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Quality Manager - QMS ISO 13485 Specialist

质量经理 - ISO 13485 QMS专员

ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations.
为医疗器械组织提供ISO 13485:2016质量管理体系的实施、维护及认证支持。

Table of Contents

目录

QMS Implementation Workflow

QMS实施工作流

Implement ISO 13485:2016 compliant quality management system from gap analysis through certification.
从差距分析到认证，实施符合ISO 13485:2016标准的质量管理体系。

Workflow: Initial QMS Implementation

初始QMS实施工作流

  1. Conduct gap analysis against ISO 13485:2016 requirements
  2. Document current state vs. required state for each clause
  3. Prioritize gaps by:
    • Regulatory criticality
    • Risk to product safety
    • Resource requirements
  4. Develop implementation roadmap with milestones
  5. Establish Quality Manual per Clause 4.2.2:
    • QMS scope with justified exclusions
    • Process interactions
    • Procedure references
  6. Create required documented procedures:
    • Document control (4.2.3)
    • Record control (4.2.4)
    • Internal audit (8.2.4)
    • Nonconforming product (8.3)
    • Corrective action (8.5.2)
    • Preventive action (8.5.3)
  7. Deploy processes with training
  8. Validation: Gap analysis complete; Quality Manual approved; all required procedures documented and trained
  1. 对照ISO 13485:2016要求开展差距分析
  2. 记录每个条款的当前状态与要求状态
  3. 按以下优先级排序差距：
    • 法规关键性
    • 产品安全风险
    • 资源需求
  4. 制定包含里程碑的实施路线图
  5. 依据第4.2.2条款建立质量手册：
    • 包含合理排除项的QMS范围
    • 流程交互关系
    • 程序引用
  6. 创建所需的成文程序：
    • 文档控制（4.2.3）
    • 记录控制（4.2.4）
    • 内部审核（8.2.4）
    • 不合格品（8.3）
    • 纠正措施（8.5.2）
    • 预防措施（8.5.3）
  7. 部署流程并开展培训
  8. 验证：差距分析完成；质量手册获批；所有必需程序已成文并完成培训

Gap Analysis Matrix

差距分析矩阵

ClauseRequirementCurrent StateGapPriorityAction
4.2.2Quality ManualNot documentedMajorHighCreate QM
4.2.3Document controlInformalModerateHighFormalize SOP
5.6Management reviewAd hocMajorHighEstablish schedule
7.3Design controlPartialModerateMediumComplete procedures
8.2.4Internal auditNoneMajorHighCreate program
条款要求当前状态差距优先级行动
4.2.2质量手册未成文重大高创建QM
4.2.3文档控制非正式中等高正式化SOP
5.6管理评审临时重大高建立计划
7.3设计控制部分完成中等中完善程序
8.2.4内部审核无重大高创建审核计划

QMS Structure

QMS结构

LevelDocument TypePurposeExample
1Quality ManualQMS overview, policyQM-001
2ProceduresHow processes workSOP-02-001
3Work InstructionsTask-level detailWI-06-012
4RecordsEvidence of conformityTraining records
层级文档类型用途示例
1质量手册QMS概述、政策QM-001
2程序文件流程运作说明SOP-02-001
3作业指导书任务级细节说明WI-06-012
4记录合规性证据培训记录

Required Procedure List

必需程序列表

ClauseProcedureMinimum Content
4.2.3Document ControlApproval, review, distribution, obsolete control
4.2.4Record ControlIdentification, storage, retention, disposal
8.2.4Internal AuditProgram, auditor qualification, reporting
8.3Nonconforming ProductIdentification, segregation, disposition
8.5.2Corrective ActionInvestigation, root cause, effectiveness
8.5.3Preventive ActionRisk identification, implementation, verification
条款程序最低内容要求
4.2.3文档控制审批、评审、分发、作废控制
4.2.4记录控制标识、存储、保留、处置
8.2.4内部审核审核计划、审核员资质、报告
8.3不合格品标识、隔离、处置
8.5.2纠正措施调查、根本原因、有效性验证
8.5.3预防措施风险识别、实施、验证

