Standard Operating Procedure (SOP)
Title: Ensuring Impartiality in Laboratory Activities
SOP No.: QMS-SOP-001
Effective Date: [Insert Date]
Revision No.: 01
Approval: Quality Manager / Technical Manager
1. Purpose
To ensure that all laboratory personnel perform testing, calibration, and related activities
impartially and that the structure and operations of the laboratory prevent any undue influences
that may compromise impartiality.
2. Scope
This SOP applies to all laboratory personnel, management, subcontractors, and external
providers involved in laboratory activities that fall under the ISO/IEC 17025:2017 scope.
3. Definitions
Impartiality: The presence of objectivity, freedom from conflict of interest, bias, or
undue influence.
Conflict of Interest (COI): Any situation in which a person or organization is involved
in multiple interests, one of which could possibly corrupt the motivation or decision-
making.
4. Responsibilities
Laboratory Management: Ensure impartiality risks are identified and mitigated.
Quality Manager: Monitor and evaluate the effectiveness of controls for impartiality.
All Personnel: Comply with impartiality policies and report potential conflicts.
5. Policy Statement on Impartiality
The laboratory is committed to impartiality in its testing and calibration activities. It understands
the importance of impartiality and manages potential conflicts of interest to ensure the
objectivity of laboratory results.
6. Procedure
6.1 Identification of Risks to Impartiality
All activities are assessed for risks to impartiality during internal audits, management
reviews, and personnel evaluations.
Risks may arise from:
o Financial pressures
o Personal relationships
o Organizational relationships
o Subcontracting and outsourcing
6.2 Controls to Safeguard Impartiality
Separation of testing functions from commercial or financial operations.
Declaration of interest forms for all employees and contractors.
Rotation of staff in sensitive roles.
Non-involvement of laboratory personnel in the marketing or sales of test results.
6.3 Conflict of Interest Management
Personnel must disclose any personal, financial, or professional interest related to test
items.
Conflicts are reviewed by the Quality Manager and mitigated (e.g., reassignment of
work).
Records of disclosures and mitigation actions are maintained.
6.4 Training and Awareness
All new employees receive impartiality training.
Annual refresher training is conducted for all personnel.
Employees sign an impartiality commitment statement.
6.5 Review and Monitoring
Impartiality risks are reviewed in management review meetings.
Internal audits assess compliance with impartiality requirements.
Corrective actions are implemented in case of breaches.
7. Documentation and Records
Document Name Responsibility Retention Period
Impartiality Declaration Form HR / Quality 5 years
Conflict of Interest Register Quality Manager 5 years
Impartiality Risk Assessment Report Quality Manager 5 years
Training Records HR 5 years
8. References
ISO/IEC 17025:2017, Clause 4.1 (Impartiality)
ISO 9001:2015, Clause 4.1 (Context of the Organization) – for integrated systems
Internal Audit Reports
Management Review Minutes
9. Revision History
Revision No. Date Details Approved By
01 [Insert Date] Initial Release Technical Manager
