Quality Management System Statement
During the COVID-19 outbreak, Orthoplastics have adapted their current working practices to ensure that all aspects of our accredited QMS and regulatory and compliance activates are adhered to, despite current restrictions in place.
Orthoplastics is fortunate enough to already have an electronic QMS in place, which has made working remotely and ensuring compliance to standards more accessible for our Quality Management team.
Orthoplastics is working closely with accreditation bodies to ensure our quality management systems are maintained and reviewed remotely. We are extremely proud of how we have continued our high-quality standards, as well as our robust Quality Management System during this time.
We are pleased to announce that we have been certified to ISO 17025:2017, which has been achieved by remote based working.
As a medical device supplier, many of our customers require a supplier audit to be performed periodically. As such we have adapted our audit process internally and externally to ensure the safety of our employees, customers and suppliers.
We are now offering our customers desktop and virtual audits of all aspects of our Quality Management System, until at least 2021. To arrange a desktop / virtual audit please contact Rebecca Field by email at field@orthoplastics.com
Despite these uncertain times, Orthoplastics remain dedicated to the continued conformity of all its quality management systems ensuring product quality is at the forefront of all working practices.
Committed to Delivering the Highest Quality Standards
At Orthoplastics, quality is at the core of everything we do and covers all aspects of production, customer service, design and the manufacture of our premium-grade medical plastics.
To emphasise this strict focus on delivering the highest grade of UHMWPE products, Orthoplastics adhere to rigorous quality inspection standards and processes. This ensures that every product that leaves its facility is guaranteed to meet and exceed customers demanding standards.
As a result of this devoted approach towards quality, Orthoplastics have been accredited to a wide range of International Quality Standards.
Employing traceability techniques during the manufacturing of all medical-grade product, allows Orthoplastics to regularly assess product quality. All data is recorded and stored for a minimum of 30 years after the manufacturing processes.
Additionally, implementing visual inspection techniques allows for the determination of the products’ quality, along with using non-destructive, ultrasonic testing. Product batch testing is then completed in accordance with ISO 5834-2, ASTM F648 and customer specifications.