This ISO 13485:2016 standard checklist helps quality managers and teams audit and improve a medical device quality management system. It aligns with key clauses 4 to 8, covering QMS documentation, management responsibility, resource management, product realization, design and development controls, purchasing, production and servicing, sterilization and cleanroom controls, identification and traceability, monitoring and measurement, complaint handling, nonconforming product, and CAPA. Use it to identify gaps, ensure regulatory compliance, manage risk, and record audit evidence while tracking status as Done, In Progress, Not Started, or Not Applicable.
With SafetyCulture you can
Digitize team workflows
Turn your workflows into digital templates or checklists so your team can conduct inspections efficiently and access them from any device.
Reduce manual errors
Help your team complete tasks more accurately with digital templates that minimize errors from manual processes.
Create and share inspection reports
Generate inspection reports and share them with your team and stakeholders to keep everyone informed.
About author
This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.