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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: