ISO 13485 Environmental Management Certification

The standard, officially known as the ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes, was first published by International Organization for Standardization (ISO) in 1996. The standard states the requirements of comprehensive quality management systems for the design and manufacture of medical devices products. Since then, it was revised twice in 2003 and 2016 respectively with the latest being the 3rd edition ISO 13485:2016.


One of the core principles of the ISO 13485 implementation is to ensure customer satisfaction. Companies that are ISO 13485 certified are considered more reliable by the customers than the company that doesn’t have one. This is because the customers strongly believe that the company has a good QMS in place. The goals of the company with ISO 13485 implementation are focused on the customer needs rather than focusing on the individual goals of the department. This will help get new customers for business and boost the revenue.