Certifications

The Sandvik wire facility in Palm Coast, Florida where EXERA™ products are manufactured, holds the following certifications:

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ISO 13485

This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements for medical devices and related services.

ISO 13485 certificate (PDF document, 898 kB)

ISO 9001

This standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements. It also aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

ISO 9001 certificate (PDF document, 872 kB)

ISO 14001, OHSAS 18001

ISO 14001 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. It is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

OHSAS 18001 is an international occupational health and safety management system specification and was created via a concerted effort from a number of the world's leading national standards bodies, certification bodies, and specialist consultancies.

ISO 14001_OHSAS 18001_15 October 2018.pdf (PDF document, 257 kB)