ISO 13485 – Medical Devices

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ISO 13485 is the international standard relating to Quality Management Systems for organizations involved in the manufacture and service of Medical Devices.

Embracing the Food and Drug Administration’s (FDA) good manufacturing practices, it provides a harmonized framework for companies to meet their customer and regulatory requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, and customer satisfaction.

Based on ISO 9001, most of ISO 13485 is taken from ISO 9001 without modification but two sections are excluded – continual improvement and customer satisfaction. In ISO 13485 there is a change in emphasis from “improving” the effectiveness of the quality system to “maintaining” the effectiveness and on meeting customer and regulatory requirements versus increasing customer satisfaction.

The Benefits of ISO 13485:

  • Registration to ISO 13485 shows commitment to quality, customers, and a willingness to work towards improving efficiency.
  • It demonstrates the existence of an effective quality system that satisfies the rigours of an independent, external audit and addresses the additional safety, regulatory and quality concerns specific to the medical device industry.
  • It enhances company image in the eyes of customers, employees and shareholders alike.
  • It gives competitive advantage in marketing efforts

Who Does it Apply to?

Any company, large or small, involved in the design, development, manufacture, distribution and servicing of medical devices can benefit from implementing ISO 13485. It is symbol of commitment for manufacturers needing to demonstrate their ability to provide products that consistently meet the requirements of customers and applicable regulations.

ISO Atlantic has a proven success record in implementing ISO 13485 with many Atlantic Canadian companies. We’d be happy to assist your company in exploiting its strengths and help you reach your market potential.