In October 2019, we announced that we have been ISO 13485-certified by BSI.
Since then, we have continued developing and improving on our quality management system in order to maintain consistently high quality safe and effective products and services for our clients in the medical devices segment.
Today, we are thrilled to share that we have passed this year’s recertification audit to maintain our ISO 13485:2016 certification status.
What is ISO 13485? It is an internationally recognised standard for a Quality Management System (QMS) where an organisation needs to demonstrate its ability to supply medical devices and related services that consistently meet customer and regulatory requirements. All ISO standards are reviewed and updated every five years. This global standard is mandatory in some countries.
This recertification provides Aesthetic Bureau another 3 years of ISO 13485 registration, subject to continuing surveillance audits carried out by BSI.
By using ISO 13485 standards to implement our quality management system, we can ensure that we have a world-class system for meeting the requirements of customers and legislators for our medical devices.
This follows our years of commitment to making sure our quality processes are continuously improving.