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ISO 13485 Audit Checklist - SafetyCulture

The document is a 25-page ISO 13485 audit checklist from SafetyCulture that provides a comprehensive list of over 250 questions to evaluate an organization's quality management system for compliance with ISO 13485 requirements. The checklist covers all sections of the ISO 13485 standard, including quality management system, management responsibility, resource management, product realization, measurement analysis and improvement. Auditors can use this checklist to systematically audit an organization's quality management system and processes to ensure conformity with ISO 13485.

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100% found this document useful (3 votes)

855 views25 pages

ISO 13485 Audit Checklist - SafetyCulture

The document is a 25-page ISO 13485 audit checklist from SafetyCulture that provides a comprehensive list of over 250 questions to evaluate an organization's quality management system for compliance with ISO 13485 requirements. The checklist covers all sections of the ISO 13485 standard, including quality management system, management responsibility, resource management, product realization, measurement analysis and improvement. Auditors can use this checklist to systematically audit an organization's quality management system and processes to ensure conformity with ISO 13485.

Uploaded by

Copyright

© © All Rights Reserved

We take content rights seriously. If you suspect this is your content, claim it here.

Available Formats

Download as PDF, TXT or read online on Scribd

ISO 13485 Audit Checklist - SafetyCulture https://public-library.safetyculture.io/products/iso-13485-audit-checklis...

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