Master List Cum Distribution List Of Documents General Requirements Quality manual Documentation Requirements Procedure for Document and Data control (Ref Clause 4.2.3) 04 Quality Management System 4.1 QM 01 4.2 PRO/SYS/02 ISO 13485:2016 requirementwise documents list: Document NoĬlause No. Total 125 files quick download in editable form by e delivery To get more information about ISO 13485 documentation kit Click Here E mail Tele: +91-79-2656 5405 word 02 files of more than 900 audit questions 21 files in Ms. Excel List of DirectoryĮxhibits Formats / Templates Name of departmentsĭocument of Details 40 Pages in Ms. The Total Editable Document kit has 8 main directories as below in Ms. Web site: Chapter-1.0 CONTENTS OF ISO 13485:2016 DOCUMENT KIT (More than 125 document files) A. D126: DEMO OF ISO 13485:2016 Medical Device Document Kit Price 399 USD Total editable documentation package Complete editable document tool kit (Quality manual, procedures, exhibits, formats, SOPs, process flow chart, audit checklist, medical device file etc.)
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