UBC — AI Solutions

Audit — Dynamic Documentation Platform

Living documentation that stays in sync with engineering, cloud, AI, and compliance activity. Documents update themselves as the organization changes.

Back to library
SOP
Fresh

SOP-QMS-09 — Performance Evaluation, Monitoring & Internal Audit

Defines monitoring, measurement, analysis, internal audit, and management review (ISO 9001 §9).

Owner: Quality DirectorApprover: SVP OperationsVersion: 3.2Updated: 11/7/1969

1. Purpose

Ensure the QMS is monitored, measured, analyzed, and evaluated for suitability, adequacy, and effectiveness.

2. Scope

All QMS processes and functions.

3. Definitions

  • Internal audit — An independent, systematic examination of a process against defined criteria.
  • Management review — Executive review of QMS performance held at planned intervals.

4. Roles & Responsibilities (RACI)

ActivityRACICadence
Plan annual audit programmeInternal Audit LeadQuality DirectorProcess ownersQuality CouncilAnnual
Conduct auditsAuditorInternal Audit LeadAuditeeProcess ownerPer plan
Track findings to closureProcess ownerQuality DirectorInternal AuditQuality CouncilContinuous
Chair Management ReviewSVP OperationsSVP OperationsQuality CouncilBoardQuarterly

5. Procedure

  1. Publish the annual internal audit programme by January.
  2. Notify auditees at least 10 business days before an audit.
  3. Conduct audits using the ISO 19011 audit approach; record findings, observations, and evidence.
  4. Rate findings (major, minor, observation) and assign CAPA owners.
  5. Track findings to closure in the CAPA register (see SOP-QMS-10).
  6. Consolidate QMS performance into the quarterly Management Review pack.

6. Inputs & Outputs

Inputs

  • Audit programme
  • Process KPIs
  • Client feedback
  • CAPA status
  • External audit findings

Outputs

  • Audit reports
  • Management Review minutes
  • QMS performance dashboard

7. Controls & Metrics

MetricTarget
Audits completed on plan≥ 95%
Major findings closed within 60 days≥ 90%

8. Exceptions & Escalation

  • Regulatory or client-triggered audits may be added out of cycle; the annual plan is amended.

9. Records & Retention

RecordRetention
Audit reports7 years
Management Review minutes7 years
Auditor qualificationsLife of employment

10. Related Documents

  • SOP-QMS-10
  • QMS Manual
  • SOP-PM-09

11. References

  • ISO 9001:2015 §9
  • ISO 19011:2018
  • CMMI-DEV PPQA, MA

12. Revision History

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

Document code: SOP-QMS-09 · Aligned to ISO 9001:2015 §9. Controlled document — reproduction outside the UBC QMS requires the Quality Manager's approval.

Suggested by AI
No suggestions right now.
Frameworks
ISO 9001
CMMI-DEV
SOC 2
ISO 27001