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FDA shifting to full adoption of ISO 13485:2016 would further solidify global regulatory harmonization efforts. And with the most recent version of this standard, ISO 13485 and 21 CFR Part 820 are very much in sync with one another. Unlimited reports and storage for premium accounts. ISO 13485:2016 has gained significant recognition globally outside the U.S.
ISO 13485:2016 PDF
Preview a sample ISO 13485 PDF report here.
ISO 13485:2016 MANUAL
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. Paper-based audits can be burdensome and time-consuming.
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Define your organization’s competencies and determine training requirements for ISO 13485:2016 certification based on the 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 adherence to ISO 13485:2016 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