Course Outline

Introduction

Overview of ISO 13485

  • Purpose and scope of ISO 13485 for government agencies and private sector entities in the medical device industry.
  • Importance of ISO 13485 in ensuring quality, safety, and regulatory compliance within the medical device industry.
  • Key terminologies and definitions relevant to understanding and implementing ISO 13485 standards.

ISO 13485 Structure and Clauses

  • Understanding the structure of ISO 13485, aligned with Annex SL for consistency with other management system standards.
  • Overview of key clauses from 4 to 8, which outline the requirements for establishing and maintaining a quality management system (QMS).

Quality Management Principles

  • The process approach and the PDCA (Plan-Do-Check-Act) cycle as foundational elements of ISO 13485.
  • Risk-based thinking in the development, production, and distribution of medical devices to enhance patient safety and product reliability.
  • The importance of maintaining a strong focus on customer needs and meeting regulatory requirements for government compliance.

Key Requirements of ISO 13485:2016

  • A detailed clause-by-clause breakdown from clauses 4 to 8, covering the essential elements of the standard.
  • Design and development controls to ensure that medical devices meet specified requirements and regulatory standards.
  • Risk management practices integrated throughout the product lifecycle to identify and mitigate potential hazards.
  • Control of documents and records to maintain traceability, accountability, and compliance with regulatory obligations for government oversight.

Implementation and Maintenance of ISO 13485 QMS

  • Steps to establish an ISO 13485-compliant quality management system within organizations.
  • Training and competency requirements for personnel involved in the design, production, and distribution of medical devices.
  • Monitoring and measuring processes to ensure continuous improvement and adherence to quality standards for government review.

Audit and Certification Process

  • Introduction to internal and external audits as critical components of maintaining ISO 13485 compliance.
  • Preparing for certification: an overview of the process, including documentation, on-site inspections, and evaluation by third-party auditors.
  • Addressing non-conformities and implementing corrective actions to resolve identified issues and maintain compliance with ISO 13485 standards for government agencies.

Summary and Next Steps

Requirements

  • Fundamental knowledge of quality management principles

Audience for Government

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

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