Swiss Technologies of New England is undergoing major changes coming into the New Year. We will continue to be ISO 9001:2015 Certified and are in the process of receiving our ISO 13485:2016 Certification, which will allow us to further break into the Medical Device industry. We are on track to have our ISO 13485:2016 Certification completed by June 1st, 2019. Our ISO Certification will enable Swiss Technologies of New England to open a new division, S.T.O.N.E. Medical.
Our ISO 9001:2015 CNC Swiss Screw machine shop will remain at our current location of 17 Cross Street Unit #8 in Plainville, MA and will continue to serve the Fiber Optic, Aerospace, Automative and Military industries. Our new ISO 13485:2016 division will be at a new location in the same industrial park, 17 Cross Street Unit #6, and will be a contract manufacturer solely focused on medical devices and components. Both locations will remain under the same ownership with the same contacts you have been doing business with for years.
What does is it mean to be ISO 13485:2016?
Adopting ISO 13485 Standards means that our company will have a practical foundation for manufacturers to address medical device regulations, FDA regulations, directives and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
Pros of ISO 13485:2016?
Improve company image and credibility: Implement a system that is focused on improvement and meeting customer requirements. Having a greater credibility will allow your customer to gain more trust in your company.
Improve customer satisfaction: Identify and meet customer's requirements. Improved customer satisfaction will give your company a greater chance of repeated customer business.
Fully integrated processes: Not only look at individual processes but also at interactions of
Evidence-based decision making: Making decisions based on good evidence is key to the success of an ISO 13485 Quality Management System (QMS), targeting resources to the best effect to correct the problems and improve your organizational efficiency and effectiveness.
Create a culture of continual improvement: Making continual improvement as the main output for the QMS. you can increase gains in saving time, money and other resources. By making this the culture of your company you can focus your workforce on improving what they are directly responsible for.
Retrieved From: http://www.hallmarknameplate.com/the-benefits-of-being-iso13485-certified/
Retrieved From: https://www.iso.org/iso-13485-medical-devices.html
Retrieved From: https://www.iso.org/files/live/sites/isoorg/files/archive/pdf/en/iso_13485_medical_devices_2016.pdf
Retrieved From: https://lne-america.com/certification/iso-certification/iso-13485-quality-management-system