Internal Audit Checklist
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Checklist
- Format
- DOCX
- Language
- English
- Tags
- Checklist, ISO 13485, Medical Devices
This checklist guides the auditor and records objective evidence during internal audits. ISO 13485:2016 clause 8.2.4 requires audits to determine conformity to planned arrangements, the standard, QMS requirements and applicable regulatory requirements, and effective implementation; records of audits and their results, including the processes and areas audited and the conclusions, must be maintained.
What's Inside
- PART A — Audit Details (Example IA-28-02)
- PART B — Process Checklist and Evidence
- Findings
- Summary
- PART C — General ISO 13485 Clause Checklist
- PART D — Regulatory Add-On Questions
- Review and sign-off section
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 8.2.4. It fits with the rest of the QEHS Vault ISO 13485 document set.
Format
Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
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