Typical quality system problems
- Procedures that nobody reads and that no longer match practice
- Superseded document versions still in use
- Nonconformities not recorded, or corrective actions closed at symptom level
- A risk register written once and never updated
- Management reviews that produce no decisions
What we cover
Document and record control
Document hierarchy, approval and revision workflow, controlled distribution, record retention and retrieval (ISO/IEC 17025 clauses 8.3–8.4).
Risks and opportunities
Process-based laboratory risk assessment, impartiality risk analysis and follow-up of actions (clauses 4.1 and 8.5).
Nonconformity and corrective action
Control of nonconforming work, root cause analysis (5 Whys, fishbone) and verification of effectiveness (clauses 7.10 and 8.7).
Management review
Prepared inputs, quality indicators and a meeting format that produces concrete decisions (clause 8.9).
Personnel competence
Job descriptions, competence criteria, training plans, authorisation and competence monitoring matrices (clause 6.2).
Suppliers and complaints
Evaluation of externally provided products and services and impartial complaint handling (clauses 6.6 and 7.9).
For internal quality control and proficiency testing — the tools that assure the validity of results — see proficiency testing and quality control.
How we work
- Current state review. We compare documents and records against actual practice.
- Process map. Processes, owners and interactions from sample receipt to reporting.
- Lean documentation. Duplicates removed; the procedures and forms you actually need.
- Risk assessment and indicators. Process risks and the quality indicators to monitor.
- Implementation and coaching. On-site support while staff adopt the new structure.
- Evaluation. Internal audit and management review to measure effectiveness.
Deliverables
- Process map and master document list
- Procedures, work instructions and forms specific to your laboratory
- Risk and opportunity register and impartiality analysis
- Nonconformity and corrective action tracking structure
- Management review template and quality indicators
Want document control and records in digital form? See LIMS and laboratory digital transformation.