TRAINING REQUIRED: Lemmy Liikkanen (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: Lemmy Liikkanen (@LemmyKilmisterish)
• Roles in scope: engineering_lead
• Controlled document deltas in scope: 14
• Optional awareness document deltas in scope: 2
• Mode: onboarding

This user has no prior training status entry. Review the latest published controlled-document revisions assigned by role.

Controlled Document Checklist

• QM-001 (Quality Manual): UNTRAINED -> R09
  • File: qm/QM-001-QualityManual.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-001 (Document and Record Control): UNTRAINED -> R15
  • File: sops/SOP-001-DocControl.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-002 (Corrective and Preventive Action (CAPA)): UNTRAINED -> R06
  • File: sops/SOP-002-CAPA.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-007 (Medical Device File Control): UNTRAINED -> R10
  • File: sops/SOP-007-MedicalDeviceFileControl.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-008 (Design and Development Control): UNTRAINED -> R11
  • File: sops/SOP-008-DesignAndDevelopmentControl.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-009 (Change Management): UNTRAINED -> R11
  • File: sops/SOP-009-ChangeManagement.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-011 (Competence, Training, and Awareness): UNTRAINED -> R12
  • File: sops/SOP-011-CompetenceTrainingAndAwareness.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-015 (Nonconforming Product Control): UNTRAINED -> R06
  • File: sops/SOP-015-NonconformingProductControl.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-017 (Infrastructure and Maintenance Control): UNTRAINED -> R06
  • File: sops/SOP-017-InfrastructureAndMaintenanceControl.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-018 (Risk Management (ISO 14971)): UNTRAINED -> R10
  • File: sops/SOP-018-RiskManagement.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-020 (Software Lifecycle, Configuration, and Release Management (IEC 62304)): UNTRAINED -> R13
  • File: sops/SOP-020-SoftwareLifecycleConfigurationAndReleaseManagement.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-021 (Information Security Management (ISO/IEC 27001)): UNTRAINED -> R02
  • File: sops/SOP-021-InformationSecurityManagement.md
  • Roles requiring document: engineering_lead
  • Links: Current document
• SOP-022 (AI Management System (ISO/IEC 42001)): UNTRAINED -> R02
  • File: sops/SOP-022-AIManagementSystem.md
  • Roles requiring document: engineering_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: engineering_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-006 (Software Validation (QMS Tools)): UNTRAINED -> R05
  • File: sops/SOP-006-SoftwareValidation.md
  • Roles with awareness assignment: engineering_lead
  • Links: Current document
• SOP-019 (Usability Engineering (IEC 62366-1)): UNTRAINED -> R13
  • File: sops/SOP-019-UsabilityEngineering.md
  • Roles with awareness assignment: engineering_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.