Quality Policy and Objectives
At HemoCue®, Quality truly matters. Quality - in how we work, what we do and in how our products perform in the hands of our customers, is indeed important to us. This is reflected both in our Quality Policy and in our Quality Objectives. We feel these important commitments should be known not only internally but among our customers and partners, and have therefore chosen to publish them also here, on our website.
Quality Assurance & Regulatory Compliance
HemoCue® develops, manufactures, markets and sells In Vitro Diagnostic medical devices (IVD). All devices are CE-marked according to the EU In Vitro Diagnostic medical device directive, 98/79/EC.
As a step in the CE-marking process, HemoCue® has selected to implement a Quality Management System according to the standard EN ISO 13485:2003. EN ISO 13485:2003 is a well recognized and established standard for Quality Management Systems. The HemoCue® Quality Management System is also in compliance with FDA's Quality System Regulations (21 CFR Part 820).
Implementing a Quality Management System means implementing specific ways of working to ensure that the products and services we offer are consistent and meets the customers' requirements.
The HemoCue® Quality Management System is inspected for its compliance with EN ISO 13485:2003 on a yearly basis by the Notified Body TÜV.
The Quality and Regulatory Management (QRM) department at HemoCue® is responsible for continuously maintaining, monitoring and improving the Quality Management System and for ensuring the organisation's compliance with other applicable national laws, regulations and standards.
Furthermore QRM is responsible for the the implementation of an Environmental Management system for HemoCue®.
Examples of Regulatory Requirements HemoCue® Complies with
Examples of Regulatory Requirements HemoCue® Complies with
- Directive 98/79 EC on In Vitro Diagnostic medical devices
- Medical Device User Fee and Modernization Act (MDUFMA)
- WEEE - Waste Electrical and Electronic Equipment (2002/96/EC)
- RoHS - Restriction of the use of certain Hazardous substances in electrical and electronic equipment (2002/95/EC)
- REACH - Registration, Evaluation, Authorisation and Restriction of chemicals
ISO 9001:2008 is an internationally recognized quality management system standard developed by the International Organization for Standardization. HemoCue® AB has a quality management system for ensuring customer satisfaction by consistently meeting customer requirements. The ISO 9001:2008 provides HemoCue® AB with a set of tools for determining customer needs and expectations, establishing goals and targets for meeting those expectations, evaluating how well those goals and targets are being achieved, and continual improvements.
The ISO 13485 standard is based on the ISO 9001 standard, but specifically intended to cover medical devices.
This International 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems.
More Information
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