Sterling focuses on and is a specialist in the medical industry. We understand the critical nature of the components and devices that we produce and the strict, regulatory environment in which they are designed manufactured and used. Quality is the key to success, and it is as important to us as it is to our customers.

The cost of poor quality can be significant in terms of time, dollars and credibility. We have implemented robust, repeatable practices and procedures that ensure the highest levels of quality for our customers and their products.

Some of the key procedures and activities that we employ are:

  • Adherence and compliance to ISO 13485, QSR, C-TPAT and ISO 9001
  • Continuous training and procedural improvement of all our staff to consistently reinforce our Total Quality Environment (TQE)
  • Continuous Improvement (CI) initiatives in every facet of our organization
  • A team of Quality Engineers and Quality Inspectors involved at every step throughout the manufacturing life-cycle
  • Implementation of new products through the First Article (FA) process or Production Part Approval Process (PPAP)
  • Complete certification of all equipment through Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
  • Integrated ERP system for production and change control management
  • Complete control plans based on Statistical Process Control (SPC)

 

Coming Soon: ISO 13485 and CFR 820 compliance