ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance Audit
This checklist covers compliance with Health and Safety at Work etc. Act 1974 and applicable UK statutory requirements for healthcare operations. Non-compliance can result in unlimited fines and enforcement action under the Health and Safety at Work etc. Act 1974 and applicable UK statutory instruments.
- Industry: Healthcare
- Frequency: Quarterly
- Estimated Time: 20-30 minutes
- Role: Quality Director
- Total Items: 20
- Compliance: Health and Safety at Work etc. Act 1974, Management of Health and Safety at Work Regulations 1999, HSE Approved Codes of Practice, BS EN ISO 45001:2018
Statutory Compliance, Registration & Risk Assessment
Verify statutory registrations, risk assessments, and Competent Person designation per UK law.
- Are all relevant statutory licences, permits, and registrations current, displayed where required, and available for inspection?
- Has a suitable and sufficient risk assessment been completed and communicated to relevant workers?
- Is a Competent Person designated for this area of compliance per the relevant statutory requirement?
- Attach photo of statutory registrations, risk assessment, and Competent Person appointment documentation:
Competence, Monitoring & Outstanding Actions
Verify worker competence, active monitoring programme, and outstanding corrective actions.
- Are all workers competent for their tasks (trained, experienced, or supervised as appropriate)?
- Is monitoring and measurement of key compliance indicators carried out at required frequencies?
- Number of outstanding corrective actions from previous inspection or audit:
- Attach photo of training records, monitoring reports, and corrective action tracker:
Emergency Procedures, Signage & Legal Notices
Verify emergency procedures, mandatory statutory signage, and drill records.
- Are emergency procedures documented, practiced through drills, and records maintained?
- Are all statutory notices, signage, and warnings correctly displayed per applicable regulations?
- Overall compliance with applicable UK statutory requirements:
- Attach photo of emergency drill records, statutory signage register, and compliance certificates:
Enforcement Compliance & Management Review
Verify enforcement notice compliance, management review programme, and senior accountability.
- Have all findings from previous regulatory inspections, enforcement notices, and prohibition orders been resolved?
- Is management review of the health and safety management system conducted at least annually?
- Number of open enforcement actions or improvement notices outstanding:
- Senior Responsible Officer certification of inspection completion:
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:
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Why Use This ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance Audit?
This iso 13485:2016 medical devices qms uk & mhra compliance 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: quarterly.
Ensures compliance with Health and Safety at Work etc. Act 1974, Management of Health and Safety at Work Regulations 1999, HSE Approved Codes of Practice, BS EN ISO 45001:2018. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What is a ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance Audit?
A ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance Audit is a standardized inspection form used by quality director to ensure consistent healthcare operations. It contains 27 inspection points organized into 5 sections. FREE PDF - ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance checklist for UK operations. Covers Health and Safety at Work etc. Act 1974 requirements. Download FREE template.
How often should I use this healthcare checklist?
This checklist is designed to be completed quarterly. Regular use ensures compliance with Health and Safety at Work etc. Act 1974 and Management of Health and Safety at Work Regulations 1999 and helps identify issues before they become problems.
Can I download this ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance Audit as a PDF?
Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 27 fields across 5 sections and typically takes 20-30 minutes to complete.
What compliance standards does this checklist cover?
This checklist helps ensure compliance with Health and Safety at Work etc. Act 1974, Management of Health and Safety at Work Regulations 1999, HSE Approved Codes of Practice, BS EN ISO 45001:2018. Following these standards protects your organization and ensures best practices.
How do I complete this healthcare inspection checklist?
Begin by completing the header fields for Site / Premises Name, Inspection Date, Inspector Name & Title, and Reference / Permit Number. Work through each of the 5 sections, marking items Yes or No as applicable. Add notes for any issues found. Finally, complete the footer fields and add your signature. The entire process takes approximately 20 to 30 minutes.
What are the key sections in this healthcare checklist?
This healthcare checklist is organized into 5 key sections: Statutory Compliance, Registration & Risk Assessment, Competence, Monitoring & Outstanding Actions, Emergency Procedures, Signage & Legal Notices, Enforcement Compliance & Management Review, Corrective Actions & Inspector Sign-Off. Each section contains specific inspection points that quality director must verify. The structured layout ensures nothing is missed during healthcare inspections and makes the process efficient, typically taking 20-30 minutes to complete.
Who should use this ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance Audit?
This checklist is primarily designed for quality director working in healthcare operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that healthcare standards are being met. Organizations of all sizes can benefit from using this ISO 13485:2016 Medical Devices QMS UK & MHRA Compliance Audit to maintain consistency and accountability.