Kvalitet og certificeringer
Kvalitet – i måden vi arbejder på, i det vi gør, og i hvordan vores produkter fungerer i hænderne på vores kunder – er afgørende for os. Det afspejles både i vores kvalitetspolitik og i vores kvalitetsmål. Vi mener, at disse vigtige forpligtelser ikke kun bør være kendt internt, men også blandt vores kunder og partnere.
HemoCue
kvalitetspolitik
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
Kun aktieselskaber kan opnå AAA-rating (triple A). Derudover skal virksomheden have været i drift i mindst ti år, have en omsætning på over 2 millioner SEK og kunne fremvise nøgletal, der ligger væsentligt over branchens gennemsnit.
ISO 13485
ISO 13485 Kvalitetsledelsessystemer for medicinsk udstyr
Denne internationale standard fastlægger kravene til et kvalitetsledelsessystem, hvor en organisation skal kunne dokumentere sin evne til at levere medicinsk udstyr og relaterede ydelser, der konsekvent opfylder kundekrav samt gældende regulatoriske krav for medicinsk udstyr og relaterede ydelser.
Standardens primære formål er at understøtte harmoniserede regulatoriske krav til kvalitetsledelsessystemer for medicinsk udstyr.
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
En samlet regulatorisk audit af en producent af medicinsk udstyrs kvalitetsledelsessystem (QMS), der opfylder kravene fra de regulatoriske myndigheder, som deltager i MDSAP. Audits udføres af godkendte tredjeparts revisionsorganisationer. MDSAP-auditten er baseret på kravene i ISO 13485 samt yderligere regulatoriske krav, der gælder for AU, BR, CA, JP og US.