Quality Management System

ARKRAY USA implements a Quality Management System and Quality Policy that aligns with the purpose of our global organization as communicated through ARKRAY’s Group Mission and Vision statements.

ARKRAY Group Mission

ARKRAY’s mission is to contribute to the health and well-being of people all over the world through the advancement of science and discovery of new technologies

ARKRAY Group Vision

ARKRAY’s vision is to positively influence society through sound, legitimate business practices

We are committed to understanding US customer and regulatory requirements and providing products, services and expertise to meet those requirements.  We accomplish this by:

  • Developing strong relationships with our suppliers, distributors and customers, and
  • Establishing a quality system compliant with ISO 13485:2016 and 21 CFR Part 820 that includes processes, procedures, operations and resources needed to support the business.

Our Quality Policy reflects our commitment to quality and ARKRAY’s Group Mission and Vision statements.

ARKRAY Quality Policy

ARKRAY is committed to providing quality products and services that meet customer and regulatory requirements.  We establish quality objectives throughout the organization to ensure continued suitability, adequacy and effectiveness of the Quality Management System.

A copy or our ISO 13485:2016 can be found here.