Quality Assurance

Biomerics facilities are ISO 13485:2003 and ISO 9001:2008 registered and utilize a variety of quality tools and control systems to ensure we meet our customers' quality needs and finished product specifications. From incoming raw material inspection to finished product validation testing, Biomerics' quality personnel and ERP system control all aspects of the production process.

Our process of quality assurance starts with the design of the product and production system. Our engineers collaborate with our customers' and make recommendations on materials, tools or design modifications to improve product manufacturability. Our suppliers and partners are all carefully qualified and audited to the highest standards. At Biomerics we understand that a carefully constructed process should be methodically validated, audited, and improved. That’s why we utilize advanced technologies such as automated vision systems and digital scales throughout each production run to ensure the highest quality product.

Biomerics utilizes the following processes and tools to ensure quality performance:

Problem Solving Tools	Six Sigma Problem Solving Tools (DMAIC, 8D) Lean Manufacturing Tools (5S, SMED, 7 Wastes) Value Stream Mapping/Work Flow Diagrams/Process Mapping Visual Management Systems (VFM) 5 Why's, Ishikawa Diagrams Root Cause Analysis
Product and Process Validation Tools	Standard Work Documentation DFMEA / PFMEA Control Plans/Charts First Article Layouts and Approvals Process Capability Studies (CpK) Real-time Monitoring Systems IQ, OQ, PQ Validations Lab testing for Analysis and Compliance Risk Analysis and Risk Assessment
Operational Quality Tools	Preventative Maintenance Program Mold Maintenance Program Clean Room Process Calibration Program Risk Assessment Studies Regular Internal Audits