Template

ISO 13485:2016 Audit Checklist

by Tomas Langhout, from the Community

10+

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.

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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.

Template
ISO 13485:2016 Checklist for Medical Device QMS
This ISO 13485:2016 checklist helps quality managers evaluate and improve a medical device quality management system. Organized around clauses 4-8, it guides QMS documentation, management responsibility, resource and contamination control, product realization (design, purchasing, production, servicing, sterilization, traceability), and measurement and improvement. Use it to verify compliance, plan audits, track corrective and preventive actions, and maintain product safety and performance.
by THI XUAN TINH VO, from the Community
Downloads: 10+
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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 13485:2016 Standard Checklist
This ISO 13485:2016 standard checklist helps quality managers and teams audit and improve a medical device quality management system. It aligns with key clauses 4 to 8, covering QMS documentation, management responsibility, resource management, product realization, design and development controls, purchasing, production and servicing, sterilization and cleanroom controls, identification and traceability, monitoring and measurement, complaint handling, nonconforming product, and CAPA. Use it to identify gaps, ensure regulatory compliance, manage risk, and record audit evidence while tracking status as Done, In Progress, Not Started, or Not Applicable.
by sofiane djebari, from the Community
Downloads: 10+
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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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ISO 13485:2016 Audit Checklist

With SafetyCulture you can

Digitize team workflows

Reduce manual errors

Create and share inspection reports

About author

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