Template Information
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.
Category: general
Template Questions
- Management Controls
- Design and Development / Design Controls
- Corrective and Preventive Actions (CAPA)
- Medical Device Reporting (MDR)
- Production and Process Controls (P&PC)
- Sterilization Process Controls
- Purchasing Controls
- Documentation and Records
- Customer Requirements
- Technical Files
- Comments/Recommendations
- Name and signature