ISO 13485 Medical Devices

Case Study: Croom Precision

ISO 13485

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.

Croom Precision engaged Almir Business to assist in the implementation of new system. Being already certified to ISO 9001 quality standard and ISO 14001 environmental standard, the progression to ISO 13485 was mapped out through an in-depth analysis of its current processes, both operational, (incoming material receipt to final inspection and release), and managerial, to determine the extra requirements to be implemented.

“The benefits and improvements gained whilst implementing ISO 13485  were visible on the shop floor…”

Paddy Byrnes,  Managing Director

The basis of strong well defined processes, implemented and understood at all functions and levels was seen to be a key success factor in the overall achievement of ISO 13485.