ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization... 12 KB (1,333 words) - 00:04, 8 November 2023 |
text of ISO 9001:2015. ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant... 65 KB (7,155 words) - 21:19, 6 January 2024 |
voluntary standards such as ISO 13485 and ISO 14971. The ISO Technical Committee responsible for the maintenance of this standard is ISO/ TC 210 working with... 9 KB (940 words) - 04:49, 15 June 2023 |
Quality management (section ISO standards) health and safety are integrated into these Quality Management Systems. ISO 13485 specifies Quality Management System requirements for organizations involved... 38 KB (4,581 words) - 06:30, 15 March 2024 |
International Standards Organization ISO 10006—Quality management—Guidelines to quality management in projects ISO 13485—Medical devices—Quality management... 4 KB (257 words) - 16:51, 13 December 2023 |
How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements. ASQ Quality Press. p. 156. ISBN 9780873899178... 28 KB (1,552 words) - 14:21, 26 February 2024 |
respectively. AAEON was awarded the TL9000 certification in 2002 and the ISO-13485 Medical certification in 2007. In addition to numerous awards from Intel... 6 KB (359 words) - 09:40, 25 July 2023 |