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: equipment calibration and metrological traceability

  • reagents and consumables acceptance testing

  • verification of examination procedures

  • validation of examination procedures

  • measurement uncertainty of measured values

  • 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 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

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,

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