ISO 13485 Certification Announcement
Fralcok ISO 13485 Certification
Fralock, Division of Lockwood Industries, is proud to announce it is now certified as ISO 13485 compliant. The certification is accredited by Det Norske Veritas Certification, Inc (DNV).
To become certified as ISO 13485 compliant, Fralock underwent a thorough evaluation process that included quality management system development, a management system documentation review, pre-audit, initial assessment, and clearance of non-conformances, all of which work to identify corrective actions that elimination non-conformance to the quality management standard. The process culminated in a comprehensive four-day registration audit by DNV. After correction and closure of all non-conformances, Fralock received its ISO 13485 certificate of registration on February 28, 2013.
The certification of compliance with ISO 13485 recognizes that the policies, practices and procedures of our firm ensure consistent quality in the services and work product we provide our customers. With this certification, our clients can be confident that Fralock is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed customer satisfaction.
Fralock is certified as meeting the requirements of ISO 13485 for the following activities
1. SALES, APPLICATION ENGINEERING, PRODUCTION AND DISTRIBUTION OF ELASTOMERS, THIN FILMS, FOAMS, FOILS AND ADHESIVES WHICH ARE LAMINATED, CONVERTED OR PRINTED TO MEET CUSTOMER APPLICATIONS IN THE MEDICAL MARKET.
To maintain our certification, DNV will perform annual audits to ensure compliance and to assess initiatives for continued improvement. Our customers can be confident that Fralock will continue to provide the high quality services they have come to expect well into the future.
We believe that our decision to become ISO 13485 Certified is a proactive one that not only anticipates the demands of our customers, but also demonstrates our commitment to providing quality services to all our customers in the medical industry.