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ISO 13485 TSSU Audit Checklist for Hospitals

by Richard Sabino, from the Community

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This ISO 13485:2016 TSSU audit checklist supports hospitals in assessing sterile services and quality management compliance. It covers documentation and records control, DMR and DHR requirements, supplier and purchasing records, sterilization parameters and validation, customer requirements and feedback integration with CAPA, and technical file expectations including design specs, risk analysis, labeling, and instructions. Use it to gauge readiness for third-party certification and drive continuous improvement across sterile processing operations.

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With SafetyCulture you can

Digitize any process, procedure or policy
Eliminate mistakes made by paper-based processes
Create and share professional reports instantly
Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.