ISO 13485 RISK MANAGEMENT ISO
ISO 13485:2016 introduces a host of subtle, yet detailed, changes requiring more thorough documentation on the work environment, risk management, design control and regulatory requirements. ISO 13485:2012 maintains its status as the harmonised standard and the presumption of conformity until the end of the transition period. The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices – Quality management systems – Requirements for regulatory purposes) was published 1 March 2016, with the International Accreditation Forum (IAF) allowing certified organisations three years to transition from previous versions. LRQA supports clients in their efforts to meet the stringent requirements of ISO 13485, fine-tuning product development lifecycles to ensure a timely market launch. In the highly-regulated world of medical device manufacturing, organisations have a duty to show that every device meets both customer expectations and applicable regulations. United Kingdom (English) United Kingdom (English).United Arab Emirates (English) United Arab Emirates (English).South Africa (English) South Africa (English).
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