Risk and Opportunity Management

Purpose

To define how the Laboratory identifies, evaluates, treats, monitors and reviews the risks and opportunities associated with its laboratory activities, including risks to impartiality, so that the management system achieves its intended results, undesired impacts are prevented or reduced, and improvement is achieved.

What is inside

10 sections, about 3 pages when printed.

1. 1. Purpose
2. 2. Scope
3. 3. References
4. 4. Definitions
5. 5. Responsibilities
6. 6. Procedure
7. Records generated by this procedure
8. Monitoring and performance indicators
9. Assessment readiness notes
10. Related documents

Records it generates

Applying this procedure produces the following records, which are the evidence an assessor samples.

• –Risk and Opportunity Register with scoring, treatments, reviews
• –Impartiality risk assessment
• –Change risk assessments

What an assessor looks for

The document closes with these points, so you can check your own practice before someone else does.

• –Whether the register exists, is specific to this Laboratory (not a generic list), and covers impartiality explicitly.
• –Whether risk-based reasoning is visible in decisions such as calibration intervals, QC frequency and nonconforming-work recall.
• –Whether treatments were implemented and evaluated for effectiveness.
• –Whether changes (new equipment, staff, scope) were risk-assessed before implementation.

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.
• Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.

Related documents

• QM-01

  Quality Manual

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

• SOP-28

  Impartiality and Confidentiality

  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-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.

• SOP-01

  Control of Documents

  Creation, review, approval, issue, change and withdrawal of internal and external documents.

• SOP-02

  Control of Records and Technical Records

  Identification, storage, protection, retention, amendment and disposal of quality and technical records.