The Importance of System Integration Certification

Contec is committed to providing quality products and services to meet the needs of our Customers. To do so, we have cultivated a customer-centric corporate culture which is supported by a strong quality management system, process control, and continual improvement. By adhering to ISO (International Organization for Standardization) standards we are able to demonstrate this dedication to our customers and hold ourselves accountable to the highest standards of excellence. Contec currently holds the following certifications:

ISO 9001:2015

The ISO 9000 family of standards provide guidance and tools to ensure an organization’s products and services consistently meet customer requirements and that quality is consistently approved. ISO 9001:2015 certification focuses on an organization’s quality management system and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. Contec has maintained ISO 9001 certification since 2004.

ISO 13485:2016

ISO 13485:2016 specifies the requirements for a comprehensive quality management system for the design and manufacture of medical devices. The primary objective of ISO 13485:2016 is to facilitate a company’s ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements. Contec has maintained ISO 13485 certification since 2006.

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