational principle that represents an important aspect of quality and safety in health care. Semantic interoperability is a basic requirement for continuity of care.
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.
ISO 9000:2015 Quality management systems – Fundamentals and vocabulary; ISO 9001:2015 Quality management systems – Requirements; ISO/TS 9002:2016 Quality management systems – Guidelines for the application of ISO 9001:2015; ISO 9004:2018 Managing for the sustained success of an organization – A quality management approach
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] This approach places emphasis on three aspects (enshrined in standards such as ISO 9001): [2] [3]
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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 ...