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ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 does not necessarily mean compliance with ISO 9001 (and vice versa).
The version in 1994 was called the ISO 9000:1994 series; consisting of the ISO 9001:1994, 9002:1994 and 9003:1994 versions. A major revision was published in the year 2000 and the series was called ISO 9000:2000 series. The ISO 9002 and 9003 standards were integrated into one single certifiable standard: ISO 9001:2000.
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.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
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]
TL 9000 Requirements Handbook, whose current release 6.2 includes the full text of ISO 9001:2015 TL 9000 Measurements Handbook, whose most recent release was 5.7 Reports on defect tracking and other measurements at various levels of granularity are accumulated by TL 9000 compliant facilities of certified organizations by the University of Texas ...
The standard shares many common traits with its predecessor, ISO 9000, the international standard of quality management, [10] which served as a model for its internal structure, [8] and both can be implemented side by side. As with ISO 9000, ISO 14000 acts both as an internal management tool and as a way of demonstrating a company's ...
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