![]() ![]() Paper-based audits can be burdensome and time-consuming. Ensure competence needs are met and that all parties involved are kept in the loop.Define your organization’s competencies and determine training requirements for ISO 13485:2016 certification based on the internal audit results. ![]() Perform quality monitoring audits and maintain a record of results.Identify areas for improvement in the current QMS by conducting a gap analysis or a readiness audit to ensure compliant to ISO 13485:2016 regulatory requirements.Obtain a copy and gain an understanding of the ISO 13485:2016 standard.ISO 13485 Audit Checklist | iAuditor 5 Steps to Prepare for ISO 13485:2016 Certification
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