Interpretation and Implementation of ISO 13485

Interpretation and Implementation of ISO 13485

The ISO 13485 Interpretation and Implementation qualification aims to enable professionals to understand and apply the requirements established by the International Quality Management System standard for organizations in the most diverse stages of the Design, Production and Supply of Health Products, with focus on establishing a management approach that pursues product safety and effectiveness by adopting a risk-based approach to the organization's activities and processes.

Methodology

Exposition and discussion of content, accompanied by exercises for assimilation of concepts and contextualization of regulatory requirements in the organization, through the development and analysis of Case Studies.

Hours: 16 Hours


Content

Fundamentals and Vocabulary of Quality Management Systems
  • The logic and objectives of Quality Management Systems
  • The 7 Principles of Quality
  • Definitions applicable to a Quality Management System
  • Organization roles, regulatory agents and Quality Management System
Quality Management System - ISO 9001: 2015
  • Introduction, Purpose, Definitions, Applicability, Scope and Exclusions
  • Quality Management System Requirements
  • Top Management Accountability Requirements
  • Resource Management Requirements
  • Requirements for Product Planning, Design and Realization
  • Process and Product Measurement, Analysis, and Improvement Requirements
Planning and Conducting a Quality Management System

Interface between Quality Management System and product regularization

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Regulatory Framework