Achieving certification represents Total Scope’s commitment to quality systems
Upper Chichester, PA – July 25, 2018 – Total Scope South (TSS), the nation’s leading medical device repair company has just received their first ISO 13485:2016 certification at their Nashville facility. The company currently repairs flexible endoscopes but is working on adding the full suite of repair and services, which will include rigid endoscope repair, surgical camera repair and surgical instrument repair.
This certification is a quality standard specific to the medical device repair industry. TSS had to meet stringent quality requirements in a range of vital areas, including handling, preservation and delivery, internal quality audits, employee training, and more.
Total Scope’s Nashville facility underwent a rigorous auditing process to obtain the ISO 13485 certification. They were subjected to a one-day audit which included TSS’s compliance to and integration of Total Scope’s quality system, documentation and traceability, training and employee knowledge of the new procedures implemented by Total Scope, and parts and other materials used during the repair process.
This process is important to the end user because TSS can better meet customer requirements, increase customer satisfaction and enhance production quality.
According to Erin Carrafa, Quality Manager at the Total Scope headquarters, “Having the ISO certification allows Total Scope to demonstrate the ability to consistently provide services that meet customer and regulatory requirements.”
ISO 13485:2016 certification is not mandatory for third-party repair facilities like Total Scope. To become ISO certified demonstrates a serious commitment to quality.
TSS is committed to continuous improvement and ways to improve their systems and customer service. “We are a better company because of the ISO 13485:2016 certification and our customers and patients are better for it as well, according to Carrafa.
In June 2017, Boston Scientific chose TSI as a Solutions partner and entered into an agreement with TSI to offer its customers an alternative to OEM scope repair services. The co-exclusive agreement allows Boston Scientific to offer scope repair services and certified pre-owned scopes and equipment to hospital and ambulatory surgical center customers.