Document Control Workflow

文档控制工作流

Establish and maintain document control per ISO 13485 Clause 4.2.3.
依据ISO 13485第4.2.3条款建立并维护文档控制体系。

Workflow: Document Creation and Approval

文档创建与审批工作流

  1. Identify need for new document or revision
  2. Assign document number per numbering convention:
    • Format: 
      [TYPE]-[AREA]-[SEQUENCE]-[REV]
    • Example: 
      SOP-02-001-01
  3. Draft document using approved template
  4. Route for review to subject matter experts
  5. Collect and address review comments
  6. Obtain required approvals based on document type
  7. Update Document Master List
  8. Validation: Document numbered correctly; all reviewers signed; Master List updated
  1. 确定新文档或修订需求
  2. 按编号规则分配文档编号：
    • 格式：
      [TYPE]-[AREA]-[SEQUENCE]-[REV]
    • 示例：
      SOP-02-001-01
  3. 使用获批模板起草文档
  4. 提交给主题专家评审
  5. 收集并处理评审意见
  6. 根据文档类型获取所需审批
  7. 更新文档主清单
  8. 验证：文档编号正确；所有评审人员签字；主清单已更新

Document Numbering Convention

文档编号规则

PrefixDocument TypeApproval Authority
QMQuality ManualManagement Rep + CEO
POLPolicyDepartment Head + QA
SOPProcedureProcess Owner + QA
WIWork InstructionSupervisor + QA
TFTemplate/FormProcess Owner
SPECSpecificationEngineering + QA
前缀文档类型审批权限
QM质量手册管理者代表 + CEO
POL政策部门负责人 + QA
SOP程序文件流程所有者 + QA
WI作业指导书主管 + QA
TF模板/表单流程所有者
SPEC规范工程部 + QA

Area Codes

领域代码

CodeAreaExamples
01Quality ManagementQuality Manual, policy
02Document ControlThis procedure
03TrainingCompetency procedures
04DesignDesign control
05PurchasingSupplier management
06ProductionManufacturing
07Quality ControlInspection, testing
08CAPACorrective actions
代码领域示例
01质量管理质量手册、政策
02文档控制本程序文件
03培训能力程序
04设计设计控制
05采购供应商管理
06生产制造
07质量控制检验、测试
08CAPA纠正措施

Document Change Control

文档变更控制

Change TypeApproval LevelExamples
AdministrativeDocument ControlTypos, formatting
MinorProcess Owner + QAClarifications
MajorFull review cycleProcess changes
EmergencyExpedited + retrospectiveSafety issues
变更类型审批级别示例
行政类文档控制人员打字错误、格式调整
次要变更流程所有者 + QA内容澄清
主要变更完整评审周期流程变更
紧急变更快速审批 + 追溯安全问题

Document Review Schedule

文档评审计划

Document TypeReview PeriodTrigger for Unscheduled Review
Quality ManualAnnualOrganizational change
ProceduresAnnualAudit finding, regulation change
Work Instructions2 yearsProcess change
Forms2 yearsUser feedback
文档类型评审周期非计划触发评审条件
质量手册年度组织变更
程序文件年度审核发现、法规变更
作业指导书2年流程变更
表单2年用户反馈

Internal Audit Workflow

内部审核工作流

Plan and execute internal audits per ISO 13485 Clause 8.2.4.
依据ISO 13485第8.2.4条款规划并执行内部审核。

Workflow: Annual Audit Program

年度审核计划工作流

  1. Identify processes and areas requiring audit coverage
  2. Assess risk factors for audit frequency:
    • Previous audit findings
    • Regulatory changes
    • Process changes
    • Complaint trends
  3. Assign qualified auditors (independent of area audited)
  4. Develop annual audit schedule
  5. Obtain management approval
  6. Communicate schedule to process owners
  7. Track completion and reschedule as needed
  8. Validation: All processes covered; auditors qualified and independent; schedule approved
  1. 确定需要审核覆盖的流程与领域
  2. 评估影响审核频率的风险因素：
    • 过往审核发现
    • 法规变更
    • 流程变更
    • 投诉趋势
  3. 指派具备资质的审核员（与被审核领域无关）
  4. 制定年度审核计划
  5. 获取管理层批准
  6. 向流程所有者传达计划
  7. 跟踪完成情况并按需重新安排
  8. 验证：所有流程均覆盖；审核员具备资质且独立；计划已获批

