What is ISO 13485:2016?
ISO 13485:2016 is an international standard for the Quality Management System (QMS) of organizations involved in the manufacturing, distribution, servicing, and disposal of medical devices. Organizations with ISO 13485:2016 certification are recognized to produce medical devices that are at par with industry standards.
What is an ISO 13485:2016 Audit Checklist?
An ISO 13485:2016 audit checklist is a tool used by quality managers to determine if the QMS of organizations align with the ISO 13485:2016 standard. This checklist is useful in evaluating readiness for a third-party ISO 13485:2016 certification audit.
This article briefly discusses (1) the steps in preparing for an ISO 13485:2016 certification audit; (2) technology to help ensure that implemented QMS is consistently aligned with the ISO 13485:2016 standard; and (3) free ISO 13485 audit checklists.
Click here to browse and download the best ISO 13485 audit checklists
ISO 13485:2016 Audit Tool
Paper-based audits can be burdensome and time-consuming. Time spent on documentation and manual filing of records can be better spent working on gaps found in the current QMS and working towards getting certified for ISO 13485. iAuditor, the world’s most powerful mobile auditing app, can help organizations meet ISO requirements and maintain the quality of medical devices. Be ready for third-party ISO certification by doing the following:
- ✔ Create mobile-ready ISO checklists.
- ✔ Empower teams to conduct efficient monitoring procedures and analysis using a smartphone or tablet.
- ✔ Save time with a mobile app that generates comprehensive reports as you finish an audit.
- ✔ Save all reports online and automatically share it with members of your organization. Preview a sample report here.
- ✔ Use for free with small teams. Unlimited reports and storage for premium accounts.