MISSION STATEMENT

Straits contract manufactures medical devices for our customers with dependable lead time and delivery; without compromising our high quality that our customers have come to expect from us; and at a cost to customers that taken together will make it easy for our customer to do business with us, and be mutually profitable in the course of doing it.

QUALITY POLICY

ISO 13485:2003; US FDA 21 CFR Pt 820, ISO 9001:2008, Japan MHLW Ordinance no. 169 and Korea GMP demand that the Straits Quality Management System addresses, comprises, and complies with the requirements set forth in the said Regulations and the said Standards. Without these commitments and actions, Straits cannot demonstrate that it is able to consistently manufacture safe and effective medical devices.

Therefore, it is the Quality Policy of Straits that Straits shall continuously take every action and undertake every activity that will enable Straits to:
• fully comply with customer, the said Regulations and the said Standards requirement; and
• continually improve the effectiveness of our Quality Management System

In accordance with the requirements set forth in the said Regulations and the said Standards.

QUALITY OBJECTIVES

Maximizing customer satisfaction is Straits’ primary objective. Straits Quality Objectives are as below:

• 100% Quality delivered to the customer
• 85% On-time delivery to the customer