Documents sur le Management de la Qualité (MQ)
Des documents dans le domaine du Management de la Qualité ont été élaborés par le Réseau général européen des OMCL. Ils sont disponibles ci-dessous en téléchargement. Ils sont reconnus par le Conseil européen de coopération pour l'accréditation (EA).
Introduction
Guidelines
- 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
- REVISÉ 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
- 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)
- 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
- REVISÉ 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
- 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
Documents de recommandation
- NOUVEAU Recommendations on setting the expiry period for commercial and in-house-prepared reagents used in the laboratories of the OMCL Network
- Risk-based Auditing Approach
- General Requirements for Infrequently performed techniques
- Interpretation of Screening Results for Unknown Peptides and Proteins by MS Based Methods
PRODUITS & SERVICES