Popular:Internal Quality ControlPerformance Verification
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Make accreditation
the start of quality.

End-to-end accreditation consulting

  1. 01
    Quality-management-system trainingStandard interpretation and system implementation
  2. 02
    On-site assessment and programme planningCurrent-state diagnosis and accreditation path
  3. 03
    System-document developmentDocument development and operational guidance
  4. 04
    Internal management-review supportFocused internal audit and assessment support
  5. 05
    Application submission and pre-assessmentDocument drafting and pre-assessment
  6. 06
    On-site assessment and corrective-action guidanceNonconformity close-out

Laboratory quality assessment and improvement

CONTINUOUS LOOPTurn improvement into a daily mechanism
QUALITY SYSTEMQuality improvement
Loop
01Risk assessmentFive-dimension diagnosis
02Specialist reportOptimisation plan
03ImplementationContinuous iteration

Diagnosis, planning and implementation form one loop, so every improvement can be reviewed, verified and sustained.

Five-dimension risk assessment

Identify risks
  1. 01Laboratory infrastructureSite, workflow, equipment and environment
  2. 02Personnel competenceRole competence and training status
  3. 03Testing capabilityTest menu and method capability
  4. 04QC statusInternal QC, EQA and bias
  5. 05LIS suitabilitySystem support, traceability and workflow alignment

Specialist optimisation report

  1. QC improvement planDiagnostic report
    Assess people, equipment, materials, methods and environment
Implementation and continuous iteration
  1. Plan implementationDefine tasks and responsibilities
  2. Training and coachingCapability building and standards implementation
  3. Follow-up reviewEffectiveness evaluation and issue closure
  4. Continuous optimisationIterative improvement and ongoing enhancement

Performance-evaluation plan

Baseline information

  1. 01Calibrated-instrument listMapped test menu
  2. 02Accreditation-scope listEnsure compliance
  3. 03Instructions for useDefine technical requirements
  4. 04Samples and quality controlsEnsure sample representativeness
  5. 05Performance-evaluation recordsTrace the evaluation process
Performance-evaluation plan
Confirm
Standard

Performance evaluation (standard methods)

  1. CorrelationEPF-1A related methods, standards and method performance
  2. TruenessCMA5-GL007 and national standards
  3. Reference intervalEPF1-9 clinical reference interval (analytical system)
  4. Reportable rangeAnalytical range and reporting range
  5. Linear rangeVerify at a minimum of four concentration levels
Non-standard

Performance verification (non-standard methods)

  1. CorrelationDefine comparability and the evaluation strategy
  2. TruenessMethod-bias confirmation
  3. Linear rangeCover multiple concentration levels
  4. Reference intervalEstablish or verify the reference interval
  5. StabilityDifferent storage conditions and durations
  6. SpecificityCross-reactivity or interference testing
  7. Carry-overHigh-dose hook effect and low-level blank samples
  8. OtherExpected performance and overall data performance
Value of the planEnsure the evaluation is scientifically sound and accurateImprove the reliability of product performanceSupport continuous product improvement

ISO 15189 quality-management system

Personnel and competence management

Clear role responsibilities, personnel training, competence assessment and a mechanism for ongoing improvement.

Equipment and environment management

Controlled management of equipment status, calibration and maintenance, laboratory environment and operating conditions.

Total testing-process control

Covers the pre-analytical, analytical and post-analytical process to keep results accurate and consistent.

Quality evaluation and result review

Internal QC, external assessment and result review keep quality stable.

Document and information management

Controlled documents, records and information traceability keep the workflow clear and auditable.

Continuous improvement and risk control

Deviations, risks and feedback feed a closed loop of quality improvement.

  1. Pre-analyticalSample receipt and preparation
  2. AnalyticalTesting and quality control
  3. Post-analyticalResult recording and review
  4. Result reviewAccuracy and traceability
  5. Quality evaluationQuality assessment and monitoring
  6. Continuous improvementImprovement and optimisation