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Quality Statement
It is the intent of
Endure Medical for the end user to be completely satisfied and
ready to do more business with our company. We are committed to:
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Meeting customer and regulatory requirements;
·
Satisfying our customers;
·
Maintaining the effectiveness of our QMS and,
·
Continually improving the processes of our QMS.
Quality
Certificates
Our Quality Management
System adheres to the following requirements and legal
regulations, and international quality standards:
ISO 9001:2000
specifies requirements for a quality
management system where an organization needs to demonstrate its
ability to consistently provide product that meets customer and
applicable regulatory requirements, 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
regulatory requirements.
ISO 13485:2003
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 requirements and
regulatory requirements applicable to medical devices and
related services. The primary objective of ISO 13485:2003 is to
facilitate harmonized medical device regulatory requirements for
quality management systems.
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