ISO 13485 Internal Audit Templates

Medical Device Internal Audit Checklist Templates - Simplifying Internal Audits for You. Written by Quality Management Experts, Proven To Work.

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		ISO 13485
ISO 13485 Internal Audit Checklist The ISO 13485:2016 medical device audit checklist is a powerful tool that reduces the administrative burden of compliance by streamlining the collection of audit data and audit evidence, generating insights that identify gaps to help prioritize corrective action. Contents Master Internal Audit Checklist - view sample Results Charts - view sample Process Report Clause Report Action Report Opportunity Report Guidance	Master Internal Audit Checklist This audit checklist comprises tables of the certifiable (‘shall’) requirements, from Section 4.0 to Section 8.0, each mandatory requirement is phrased as a question. 398 Audit Questions - view sample MS Excel Quality Management System Management Responsibility Resource Management Product Realization Measurement, Analysis & Improvement Easily evaluate process performance. Use the drop-menus to input audit findings, create interactive trend charts and develop improvement plans. The answers will automatically populate and update the Results Charts, Process Report & Action Report. Result Charts More than just a static checklist, we offer a practical and versatile solution for reporting and analyzing data and generating actionable insights. Automated Charts - view sample Compliance Summary Nonconformances Issues to Correct Errors to Correct Nonconformances by Clause Conformity of the MDQMS Processes to Requirements Requirements to Audit per Process Summary of Audit Results by Process Summary of Audit Results by Clause Pareto Diagram of the Most Frequent Root Causes Action Planning to Address Root Causes Improvement Action Summary Opportunities by Clause Process Report Using filters and buttons, the Process Report allows you to summarize the processes and their audit results from the data collected in your audit checklist into a table for reporting or analysis purposes. Clause Report Summarizes the audit results against the clause headings of ISO 13485. Action Report Allows you to summarize the root-causes and the corrective actions required for each process. Opportunity Report Summarizes the opportunities for improvement and the actions required to implement them into your processes.	USD $89 Add to Cart Get a Quote

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