TRAINING REQUIRED: Søren Thorup (QMS-2026-07-09-R005)

[github-actions]

Training Release Review

• Trigger release: QMS-2026-07-09-R005
• Trigger release URL: https://github.com/AliakseiT/dearauditor-qms-baseline/releases/tag/QMS-2026-07-09-R005
• Assignment source ref: QMS-2026-07-09-R005
• Training user: Søren Thorup (@SorenWesThorup)
• Roles in scope: qa_lead
• Controlled document deltas in scope: 23
• Optional awareness document deltas in scope: 1
• Mode: incremental

Controlled Document Checklist

Diff previews were omitted because the generated issue body would exceed GitHub's size limit. Use the revision-compare links below for the full change set.

• QM-001 (Quality Manual): R01 -> R09
  • File: qm/QM-001-QualityManual.md
  • Roles requiring document: qa_lead
  • Links: Compare R01 -> R09 | Current document
• SOP-001 (Document and Record Control): R12 -> R15
  • File: sops/SOP-001-DocControl.md
  • Roles requiring document: qa_lead
  • Links: Compare R12 -> R15 | Current document
• SOP-002 (Corrective and Preventive Action (CAPA)): R03 -> R06
  • File: sops/SOP-002-CAPA.md
  • Roles requiring document: qa_lead
  • Links: Compare R03 -> R06 | Current document
• SOP-003 (Internal Audit): R04 -> R07
  • File: sops/SOP-003-InternalAudit.md
  • Roles requiring document: qa_lead
  • Links: Compare R04 -> R07 | Current document
• SOP-005 (QMS Governance): R15 -> R23
  • File: sops/SOP-005-QMSGovernance.md
  • Roles requiring document: qa_lead
  • Links: Compare R15 -> R23 | Current document
• SOP-006 (Software Validation (QMS Tools)): R02 -> R05
  • File: sops/SOP-006-SoftwareValidation.md
  • Roles requiring document: qa_lead
  • Links: Compare R02 -> R05 | Current document
• SOP-007 (Medical Device File Control): R06 -> R10
  • File: sops/SOP-007-MedicalDeviceFileControl.md
  • Roles requiring document: qa_lead
  • Links: Compare R06 -> R10 | Current document
• SOP-008 (Design and Development Control): R07 -> R11
  • File: sops/SOP-008-DesignAndDevelopmentControl.md
  • Roles requiring document: qa_lead
  • Links: Compare R07 -> R11 | Current document
• SOP-009 (Change Management): R07 -> R11
  • File: sops/SOP-009-ChangeManagement.md
  • Roles requiring document: qa_lead
  • Links: Compare R07 -> R11 | Current document
• SOP-010 (Supplier and Purchasing Control): R02 -> R05
  • File: sops/SOP-010-SupplierAndPurchasingControl.md
  • Roles requiring document: qa_lead
  • Links: Compare R02 -> R05 | Current document
• SOP-011 (Competence, Training, and Awareness): R08 -> R12
  • File: sops/SOP-011-CompetenceTrainingAndAwareness.md
  • Roles requiring document: qa_lead
  • Links: Compare R08 -> R12 | Current document
• SOP-012 (Feedback and Complaint Handling): R03 -> R08
  • File: sops/SOP-012-FeedbackAndComplaintHandling.md
  • Roles requiring document: qa_lead
  • Links: Compare R03 -> R08 | Current document
• SOP-013 (Regulatory Incident Reporting): R03 -> R07
  • File: sops/SOP-013-RegulatoryIncidentReporting.md
  • Roles requiring document: qa_lead
  • Links: Compare R03 -> R07 | Current document
• SOP-014 (Post-Market Surveillance): R03 -> R07
  • File: sops/SOP-014-PostMarketSurveillance.md
  • Roles requiring document: qa_lead
  • Links: Compare R03 -> R07 | Current document
• SOP-015 (Nonconforming Product Control): R03 -> R06
  • File: sops/SOP-015-NonconformingProductControl.md
  • Roles requiring document: qa_lead
  • Links: Compare R03 -> R06 | Current document
• SOP-016 (Quality Metrics and Data Analysis): R03 -> R07
  • File: sops/SOP-016-QualityMetricsAndDataAnalysis.md
  • Roles requiring document: qa_lead
  • Links: Compare R03 -> R07 | Current document
• SOP-017 (Infrastructure and Maintenance Control): R03 -> R06
  • File: sops/SOP-017-InfrastructureAndMaintenanceControl.md
  • Roles requiring document: qa_lead
  • Links: Compare R03 -> R06 | Current document
• SOP-018 (Risk Management (ISO 14971)): R06 -> R10
  • File: sops/SOP-018-RiskManagement.md
  • Roles requiring document: qa_lead
  • Links: Compare R06 -> R10 | Current document
• SOP-019 (Usability Engineering (IEC 62366-1)): R09 -> R13
  • File: sops/SOP-019-UsabilityEngineering.md
  • Roles requiring document: qa_lead
  • Links: Compare R09 -> R13 | Current document
• SOP-020 (Software Lifecycle, Configuration, and Release Management (IEC 62304)): R08 -> R13
  • File: sops/SOP-020-SoftwareLifecycleConfigurationAndReleaseManagement.md
  • Roles requiring document: qa_lead
  • Links: Compare R08 -> R13 | Current document
• SOP-021 (Information Security Management (ISO/IEC 27001)): UNTRAINED -> R02
  • File: sops/SOP-021-InformationSecurityManagement.md
  • Roles requiring document: qa_lead
  • Links: Current document
• SOP-022 (AI Management System (ISO/IEC 42001)): UNTRAINED -> R02
  • File: sops/SOP-022-AIManagementSystem.md
  • Roles requiring document: qa_lead
  • Links: Current document
• SOP-023 (Data Protection and Privacy Management (GDPR and Swiss nFADP)): UNTRAINED -> R00
  • File: sops/SOP-023-DataProtectionAndPrivacyManagement.md
  • Roles requiring document: qa_lead
  • Links: Current document

Optional Awareness Documents

These documents are assigned as awareness-only for one or more roles in scope. Review is recommended, but these items do not block signature request or issue closure.

• SOP-004 (Management Review): UNTRAINED -> R09
  • File: sops/SOP-004-ManagementReview.md
  • Roles with awareness assignment: qa_lead
  • Links: Current document

Required Completion Workflow

1. Review each document delta link in this issue and check every checkbox in Controlled Document Checklist.
2. Optional awareness documents, when listed, are informational and do not need to be checked before signature request.
3. When all checkboxes are completed, automation posts a signature request comment for this issue.
4. Open the generated signature link, authenticate, and complete signature.
5. The issue closes automatically after valid signature attestation is posted.