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).

Guidelines

• 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
• 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 1. Rounding
• Evaluation & Reporting of Results – Annex 2. Evaluation of results from quantitative testing
• Evaluation & Reporting of Results – Annex 3. Verification of OOS results
  • Evaluation & Reporting of Results – Annex 3.1: General Introduction - Verification of Initial out-of-specification (OOS) results
  • Evaluation & Reporting of Results – Annex 3.2: Verification of OOS results in quantitative testing
  • Evaluation & Reporting of Results – Annex 3.3: Verification of OOS results in qualitative testing
  • REVISED Evaluation & Reporting of Results – Annex 3.4: Verification of OOS results in animal testing
• Externally Provided Products and Service
  • Externally Provided Products and Services Annex 1: Qualification of Testing Service Provider
  • Externally Provided Products and Services Annex 2: Contracting Principles and OMCL Model Contract for Outsourcing Testing Services
• 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
  • NEW Qualification of Equipment Annex 6: Qualification of Piston Operated Volumetric Apparatus (POVA)
  • REVISED 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
  • REVISED Qualification of Equipment Annex 11: Qualification of Analytical Columns
• Validation of Computerised Systems - Core Document
  • Validation of Computerised Systems Annex 1: Validation of Excel Spreadsheets
  • Validation of Computerised Systems Annex 2: Validation of Complex Computerised Systems

Recommendation documents

• 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
• Interpretation of Screening Results for Unknown Peptides and Proteins by MS Based Methods

Other documents

• 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