The Lee Company Electro-Fluidic Systems Division Quality Policy demonstrates our commitment to the highest standards of product quality and reliability as well as continuous improvements of our product and Quality Management system.
Our quality ethic is deployed throughout the organization to continually improve our products, services and methods. We do this to exceed customer expectations, and to deliver a quality, on time product. Through our management system, we are committed to upholding the high standards of quality as well as the safety, education, and well being of our employees and our environment.
The Quality Assurance System is registered to ISO 9001. Our Quality Management System complies with the following specifications:
ANSI/ISO/ ASQ Q9001
Quality Management Systems – Requirements
Guidelines for Auditing Management Systems
Requirements for Measurement Processes and Measuring Equipment
IPC-610 & 620
Acceptability of Electrical Assemblies
Zero Acceptance Number Sampling Plan, C = 0, ASQC Quality Press
Sampling Procedures and Tables for Inspection By Attributes
Our Quality Management System also complies with elements of the following specifications:
Medical Devices: Quality Management Systems, Requirements for Regulatory Purposes
FDA’s 21 CFR Part 820 QSRs
FDA Quality System Regulation; Medical Devices; Current Good Manufacturing Practice (CGMP)
General Requirements for Competence of Testing and Calibration Laboratories.
Quality Assurance surveys or audits by our customers are welcomed. Source inspection is permitted at The Lee Company in Essex, Connecticut, where most manufacturing is performed.