Beschreibung
Internal Auditor ISO 13485 Training Course (Englisch)
Ziel
This intensive two day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization.
Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2011.
An experienced instructor guides students through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions. Participants will gain necessary auditing skills through a balance of formal classroom tutorials, practical role-playing, and group workshops.
Kommende Starttermine
Inhalte / Module
On completion of this training, participants will be able to:
Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
Identify the key principles of auditing and auditor responsibilities
Plan an internal audit
Conduct an effective audit based on process identification, sampling and questioning
Determine if corrective action has been effectively implemented
Zielgruppe / Voraussetzungen
Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
Individuals interested in conducting first-party or second-party audits
Management representatives
Internal auditors
Consultants
Abschlussqualifikation / Zertifikat
You’ll be awarded an internationally recognized BSI Training Academy certificate.
Infos anfordern
BSI Group Deutschland GmbH
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