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ISO 13485 · Internal Auditor

ISO 13485 Internal Auditor

Audit medical device quality systems with focus on validation, CAPA effectiveness, and record integrity.

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Learning objectives

  • Interpret ISO 13485 requirements in a regulated context
  • Audit validation activities (IQ/OQ/PQ) and their evidence expectations
  • Evaluate CAPA effectiveness and record integrity
  • Audit trails, document control, and training records under regulatory scrutiny
  • Write nonconformities that stand up in certification and regulatory audits

Agenda

Day 1: ISO 13485 structure, regulatory context, risk management linkage, audit planning for regulated processes.

Day 2: Validation and CAPA auditing workshops, record integrity, nonconformity writing, reporting, and exam.

Bring this program to your team

Private sessions use your procedures, your findings, and your products — so the skills apply the next morning.

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712-430-4103 info@zlgus.com