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quality-manager-qmr

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Senior Quality Manager Responsible Person (QMR)

高级质量经理负责人（QMR）

Quality system accountability, management review leadership, and regulatory compliance oversight per ISO 13485 Clause 5.5.2 requirements.
依据ISO 13485第5.5.2条款要求，负责质量管理体系（QMS）问责、管理评审领导以及合规监管。

Table of Contents

目录

QMR Responsibilities

QMR职责

ISO 13485 Clause 5.5.2 Requirements

ISO 13485第5.5.2条款要求

ResponsibilityScopeEvidence
QMS effectivenessMonitor system performance and suitabilityManagement review records
Reporting to managementCommunicate QMS performance to top managementQuality reports, dashboards
Quality awarenessPromote regulatory and quality requirementsTraining records, communications
Liaison with external partiesInterface with regulators, Notified BodiesMeeting records, correspondence
职责范围证据
质量管理体系（QMS）有效性监控体系性能与适用性管理评审记录
向管理层汇报向最高管理层沟通QMS绩效质量报告、仪表板
质量意识推广监管与质量要求培训记录、沟通材料
与外部方联络与监管机构、公告机构对接会议记录、往来信函

QMR Accountability Matrix

QMR问责矩阵

DomainAccountable ForReports ToFrequency
Quality PolicyPolicy adequacy and communicationCEO/BoardAnnual review
Quality ObjectivesObjective achievement and relevanceExecutive TeamQuarterly
QMS PerformanceSystem effectiveness metricsManagementMonthly
Regulatory ComplianceCompliance status across jurisdictionsCEOQuarterly
Audit ProgramAudit schedule completion, findings closureManagementPer audit
CAPA OversightCAPA effectiveness and timelinessExecutive TeamMonthly
领域负责内容汇报对象频率
质量方针方针充分性与沟通CEO/董事会年度评审
质量目标目标达成情况与相关性执行团队季度
QMS绩效体系有效性指标管理层月度
合规性各辖区合规状态CEO季度
审核计划审核计划完成情况、问题闭环管理层每次审核后
CAPA监管CAPA有效性与及时性执行团队月度

Authority Boundaries

权限边界

Decision TypeQMR AuthorityEscalation Required
Process changes within QMSApprove with ownerMajor process redesign
Document approvalFinal QA approvalPolicy-level changes
Nonconformity dispositionAccept/reject with MRBProduct release decisions
Supplier quality actionsQuality holds, auditsSupplier termination
Audit schedulingAdjust internal audit scheduleExternal audit timing
Training requirementsDefine quality training needsOrganization-wide training budget
决策类型QMR权限是否需要升级上报
QMS范围内的流程变更与流程所有者共同批准重大流程重新设计
文档批准最终QA批准政策层面变更
不合格品处置与MRB共同决定接受/拒收产品放行决策
供应商质量行动质量扣留、审核供应商终止合作
审核日程安排调整内部审核日程外部审核时间
培训要求定义质量培训需求全公司培训预算

Management Review Workflow

管理评审工作流程

Conduct management reviews per ISO 13485 Clause 5.6 requirements.
依据ISO 13485第5.6条款要求开展管理评审。

Workflow: Prepare and Execute Management Review

工作流程：准备与执行管理评审

  1. Schedule management review (minimum annually, typically quarterly or semi-annually)
  2. Notify all required attendees minimum 2 weeks prior
  3. Collect required inputs from process owners:
    • Audit results (internal and external)
    • Customer feedback (complaints, satisfaction, returns)
    • Process performance and product conformity
    • CAPA status and effectiveness
    • Previous review action items
    • Changes affecting QMS (regulatory, organizational)
    • Recommendations for improvement
  4. Compile input summary report with trend analysis
  5. Prepare presentation materials with supporting data
  6. Distribute agenda and input package 1 week prior
  7. Conduct review meeting per agenda
  8. Validation: All required inputs reviewed; decisions documented with owners and due dates
  1. 安排管理评审（至少每年一次，通常为季度或半年度）
  2. 提前至少2周通知所有必要参会人员
  3. 从流程所有者处收集必要输入：
    • 审核结果（内部与外部）
    • 客户反馈（投诉、满意度、退货）
    • 流程绩效与产品符合性
    • CAPA状态与有效性
    • 上一次评审的行动项
    • 影响QMS的变更（监管、组织架构）
    • 改进建议
  4. 编写包含趋势分析的输入摘要报告
  5. 准备带支撑数据的演示材料
  6. 提前1周分发议程与输入包
  7. 按议程开展评审会议
  8. 验证： 所有必要输入已评审；决策已记录并分配负责人与截止日期

