ISO/IEC 17025
Benefit from Our Experience
An ISO 17025 Internal Audit is
a systematic, independent, and documented review of your Laboratory Test & Calibration Management System. Ensuring it
conforms to ISO 17025 requirements
is effectively implemented
is efficient
drives continuous improvement.
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ISO 17025
ISO/IEC 17025:2017 is the global standard for testing and calibration laboratory competence, published by ISO and IEC, ensuring accurate, reliable, and impartial results across medical, environmental, food safety, and manufacturing sectors. It establishes rigorous requirements for quality management, technical processes, and operational consistency, enabling accredited labs to earn trust from clients, regulators, and stakeholders worldwide.
Applies to testing, calibration, and sampling in diverse technical fields
Structures five core clauses — general, structural, resource, process, and management system
Ensures personnel competence (Clause 6.2) through training and qualifications
Validates test/calibration methods (Clause 7.2) for accuracy and reproducibility
Maintains equipment traceability (Clause 6.4) to national/international standards
Manages risks to impartiality (Clause 4.1) to prevent bias or influence
Requires internal audits (Clause 8.8) and management reviews (Clause 8.9) for continual improvement
Supports accreditation by A2LA, UKAS, etc., enhancing global recognition and regulatory compliance
Core Purpose
ISO/IEC 17025 ensures testing and calibration laboratories produce accurate, reliable, and reproducible results, building trust in data critical for medical diagnostics, environmental monitoring, and product safety. By enforcing technical competence, quality management, and impartiality, it reduces errors and supports consistent, standardized operations worldwide.
Minimizes errors and variability in high-stakes testing applications
Promotes impartiality to eliminate bias or external influence
Enforces standardized methods for consistent, reproducible outcomes
Builds confidence among clients, regulators, and the public
Supports global trust in scientific and technical laboratory data
What Triggers an ISO 17025 Internal Audit?
| Event | Frequency | Scope | Typical Responsibility |
| Scheduled Internal Audit | Annually or as defined in the audit program (typically every 12 months to cover the full QMS and technical requirements) | Entire laboratory QMS and technical operations, covering all ISO 17025 clauses (e.g., 4-8), including testing, calibration, and sampling processes | Quality Manager or Internal Audit Team Lead |
| Significant Method or Equipment Change | As needed (e.g., after introducing new test/calibration methods or equipment) | Affected processes, such as method validation or equipment calibration (e.g., clause 7.2 selection of methods, clause 6.4 equipment) | Technical Manager or Quality Manager |
| Nonconformity or Complaint | Upon identification of major nonconformities, customer complaints, or test/calibration failures | Specific areas related to the nonconformity or complaint (e.g., clause 7.10 nonconforming work, clause 7.9 complaints) | Quality Manager or Corrective Action Team |
| Regulatory or Accreditation Changes | After updates to relevant regulations or accreditation requirements (e.g., ILAC, FDA, or local standards) | Processes impacted by new compliance obligations (e.g., clause 4.1 impartiality, clause 6.2 personnel competence) | Quality Manager or Regulatory Affairs Manager |
| Management Review Follow-Up | After management review meetings (typically annually) | Areas identified for improvement in management reviews (e.g., clause 8.9 management review) | Quality Manager or Management Review Team |
| Personnel or Training Changes | Upon significant changes in staff, training, or competence requirements | Personnel competence and training processes (e.g., clause 6.2 personnel, clause 6.6 externally provided services) | Technical Manager or Quality Manager |
| Quality Control or Proficiency Testing Failures | When quality control checks or proficiency testing results indicate issues | Processes related to test/calibration accuracy and quality control (e.g., clause 7.7 ensuring result validity) | Technical Manager or Quality Manager |
| Pre-Accreditation or Surveillance Audit | Prior to initial accreditation, reassessment, or surveillance audits (e.g., every 1-2 years) | Full QMS and technical operations or areas flagged in prior external audits | Quality Manager or Internal Audit Team |
Triggers to cause an ISO 17025 Internal Audit
