Blatchford is proud to be awarded two significant ISO accreditations which demonstrate our committment to ethical work practices and to enhancing product management systems. We believe that this recognises our continuous developments in design, testing and manufacturing processes, all of which combine to ensure safe and technically superior products for amputees worldwide.

ISO14001 Environmental Management Standard – Basingstoke Registration 10/09/09 for accreditation

ISO 14001 is an international standard that sets out a framework for an effective Environmental Management System (EMS). The standard is designed to address the delicate balance between maintaining profitability and reducing environmental impact. Specifically the standard requires us to produce objectives for improvement and a management programme to achieve them, with regular reviews for continual improvement.

ISO 13485 Medical Device Regulatory Quality Management Systems - Basingstoke Registration 01/09/09 for accreditation

ISO 13485 is harmonized with ISO 9001. The main difference is ISO 9001 requires the company to demonstrate continuous improvement, whereas ISO 13485 requires specific additional controls within the quality system, a few examples below:-

• controls in the work environment to ensure product safety

• focus on risk management activities and design transfer activities during product development

• specific requirements for inspection and traceability

• specific requirements for verification of the effectiveness of corrective and preventive actions