This article briefly discusses
- what is ISO 13485:2016 audit checklist;
- the steps in preparing for an ISO 13485:2016 certification audit;
- technology to help ensure that implemented QMS is consistently aligned with the ISO 13485:2016 standard; and
- free ready to use ISO 13485 audit checklists.
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.
- Obtain a copy and gain an understanding of the ISO 13485:2016 standard.
- Identify areas for improvement in the current QMS by conducting a gap analysis or a readiness audit to ensure adherence to ISO 13485:2016 requirements.
- Perform quality monitoring audits and maintain a record of results.
- Define your organization’s competencies and determine training requirements for ISO 13485:2016 certification based on the audit results.
- Ensure competence needs are met and that all parties involved are kept in the loop.
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, a cloud-based 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 a mobile-ready ISO 13485 checklist.
- Empower teams to conduct efficient monitoring procedures and analysis using a smartphone or tablet.
- Save time with a mobile app that generates comprehensive ISO 13485 reports as you finish an audit.
- Save the ISO 13485 template online and automatically share reports with members of the organization. Preview a sample ISO 13485 PDF report here.
- Use for free with small teams. Unlimited reports and storage for premium accounts.
Here is a collection of our carefully prepared ISO 13485 audit checklists you can browse and use as part of achieving ISO 13485 certification and ongoing compliance.
ISO Audit Checklists
ISO 13485:2016 Standard Checklist
An ISO 13485:2016 standard checklist can help quality managers find gaps in the organization’s current processes. This digital checklist is divided into 5 sections following ISO 13485:2016’s key clauses:
4) Quality management system
5) Management responsibility
6) Resource management
7) Product realization
8) Measurement, analysis, and improvement
Each section assesses your organization’s preparedness in implementing an ISO-certified Quality Management System. This digitized checklist allows you to select “Done,” “In Progress,” “Not Started,” and, for sections 6, 7, & 8, “Not Applicable.”