Gap Analysis Tool – QSR 21 CFR § 820 vs ISO 13485:2016 (v1.0)

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Gap Analysis Tool – QSR 21 CFR § 820 vs ISO 13485:2016 (v1.0)

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Description

This document is a gap analysis tool (Excel) to compare the clauses of the Quality System Regulation of the U.S. (21 CFR § 820) and the clauses of the ISO 13485:2016.

3 tabs:

  • Tab1: Gap Analysis FDA 21 CFR Part § 820 vs ISO 13485:2016 (103 lines)
  • Tab 2: Relationship of FDA 21 CFR Part § 820 with ISO 13485:2016 (100 lines)
  • Tab 3: General Information: FDA 21 CFR Part § 820 and the ISO 13485:2016 (28 lines)

Template version: 1.0

Sample:

Tab 1

Tab 2

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