Quality Management (QM) Documents
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
- REVISED General Requirements for Infrequently performed techniques
- Handling and Use of Non-Compendial Reference Standards in the OMCL Network
- Management of Changes
- Management of Documents and Records
- Management of Environmental Conditions
- Management of Reagents
- Management of Samples
- REVISED Management of Volumetric glassware
- Qualification and Re-qualification of Personnel involved in Laboratory Activities
- Validation/Verification of Analytical Procedures
- 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
- REVISED 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
- REVISED Evaluation & Reporting of Results – Core Document
- New Evaluation & Reporting of Results – Annex 1. Rounding
- New Evaluation & Reporting of Results – Annex 2. Evaluation of results from quantitative testing
- New Evaluation & Reporting of Results – Annex 3. Verification of OOS results
- New Evaluation & Reporting of Results – Annex 3.1: General Introduction - Verification of Initial out-of-specification (OOS) results
- New Evaluation & Reporting of Results – Annex 3.2: Verification of OOS results in quantitative testing
- New Evaluation & Reporting of Results – Annex 3.3: Verification of OOS results in qualitative testing
- New Evaluation & Reporting of Results – Annex 3.4: Special considerations for animal testing in connection with verification of OOS results
- Externally Provided Products and Service
- Qualification of Equipment - Core document
- Qualification of Equipment Annex 1: Qualification of Liquid Chromatography Equipment
- Qualification of Equipment Annex 2: Qualification of GC Equipment
- Qualification of Equipment Annex 3: Qualification of UV-Visible Spectrophotometers
- 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
- REVISED Qualification of Equipment Annex 8: Qualification of Balances
- Qualification of Equipment Annex 9: Calibration/Qualification of pH Meters
- Qualification of Equipment Annex 10: Qualification of Atomic Absorption / Atomic Emission Spectrometers
- Qualification of Equipment Annex 11: Qualification of Analytical Columns
- Validation of Computerised Systems - Core Document
Other documents
- NEW Alternatives to Proficiency Testing Schemes
- Standard ‘Aide-Mémoire’ for the Mutual Joint Audit/Visits of Official Medicines Control Laboratories
- 'Aide-Mémoire' for Environmental Conditions & Treatment of Biological Models
- VBRN/ OCABR: 3R Issues for method validation and maintenance of competence
PRODUCTS & SERVICES