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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.
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.
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 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 10360-7:2011 Part 7: CMMs equipped with imaging probing systems; ISO 10360-8:2013 Part 8: CMMs with optical distance sensors; ISO 10360-9:2013 Part 9: CMMs with multiple probing systems; ISO 10360-10:2016 Part 10: Laser trackers for measuring point-to-point distances; ISO 10360-12:2016 Part 12: Articulated arm coordinate measurement ...
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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