Quality and certificates
Quality – in how we work, what we do and 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.
HemoCue
Quality Policy
HemoCue is committed to being a global leader in the professional point-of-care testing market with products and services of high quality. We will accomplish this by the following Top Management Commitments.
- Compliance with applicable national laws, regulations and standards
- Securing a professional relationship with our customers through effective two-way communication
- Securing sufficient resources and efficient processes
- Maintaining, monitoring and improving the Quality Management System
- A decision-making process that is built on well-founded data and relevant trend analysis
- Securing suitability and an appropriate number of supplier
AAA Rating
Only limited liability companies can hold the AAA (triple A) rating. Furthermore, the company must have been trading for at least ten years, have a turnover exceeding SEK 2 million, and be able to show financial ratios well in excess of the industry average.
ISO 13485
ISO 13485 Medical Devices Quality Management Systems
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.
ISO 14001
ISO 14001 Environmental Management
The HemoCue environmental activities will be guided by commitment to and strive for continuous improvement. We will comply with applicable legal requirements and other applicable environmental requirements. We will also work to prevent pollution. HemoCue will consider interested parties environmental requirements and provide relevant and appropriate environmental information about our products and processes to support their environmental work.
The environmental impact from HemCue products starts with the shipment of raw material to production and continues through the products’ entire lifecycle. Our main objective is therefore to develop processes and products with consideration to the environment.
This involves:
- choosing raw material with care to minimize the environmental impact
- economizing with raw material and minimizing waste
- choosing our suppliers with care to minimize our indirect environmental impact HemoCue will also take responsibility for the environment by:
- managing waste responsibly according to applicable requirements
- striving to use environmental friendly products
- educating and make employees take active interest in environmental issues.
MDSAP
Medical Device Single Audit Program
A single regulatory audit of a medical device manufacturer´s quality management system (QMS) to satisfy the needs of MDSAP participating regulatory authorities. Audits are performed by authorized third party auditing organizations. MDSAP Audit is based on requirements in ISO 13485 and additional regulatory requirements applicable to AU, BR, CA, JP and US.