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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 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to ...
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 ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. [34] [35] The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of ...
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
[9] [8] They are ISO 13485:2003, EN ISO 13485:2012, ISO 13485:2003-CMDCAS and ISO 9001:2008 certified[1] and is listed in Kuala Lumpur Stock Exchange. [6] [4] Their revenue in 2017 was RM 1.96 billion and net profit was RM182.06 million. [4] [9] In 2020, the COVID-19 global pandemic drove demands for rubber gloves.
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 standards are thought to represent the best interests and needs of the broader global society. [8] ISO 9001 is a set of standards for quality management systems. [9] ISO 13485 is a set of standards, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. [10]
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