Required Attendees

必要参会人员

RoleRequirementInput Responsibility
CEO/General ManagerRequiredStrategic decisions
QMRChairOverall QMS status
Department HeadsRequiredProcess performance
RA ManagerRequiredRegulatory changes
Production ManagerRequiredProduct conformity
Customer QualityRequiredComplaint data
角色要求输入职责
CEO/总经理必须参会战略决策
QMR主持整体QMS状态
部门负责人必须参会流程绩效
RA经理必须参会监管变更
生产经理必须参会产品符合性
客户质量人员必须参会投诉数据

Management Review Input Template

管理评审输入模板

MANAGEMENT REVIEW INPUT SUMMARY

Review Period: [Start Date] to [End Date]
Review Date: [Scheduled Date]
Prepared By: [QMR Name]

1. AUDIT RESULTS
   Internal audits completed: [X] of [X] planned
   External audits completed: [X]
   Total findings: [X] major / [X] minor
   Open findings: [X]
   Finding trends: [Analysis]

2. CUSTOMER FEEDBACK
   Complaints received: [X]
   Complaint rate: [X per 1000 units]
   Customer satisfaction score: [X.X/5.0]
   Returns: [X] units ([X]%)
   Top issues: [Categories]

3. PROCESS PERFORMANCE
   [Process 1]: [Metric] vs [Target] - [Status]
   [Process 2]: [Metric] vs [Target] - [Status]
   Out-of-spec processes: [List]

4. PRODUCT CONFORMITY
   First pass yield: [X]%
   Nonconformance rate: [X]%
   Scrap cost: $[X]
   Top defect categories: [List]

5. CAPA STATUS
   Open CAPAs: [X]
   Overdue: [X]
   Effectiveness rate: [X]%
   Average age: [X] days

6. PREVIOUS ACTIONS
   Total from last review: [X]
   Completed: [X] | In progress: [X] | Overdue: [X]

7. CHANGES AFFECTING QMS
   Regulatory: [List changes]
   Organizational: [List changes]
   Process: [List changes]

8. RECOMMENDATIONS
   [Collected improvement opportunities]
MANAGEMENT REVIEW INPUT SUMMARY

Review Period: [Start Date] to [End Date]
Review Date: [Scheduled Date]
Prepared By: [QMR Name]

1. AUDIT RESULTS
   Internal audits completed: [X] of [X] planned
   External audits completed: [X]
   Total findings: [X] major / [X] minor
   Open findings: [X]
   Finding trends: [Analysis]

2. CUSTOMER FEEDBACK
   Complaints received: [X]
   Complaint rate: [X per 1000 units]
   Customer satisfaction score: [X.X/5.0]
   Returns: [X] units ([X]%)
   Top issues: [Categories]

3. PROCESS PERFORMANCE
   [Process 1]: [Metric] vs [Target] - [Status]
   [Process 2]: [Metric] vs [Target] - [Status]
   Out-of-spec processes: [List]

4. PRODUCT CONFORMITY
   First pass yield: [X]%
   Nonconformance rate: [X]%
   Scrap cost: $[X]
   Top defect categories: [List]

5. CAPA STATUS
   Open CAPAs: [X]
   Overdue: [X]
   Effectiveness rate: [X]%
   Average age: [X] days

6. PREVIOUS ACTIONS
   Total from last review: [X]
   Completed: [X] | In progress: [X] | Overdue: [X]

7. CHANGES AFFECTING QMS
   Regulatory: [List changes]
   Organizational: [List changes]
   Process: [List changes]

8. RECOMMENDATIONS
   [Collected improvement opportunities]

Management Review Output Requirements

管理评审输出要求

OutputDocumentationOwner
QMS improvement decisionsAction items with due datesAssigned per item
Resource needsResource plan updatesDepartment heads
Quality objectives changesUpdated objectives documentQMR
Process improvement needsImprovement project chartersProcess owners
See: references/management-review-guide.md
输出文档记录负责人
QMS改进决策带截止日期的行动项按项分配
资源需求资源计划更新部门负责人
质量目标变更更新后的目标文档QMR
流程改进需求改进项目章程流程所有者
参考：references/management-review-guide.md

