• 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
  • 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
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    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...
    77 KB (8,638 words) - 17:27, 21 March 2024
  • 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
  • Thumbnail for ISO 8601
    notation: ISO 2014, ISO 2015, ISO 2711, ISO 3307, and ISO 4031. It has been superseded by a second edition ISO 8601:2000 in 2000, by a third edition ISO 8601:2004...
    61 KB (6,708 words) - 11:59, 27 March 2024
  • Thumbnail for AAEON
    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
  • Thumbnail for ISO 4217
    ISO 4217 is a standard published by the International Organization for Standardization (ISO) that defines alpha codes and numeric codes for the representation...
    69 KB (3,768 words) - 12:03, 22 March 2024