| 🔹 1. General QMS Documentation Structure (Applicable to All Labs) Typical hierarchy: Level 1: Quality Manual (optional in ISO/IEC 17025:2017 but often used) Level 2: Policies & Procedures Level 3: Standard Operating Procedures (SOPs) / Work Instructions Level 4: Records & Forms ✔️ Core Documents Quality Policy & Objectives Organization chart Document control procedure Record control procedure Internal audit procedure Corrective action procedure Risk management procedure 🔬 i. Testing Laboratories (ISO/IEC 17025) 🔹 Key Documentation 1. Management System Documents Quality manual (if maintained) Policies (impartiality, confidentiality) SOPs for all testing activities 2. Technical Documents Test methods (standard/non-standard) Method validation/verification records Sampling procedures 3. Equipment & Calibration Equipment list and inventory Calibration schedules Calibration certificates Maintenance records 4. Quality Control Records Control charts Proficiency testing (PT) results Inter-laboratory comparison (ILC) records 5. Sample Handling Sample receipt and registration forms Chain of custody records Storage and disposal procedures 6. Reporting Test reports Result interpretation and authorization records ⚙️ ii. Calibration Laboratories (ISO/IEC 17025) 🔹 Key Documentation 1. Calibration Procedures Detailed calibration methods Reference standards documentation Traceability records to SI units 2. Measurement Records Raw data sheets Calibration calculations Correction factors ✔️ Calibration Relationship Correction=Standard Value−Measured Value 3. Uncertainty Documentation Uncertainty budgets Calculation sheets Assumptions and models 4. Equipment Management Reference standards certificates Equipment logs Environmental monitoring records 5. Calibration Certificates Measurement results Uncertainty values Traceability statements 🏥 iii. Medical Laboratories (ISO 15189) 🔹 Key Documentation 1. Quality & Administrative Documents Quality manual Patient confidentiality policy Ethics and consent procedures 2. Pre-Analytical Phase Patient preparation instructions Sample collection procedures Sample labeling and transport 3. Analytical Phase Test methods and SOPs Internal quality control (IQC) records Equipment calibration and maintenance 4. Post-Analytical Phase Test reports (with reference ranges) Critical result reporting procedures Result validation and authorization 5. Patient & Clinical Records Patient data records Laboratory information system (LIS) data Data security and backup 🔹 2. Common Documentation Requirements Across All Labs Document Control Version control Approval and authorization Distribution and access Record Control Retention policies Storage and protection Retrieval system Traceability Measurement traceability Data traceability Audit & Review Internal audit reports Management review records 🔹 3. Differences at a Glance Area Testing Labs Calibration Labs Medical Labs Focus Testing samples Measurement accuracy Patient diagnosis Standard ISO/IEC 17025 ISO/IEC 17025 ISO 15189 Key Output Test report Calibration certificate Patient report Special Docs Sampling, PT Uncertainty budgets Patient records 🔹 4. Common Mistakes in Documentation Outdated or uncontrolled documents Missing signatures/approvals Incomplete records Poor traceability Lack of version control 🔹 5. Best Practices Keep documentation simple and clear Ensure regular updates and reviews Train staff on document usage Maintain electronic + backup systems Align documents with actual practices ✔️ Key Takeaways Documentation is the backbone of QMS compliance Each lab type has specific documentation needs Proper control ensures traceability, reliability, and audit readiness |
📘 Quality Management System Documentation Laboratories (Testing, Calibration & Medical ) ISO/IEC 17025:2017 and (for medical labs) ISO 15189
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