ISO 13485:2016 Medical Device Quality Management System Audit
This checklist covers ISO 13485:2016 Medical Device Quality Management System Audit requirements under applicable federal and industry regulations. Violations may result in civil penalties up to $15,625 per violation per day and potential operational suspension.
- Industry: Healthcare
- Frequency: Annual
- Estimated Time: 20-30 minutes
- Role: Quality Director
- Total Items: 20
- Compliance: OSHA General Duty Clause, 29 CFR 1910, Industry Best Practices
Regulatory Documentation & Compliance Status
Verify current regulatory compliance status and required documentation is in order.
- Are all applicable permits, licenses, and registrations current and posted?
- Has required training been completed and documented for all personnel assigned to this area?
- Are all required safety signs, labels, and warnings in place and legible?
- Attach photo of permit postings and safety signage:
Safety Equipment & Inspection Records
Verify safety equipment condition and inspection record currency.
- Are all required safety inspections current and documented?
- Is personal protective equipment available, maintained, and used correctly?
- Number of open deficiencies from previous inspection:
- Attach photo of safety equipment and inspection records:
Work Practices & Housekeeping
Evaluate worker compliance with safe work practices and housekeeping standards.
- Are workers following established safe work procedures and using required PPE?
- Is housekeeping adequate with no trip hazards, blocked egress, or unsecured materials?
- Work area safety and housekeeping assessment:
- Attach photo of work area conditions and housekeeping:
Nonconformity Management & Continual Improvement
Verify nonconformity tracking and continual improvement evidence.
- Is the nonconformity management process capturing, investigating, and resolving issues?
- Are continual improvement actions tracked and results communicated to top management?
- Number of nonconformities open beyond target closure date:
- Management Representative or Quality Director sign-off:
Corrective Actions & Inspector Sign-Off
Document all deficiencies and assign corrective actions. POPProbe auto-assigns these to team members, generates a signed PDF report instantly, and tracks compliance status across all locations. -> Start free, no credit card required
- List all deficiencies identified in this inspection:
- Overall compliance status?
- Corrective actions assigned to (name and department):
- Inspector digital signature and date:
Related Health Services Checklists
- ISO 17025:2017 Laboratory Management System Accreditation Checklist
- HITRUST CSF Assessment Readiness Checklist
- FDA 21 CFR 820.40 Document Controls Compliance Audit Checklist
- FDA 21 CFR 820.80 Receiving In-Process & Finished Device Acceptance
- FDA 21 CFR 820 Design Validation & Verification V&V Checklist
- FDA 21 CFR 820 FDA 483 Observation Response Checklist
- FDA 21 CFR 806 Medical Device Corrections & Removals Audit
- CMS EMTALA Emergency Screening & Stabilization Compliance
Related Clinical Compliance Checklists
- Sterile Processing Checklist - FREE Download
- Patient Fall Risk Assessment - FREE Download
- Hand Hygiene Compliance Audit - FREE Download
- UK CQC Healthcare Compliance Checklist - FREE Download
- Australia ACSQHC Healthcare Safety Checklist - FREE Download
- India NABH Hospital Accreditation Checklist - FREE Download
- Joint Commission Hospital Accreditation Checklist - FREE Download
- Blood Bank & Transfusion Safety Checklist [FREE PDF] - FREE Download
- Ambulatory Surgery Center Safety Checklist [FREE PDF] - FREE Download
- Optometry Practice Safety & Compliance Checklist [FREE PDF] - FREE Download
Why Use This ISO 13485:2016 Medical Device Quality Management System Audit?
This iso 13485:2016 medical device quality management system audit helps healthcare teams maintain compliance and operational excellence. Designed for quality director professionals, this checklist covers 20 critical inspection points across 5 sections. Recommended frequency: annual.
Ensures compliance with OSHA General Duty Clause, 29 CFR 1910, Industry Best Practices. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What does the ISO 13485:2016 Medical Device Quality Management System Audit cover?
This checklist covers 20 inspection items across 5 sections: Regulatory Documentation & Compliance Status, Safety Equipment & Inspection Records, Work Practices & Housekeeping, Nonconformity Management & Continual Improvement, Corrective Actions & Inspector Sign-Off. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed annual. Each completion takes approximately 20-30 minutes.
Who should use this ISO 13485:2016 Medical Device Quality Management System Audit?
This checklist is designed for Quality Director professionals in the healthcare 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.