What is ISO 13485?

The quality management system (QMS) harmonised standard for the medical device industry is EN ISO 13485. It was created to outline the requirements for an organisation to design and implement a QMS in order to show that it can consistently provide medical devices and related services that meet customer and applicable regulatory requirements.

ISO 13485 places a strong emphasis on patient safety and aims to guarantee that medical devices are designed, developed, produced, stored, distributed, installed, serviced, and disposed of consistently. Organisations are required by ISO 13485 to execute these processes in compliance with the necessary regulatory requirements that have been recognized for the markets in which they want to operate.

Based on ISO 9001:2008, which has been replaced by ISO 9001:2015, ISO 13485 is a stand-alone QMS standard. Despite being built for regulatory compliance, ISO 13485 is based on the “Plan, Do, Check, Act” principles of the ISO 9001 process model. Consequently, some of the inappropriate standards of ISO 9001 are excluded from ISO 13485, which also includes specific requirements for organisations involved in the life-cycle of medical devices. As a result, it becomes more prescriptive and necessitates a QMS with more extensive documentation.

Benefits

• For those involved in medical devices, ISO 13485 is essential as it offers a complete QMS solution.
• For manufacturers, ensuring legal compliance and a dedication to safety are critical.
• Maintaining an effective QMS is essential for regulatory compliance, patient safety, and brand reputation.
• The marketability of ISO 13485 certification is improved, satisfying the increasing demand from manufacturers.