Course Outline

Introduction

Overview of ISO 13485

  • Purpose and scope of ISO 13485
  • Importance of ISO 13485 in the medical device industry
  • Key terminologies and definitions

ISO 13485 Structure and Clauses

  • Understanding the structure (Annex SL)
  • Overview of key clauses: 4 to 8

Quality Management Principles

  • Process approach and PDCA (Plan-Do-Check-Act)
  • Risk-based thinking in medical devices
  • The importance of customer focus and regulatory requirements

Key Requirements of ISO 13485:2016

  • Clause-by-clause breakdown (4 to 8)
  • Design and development controls
  • Risk management throughout the product lifecycle
  • Control of documents and records

Implementation and Maintenance of ISO 13485 QMS

  • Steps to establish an ISO 13485-compliant QMS
  • Training and competency requirements for personnel
  • Monitoring and measuring processes

Audit and Certification Process

  • Introduction to internal and external audits
  • Preparing for certification: what to expect
  • Non-conformities and corrective actions

Summary and Next Steps

Requirements

  • Basic understanding of quality management concepts

Audience

  • Quality managers
  • Quality engineers
  • Auditors and regulatory compliance staff
 14 Hours

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