Open-Source Quality Management System (OS-QMS)

Please Read: Public Use License (Link)

New to Quality Systems? 📍 Start Here: COMPASS Overview Document (Link)

Design History File (DHF) Templates

Organization

  • TMP0002-TemplateOrgChartAndResponsibilities (Link)

  • TMP0003-TemplateProjectPlan (Link)

  • TMP0005-TemplateProjectMemo (Link)

Needs & Requirements

  • TMP0006-TemplateUserNeeds (Link)

  • TMP0007-TemplateProductRequirementsSpecification (Link)

  • TMP0008-TemplateSoftwareRequirementsSpecification (Link)

Interface Control

  • TMP0009-TemplateInterfaceControlDocument (Link)

Risk Analysis

  • TMP0010-TemplateRiskAnalysis (Link)

  • TMP0010_TemplateRiskAnalysisSpreadsheet (Link)

Design Documents

  • TMP0011-TemplateDesignDescriptionDocument (Link)

  • TMP0012-TemplateSoftwareDesignDocument (Link)

Verification Testing

  • TMP0015-TemplateDesignVerificationPlan (Link)

  • TMP0016-TemplateDesignVerificationProtocol (Link)

  • TMP0016A-TemplateDesignVerificationProtocol-Attachment (Link)

  • TMP0017-TemplateDesignVerificationReport (Link)

  • TMP0021-TemplateDesignVerificationSummaryReport (Link)

Device Master Record (DMR) Templates

  • TMP1001-Template-ASizeDrawing (Link)

  • TMP1002-Template-SoftwareEndItem (Link)

Forms

  • FRM0001-TemplateReviewMinutes (Link)

SPOs

  • SOP0001-TemplateQualityManual (Link)

  • SOP0002-TemplateDocumentControlSystem (Link)

  • SOP0003-TemplateRiskManagement (Link)

  • SOP0004-TemplateProductDevelopmentProcess (Link)