Quality KPI Management Workflow

质量KPI管理工作流程

Establish, monitor, and report quality performance indicators.
建立、监控并报告质量绩效指标。

Workflow: Establish Quality KPI Framework

工作流程：建立质量KPI框架

  1. Identify quality objectives requiring measurement
  2. Select KPIs per objective using SMART criteria:
    • Specific: Clear definition and calculation
    • Measurable: Quantifiable with available data
    • Actionable: Team can influence results
    • Relevant: Aligned to quality objectives
    • Time-bound: Defined measurement frequency
  3. Define target values based on baseline data and benchmarks
  4. Assign data source and collection responsibility
  5. Establish reporting frequency per KPI category
  6. Configure dashboard displays and trend analysis
  7. Define escalation thresholds and alert triggers
  8. Validation: Each KPI has owner, target, data source, and escalation criteria
  1. 识别需要测量的质量目标
  2. 依据SMART标准为每个目标选择KPI：
    • 具体（Specific）：清晰的定义与计算方式
    • 可测量（Measurable）：可通过现有数据量化
    • 可行动（Actionable）：团队可影响结果
    • 相关（Relevant）：与质量目标对齐
    • 有时限（Time-bound）：定义测量频率
  3. 基于基线数据与基准值设定目标值
  4. 分配数据源与收集责任人
  5. 按KPI类别确定报告频率
  6. 配置仪表板展示与趋势分析
  7. 定义升级上报阈值与警报触发条件
  8. 验证： 每个KPI都有负责人、目标值、数据源与升级标准

Core Quality KPIs

核心质量KPI

CategoryKPITargetCalculation
ProcessFirst Pass Yield>95%(Units passed first time / Total units) × 100
ProcessNonconformance Rate<1%(NC count / Total units) × 100
CAPACAPA Closure Rate>90%(On-time closures / Due closures) × 100
CAPACAPA Effectiveness>85%(Effective CAPAs / Verified CAPAs) × 100
AuditFinding Closure Rate>90%(On-time closures / Due closures) × 100
AuditRepeat Finding Rate<10%(Repeat findings / Total findings) × 100
CustomerComplaint Rate<0.1%(Complaints / Units sold) × 100
CustomerSatisfaction Score>4.0/5.0Average of survey scores
类别KPI目标计算方式
流程首次通过率>95%(首次通过的产品数量 / 总产品数量) × 100
流程不合格率<1%(不合格品数量 / 总产品数量) × 100
CAPACAPA闭环率>90%(按时闭环的CAPA数量 / 到期的CAPA数量) × 100
CAPACAPA有效性>85%(有效的CAPA数量 / 已验证的CAPA数量) × 100
审核问题闭环率>90%(按时闭环的问题数量 / 到期的问题数量) × 100
审核重复问题率<10%(重复问题数量 / 总问题数量) × 100
客户投诉率<0.1%(投诉数量 / 已销售产品数量) × 100
客户满意度得分>4.0/5.0调查得分平均值

KPI Review Frequency

KPI评审频率

KPI TypeReview FrequencyTrend PeriodAudience
Safety/ComplianceDaily monitoringWeeklyOperations
Production QualityWeeklyMonthlyDepartment heads
Customer QualityMonthlyQuarterlyExecutive team
Strategic QualityQuarterlyAnnualBoard/C-suite
KPI类型评审频率趋势周期受众
安全/合规每日监控每周运营团队
生产质量每周每月部门负责人
客户质量每月季度执行团队
战略质量季度年度董事会/高管层

Performance Response Matrix

绩效响应矩阵

Performance LevelStatusAction Required
>110% of targetExceedingConsider raising target
100-110% of targetMeetingMaintain current approach
90-100% of targetApproachingMonitor closely
80-90% of targetBelowImprovement plan required
<80% of targetCriticalImmediate intervention
See: references/quality-kpi-framework.md
绩效水平状态所需行动
>目标的110%超额达成考虑提高目标
目标的100-110%达成维持当前方法
目标的90-100%接近达成密切监控
目标的80-90%未达标需要改进计划
<目标的80%严重立即干预
参考：references/quality-kpi-framework.md

Quality Objectives Workflow

质量目标工作流程

Establish and maintain measurable quality objectives per ISO 13485 Clause 5.4.1.
依据ISO 13485第5.4.1条款建立并维护可测量的质量目标。

