Template

ISO 13485 TSSU Audit Checklist for Hospitals

by Richard Sabino, from the Community

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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About author

Community

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.

Template
ISO 13485 Audit Checklist
This ISO 13485 audit checklist helps medical device organizations evaluate the readiness and compliance of their quality management system against ISO 13485:2016. It covers management controls, quality policy and objectives, internal audits, and management review. The checklist also guides design and development controls, risk management, verification and validation, and design transfer. It includes robust CAPA and complaint handling, MDR reporting, production and process controls, supplier and purchasing controls, and sterilization validation. Documentation and records requirements, DMR, DHR, technical files, customer requirements, and traceability are addressed to support certification preparation.
by Ahmad Magableh, from the Community
Downloads: 20+
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Template
ISO 13485 Audit Checklist for QMS Compliance
Use this ISO 13485 audit checklist to evaluate whether your quality management system aligns with ISO 13485:2016 for medical devices. The checklist covers management controls, design and development, risk management, CAPA, medical device reporting, production and process controls, supplier and purchasing controls, sterilization validation, documentation and records, customer requirements, and technical files. Ideal for quality managers preparing for third party certification audits and ongoing compliance.
by Rohan Pawar, from the Community
Downloads: 10+
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Template
ISO 13485:2016 Audit Checklist
A comprehensive ISO 13485:2016 audit checklist for medical device organizations. It guides internal auditors through quality management system requirements, including documentation control, management responsibility, resource and work environment controls, product realization, risk management, design and development, supplier evaluation, production and servicing, sterilization and sterile barrier validation, UDI and traceability, preservation, monitoring and measurement, calibration and software validation, feedback and complaints, internal audits, control of nonconforming product, analysis of data, and corrective and preventive actions. Ideal for audit preparation, gap assessments, and maintaining regulatory compliance across the medical device lifecycle.
by Tomas Langhout, from the Community
Downloads: 10+
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Template
ISO 13485 Audit Checklist
An ISO 13485 audit checklist is utilized by quality managers to determine if the organization's QMS is aligned with the ISO 13485:2016 standard. It helps evaluate an organization's readiness for a third-party ISO 13485:2016 certification audit.
by SafetyCulture
Downloads: 4,000+
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ISO 13485 TSSU Audit Checklist for Hospitals

With SafetyCulture you can

Digitize team workflows

Reduce manual errors

Create and share inspection reports

About author

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