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 Duration 14 hours

Course Outline

Introduction

ISO 13485 Overview

  • Purpose and scope of ISO 13485
  • Relevance of ISO 13485 within the medical device industry
  • Essential terms and definitions

ISO 13485 Framework and Clauses

  • Interpreting the structure (Annex SL)
  • Summary of primary clauses: 4 through 8

Quality Management Principles

  • Process approach and the PDCA (Plan-Do-Check-Act) cycle
  • Risk-based thinking applied to medical devices
  • Emphasis on customer focus and regulatory obligations

Core Mandates of ISO 13485:2016

  • Detailed review of clauses (4 to 8)
  • Design and development controls
  • Risk management across the product lifecycle
  • Management of documents and records

Implementation and Sustainment of ISO 13485 QMS

  • Procedure for establishing an ISO 13485-compliant QMS
  • Personnel training and competency standards
  • Process monitoring and measurement

Auditing and Certification Procedures

  • Basics of internal and external audits
  • Certification preparation: key expectations
  • Handling non-conformities and corrective actions

Conclusion and Future Actions

Requirements

  • Familiarity with core quality management concepts

Target Audience

  • Quality managers
  • Quality engineers
  • Auditors and regulatory compliance personnel

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