Quality Policy and Objectives

Quality Policy – Mission and Vision Statements

ISO 13485:2003 Certified

SQI Diagnostics Systems’ primary quality goal is to operate an ISO 13485:2003 Quality Management System that will fulfill relevant regulatory requirements in multiple regulatory jurisdictions so that we are able to provide products that completely meet customer safety and effectiveness requirements.
It is SQI Diagnostics Systems Quality Policy to provide high quality, safe, effective and trusted diagnostic products.
SQI Diagnostics Systems shall fulfill the needs and expectations of our customers by adhering to a sustainable and continuously reviewed and improved Quality Management System.
SQI Diagnostics Systems shall always guarantee full traceability of its diagnostic products for its customers.
Each individual at SQI Diagnostics Systems shall be trained to ensure they can fulfill their responsibilities and that they are able to execute their work in a professional manner, in accordance with established and clearly documented quality procedures.

Quality Objectives

SQI Diagnostics Systems is dedicated to our customers' ultimate success and is committed to the continuous improvement of our processes, products and services to deliver solutions of the highest value thereby providing a competitive advantage to our customers through achieving the following seven strategic objectives philosophies:

Permit the development and growth of new products within a documented and controlled design and development environment.
New product submissions to appropriate regulatory bodies have a predictable response from submission to approval timing.
Predictable and repeatable supply of quality approved products to our customers.
Controlled and documented performance of vendor supplied components.
Prompt, timely and measurable corrective and preventive actions (CAPA) to reported non-conformances.
Reduce and eliminate non-conforming product.
Ultimately, building customer trust and confidence in our products.