Risk and Opportunity Register

Purpose

The register of risks and opportunities required by clause 8.5, including the context review, the scoring of each risk, existing controls, treatments, owners, and the record of quarterly and annual reviews. Impartiality risks are cross-referenced to FRM-32.

What it covers

• Part A - Context (internal and external issues)
• Part B - Risk register
• Part C - Opportunities
• Part D - Review record

How to complete it

1. 1.Complete Part A (context) annually before management review: list the internal and external issues that affect the Laboratory's ability to achieve its objectives.
2. 2.In Part B describe each risk as cause - event - consequence; list existing controls; score likelihood (1-5) and consequence (1-5) for the residual risk per SOP-06; rating = product; HIGH >= 12, MEDIUM 6-10, LOW <= 5.
3. 3.For risks above LOW, record the treatment option, actions, owner and due date, and where the treatment is embedded (procedure, audit plan, QC plan, interval, training).
4. 4.Record opportunities in Part C with benefit, requirements and decision.
5. 5.Record each review in Part D with re-scoring and evaluation of treatment effectiveness.

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

  Quality Manual

  Top-level description of the management system against every clause of ISO/IEC 17025:2017.

• SOP-06

  Risk and Opportunity Management

  Identifying, evaluating, treating and reviewing risks and opportunities, including risks to impartiality.

• SOP-28

  Impartiality and Confidentiality

  Structural safeguards, declarations, risk identification and handling of confidential information.

• FRM-32

  Impartiality Risk Assessment

  Identification and evaluation of risks to impartiality by relationship, activity and person.

• 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.