Workflow: Individual Audit Execution

单次审核执行工作流

  1. Prepare audit plan with scope, criteria, and schedule
  2. Notify auditee minimum 1 week prior
  3. Review procedures and previous audit results
  4. Prepare audit checklist
  5. Conduct opening meeting
  6. Collect evidence through:
    • Document review
    • Record sampling
    • Process observation
    • Personnel interviews
  7. Classify findings:
    • Major NC: Absence or breakdown of system
    • Minor NC: Single lapse or deviation
    • Observation: Risk of future NC
  8. Conduct closing meeting
  9. Issue audit report within 5 business days
  10. Validation: All checklist items addressed; findings supported by evidence; report distributed
  1. 制定包含范围、准则与时间表的审核计划
  2. 提前至少1周通知被审核方
  3. 评审程序文件与过往审核结果
  4. 准备审核检查表
  5. 召开首次会议
  6. 通过以下方式收集证据：
    • 文档评审
    • 记录抽样
    • 流程观察
    • 人员访谈
  7. 对发现项分类：
    • 重大不合格项（NC）：体系缺失或失效
    • 次要不合格项（NC）：单次失误或偏差
    • 观察项：未来可能出现不合格的风险
  8. 召开末次会议
  9. 5个工作日内发布审核报告
  10. 验证：所有检查表项均已覆盖；发现项有证据支持；报告已分发

Audit Program Template

审核计划模板

Audit #ProcessClausesQ1Q2Q3Q4Auditor
IA-001Document Control4.2.3, 4.2.4X[Name]
IA-002Management Review5.6X[Name]
IA-003Design Control7.3X[Name]
IA-004Production7.5X[Name]
IA-005CAPA8.5.2, 8.5.3X[Name]
审核编号流程条款Q1Q2Q3Q4审核员
IA-001文档控制4.2.3, 4.2.4X[姓名]
IA-002管理评审5.6X[姓名]
IA-003设计控制7.3X[姓名]
IA-004生产7.5X[姓名]
IA-005CAPA8.5.2, 8.5.3X[姓名]

Auditor Qualification Requirements

审核员资质要求

CriterionRequirement
TrainingISO 13485 awareness + auditor training
ExperienceMinimum 1 audit as observer
IndependenceNot auditing own work area
CompetenceUnderstanding of audited process
标准要求
培训ISO 13485认知 + 审核员培训
经验至少1次作为观察员参与审核
独立性不得审核自身工作领域
能力理解被审核流程

Finding Classification Guide

发现项分类指南

ClassificationCriteriaResponse Time
Major NCSystem absence, total breakdown, regulatory violation30 days for CAPA
Minor NCSingle instance, partial compliance60 days for CAPA
ObservationPotential risk, improvement opportunityTrack in next audit
分类标准响应时间
重大NC体系缺失、完全失效、违反法规30天内完成CAPA
次要NC单次事件、部分合规60天内完成CAPA
观察项潜在风险、改进机会下次审核跟踪

Process Validation Workflow

过程验证工作流

Validate special processes per ISO 13485 Clause 7.5.6.
依据ISO 13485第7.5.6条款验证特殊过程。

