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ISO 13485:2016 in Uttam Nagar, Delhi

ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the necessities for a comprehensive quality management system for the plan and manufacture of medical devices. This standard supersedes previous documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996). ISO 13485 is generally coordinated with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to show continual improvement, whereas ISO 13485 requires only that the certified organization show the quality system is successfully implemented and maintained. Additionally, the ISO 9001 necessities regarding customer satisfaction are absent from the medical device standard.