BS EN ISO 13485:2012 is a key standard to measure the quality of medical equipment, medical instruments and medical technology. This standard sets out the requirements for a quality management system and quality assurance systems relating to the design, development, production, installation and servicing of medical devices. BS EN ISO 13485 can be used by internal and external parties, including certification bodies which test an organization’s ability to meet both customer and regulatory requirements.
This edition is the UK implementation of EN ISO 13485:2012. It is identical to ISO 13485:2003, incorporating the corrigendum from August 2009. It supersedes BS EN ISO 13485:2003, which will be withdrawn on August 31, 2012.
The document is now 86 pages in length, compared to the 72 pages of the 2003 Edition republished in 2010 with the 3 corrigenda interfiled. Changes have been made to the foreword and especially to the annexes, which accounts for the additional material.
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