Crothall Healthcare's Healthcare Technology Solutions division achieves rigorous international ISO 13485: 2016 recertification
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| June 06, 2022
Mooresville, NC (June 2, 2022) – The Healthcare Technology Solutions (HTS) operating division of Crothall Healthcare (Crothall) has received ISO 13485: 2016 recertification, an internationally recognized standard that includes servicing of medical devices. The certification process, overseen by NSF International Registrar, is conducted once every three years. Crothall's HTS division has been an industry leader in this space, receiving its initial certification in 2019.
"Our ISO 13485 recertification provides a tremendous benefit to our hospital and health system partners who can be reassured we have the policies, practices, and procedures to deliver consistent quality in repair and support services," said Jim Cheek President, Crothall Healthcare HTS. "This recertification reinforces the common quality language we speak that focuses on reducing variability in processes, utilizing client feedback to drive enhancements, and working with Best-In-Class suppliers. The result is enhanced patient safety and reduced medical device risk."
The ISO 13485: 2016 standard sets the requirements for a Quality Management System with a focus on medical device safety. Certification is a recognition that Crothall's policies, processes, and procedures ensure consistent quality in the repair and support services provided to clients. The certification audit covers everything from the uptime of medical devices and turnaround time on critical corrective maintenance work orders to ensuring the availability of equipment, device traceability, and supplier qualifications. The certification and recertification process includes a lengthy, in-person, comprehensive audit that reviews medical device safety, risk management, and process improvement.
"Crothall's HTS division oversees the entire life cycle of medical devices and clinical technologies at more than 200 hospitals nationwide," added Cheek. "Our clients and suppliers reap the benefits of the comprehensive continuous quality improvement program reflected by ISO's rigorous certification standards and processes."
About Crothall Healthcare
Crothall Healthcare (Crothall) is a Compass One Company that provides specialized, high-quality, innovative, and responsive support services exclusively to the healthcare industry. Crothall is the market share leader in Environmental Services (EVS) and serves many of the Top 100 Hospitals throughout its almost 1,200 healthcare service teams in 47 states and territories. Crothall has been recognized as one of Modern Healthcare's Best Places to Work and Best Places to Work in Pennsylvania since 2013. A division of Compass Group USA, Crothall has almost 25,000 team members. Its Healthcare Technology Solutions (HTS) division has been ISO 13485 certified since 2019, and the EVS division is CIMS and CIMS-GB certified by the ISSA since 2009. Crothall's core services include HTS, EVS, Ambulatory, Patient Transportation, Patient Observation, Facilities Management, and Sterile Processing.
NSF is an independent, global organization that facilitates standards development, and tests and certifies products for the food, water, health sciences and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With operations in 180 countries, NSF is a Pan American Health Organization/World Health Organization Collaborating Centre on Water Quality, Food Safety, and Medical Device Safety.
NSF International Strategic Registrations (NSF-ISR) offers a comprehensive portfolio of management systems registration solutions to meet the demands of the global marketplace (nsf-isr.org). NSF-ISR is the largest automotive registrar in North America and is recognized by the International Automotive Task Force (IATF) to provide IATF 16949 registrations in the automotive sector. NSF-ISR also provides registrations for the following programs: ISO 9001, ISO 14001, ISO 45001, ISO 27001, AS 9100/10/20, ISO 13485, ISO 20000-1, Responsible Care (RC) 14001 and Responsible Care Management Systems (RCMS), as well as greenhouse gas verification/validation.
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