Quality manual iso 13485:2016 pdf

 

 

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A major update of the QMS was introduced in 2018 to meet the updated requirements of EN. ISO 13485:2016 ”Medical devices – Quality management systems – Describe the scope of your QMS: The quality manual outlines the policies, procedures and requirements of the Quality. Management System. The system is Milford Quality Management System Non-Applicability of Requirements . The QMS is based on the requirements of ISO 9001, ISO 13485, In-Vitro Diagnostic This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the 1 SDIX has documented a Quality Management System (QMS) in accordance with the requirements of the ISO 13485:2016 Standard and applicable regulatoryDOCUMENT NUMBER. REVISION. TITLE. REV DATE. 91-QM-13485. C. Product Resources Quality. Manual ISO 13485. 09/2019. Page. 1 of 30. PRODUCT RESOURCES.

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