Commitment to Impartiality
Impartiality risk assessment, mitigation measures, and declaration requirements for all laboratory personnel per ISO/IEC 17025:2017 clause 4.1.
Management Commitment to Impartiality
Analyt MTC's calibration laboratory commits to conducting all laboratory activities impartially and in a structurally sound manner. Management (CEO Alexandra Roberg) is committed to safeguarding impartiality. The laboratory shall not allow commercial, financial, or other pressures to compromise impartiality.
This commitment is established in accordance with ISO/IEC 17025:2017, Clause 4.1.
Identified Risks to Impartiality
The laboratory has identified the following risks to impartiality per clause 4.1.3 and 4.1.4 of ISO/IEC 17025:2017. As a small enterprise of five employees, complete organizational separation of functions is not feasible. This constraint has been assessed and accepted.
| Risk | Source | Risk Level | Status |
|---|---|---|---|
| Role overlap | As a five-person organization, the Lab Manager serves as backup for Sales and CEO functions. Complete separation of commercial and technical roles is structurally impossible at this scale. | Inherent | Monitored |
| Commercial pressure | Major clients representing a significant share of revenue may exert pressure on calibration results. | Low | Mitigated |
| Repair and calibration conflict | The laboratory performs both instrument repairs and subsequent calibrations. The same team that repairs an instrument may be motivated to overlook instability or marginal performance during calibration. | Medium | Mitigated |
| Ownership and governance | Analyt MTC is privately owned. The CEO (Alexandra Roberg) holds no technical role in the laboratory. Ownership interests do not directly influence calibration activities. | Low | Monitored |
| Shared resources | The laboratory does not share equipment, facilities, or personnel with external organizations. All calibration resources are dedicated. | Not applicable | N/A |
| Contracts and service agreements | Service contracts do not include provisions that could influence measurement results. No client contract stipulates expected calibration outcomes. | Low | Monitored |
| Marketing and branding | Laboratory marketing does not make claims about specific measurement outcomes. Branding does not create implicit commitments that could pressure technical findings. | Not applicable | N/A |
| Sales commissions and inducements | No laboratory personnel receive commissions or financial inducements tied to calibration volume or outcomes. | Not applicable | N/A |
Mitigation Measures
In accordance with clause 4.1.5 of ISO/IEC 17025:2017, the laboratory eliminates or minimizes identified risks through the following measures.
Role overlap (accepted risk)
- Each staff member signs an individual impartiality declaration upon joining the organization or upon introduction of this policy. Declarations are renewed only upon change of function.
- The Lab Manager has no authority to alter calibration results under commercial pressure. Any dispute regarding calibration outcomes is escalated to the CEO.
- This risk is reviewed during each management review.
Commercial pressure
- Calibration results are non-negotiable. The laboratory's DAkkS accreditation serves as the explicit safeguard: no commercial interest shall override the validity of measurement results.
- Any technician may refuse to validate a calibration result without adequate technical justification, without consequence.
- Client complaints related to calibration results are tracked through the complaint handling process.
Repair and calibration conflict
- Calibration procedures define objective stability criteria (stabilization time, repeatability thresholds) that must be met before a calibration result is accepted.
- A temporal separation between repair completion and calibration execution is maintained. The minimum separation is determined by the stabilization requirements of the instrument under calibration.
- The technician documents the repair independently. Conformity assessment after calibration relies solely on the documented objective criteria, not on subjective judgment.
Review and Continuous Improvement
The impartiality risk assessment is maintained as a living document, reviewed and updated through the following mechanisms.
- Impartiality risks are reviewed during each management review per clause 8.9. No separate review process is maintained.
- Any employee may report a new impartiality risk to the Lab Manager at any time. If the risk concerns the Lab Manager, it shall be reported directly to the CEO. If the risk concerns the CEO herself, any employee may report it directly to DAkkS.
- This policy is updated when a new risk is identified or when the organizational context changes (e.g., significant new client, organizational restructuring, addition of new calibration services).
- All changes to this policy are tracked through the document management system (Git version control).
Individual Impartiality Declarations
Each member of the laboratory staff signs an individual impartiality declaration. The declaration is signed once, at onboarding or upon introduction of this policy, and renewed only upon change of function.
The declaration includes:
- Acknowledgment of having read and understood this impartiality policy
- Personal commitment to conduct all laboratory activities impartially
- Commitment to report any actual or potential conflict of interest to the Lab Manager, or to the CEO if the conflict involves the Lab Manager
Impartiality-related duties, responsibilities, and authorities are communicated to each staff member as part of their role assignment, in accordance with clause 6.2.4 of ISO/IEC 17025:2017. The detailed assignment of activities and authorization levels is maintained in the authorization and competency matrix.
Signed declarations are maintained as quality records in each employee's personnel file.