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ISO 13485 Audit Checklist for QMS Compliance

by Rohan Pawar, from the Community

10+

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.

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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.

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
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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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 13485:2016 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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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

20+

Get

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

4,000+

Get

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

10+

Get

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

10+

Get

ISO 13485 Audit Checklist for QMS Compliance

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