Quality Management (QM) documents have been developed for application within the General European OMCL Network. They are available to download below. They are recognised by the European co-operation for Accreditation (EA).
Introduction
Guidelines
- Sub-Contracting of Tests
- REVISED Validation/Verification of Analytical Procedures
- NEW Evaluation of Measurement Uncertainty – Core Document
- Evaluation of MU - Annex 1: Bottom-up approach – Annex 1.1. Estimation of the measurement uncertainty of concentration of solutions prepared in laboratory
- Evaluation of MU - Annex 1: Bottom-up approach – Annex 1.2 Estimation of measurement uncertainty for quantitative determination using spectrophotometric method
- Evaluation of MU - Annex 1: Bottom-up approach – Annex 1.3 Estimation of the measurement uncertainty for assay using HPLC method
- Evaluation of MU - Annex 2: Top-down approach – Annex 2.1 Use of data from validation studies
- Evaluation of MU - Annex 2: Top-down approach – Annex 2.2 Use of data from control charts
- Evaluation of MU - Annex 2: Top-down approach – Annex 2.3 Use of certified reference materials
- Evaluation of MU - Annex 2: Top-down approach – Annex 2.4 Use of data from collaborative studies
- Evaluation of MU - Annex 2: Top-down approach – Annex 2.5 Use of data from PTS
- Evaluation of MU - Annex 3: Estimation of measurement uncertainty expressed as confidence interval using standard deviation from testing results
- Evaluation & Reporting of Results – Core Document
- Evaluation & Reporting of Results – Annex 1A: Model Template for Failure Investigation of OOS Results
- Evaluation & Reporting of Results – Annex 1B: Responsibilities of the Laboratory Supervisor
- Evaluation & Reporting of Results – Annex 2A: Examples of Re-Test Programmes for Quantitative Tests
- Evaluation & Reporting of Results – Annex 2C: Re-Test Programmes for Qualitative Tests
- Evaluation & Reporting of Results – Annex 2D: Special Considerations for Animal Testing (Verification of OOS Results)
- Qualification of Equipment - Core document
- Qualification of Equipment Annex 1: Qualification of Liquid Chromatography Equipment
- REVISED Qualification of Equipment Annex 2: Qualification of GC Equipment
- REVISED Qualification of Equipment Annex 3: Qualification of UV-Visible Spectrophotometers
- REVISED Qualification of Equipment Annex 4: Qualification of IR Spectrophotometers
- Qualification of Equipment Annex 5: Qualification of Automatic Titrators
- Qualification of Equipment Annex 6: Qualification of Piston Pipettes
- Qualification of Equipment Annex 7: Qualification of Mass Spectrometer
- Qualification of Equipment Annex 8: Qualification of Balances
- Qualification of Equipment Annex 9: Calibration/Qualification of pH Meters
- REVISED Qualification of Equipment Annex 10: Qualification of Atomic Absorption / Atomic Emission Spectrometers
- REVISED Qualification of Equipment Annex 11: Qualification of Analytical Columns
- Management of Documents and Records
- Validation of Computerised Systems - Core Document
- REVISED Management of Samples
- REVISED Management of Reagents
- REVISED Handling and Use of Non-Compendial Reference Standards in the OMCL Network
Recommendation documents
- NEW Risk-based Auditing Approach
- Qualification and Requalification of Analysts
- General Requirements for Infrequently performed techniques
- Management of Volumetric Glassware
- Management of Environmental Conditions
- Interpretation of Screening Results for Unknown Peptides and Proteins by MS Based Methods
- Change Control