Course Outline

Introduction

Overview of ISO 13485

  • Purpose and scope of ISO 13485 for government and the medical device industry
  • Importance of ISO 13485 in ensuring quality and compliance in the medical device sector
  • Key terminologies and definitions relevant to this standard

ISO 13485 Structure and Clauses

  • Understanding the structure based on Annex SL for government agencies
  • Overview of key clauses from 4 to 8, focusing on their relevance for government operations

Quality Management Principles

  • The process approach and PDCA (Plan-Do-Check-Act) cycle in the context of medical devices for government use
  • Risk-based thinking and its application in the development and management of medical devices for government agencies
  • The importance of customer focus and adherence to regulatory requirements for government entities

Key Requirements of ISO 13485:2016

  • Detailed clause-by-clause breakdown from 4 to 8, tailored for government compliance
  • Design and development controls specific to medical devices used by government agencies
  • Risk management throughout the product lifecycle in a government context
  • Control of documents and records for government operations

Implementation and Maintenance of ISO 13485 QMS

  • Steps to establish an ISO 13485-compliant Quality Management System (QMS) for government agencies
  • Training and competency requirements for personnel within government organizations
  • Monitoring and measuring processes to ensure ongoing compliance with ISO 13485 for government entities

Audit and Certification Process

  • Introduction to internal and external audits for government agencies
  • Preparing for certification: key considerations and what to expect in a government setting
  • Addressing non-conformities and implementing corrective actions within government organizations

Summary and Next Steps

Requirements

  • Fundamental knowledge of quality management principles

Audience for Government

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

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