Perform ISO 17025 Assessment using eAuditor
ISO 17025 is the international standard that specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. It applies to all organizations performing laboratory activities, regardless of their size or the sector they serve (e.g., testing, calibration, or sampling).
Performing an ISO/IEC 17025 Assessment using eAuditor enables laboratories to systematically evaluate their technical competence, quality management practices, and conformance to ISO 17025 requirements. By digitizing the assessment process, eAuditor allows teams to capture real-time data, assign corrective actions, track compliance across multiple lab functions, and ensure preparedness for accreditation or surveillance audits. It provides a structured, transparent, and repeatable process to uphold laboratory credibility and traceability.
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Preparation for ISO 17025 Assessment Using eAuditor
1.1 Define Scope and Objective of the Assessment
- Objective:
- Evaluate compliance with ISO/IEC 17025
- Identify gaps in technical and management systems
- Prepare for accreditation or internal audits
- Scope:
- Entire laboratory or specific functions (e.g., testing, calibration, sampling)
- Specific departments (e.g., quality control, metrology, chemistry lab)
1.2 Gather Key Laboratory Documentation
- Quality manual and standard operating procedures (SOPs)
- Equipment calibration logs and maintenance schedules
- Personnel training and competency records
- Method validation and verification data
- Internal audit reports and nonconformity logs
- Contracts, test reports, and result traceability records
1.3 Create or Import an eAuditor Checklist
Build a checklist based on ISO/IEC 17025 sections:
- General Requirements (Impartiality & Confidentiality)
- Structural Requirements
- Resource Requirements
- Process Requirements
- Management System Requirements
Checklist should include:
- Compliance status options (Compliant, Partial, Non-Compliant)
- Fields for observations and detailed comments
- Evidence attachments (photos, certificates, test logs)
- Responsibility assignment with deadlines
- Tags for risk, department, or nonconformity type
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Conducting the ISO 17025 Assessment Using eAuditor
2.1 Assess Each Requirement Area
- General Requirements
- Are impartiality policies and procedures documented and implemented?
- Is confidentiality ensured across personnel, systems, and third-party access?
- Structural Requirements
- Is the lab’s organizational structure documented?
- Are roles, authorities, and responsibilities clearly defined?
- Resource Requirements
- Are staff competent, trained, and regularly evaluated?
- Are environmental and facility conditions controlled and suitable?
- Is equipment maintained, calibrated, and traceable to national/international standards?
- Process Requirements
- Are methods validated and appropriate for intended uses?
- Are sampling and test procedures clearly defined and followed?
- Is measurement uncertainty calculated and reported accurately?
- Are customer requirements and contracts reviewed and accepted formally?
- Are reports clearly issued with traceable results and approvals?
- Management System Requirements
- Are internal audits conducted regularly and documented?
- Have nonconformities been tracked and resolved effectively?
- Are management reviews scheduled, attended, and recorded?
- Is continual improvement demonstrated in practice?
2.2 Record Observations and Evidence
- Input findings in real time using the eAuditor app
- Capture and upload supporting evidence:
- Equipment calibration certificates
- Photos of testing setups or SOP binders
- Staff training logs and validation records
- Use time-stamps, digital signatures, and GPS features for traceability
2.3 Assign Immediate Actions
- Tag audit findings with severity or risk level
- Use eAuditor to assign corrective actions with due dates
- Tag responsible lab personnel or quality managers
- Collaborate using in-app communication or comments
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Post-Assessment Activities and Reporting
3.1 Generate the Digital Audit Report
eAuditor auto-generates a detailed, professional report including:
- Clause-by-clause compliance assessment
- Nonconformities with attached photos or documents
- Assigned actions with owners and target dates
- Compliance score or lab readiness level
- Export formats: PDF, Excel, or shareable web links
3.2 Track and Verify Corrective Actions
- View and manage all actions from the assessment dashboard
- Update statuses: Open, In Progress, Overdue, Closed
- Attach evidence of resolution (e.g., updated SOPs, retraining records)
- Ensure closure of actions before external audits
3.3 Use eAuditor Analytics for Trend Review
- Monitor key metrics:
- Nonconformity trends by department or standard clause
- Action completion rates and average resolution time
- Comparison of assessment scores over time or across labs
- Support management review with data-driven insights
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Checklist Essentials for ISO 17025 in eAuditor
- Evidence of impartiality and data confidentiality
- Organization chart and personnel responsibilities
- Equipment calibration, verification, and maintenance logs
- Method validation and documentation
- Sampling plans and testing protocols
- Test result traceability and customer reporting
- Internal audit program and follow-up
- Continuous improvement and training records
- Document control system
- Records of customer feedback and complaint resolution
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Benefits of Using eAuditor for ISO 17025 Assessment
- Clause-aligned checklists ensure thorough evaluations
- Mobile and desktop access for remote or onsite assessments
- Real-time evidence capture (photos, reports, signatures)
- Automated reporting reduces manual workload
- Action assignment and tracking streamline resolution
- Analytics dashboard for ongoing compliance monitoring
- Secure cloud storage ensures complete audit history
Summary
Conducting an ISO 17025 Assessment using eAuditor equips laboratories with a robust, digital framework to assess and improve their management and technical systems. It enhances transparency, accountability, and audit readiness while promoting continual improvement and confidence in test and calibration results.