![]() ![]() ![]() Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO13485:2016. Experienced BSI tutors will guide delegates through the entire audit process, from initiating the audit through to conducting audit follow-up. ISO 13485:2016 Medical Devices Quality Management Systems Auditor/Lead Auditor Training Course IRCA Certified Course (18190) Course AimīSI’s “Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016)” course teaches the principles and practices of effective quality management system audits against ISO 13485, in accordance with ISO 19011, “Guidelines for auditing management systems” and ISO 17021, as applicable.
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