Form · FRM-32
Impartiality Risk Assessment
Identification and evaluation of risks to impartiality by relationship, activity and person.
Purpose
The impartiality risk assessment required by clause 4.1.4 and 4.1.5: identifies risks to impartiality arising from relationships, activities and personnel, evaluates them, records safeguards and residual risk, and is reviewed and approved by top management at least annually.
What it covers
- 1. Context
- 2. Risk identification and evaluation
- 3. Review history
How to complete it
- 1.Complete Section 1 describing the Laboratory's actual ownership, group structure, other business activities and key relationships; generic statements are not sufficient.
- 2.In Section 2 list each identified risk with source, how it could affect objectivity, existing safeguards, residual likelihood and consequence, rating and any additional action.
- 3.Section 3 records the annual review and approval by top management and the triggers (new service, relationship, ownership change, reported pressure).
- 4.Cross-reference risks to FRM-10 and treatments to procedures.
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
Related documents
- QM-01
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Top-level description of the management system against every clause of ISO/IEC 17025:2017.
- SOP-06
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- SOP-28
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Structural safeguards, declarations, risk identification and handling of confidential information.
- FRM-10
Risk and Opportunity Register
Register of risks and opportunities with likelihood, consequence, treatment and review.
- FRM-33
Confidentiality and Impartiality Declaration
Signed undertaking by staff, contractors and committee members.
- CHK-01
ISO/IEC 17025:2017 Gap Analysis and Self-Assessment
Clause-by-clause self-assessment with evidence, gap and action columns.
- FRM-01
Master Document Register
Register of every controlled internal and external document with revision, status and distribution.
- FRM-02
Document Change Request
Request, impact assessment and approval of a change to a controlled document.