Workflow: Process Validation Protocol

过程验证方案工作流

  1. Identify processes requiring validation:
    • Output cannot be verified by inspection
    • Deficiencies appear only in use
    • Sterilization, welding, sealing, software
  2. Form validation team with subject matter experts
  3. Write validation protocol including:
    • Process description and parameters
    • Equipment and materials
    • Acceptance criteria
    • Statistical approach
  4. Execute Installation Qualification (IQ):
    • Verify equipment installed correctly
    • Document equipment specifications
  5. Execute Operational Qualification (OQ):
    • Test parameter ranges
    • Verify process control
  6. Execute Performance Qualification (PQ):
    • Run production conditions
    • Verify output meets requirements
  7. Write validation report with conclusions
  8. Validation: IQ/OQ/PQ complete; acceptance criteria met; validation report approved
  1. 确定需要验证的流程：
    • 输出无法通过检验验证
    • 缺陷仅在使用中显现
    • 灭菌、焊接、密封、软件等
  2. 组建由主题专家构成的验证团队
  3. 编写验证方案，包含：
    • 流程描述与参数
    • 设备与材料
    • 验收标准
    • 统计方法
  4. 执行安装确认（IQ）：
    • 验证设备安装正确
    • 记录设备规格
  5. 执行运行确认（OQ）：
    • 测试参数范围
    • 验证流程控制
  6. 执行性能确认（PQ）：
    • 按生产条件运行
    • 验证输出符合要求
  7. 编写包含结论的验证报告
  8. 验证：IQ/OQ/PQ完成；验收标准满足；验证报告获批

Validation Documentation Requirements

验证文档要求

PhaseContentEvidence
ProtocolObjectives, methods, criteriaApproved protocol
IQEquipment verificationInstallation records
OQParameter verificationTest results
PQPerformance verificationProduction data
ReportSummary, conclusionsApproval signatures
阶段内容证据
方案目标、方法、标准获批方案
IQ设备验证安装记录
OQ参数验证测试结果
PQ性能验证生产数据
报告总结、结论审批签字

Revalidation Triggers

再验证触发条件

TriggerAction Required
Equipment changeAssess impact, revalidate affected phases
Parameter changeOQ and PQ minimum
Material changeAssess impact, PQ minimum
Process failureFull revalidation
PeriodicPer validation schedule (typically 3 years)
触发因素所需行动
设备变更评估影响，重新验证受影响阶段
参数变更至少重新执行OQ与PQ
材料变更评估影响，至少重新执行PQ
流程失效完整再验证
定期按验证计划（通常3年）

Special Process Examples

特殊过程示例

ProcessValidation StandardCritical Parameters
EO SterilizationISO 11135Temperature, humidity, EO concentration, time
Steam SterilizationISO 17665Temperature, pressure, time
Radiation SterilizationISO 11137Dose, dose uniformity
SealingInternalTemperature, pressure, dwell time
WeldingISO 11607Heat, pressure, speed
流程验证标准关键参数
EO灭菌ISO 11135温度、湿度、EO浓度、时间
蒸汽灭菌ISO 17665温度、压力、时间
辐射灭菌ISO 11137剂量、剂量均匀性
密封内部标准温度、压力、保压时间
焊接ISO 11607热量、压力、速度

Supplier Qualification Workflow

供应商资质审核工作流

Evaluate and approve suppliers per ISO 13485 Clause 7.4.
依据ISO 13485第7.4条款评估并批准供应商。

Workflow: New Supplier Qualification

新供应商资质审核工作流

  1. Identify supplier category:
    • Category A: Critical (affects safety/performance)
    • Category B: Major (affects quality)
    • Category C: Minor (indirect impact)
  2. Request supplier information:
    • Quality certifications
    • Product specifications
    • Quality history
  3. Evaluate supplier based on:
    • Quality system (ISO certification)
    • Technical capability
    • Quality history
    • Financial stability
  4. For Category A suppliers:
    • Conduct on-site audit
    • Require quality agreement
  5. Calculate qualification score
  6. Make approval decision:
    • 80: Approved
    • 60-80: Conditional approval
    • <60: Not approved
  7. Add to Approved Supplier List
  8. Validation: Evaluation criteria scored; qualification records complete; supplier categorized
  1. 确定供应商类别：
    • A类：关键（影响安全/性能）
    • B类：主要（影响质量）
    • C类：次要（间接影响）
  2. 索取供应商信息：
    • 质量认证
    • 产品规格
    • 质量历史
  3. 基于以下维度评估供应商：
    • 质量体系（ISO认证）
    • 技术能力
    • 质量历史
    • 财务稳定性
  4. 对于A类供应商：
    • 开展现场审核
    • 要求签订质量协议
  5. 计算资质得分
  6. 做出批准决策：
    • 80分：批准
    • 60-80分：有条件批准
    • <60分：不批准
  7. 加入合格供应商清单
  8. 验证：评估标准已打分；资质记录完整；供应商已分类

