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ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course
Description:
  • To follow the instructions of the lead auditor and support him
  • To collect and analyze enough evidences (e.g. through interview, observation and sampling of documentation) to determine the audit findings and define the audit conclusions
  • To document the audit findings
  • To collaborate in drafting the audit report
  • To interchange information with the rest of the members of the audit team and with the auditee personnel.
Previous skills/knowledge:
  • Knowledge of ISO 13485 requirements
  • Professional experience, including in medical devices management systems – ISO 13485 (recommended)
  • Knowledge of the methods and techniques of assessment.
Authorized Partners:

Teaching requirements: Trainer should to be a qualified ISO 13485 Lead Auditor
Objectives to achieve: To get the necessary knowledge and skills to:

  • Be qualifiable as ISO 13485 internal auditor (additional requirements from qualifying entity may apply)
  • Understand the principles of internal audit
  • Be able to assume responsibilities in any activity of the internal auditing process
  • Understand the functions and competences that any auditor must have to carry out first, second party, and certification audits
  • Be able to apply auditing guidelines to ISO 13485 internal audits.
Authorized Partners:
SIQ