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SOP-QMS-04 — Context of the Organization

Defines how UBC identifies internal/external issues, interested parties, and the scope of the QMS (ISO 9001 §4).

Owner: Quality DirectorApprover: B. HuseltonVersion: 3.1Updated: 11/2/1969

1. Purpose

Ensure UBC systematically determines the internal and external issues, interested parties, and requirements that shape the QMS.

2. Scope

All UBC business units within the QMS boundary. Executed annually by the Quality Director and reviewed at each Management Review.

3. Definitions

  • Interested party — Any person or organization that can affect, be affected by, or perceive themselves to be affected by UBC's decisions.
  • Context — The combination of internal and external factors that can have an effect on UBC's approach to its products, services, and stakeholders.

4. Roles & Responsibilities (RACI)

ActivityRACICadence
Identify external issues (PESTLE)Strategy LeadSVP OperationsGRC, LegalQuality CouncilAnnual
Identify internal issues (SWOT)Quality DirectorSVP OperationsFunction leadsQuality CouncilAnnual
Update interested parties registerQuality AnalystQuality DirectorLegal, GRCOwnersSemi-annual
Confirm QMS scopeQuality DirectorSVP OperationsFunction leadsAll staffAnnual

5. Procedure

  1. Convene the annual Context Review workshop with function leads.
  2. Refresh the PESTLE analysis of external issues and record it in the Context Register.
  3. Refresh the SWOT analysis of internal issues, including capability, culture, and technology.
  4. Update the Interested Parties Register with expectations and monitoring frequency.
  5. Reaffirm or amend the QMS scope statement in the QMS Manual §1.
  6. Publish the updated Context Register and route for approval.
  7. Feed outputs into the Risk & Opportunities register (SOP-QMS-06).

6. Inputs & Outputs

Inputs

  • Prior year Context Register
  • Market and regulatory intelligence
  • Client feedback and NPS
  • Incident and CAPA trends

Outputs

  • Updated Context Register
  • Interested Parties Register
  • Amended QMS scope statement

7. Controls & Metrics

MetricTarget
Context Review completion100% annually by Q1
Interested Parties Register freshness≤ 6 months

8. Exceptions & Escalation

  • Material change events (M&A, major regulatory update) trigger an out-of-cycle context refresh within 30 days.

9. Records & Retention

RecordRetention
Context Register7 years
Interested Parties Register7 years
Workshop minutes3 years

10. Related Documents

  • QMS Manual
  • SOP-QMS-06 Risk & Opportunities
  • Management Review Procedure

11. References

  • ISO 9001:2015 §4.1–4.4
  • ISO 31000:2018

12. Revision History

See the Versions tab for the full change history maintained by the Auto-Doc Engine.

Document code: SOP-QMS-04 · Aligned to ISO 9001:2015 §4.1–4.4. Controlled document — reproduction outside the UBC QMS requires the Quality Manager's approval.

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ISO 9001