Event / Trigger | Typical Frequency | Scope | Typical Responsibility |
Planned internal audit per audit program | At least annually; risk-based cadence by area/method | All QMS processes and selected technical activities (sampling, testing, calibration, method validity, MU, traceability) | Quality Manager (QM) plans; trained Internal Auditor(s) execute; Technical Manager (TM) supports |
New or significantly changed test/calibration method | Before or shortly after release to routine use | Method development/validation records, competence, equipment/software, MU and decision rules | TM initiates; Method Owner and Internal Auditor verify implementation |
Major equipment installation, repair, or out-of-tolerance event | Upon event | Metrological traceability, intermediate checks, recalibration, impact analysis on results | TM & Equipment Owner; QM verifies corrective actions; Auditor samples effectiveness |
Proficiency testing (PT)/interlaboratory comparison (ILC) failure or concerning z-score | Upon result | Root cause, corrective actions, method performance, competence, MU review | TM leads RCA; QM adds focused audit; Auditor verifies closure |
Significant nonconformity, complaint, or trend of minor NCs | Upon detection; trending at least quarterly | Affected processes, records, decision rules, release of results, communication | Process Owner & QM; Internal Auditor validates effectiveness |
Management review outputs requiring verification | After each management review (typically annually or semi-annually) | Actions on risks/opportunities, resources, improvements, KPIs | Top Management assigns; QM schedules follow-up audit |
Significant changes to personnel competence (new staff, role changes) | Upon change | Authorizations, training/competence records, supervision, witnessing | TM & HR/Training Coordinator; Auditor samples authorizations |
Relocation or environmental change affecting activities | Upon change | Facility conditions (temperature, humidity, vibration), method validity, equipment relocation checks | Lab Manager & TM; QM adds targeted audit |
Software/LIMS/spreadsheet newly introduced or modified | Before release and post-deployment | Validation/verification, data integrity, security, backup, change control | IT/Software Owner & TM; Internal Auditor reviews validation evidence |
Customer/regulatory requirement changes impacting scope | Upon change | Contract review, methods, decision rules, reporting, accreditation scope alignment | Contract Review Owner & QM; Auditor samples recent jobs |
Accreditation body (AB) assessment findings | After each AB assessment | Areas with nonconformities/observations, corrective actions, systemic issues | QM coordinates; Internal Auditor verifies effectiveness |
Measurement uncertainty (MU) model changes or anomalies | Upon change or anomaly detection | MU inputs, calculations, guard bands, decision rules, records | TM/Method Owner; Auditor checks application in reports |
Supplier/subcontractor performance issues (e.g., reference standards, calibrations) | Upon issue; supplier reviews at least annually | Approval status, incoming checks, impact on traceability and results | Purchasing & QM; Auditor samples affected jobs |
Documented information/control failures | Upon detection | Version control, accessibility at point of use, records integrity/retention | QM/Document Controller; Internal Auditor validates fixes |
Risk/opportunity register updates indicating elevated risk | When risk rating increases; periodic (e.g., quarterly) review | Controls effectiveness, contingency plans, continuity for critical activities | QM & Process Owners; Auditor verifies control implementation |
Quality objectives not met or adverse KPI trends | Upon KPI review (monthly/quarterly) | Related processes, resources, training, improvement actions | Top Management & QM; Internal Auditor samples corrective actions |
Incidents/accidents affecting validity of results | Upon incident | Containment of impacted results, notifications, RCA, competence/equipment checks | Lab Manager & QM; Auditor confirms effectiveness |
Expansion or reduction of accredited scope | Upon scope change | Capability evidence, validation, resources, impartiality, reporting | TM & QM; Internal Auditor verifies readiness |
Impartiality or confidentiality concerns raised | Upon concern | Conflict-of-interest controls, declarations, access controls, customer data handling | Impartiality Function/Committee & QM; Auditor checks implementation |
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