The Lee Company Quality Policy ensures our ability to comply with the Quality Management System Standard requirements.
Through our management system, we strive to uphold high standards of quality, on-time delivery, and exemplary service. This supports our strategic direction and better satisfies the needs and expectations of all our interested parties.
Our culture and commitment is to continually improve our products, processes, and services. We are committed to upholding these standards for all our interested parties as well as the safety, education, and wellbeing 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.