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Lucky B&W Sensitive Material Factory Passed Quality Audit of ISO13485
Date:2014-04-04 Source:Lucky Publicity Center
Lucky B&W Sensitive Material Factory’s ISO13485 passed the recertification and expansion audit recently by TÜV SÜD, which is the largest certification and notified body in Europe. This is the 3rd recertification audit since B&W factory got ISO13485 certification in 2005.
The recertification audit this time brought the medical dry imager produced in 2013 into certification scope, including all elements and involving each department and process of B&W factory. The audit team communicated with staffs of all departments and levels in B&W on site and consulted large amounts of records to collect much information and obtain convinced objective evidence. After two day audit at the job site, the audit team comes to a conclusion that the ISO13485 certification can be renewed and the medical dry imager will be included in the scope of certification. B&W factory continues to keep the CE mark certificate of 3 medical products. Meanwhile, the audit team issued 12 minor nonconformities.
The B&W factory director, Mr. Wang Hongze put forward three requirements, firstly, do well management of outsourcing process to ensure that the OEM products in conformity with the standards and requirements of process control. Secondly, to sort out the non-conformities of procedure and actual operation in the producing process and do well optimizing and rectification work. Thirdly, to put efforts in improving effectiveness, raising efficiency and enhancing effect to improve quality management system continuously.
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