ISO-9001/ISO-13485 › ISO 9001 and ISO 13485 Medical and Quality Management Set

ISO-9001/ISO-13485 - 1ST EDITION - CURRENT


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ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set provides the regulatory reguirements for your medical devices quality management system. ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set enables an organization to consistently meet customer and regulatory expectations as it pertains to the quality management of medical devices. The ISO 9001 / ISO 13485 - Quality Management for Medical Devices Set is applicable to all medical devices organizations and it includes:

ISO 9001:2015
ISO 13485:2016
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Document Number

ISO 9001 / ISO 13485 - Quality Management for Medical Device

Revision Level

1ST EDITION

Status

Current

Publication Date

Jan. 1, 2016