At EFB Power, we adhere to the highest standards that ensure the best in quality and reliability, including the following:
- ISO9001:2008 certified
- ISO13485:2003 (pending)
- Corrective / preventive action processes
- Product / process qualifications
- UL compliance
- Lean and six sigma processes
- Product serialization with traceability to specific manufacturing day, line and cell lot
- Highly skilled and seasoned production personnel with extensive experience in the design of medical batteries and chargers for the healthcare industry
- A robust supply chain that includes qualified cell manufacturers who are approved for use in critical battery pack designs
- Process Failure Mode and Effect Analysis (PFMEA) of the manufacturing process
- Design Failure Mode and Effect Analysis (DFMEA)
- Identification and traceability is established by the manufacturing order and is maintained for each product order, recording, assembly, inspection, and test steps enabling Electrochem to track and pinpoint the affected product (unfinished or finished product) within and outside our manufacturing facility
- Built in quality with next step inspection, final production tests & sign-offs on each production run -Generation and maintenance of Design History Files (DHF), and Device History Records (DHR). DHFs include any records which describe the design history of a device — design review notes, verification plan and results, validation plan and results, FMEA results. DHRs include documentation affiliated with production — test reports, test data, signed build documents, Certificate of Compliance (CoC), and quality assurance checklist.
Our Quality Policy:
"To fully understand and to exceed our customers’ expectations by continually improving our QMS."