UK Freephone Orders
0800 387732
9am to 5pm Mon-Fri
International Orders
+44 2380 487209
Select Your Country

ISO 15189 Support

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 the new 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 Manual

Alpha Laboratories can provide help and support through its products and services, for laboratories implementing 
ISO 15189.


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.

 

3rd 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:

 

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 notenumerate 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:
 
 

Frozen Plasma Products Improve Quality

The PrecisionBiologic 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:
 

Contact Us for more advice on products that can help support ISO 15189 Accreditation

Download the ISO 15189 Brochure