Skill Profile
Quality Control & Assurance
"The observable action of implementing and monitoring quality control procedures in a laboratory or clinical setting — running internal quality controls, participating in external quality assessment schemes, investigating out-of-range results, and maintaining accreditation standards — to ensure that test results are accurate, reliable, and fit for clinical use."
YOUR SKILLS
Problems This Skill Solves
- Inaccurate test results used for clinical decision-making because quality controls were not run or interpreted correctly — systematic internal quality control (IQC) running at defined intervals detects instrument drift, reagent failure, and calibration problems before patient results are affected.
- Results that vary between laboratories and between runs — participation in external quality assessment (EQA) schemes benchmarks the laboratory's performance against peers and identifies systematic bias that IQC alone cannot detect.
- Laboratory accreditation loss because quality system documentation is incomplete or non-compliant — maintaining ISO 15189-compliant quality documentation ensures the laboratory can demonstrate its quality system to UKAS assessors.
- Clinicians making poor decisions because they do not understand the analytical limitations of laboratory tests — communicating measurement uncertainty, reference intervals, and interferences to clinical users prevents misinterpretation of laboratory data.
Tools Used
Roles That Use This Skill
1 total · 1 industryThis skill is concentrated in one industry.
Biomedical Science / NHS Pathology / Biotech
"If the IQC passes, the patient results must be correct."
Internal QC detects random and systematic analytical errors within the run being monitored, but it cannot detect all sources of pre-analytical error (sample haemolysis, lipemia, incorrect collection tube, sample mix-up), post-analytical errors (transcription, reference interval mismatch), or rare calibration failures that affect patient and QC material differently. Quality assurance requires a holistic approach covering all three phases of the testing process — pre-analytical, analytical, and post-analytical — not just IQC on the analyser.
Research & Outlook
Point-of-care testing (POCT) is expanding the use of laboratory diagnostics outside the accredited laboratory setting — into GP surgeries, urgent care centres, and ambulances — creating new quality assurance challenges for ensuring POCT devices perform to the same accuracy standards as laboratory analysers. Digital QC and real-time QC monitoring platforms are enabling laboratory managers to monitor QC performance across multiple analysers and sites from a centralised dashboard. ISO 15189:2022 has expanded its scope to include POCT and brought in stronger requirements for measurement uncertainty and pre-analytical quality.
See This Skill In Action
Watch a professional demonstrate Quality Control & Assurance in a real working environment — what it looks like, how it's applied, and why it matters.
Healthcare / Laboratory Science
Quality Control & Assurance
Also Known As
Growth Path
Runs internal quality control materials at defined intervals and interprets the results against acceptance criteria. Recognises out-of-control situations and follows the documented investigation procedure. Records QC results in the LIMS and reports problems to the supervisor.
Manages the IQC programme for a defined laboratory section — setting target values and ranges, investigating systematic QC failures, and maintaining QC records. Participates in EQA schemes, investigates outlying EQA results, and reports to the quality manager. Maintains ISO 15189 quality documentation for a defined scope of testing.
Leads the laboratory quality system — designing IQC and EQA programmes, maintaining ISO 15189 accreditation, managing non-conformances and corrective actions, and preparing for UKAS assessment. Contributes to method verification and validation studies. Trains laboratory staff in quality system requirements. Serves on NEQAS or professional quality working groups.
How to Practise
- 1.Set up and interpret a Levey-Jennings chart for a laboratory analyte — plot daily IQC results, apply Westgard rules, identify out-of-control situations, and practise the investigation and corrective action process.
- 2.Complete an EQA programme exercise — analyse the provided samples, review your results against the consensus, and investigate any results that fall outside the acceptable limits.
- 3.Write a standard operating procedure for an analytical test — include the IQC requirements, acceptance criteria, actions to take for failed QC, and the reference interval for the analyte.
- 4.Study an ISO 15189 laboratory accreditation report — identify the types of non-conformances raised and what corrective actions the laboratory was required to implement.
How to Prove
- ·IBMS (Institute of Biomedical Science) membership — the professional body for biomedical scientists, with quality assurance as a core competency.
- ·HCPC registration as a Biomedical Scientist — the regulated professional registration for laboratory practice in the UK.
- ·ISO 15189 or UKAS accreditation maintenance record — demonstrating personal contribution to maintaining a laboratory's accredited status.
- ·Quality manager role — direct evidence of responsibility for the laboratory quality system.