Quality Assurance

(1) Quality assurance systems of laboratories. Quality assurance systems of testing and calibration laboratories: (i) Good Laboratory Practice (GLP), (ii) ISO/IEC/MSZ 17025/2005 standard for accreditation. General requirements and application sectors.

Accreditation under ISO/IEC/MSZ 17025/2005 standard:

Management requirements_1: Characterization of the organization. Staff requirements, academic qualification, work experience, key posts within the laboratory. Quality manager. Development and documentation of the quality assurance system of the laboratory. Quality Manual. Document control, approval and issue. Document changes.

Management requirements_2: Review of requests, tenders and contracts. Subcontraction. Purchasing of services and supplies. Service to client. Complains. Control of non-conforming work. Improvement, cause analysis, corrective actions. Internal audits and management reviews.

Technical requirements_1: General technical requirements. Personnel: staff requirements, documentation of the staff, academic qualification, work experience, competencies, authorities, supervision, training of the staff, on-the-job training, documentation of the trainings. Accommodation and environmental conditions, special needs. Equipments. Equipment categories: (i) general service equipment, (ii) volumetric equipment, (iii) complex instruments of testing and calibration laboratories, (iv) etalons, standards, reference materials, (v) computers and programs. Documentation, maintenance and calibration of equipments. Traceability of measurements.

Technical requirements_2: Sampling. Handling of test or calibration items: transport, storage, identification, disposal. Labeling and documentation of samples. Reporting the results. Test reports and calibration certificates. Test reports of test laboratories. Opinions and interpretations.

Technical requirements_3: Test and calibration methods. Documentation of the test and calibration methods used. Method validation.

Technical requirements_4: Quality control of test and calibration results. Internal quality control. Use of reference materials or certified reference materials. Comparison with independent method. Recovery studies. Proficiency testing. Inter laboratory tests.

(2) Validation of analytical methods. Cycles of method development and method validation. The three main documents of method validation: (i) detailed documentation of analytical method, (ii) validation plan (protocol) and (iii) validation report. Functional and content requirements of the documents. System suitability and method suitability. Method performance characteristics, analytical parameters.

Definition and determination of identity. Selectivity terms and definitions. Effects of interferences. Assessment of selectivity.

Limit of detection and limit of quantitation. Terms and definitions. Method based on the determination of the standard deviation at low levels. Estimating LOD and LOQ. Alternative procedures. Capability of detection for qualitative analysis.

Working range. Definition, considerations for the validation study. Method and instrument working range. Assessing instrument and method working range. Linearity. Application of linear and nonlinear calibration functions. Analytical sensitivity.

Trueness. Terminology to describe measurement quality. Determination and interpretation of bias. Precision, repeatability and reproducibility. Replication, precision conditions. Measurement uncertainty.

Ruggedness (robustness). Definitions. Definition. Ruggedness test using experimental design methods.