Case Study: Croom Precision
Croom Precision Medical with Almir Business’s assistance, has successfully achieved certification to the ISO 13485 Medical Devices –Quality Management Systems Standard, Quality Management Systems Standard, despite a demanding time scale.
Croom Precision Medical was established in 1995 for the purpose of providing an exclusive manufacturing service to the growing Medical Device market. Based in Croom, County Limerick, the company has a staff of 30 highly qualified personnel and is located in a new 20,000 square foot custom built premises on a 2 acre site. Croom Precision Medical specialises in the sub-contract manufacture, assembly and packaging of medical devices.
Facilitating a more streamlined implementation approach
Paddy Byrnes, Managing Director stated, “The benefits and improvements gained whilst implementing ISO 13485 were visible on the shop floor both in terms of identification and traceability to housekeeping and the overall positive visual impact of the shop floor”.
The integration of the ISO 13485 requirements with the current ISO 9001 system allowed for minimum impact into the operations of the company and facilitated a more streamlined implementation approach overall. Successful certification to ISO 13485, awarded by NSAI, has provided Croom Precision Medical with a worldwide recognised quality management system for its Medical Device business.
A future perspective
Based on a review of its current activities, its clients and looking towards the future the management and staff of the company decided that certification to ISO 13485, the International Quality Management System Standard for Medical Devices, would provide the required platform to further advance its current reputation for providing quality products and exceeding customer expectations.