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Course Outline

Introduction

Overview of ISO 13485

  • Stated objectives and applicable scope of ISO 13485
  • Significance of ISO 13485 within the medical device sector
  • Essential terminology and defined concepts

Architectural Framework and Clauses of ISO 13485

  • Interpretation of the Harmonized Structure (Annex SL)
  • Summary of core requirements: Clauses 4 through 8

Core Quality Management Principles

  • Process approach and the Plan-Do-Check-Act (PDCA) cycle
  • Application of risk-based thinking in medical device contexts
  • Emphasis on customer orientation and adherence to regulatory mandates

Principal Requirements of ISO 13485:2016

  • Detailed examination of clauses (4 to 8)
  • Controls for design and development activities
  • Risk management integrated across the product lifecycle
  • Administration of documentation and record-keeping

Deployment and Sustainment of the ISO 13485 QMS

  • Methodology for establishing an ISO 13485-conformant Quality Management System
  • Personnel training and competency assurance requirements
  • Process surveillance and performance measurement

Audit and Certification Procedures

  • Fundamentals of internal and external audit activities
  • Certification preparation and procedural expectations
  • Identification of non-conformities and execution of corrective actions

Conclusion and Recommended Follow-up Actions

Requirements

  • Familiarity with fundamental quality management concepts

Target Audience

  • Quality Management Directors
  • Quality Engineers
  • Auditors and Regulatory Compliance Specialists
 14 Hours

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