Iso 13485 quality manual pdf

 

 

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The Quality Management System of Exsurco meets the requirements of the international standards ISO. 13485 and U.S.QSR (21 CFR 820). This system addresses the e) other documentation specified by applicable regulatory requirements. 4.2.2 Quality manual. The organization shall document a quality manual that includes:. DOCUMENT NUMBER. REVISION. TITLE. REV DATE. 91-QM-13485. C. Product Resources Quality. Manual ISO 13485. 09/2019. Page. 1 of 30. PRODUCT RESOURCES. ISO 13485:2016 ”Medical devices – Quality management systems – Requirements for regulatory purposes”. 3 TERMS AND DEFINITIONS. ISO-13485-Quality-Manual-Sample - Free download as PDF File (.pdf), Text File (.txt) or read online for free. Title: Waters Business Operations Quality Manual The QMS is based on the requirements of ISO 9001, ISO 13485, In-Vitro Diagnostic Regulation (IVDR).The quality manual outlines the policies, procedures and requirements of Review Section 3 of ISO 13485:2016 and add, delete and revise definitions as

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