Rudas Lab - Clinical Laboratory - Χημείο Ρούδα

Quality Management

     Our Laboratory is awarded by the International Organization for Standardization through the Cyprus Organization for the Promotion of Quality (CYS) with the Accreditation EN ISO 15189:2007 (Document No …… ). Accreditation with EN ISO 15189:2007 is the Quality International Standard that provides the requirements for Quality and Competence of Clinical Laboratories. This means that our Laboratory strictly follows all provisions, requirements and guidelines that these organizations demand from a Laboratory in order to certify its competence. ÂÂ

The EN ISO 15189:2007 certifies that our Laboratory operates fully in accordance with the requirements scheme of International Quality System. Some of there are:

Management Requirements

• Quality Management System
  
• External Services and Supplies
  
• Advisory Services
  
• Resolution of Complains
  
• Continual Improvement
  
• Internal Audits

Technical Requirements

• Personnel
  
• Laboratory Equipment
  
• Assuring Quality of Examination Procedures
  
• Reporting of ResultsÂÂ

A large number of tests of our Laboratory are accredited under the EN ISO 15189:2007, covering all specialties of a modern Clinical Laboratory:ÂÂ

• Immunofluorescence IFA tests: ANA (Hep2 Cells) Auto-antibodies, Microbiology tests
  
• HPLC (High Performance Liquid Chromatography): HbA₂ (β-Thalassaemia marker), HbS (Sickle Cell anemia marker), HbF (Fetal Haemoglobinopathy marker), HbA_1c (Diabetes marker)
• Immunology (Tumour Markers, Hormones, Anaemia Markers)
  
• Virology
  
• Biochemistry
  
• Haematology    ÂÂ

Quality Control

Our Laboratory follows rigorously the comprehensive Internal and External Quality Control Programs mandatory required by the ISO System:

Internal Quality Control Program

• Levey-Jennings Diagram Analysis
  
• Youden Bi Dimensional Analysis
  
• Westgard Quality Assessment Criteria (Six Criteria)

External Quality Control Program

• UK NEQAS Immunofluorescence, ELISA, Western Blot: ANA Hep2 Cells, dsDNA, ENA, HAV
  
• GR ESEAP Biochemistry
  
• UK NEQAS Haematology FBC, Differential Leucocytes Count
  
• GR ESEAP HPLC, HbA_1c
  
• UK RIQAS Chemiluminiscence Hormones, Tumour markers, Therapeutic Drugs Monitoring
  
• UK NEQAS Virology
• UK NEQAS HPLC HbA₂ (β-Thalassaemia), HbS (Sickle Cell Anaemia), HbF (Fetal Anaemia)ÂÂ