Approx 2 minute read |
The team at WOW facial® have a huge announcement to make: the WOW fusion® device has passed the ISO 13485:2016 quality certification!
We asked our CEO and founder, Claire Williams, what an ISO certification is and why it is so important for WOW facial®.
ISO Explained
“It is a quality management system designed to ensure companies are manufacturing medical devices to the highest standards and within the regulatory framework” explains Claire. “It is an internationally recognised system that specifies the requirements for a comprehensive quality system suitable to design and develop medical devices. It is one of the most difficult ISO certifications a company can get.”
Is an ISO important?
“This is all for safety and regulation purposes,” says Claire. “We know exactly how our device is designed, developed and manufactured. We know every single supplier of every single component in the device, we know that it is safe to be used on skin and has the sterilisation process validated to ensure that our customers are getting a clean, safe and well-designed device.” She continues: “If a micro-needling device manufacturer cannot supply you with their ISO certificates, design history file and sterilisation validation then I would avoid using them.”
“I’m super proud of the WOW team keeping safety and quality at the core of our business. Well done us!” - Claire Williams, CEO and Founder of WOW facial®
How do you get an ISO?
“It has taken 13 months to implement and cost us a lot of money” reveals Claire. “I went through 18 manufacturers before I found the best subcontracted manufacturer to ensure safety. They have been audited and approved and have to follow our quality management system as well as their own.”
If you are considering becoming a certified WOW practitioner, please contact our team at info@wowfacial.co.uk. We offer regular training courses both in-person and online, as well as ongoing support to all our practitioners.
Author: Danielle
Category: WOW Journal