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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
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 to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
Download QR code; Print/export Download as PDF; Printable version; In other projects Wikimedia Commons; ... ISO 1 – ISO 1999; ISO 2000 – ISO 2999; ISO 3000 ...
ISO 13473-1:1997 Part 1: Determination of Mean Profile Depth; ISO 13473-2:2002 Part 2: Terminology and basic requirements related to pavement texture profile analysis; ISO 13473-3:2002 Part 3: Specification and classification of profilometers; ISO/TS 13473-4:2008 Part 4: Spectral analysis of surface profiles