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 Duration 14 hours

Course Outline

Introduction

Overview of ISO 13485

  • Objective and applicability of ISO 13485
  • Significance of ISO 13485 within the medical device sector
  • Essential terminology and definitions

ISO 13485 Architecture and Clauses

  • Comprehension of the framework (Annex SL)
  • Summary of principal clauses: 4 through 8

Quality Management Principles

  • Process methodology and PDCA (Plan-Do-Check-Act) cycle
  • Risk-based reasoning applied to medical devices
  • Emphasis on customer orientation and regulatory obligations

Core Requirements of ISO 13485:2016

  • Detailed analysis of clauses 4 through 8
  • Design and development oversight
  • Risk management across the product lifecycle
  • Control of documentation and records

Establishment and Sustainment of ISO 13485 QMS

  • Procedure for instituting an ISO 13485-aligned QMS
  • Education and proficiency standards for personnel
  • Surveillance and assessment of processes

Inspection and Accreditation Procedures

  • Basics of internal and external inspections
  • Preparation for accreditation: expected protocols
  • Identification of non-conformities and corrective measures

Conclusion and Subsequent Actions

Requirements

  • Elemental knowledge of quality management frameworks

Intended Audience

  • Quality Assurance Managers
  • Quality Engineers
  • Auditors and Regulatory Compliance Personnel

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