ISO 9001:2008/ISO 13485:2003:
As part of our commitment in providing top quality products and services, Brenner Fiedler has both ISO 9001:2008 and ISO 13485:2003 certifications. Our ISO 9001 certificate provides the framework for much of what we do. A Quality Management System has been implemented, and is evaluated quarterly by our Quality Review Board and Senior Management group to ensure it is functioning properly and remaining consistent with the company objectives. We regularly review NCRs (non-conformance reports), SCARs (supplier corrective action requests) and various performance measures to ensure that appropriate responses to non-conformance reports and any performance shortfalls are effectively implemented. This system/certification has been in place since October 1, 2009.
In addition to our 9001:2008 Quality System, Brenner Fiedler has recently received a 13485:2003 Certification. The ISO 13485 standard, officially named EN ISO 13485:2003, is used in the design, development and production process for medical devices but also related services. Though replicating the format of our ISO 9001, ISO 13485 switches the focus from customer satisfaction and continual improvement to standardization of regulatory requirements for medical device manufacturers. Brenner Fiedler has been ISO 13485:2003 certified since October 23, 2015.
View a copy of our ISO 9001:2008 & ISO 13485:2003 Certificates using below links.
Brenner Fiedler is committed to providing our customers with top quality products and top quality services. As part of our commitment we have become a Panel Shop with capabilities to meet UL508A standards covering PLC, Process Control, Pneumatic, VFD, and Motor Starters. Our UL 508A certified panel shop maintains the most rigorous quality processes and standards, so you can be sure your panel will be made right. Our UL 508A knowledge and experience provides the inspection authority and our customer’s evidence that the control panel complies with nationally recognized safety standards. These standards ensure public safety and provide assurances that the electrical control panel is compliant with national and local electrical codes. The certification also ensures that all individual components within the panel meet those same standards individually. We can build your panels to print using the relays, power supplies, and other components you already purchase from us.
In addition to our certifications, we also design according to the IEC 60601-1 standard requirements. IEC 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment. Many of today's products appear simple; yet embed sophisticated circuits and software that are invisible to the user. By using IEC 60601-1 standard we are able to manage this reality by becoming intimately involved in the product-development process and going beyond performance test and verification. Using these standards hand in hand with our certifications enables us to provide our customers with the uttermost top quality products and services.