Workflow: Annual Quality Objectives Setting

工作流程：年度质量目标设定

  1. Review prior year objective achievement
  2. Analyze quality performance trends and gaps
  3. Align with organizational strategic plan
  4. Draft objectives with measurable targets
  5. Validate resource availability for achievement
  6. Obtain executive approval
  7. Communicate objectives organization-wide
  8. Validation: Each objective is measurable, has owner, target, and timeline
  1. 回顾上一年度目标达成情况
  2. 分析质量绩效趋势与差距
  3. 与组织战略计划对齐
  4. 起草带可测量目标的方案
  5. 验证达成目标所需的资源可用性
  6. 获取高管批准
  7. 向全公司传达目标
  8. 验证： 每个目标都可测量，有负责人、目标值与时间线

Quality Objective Structure

质量目标结构

QUALITY OBJECTIVE [Number]

Objective Statement: [Clear, measurable statement]
Aligned to Policy Element: [Quality policy section]
Target: [Specific measurable target]
Baseline: [Current performance]
Owner: [Name and title]
Due Date: [Target achievement date]

Success Criteria:
- [Criterion 1]
- [Criterion 2]

Measurement Method: [How progress is tracked]
Reporting Frequency: [Monthly/Quarterly]

Supporting Initiatives:
- [Initiative 1]
- [Initiative 2]

Resource Requirements:
- [Resource 1]
- [Resource 2]
QUALITY OBJECTIVE [Number]

Objective Statement: [Clear, measurable statement]
Aligned to Policy Element: [Quality policy section]
Target: [Specific measurable target]
Baseline: [Current performance]
Owner: [Name and title]
Due Date: [Target achievement date]

Success Criteria:
- [Criterion 1]
- [Criterion 2]

Measurement Method: [How progress is tracked]
Reporting Frequency: [Monthly/Quarterly]

Supporting Initiatives:
- [Initiative 1]
- [Initiative 2]

Resource Requirements:
- [Resource 1]
- [Resource 2]

Objective Categories

目标类别

CategoryExample ObjectivesTypical Targets
Customer QualityReduce complaint rate<0.1% of units sold
Process QualityImprove first pass yield>96%
ComplianceMaintain certificationZero major NCs
EfficiencyReduce quality costs<4% of revenue
CultureIncrease training completion>98% on-time
类别示例目标典型目标值
客户质量降低投诉率<已销售产品的0.1%
流程质量提高首次通过率>96%
合规性维持认证无重大不合格项
效率降低质量成本<营收的4%
文化提高培训完成率>98%按时完成

Quarterly Objective Review

季度目标评审

Review ElementAssessmentAction
Progress vs. targetOn track / Behind / AheadAdjust resources if behind
RelevanceStill valid / Needs updateModify if conditions changed
ResourcesAdequate / InsufficientRequest additional if needed
BarriersIdentified obstaclesEscalate for resolution
评审要素评估行动
目标进度按计划/滞后/超前若滞后则调整资源
相关性仍然有效/需要更新若条件变化则修改
资源充足/不足若不足则申请额外资源
障碍已识别的阻碍升级上报以解决

Quality Culture Assessment Workflow

质量文化评估工作流程

Assess and improve organizational quality culture.
评估并改进组织的质量文化。

Workflow: Annual Quality Culture Assessment

工作流程：年度质量文化评估

  1. Design or select quality culture survey instrument
  2. Define survey population (all employees or sample)
  3. Communicate survey purpose and confidentiality
  4. Administer survey with 2-week response window
  5. Analyze results by department, role, and tenure
  6. Identify strengths and improvement areas
  7. Develop action plan for culture gaps
  8. Validation: Response rate >60%; action plan addresses bottom 3 scores
  1. 设计或选择质量文化调查工具
  2. 定义调查人群（全体员工或抽样）
  3. 传达调查目的与保密性
  4. 开展调查，设置2周响应窗口
  5. 按部门、角色与任职年限分析结果
  6. 识别优势与改进领域
  7. 针对文化差距制定行动计划
  8. 验证： 响应率>60%；行动计划针对得分最低的3个维度

Quality Culture Dimensions

质量文化维度

DimensionIndicatorsAssessment Method
Leadership commitmentManagement visible support for qualitySurvey, observation
Quality ownershipEmployees feel responsible for qualitySurvey
CommunicationQuality information flows effectivelySurvey, audit
Continuous improvementSuggestions submitted and implementedMetrics
Training and competenceEmployees feel adequately trainedSurvey, records
Problem solvingIssues addressed at root causeCAPA analysis
维度指标评估方法
领导力承诺管理层对质量的可见支持调查、观察
质量所有权员工对质量的责任感调查
沟通质量信息的有效流动调查、审核
持续改进建议的提交与实施指标
培训与能力员工对培训充足性的感受调查、记录
问题解决从根本原因解决问题CAPA分析

