BSI
156 Case Studies
A BSI Case Study
Trauson, an orthopaedic device manufacturer based in China, needed to update its quality management system to meet the new ISO 13485:2016 requirements before the transition deadline. To prepare, Trauson turned to BSI and enrolled staff in the ISO 13485:2016 Internal Auditor course to better understand the changes and their impact on the business.
BSI delivered training that enabled Trauson to train colleagues across the organization, perform internal audits against the new standard, and plan its transition more effectively. As a result, Trauson improved overall quality awareness and gained the knowledge needed to modify its QMS for ISO 13485:2016, though no specific numerical metrics were provided.
Chunfeng Li
Quality System Manager