Medical Device Manufacturing Quality Audit Checklist [FREE PDF]

This medical device manufacturing quality audit checklist ensures compliance with FDA 21 CFR 820 Quality System Regulation requirements. Quality System Manager / Auditors use this checklist to verify regulatory compliance, document findings, and maintain safety and quality standards.

Industry: Medical Devices
Frequency: Annually
Estimated Time: 8-16 hours
Role: Quality System Manager / Auditor
Total Items: 21
Compliance: FDA 21 CFR 820 Quality System Regulation, ISO 13485:2016 Medical Devices QMS, EU MDR 2017/745 Medical Device Regulation, IEC 62304 Medical Device Software

Documentation and Regulatory Review

Verify required documentation is current and complete.

Standard Operating Procedures (SOPs) current and accessible?
All personnel training records current for this activity?
Required permits, licenses, and registrations current?
Previous inspection findings reviewed and corrective actions verified?

Safety and Equipment Requirements

Verify safety equipment, PPE, and emergency preparations.

Required PPE available, clean, and in good condition?
Emergency equipment (eyewash, shower, extinguisher) accessible?
Safety Data Sheets (SDS) available for all hazardous materials?
Emergency contact and response procedures posted?

Operational Compliance Checks

Verify operations comply with regulatory requirements.

Approved procedures being followed without deviation?
Equipment qualified/calibrated and within calibration period?
Environmental monitoring (temp, humidity, pressure) within spec?
All materials, products, and containers properly labeled?
Data recorded contemporaneously with no unexplained alterations?

Waste Disposal and Environmental Compliance

Verify proper waste handling and disposal.

All waste properly labeled with contents and hazard class?
Waste containers appropriate for waste type and in good condition?
Waste streams segregated per regulatory requirements?
Waste disposal records maintained?

Findings and CAPA

Document findings and corrective/preventive actions.

Any deviations or non-conformances identified?
CAPA initiated for any findings?
Photo documentation of findings?
Inspection findings and recommendations

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Why Use This Medical Device Manufacturing Quality Audit Checklist [FREE PDF]?

This medical device manufacturing quality audit checklist [free pdf] helps medical devices teams maintain compliance and operational excellence. Designed for quality system manager / auditor professionals, this checklist covers 21 critical inspection points across 5 sections. Recommended frequency: annually.

Ensures compliance with FDA 21 CFR 820 Quality System Regulation, ISO 13485:2016 Medical Devices QMS, EU MDR 2017/745 Medical Device Regulation, IEC 62304 Medical Device Software. Regulatory-aligned for audit readiness and inspection documentation.

Frequently Asked Questions

What does the Medical Device Manufacturing Quality Audit Checklist [FREE PDF] cover?

This checklist covers 21 inspection items across 5 sections: Documentation and Regulatory Review, Safety and Equipment Requirements, Operational Compliance Checks, Waste Disposal and Environmental Compliance, Findings and CAPA. It is designed for medical devices operations and compliance.

How often should this checklist be completed?

This checklist should be completed annually. Each completion takes approximately 8-16 hours.

Who should use this Medical Device Manufacturing Quality Audit Checklist [FREE PDF]?

This checklist is designed for Quality System Manager / Auditor professionals in the medical devices industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.

Can I download this checklist as a PDF?

Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.