ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization...

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...

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...

health and safety are integrated into these Quality Management Systems. ISO 13485 specifies Quality Management System requirements for organizations involved...

International Standards Organization ISO 10006—Quality management—Guidelines to quality management in projects ISO 13485—Medical devices—Quality management...

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 It has been superseded by a second edition ISO 8601:2000 in 2000, by a third edition ISO 8601:2004...

specifications including: ISO 9001 (Quality), ISO 13485 (Quality management systems for medical devices) ISO 14001 (Environment), ISO 50001 (Energy management...

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...

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...

ISO 4217 is a standard published by the International Organization for Standardization (ISO) that defines alpha codes and numeric codes for the representation...