Culture Survey Categories

文化调查类别

CategorySample Questions
Leadership"Management demonstrates commitment to quality"
Resources"I have the tools and training to do quality work"
Communication"Quality expectations are clearly communicated"
Empowerment"I am encouraged to report quality issues"
Recognition"Quality achievements are recognized"
类别示例问题
领导力“管理层展示了对质量的承诺”
资源“我拥有开展高质量工作所需的工具与培训”
沟通“质量期望已清晰传达”
授权“我被鼓励报告质量问题”
认可“质量成就得到认可”

Culture Improvement Actions

文化改进行动

Gap IdentifiedPotential Actions
Low leadership visibilityQuality gemba walks, all-hands quality updates
Inadequate trainingCompetency-based training program
Poor communicationQuality newsletters, department huddles
Low reportingAnonymous reporting system, no-blame culture
Lack of recognitionQuality award program, team celebrations
识别的差距潜在行动
管理层可见度低质量现场走访、全员质量更新会议
培训不足基于能力的培训项目
沟通不畅质量通讯、部门碰头会
报告率低匿名报告系统、无责文化
缺乏认可质量奖励计划、团队庆祝活动

Regulatory Compliance Oversight

合规监管

Monitor and maintain regulatory compliance across jurisdictions.
监控并维持跨辖区的合规性。

Multi-Jurisdictional Compliance Matrix

跨辖区合规矩阵

JurisdictionRegulationRequirementStatus Tracking
EUMDR 2017/745CE marking, Notified BodyTechnical file, annual review
USA21 CFR 820FDA registration, QSR complianceAnnual registration, inspections
InternationalISO 13485QMS certificationSurveillance audits
GermanyMPG/MPDGNational implementationCompetent authority filings
辖区法规要求状态跟踪
欧盟MDR 2017/745CE标志、公告机构技术文档、年度评审
美国21 CFR 820FDA注册、QSR合规年度注册、检查
国际ISO 13485QMS认证监督审核
德国MPG/MPDG国家层面实施主管机构备案

Compliance Monitoring Workflow

合规监控工作流程

  1. Maintain regulatory requirement register
  2. Subscribe to regulatory update services
  3. Assess impact of regulatory changes monthly
  4. Update affected processes within 90 days of effective date
  5. Verify training completion for regulatory changes
  6. Document compliance status in management review
  7. Maintain inspection readiness checklist
  8. Validation: All applicable requirements mapped; no expired registrations
  1. 维护法规要求登记册
  2. 订阅法规更新服务
  3. 每月评估法规变更的影响
  4. 在生效日期后90天内更新受影响的流程
  5. 验证员工已完成法规变更的培训
  6. 在管理评审中记录合规状态
  7. 维护检查准备清单
  8. 验证： 所有适用要求已映射；无过期注册

Regulatory Authority Interface

监管机构对接

ActivityQMR RolePreparation Required
Notified Body auditPrimary contactAudit package, personnel schedules
FDA inspectionHost, escort coordinatorInspection readiness review
Competent Authority inquiryResponse coordinatorTechnical file access
Regulatory meetingAttendee or delegateBriefing materials
活动QMR角色所需准备
公告机构审核主要联系人审核包、人员日程
FDA检查主办人、陪同协调员检查准备评审
主管机构问询响应协调员技术文档访问权限
监管会议参会者或代表简报材料

Inspection Readiness Checklist

检查准备清单

AreaReadyAction Needed
Document control system current☐
Training records complete☐
CAPA system current, no overdue items☐
Complaint files complete☐
Equipment calibration current☐
Supplier qualification files complete☐
Management review records available☐
Internal audit program current☐
领域已准备所需行动
文档控制系统最新☐
培训记录完整☐
CAPA系统最新，无逾期项☐
投诉文件完整☐
设备校准最新☐
供应商资质文件完整☐
管理评审记录可用☐
内部审核计划最新☐