Supplier Evaluation Criteria

供应商评估标准

CriterionWeightScoring
Quality System30%ISO 13485=30, ISO 9001=20, Documented=10, None=0
Quality History25%Reject rate: <1%=25, 1-3%=15, >3%=0
Delivery20%On-time: >95%=20, 90-95%=10, <90%=0
Technical Capability15%Exceeds=15, Meets=10, Marginal=5
Financial Stability10%Strong=10, Adequate=5, Questionable=0
标准权重评分
质量体系30%ISO 13485=30分, ISO 9001=20分, 成文体系=10分, 无=0分
质量历史25%拒收率：<1%=25分, 1-3%=15分, >3%=0分
交付20%准时率：>95%=20分, 90-95%=10分, <90%=0分
技术能力15%超出要求=15分, 满足要求=10分, 勉强达标=5分
财务稳定性10%良好=10分, 充足=5分, 存疑=0分

Supplier Category Requirements

供应商类别要求

CategoryQualificationMonitoringAgreement
A - CriticalOn-site auditAnnual reviewQuality agreement
B - MajorQuestionnaireSemi-annual reviewQuality requirements
C - MinorAssessmentIssue-basedStandard terms
类别资质审核监控协议
A - 关键现场审核年度评审质量协议
B - 主要问卷调查半年度评审质量要求
C - 次要评估问题触发式标准条款

Supplier Performance Metrics

供应商绩效指标

MetricTargetCalculation
Accept Rate>98%(Accepted lots / Total lots) × 100
On-Time Delivery>95%(On-time / Total orders) × 100
Response Time<5 daysAverage days to resolve issues
Documentation100%(Complete CoCs / Required CoCs) × 100
指标目标计算方式
验收率>98%(合格批次/总批次) × 100
准时交付率>95%(准时订单/总订单) × 100
响应时间<5天问题解决平均天数
文档完整性100%(完整CoC数量/所需CoC数量) × 100

QMS Process Reference

QMS流程参考

ISO 13485 Clause Structure

ISO 13485条款结构

ClauseTitleKey Requirements
4.1General RequirementsProcess identification, interaction, outsourcing
4.2DocumentationQuality Manual, procedures, records
5.1-5.5Management ResponsibilityCommitment, policy, objectives, organization
5.6Management ReviewInputs, outputs, records
6.1-6.4Resource ManagementPersonnel, infrastructure, environment
7.1Product Realization PlanningQuality plan, risk management
7.2Customer RequirementsDetermination, review, communication
7.3Design and DevelopmentPlanning, inputs, outputs, review, V&V, transfer, changes
7.4PurchasingSupplier control, purchasing info, verification
7.5ProductionControl, cleanliness, validation, identification, traceability
7.6Monitoring EquipmentCalibration, control
8.1Measurement PlanningMonitoring and analysis planning
8.2MonitoringFeedback, complaints, reporting, audits, process, product
8.3Nonconforming ProductControl, disposition
8.4Data AnalysisTrend analysis
8.5ImprovementCAPA
条款标题核心要求
4.1通用要求流程识别、交互、外包管理
4.2文档要求质量手册、程序文件、记录
5.1-5.5管理职责承诺、政策、目标、组织架构
5.6管理评审输入、输出、记录
6.1-6.4资源管理人员、基础设施、环境
7.1产品实现策划质量计划、风险管理
7.2顾客要求确定、评审、沟通
7.3设计与开发策划、输入、输出、评审、验证与确认、转移、变更
7.4采购供应商控制、采购信息、验证
7.5生产控制、清洁度、验证、标识、可追溯性
7.6监视设备校准、控制
8.1测量策划监视与分析策划
8.2监视反馈、投诉、报告、审核、流程、产品
8.3不合格品控制、处置
8.4数据分析趋势分析
8.5改进CAPA

