Velocity 360 USA Training

• Understand quality management definitions, concepts, and guidelines for ISO 13485:2016

• Know the requirements of the ISO 13485:2016 standard

• Understand the process approach

• Know the records required for internal and external audits

• Understand audit team leader responsibilities and how to communicate effectively during the audit

• Possess the skills to evaluate the competence and skills of auditors and select the audit team members

• Realize the roles and responsibilities of the auditor

• Be capable of conducting all phases of an audit using a risk-based approach and identifying nonconformances

• Understand the requirements for planning the audit and conducting the opening and closing meetings

• Know methods to prepare audit conclusions and the audit report

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