Decision Frameworks

决策框架

Escalation Decision Tree

升级上报决策树

Issue Identified
      │
      ▼
Is it a regulatory violation?
      │
  Yes─┴─No
  │      │
  ▼      ▼
Escalate to    Is it a safety issue?
Executive          │
immediately    Yes─┴─No
               │      │
               ▼      ▼
          Escalate to   Does it affect
          Safety Team   multiple departments?
                             │
                         Yes─┴─No
                         │      │
                         ▼      ▼
                    Escalate to  Handle at
                    Executive    department level
Issue Identified
      │
      ▼
Is it a regulatory violation?
      │
  Yes─┴─No
  │      │
  ▼      ▼
Escalate to    Is it a safety issue?
Executive          │
immediately    Yes─┴─No
               │      │
               ▼      ▼
          Escalate to   Does it affect
          Safety Team   multiple departments?
                             │
                         Yes─┴─No
                         │      │
                         ▼      ▼
                    Escalate to  Handle at
                    Executive    department level

Quality Investment Prioritization

质量投资优先级

CriteriaWeightScore Method
Regulatory requirement30%Required=10, Recommended=5, Optional=2
Customer impact25%Direct=10, Indirect=5, None=0
Cost savings potential20%>$100K=10, $50-100K=7, <$50K=3
Implementation complexity15%Simple=10, Moderate=5, Complex=2
Strategic alignment10%Core=10, Supporting=5, Peripheral=2
标准权重评分方法
法规要求30%强制=10，推荐=5，可选=2
客户影响25%直接=10，间接=5，无=0
成本节约潜力20%>10万美元=10，5-10万美元=7，<5万美元=3
实施复杂度15%简单=10，中等=5，复杂=2
战略对齐10%核心=10，支撑=5，外围=2

Resource Allocation Matrix

资源分配矩阵

Resource TypeAllocation AuthorityEscalation Threshold
Quality personnelQMR>1 FTE addition
Quality equipmentQMR>$25K
External consultantsQMR>$50K or >30 days
Quality systemsExecutive approval>$100K
资源类型分配权限升级上报阈值
质量人员QMR新增超过1名全职员工
质量设备QMR超过2.5万美元
外部顾问QMR超过5万美元或30天
质量体系高管批准超过10万美元

Tools and References

工具与参考

Scripts

脚本

ToolPurposeUsage
management_review_tracker.pyTrack review inputs, actions, metrics
python management_review_tracker.py --help
Management Review Tracker Features:
  • Track input collection status from process owners
  • Monitor action item completion and aging
  • Generate metrics summary for review
  • Produce recommendations for review focus areas
工具用途使用方法
management_review_tracker.py跟踪评审输入、行动项、指标
python management_review_tracker.py --help
管理评审跟踪器功能：
  • 跟踪从流程所有者处收集输入的状态
  • 监控行动项的完成情况与逾期时间
  • 生成评审用的指标摘要
  • 提出评审重点领域的建议

References

参考文档

DocumentContent
management-review-guide.mdISO 13485 Clause 5.6 requirements, input/output templates, action tracking
quality-kpi-framework.mdKPI categories, targets, calculations, dashboard templates
文档内容
management-review-guide.mdISO 13485第5.6条款要求、输入/输出模板、行动跟踪
quality-kpi-framework.mdKPI类别、目标值、计算方式、仪表板模板

Quick Reference: Management Review Inputs (ISO 13485 Clause 5.6.2)

快速参考：管理评审输入（ISO 13485第5.6.2条款）

InputSourceRequired
FeedbackCustomer complaints, surveysYes
Audit resultsInternal and external auditsYes
Process performanceProcess metricsYes
Product conformityInspection, NC dataYes
CAPA statusCAPA systemYes
Previous actionsPrior review recordsYes
ChangesRegulatory, organizationalYes
RecommendationsAll sourcesYes
输入来源是否必需
反馈客户投诉、调查是
审核结果内部与外部审核是
流程绩效流程指标是
产品符合性检验、不合格品数据是
CAPA状态CAPA系统是
上一次行动之前的评审记录是
变更监管、组织架构是
建议所有来源是

Quick Reference: Management Review Outputs (ISO 13485 Clause 5.6.3)

快速参考：管理评审输出（ISO 13485第5.6.3条款）

OutputDocumentation Required
Improvement to QMS and processesAction items with owners
Improvement to productProject initiation if needed
Resource needsResource plan updates
输出所需文档
QMS与流程改进带负责人的行动项
产品改进如需则启动项目
资源需求资源计划更新

Related Skills

相关技能

SkillIntegration Point
quality-manager-qms-iso13485QMS process management
capa-officerCAPA system oversight
qms-audit-expertInternal audit program
quality-documentation-managerDocument control oversight
技能集成点
quality-manager-qms-iso13485QMS流程管理
capa-officerCAPA系统监管
qms-audit-expert内部审核计划
quality-documentation-manager文档控制监管