Products and Services to Support Your ISO 15189 Accreditation
Helping You to Meet the Quality Standard
Medical Laboratory Accreditation
The NHS and private practices rely heavily on the quality of diagnostic testing provided by Medical Laboratory Services and Pathology Laboratories. The provision of accurate and consistent testing, result validation, interpretation and reporting is essential for patient assessment and directed care.
Today’s busy medical laboratories should be aiming to validate their test methodology according to criteria outlined in the ISO 15189 Quality Management System guidelines. Adopting ISO 15189 standards will increase confidence in the results produced by eliminating, wherever possible, any causes of variability in test protocols.
Specific focus should be on those sections relating to method validation, system calibration, internal quality assurance and
result consistency:188.8.131.52 equipment calibration and metrological traceability
184.108.40.206 reagents and consumables acceptance testing
220.127.116.11 verification of examination procedures
18.104.22.168 validation of examination procedures
22.214.171.124 measurement uncertainty of measured values
126.96.36.199 Quality control materials
ISO 15189 Made Easier
How can Alpha Laboratories provide help and support,
for laboratories implementing ISO 15189 Quality Standards?
Third Party Controls
Alpha Laboratories’ diverse range of multi-constituent controls provide verified 3rd party Quality Controls that can help support your laboratory’s compliance with the latest ISO 15189 quality management guidelines.
Controls can be ordered direct or alternatively, added to your Managed Service Contract.
Follow the Patient Pathway
Control materials that follow the patient pathway can assist with ISO 15189 compliance by providing greater confidence in test system results, over controls that use artificial materials, or that do not enumerate accurately over a number of parameters.
Streck controls contain true cellular material that undergoes the same procedural conditions as a patient sample.
Available for numerous analytes each control provides at least two clinically relevant ranges:
Haematology controls, Cellular urine control for automated microscopy, Flow cytometry controls
Frozen Plasma Products
The Precision Biologic CRYOcheck™ frozen plasma range can enhance your quality procedures compared to traditional lyophilised plasma controls.
Ready-to-use buffered, frozen product:
consistent vial to vial
Prevents reconstitution errors:
no pipetting inaccuracy risks
Every lot has an assay certificate - fully traceable
Saves time, ready to use in just 5 minutes