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:5.3.1.4 equipment calibration and metrological traceability
5.3.2.3 reagents and consumables acceptance testing
5.5.1.2 verification of examination procedures
5.5.1.3 validation of examination procedures
5.5.1.4 measurement uncertainty of measured values
5.6.2.2 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.
Controls are available for: Clinical Chemistry, Haematology and Flow Cytometry
Cellular Controls
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
Improved Quality
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 vialPrevents reconstitution errors:
no pipetting inaccuracy risksEvery lot has an assay certificate - fully traceable
Saves time, ready to use in just 5 minutes
Read more about the frozen plasma range: Normal Pooled Plasma, Reference Plasma, Factor Deficient Plasma
Equipment Calibration and Validation Services
The guidelines specify the requirement for instrument calibration and testing regimes for all pieces of equipment that may have a significant impact on results. We can help with:
Choose Your Controls
Haematology Controls
Streck's proprietary cell stabilization technology creates dependable controls with exceptional physical similarity to actual patient samples.
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Flow Cytometry Controls
A comprehensive line of positive procedural controls for immunophenotyping by flow cytometry.
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Clinical Chemistry Controls
Verified controls must be used to monitor the precision of chemistry assays and instruments,
Read MoreFor more advice on products and services that can help support your ISO 15189 Accreditation
