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ISO 13485 Quality Management System for Medical Devices

ISO 13485 published by the International Organization for Standardization (ISO), is a Quality Management standard for organizations involved in the life-cycle of a medical device, including service and delivery. Many organizations require ISO 13485 compliance or certification for entry onto their approved vendors list (AVL).

ISO 13485 Overview

  • Medical Device File
  • Management Responsibility
  • Customer Focus
  • Responsibility, Authority and Communication
  • Management Review
  • Resource Management
  • Human Resources
  • Infrastructure
  • Contamination Control
  • Planning of Product Realization
  • Design and Development
  • Cleanliness of Product
  • Installation Activities
  • Servicing Activities
  • Particular Requirements for Sterile Medical Devices
  • Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems
  • Measurement, Analysis and Improvement
  • Complaint Handling
  • Internal Auditing
  • Control of Nonconforming Product
  • Corrective and Preventive Action

Benefits of ISO 13485 Certification

  • Win more bids where certification is a requirement or a competitive advantage
  • Meet customers’ requirement for certification
  • Improved structure, processes and procedures internally
  • Better internal controls, which will improve operations and reduce risks
  • Achieve ISO 13485 certification

How We Can Help

The ISO 9001 Group understands how to design, develop and implement ISO 13485 certification ready management systems from the ground up to meet the latest ISO 13485 standards. If your organization already has an ISO 9001 quality management system, we will help you integrate ISO 13485.


We have a 5 x 4 methodology that ensures that your management system meets the specific needs of your organization and ensures compliance or certification of your management system.


Contact us today to find out more about how The ISO 9001 Group can assist your organization achieve its business goals.

Request a proposal via the button below. We look forward to speaking with you on how the ISO Group 9001 can help your company achieve sustainable success through your quality, health, safety and environmental management systems.


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