ISO 15189 Made Easier
Helping You to Meet the 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 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:
- 220.127.116.11 equipment calibration and metrological traceability
- 18.104.22.168 reagents and consumables acceptance testing
- 22.214.171.124 verification of examination procedures
- 126.96.36.199 validation of examination procedures
- 188.8.131.52 measurement uncertainty of measured values
- 184.108.40.206 Quality control materials
Alpha Laboratories can provide help and support through its products and services, for laboratories implementing
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:
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:
Follow the Patient Pathway
Frozen Plasma Products Improve Quality
- Ready-to-use buffered, frozen product:
consistent vial to vial
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no pipetting inaccuracy risks
- Every lot has an assay certificate - fully traceable
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Contact Us for more advice on products that can help support ISO 15189 Accreditation