Beschreibung
ISO 13485 Lead Auditor quality management training course (Englisch)
Ziel
This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
Kommende Starttermine
Inhalte / Module
Identify the aims and benefits of an ISO 13485:2016 audit
Interpret ISO 13485:2016 requirements for audit application
Plan, conduct and follow-up auditing activities that add real value
Grasp the application of risk-based thinking, leadership and process management
Access the latest auditor techniques and identify appropriate use
Build stakeholder confidence by managing processes in line with the latest requirements
Understand the arrangements for BSI certification
Nutzen & Mehrwert
On completion of this training, participants will be able to:
Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
Identify the purpose and benefits of an ISO 13485:2016 QMS
Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).
Zielgruppe / Voraussetzungen
Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
Management representatives
Quality directors, managers, and engineers
Consultants
Abschlussqualifikation / Zertifikat
You’ll be awarded an internationally recognized BSI Training Academy certificate.
Infos anfordern
BSI Group Deutschland GmbH
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