Management Review Required Inputs (Clause 5.6.2)

管理评审必需输入（第5.6.2条款）

InputSourcePrepared By
Audit resultsInternal and external auditsQA Manager
Customer feedbackComplaints, surveysCustomer Quality
Process performanceProcess metricsProcess Owners
Product conformityInspection data, NCsQC Manager
CAPA statusCAPA systemCAPA Officer
Previous actionsPrior review recordsQMR
Changes affecting QMSRegulatory, organizationalRA Manager
RecommendationsAll sourcesAll Managers
输入来源编制人
审核结果内部与外部审核QA经理
顾客反馈投诉、调查顾客质量部
流程绩效流程指标流程所有者
产品合规性检验数据、不合格品QC经理
CAPA状态CAPA系统CAPA专员
过往行动历史评审记录QMR
影响QMS的变更法规、组织变更RA经理
建议所有来源所有经理

Record Retention Requirements

记录保留要求

Record TypeMinimum RetentionRegulatory Basis
Device Master RecordLife of device + 2 years21 CFR 820.181
Device History RecordLife of device + 2 years21 CFR 820.184
Design History FileLife of device + 2 years21 CFR 820.30
Complaint RecordsLife of device + 2 years21 CFR 820.198
Training RecordsEmployment + 3 yearsBest practice
Audit Records7 yearsBest practice
CAPA Records7 yearsBest practice
Calibration RecordsEquipment life + 2 yearsBest practice
记录类型最低保留期限法规依据
设备主记录设备全生命周期 + 2年21 CFR 820.181
设备历史记录设备全生命周期 + 2年21 CFR 820.184
设计历史文件设备全生命周期 + 2年21 CFR 820.30
投诉记录设备全生命周期 + 2年21 CFR 820.198
培训记录在职期间 + 3年最佳实践
审核记录7年最佳实践
CAPA记录7年最佳实践
校准记录设备使用寿命 + 2年最佳实践

Decision Frameworks

决策框架

Exclusion Justification (Clause 4.2.2)

排除项合理性说明（第4.2.2条款）

ClausePermissible ExclusionJustification Required
6.4.2Contamination controlProduct not affected by contamination
7.3Design and developmentOrganization does not design products
7.5.2Product cleanlinessNo cleanliness requirements
7.5.3InstallationNo installation activities
7.5.4ServicingNo servicing activities
7.5.5Sterile productsNo sterile products
条款允许排除项需提供合理性说明
6.4.2污染控制产品不受污染影响
7.3设计与开发组织不从事产品设计
7.5.2产品清洁度无清洁度要求
7.5.3安装无安装活动
7.5.4服务无服务活动
7.5.5无菌产品无无菌产品

Nonconformity Disposition Decision Tree

不合格品处置决策树

Nonconforming Product Identified
            │
            ▼
    Can it be reworked?
            │
       Yes──┴──No
        │       │
        ▼       ▼
    Is rework     Can it be used
    procedure     as is?
    available?        │
        │        Yes──┴──No
    Yes─┴─No     │       │
     │    │     ▼       ▼
     ▼    ▼  Concession  Scrap or
  Rework  Create    approval    return to
  per SOP  rework    needed?    supplier
          procedure     │
                    Yes─┴─No
                     │    │
                     ▼    ▼
                 Customer  Use as is
                 approval  with MRB
                          approval
识别到不合格品
            │
            ▼
    是否可返工？
            │
       是──┴──否
        │       │
        ▼       ▼
    是否有返工     是否可直接
    程序文件？     使用？
        │        │
    是─┴─否     是──┴──否
     │    │     │       │
     ▼    ▼     ▼       ▼
  按SOP返工  创建返工    需让步     报废或
            程序文件    批准？     退回供应商
                          │
                    是─┴─否
                     │    │
                     ▼    ▼
                 顾客批准  经MRB批准
                          后直接使用

CAPA Initiation Criteria

CAPA启动标准

SourceAutomatic CAPAEvaluate for CAPA
Customer complaintSafety-relatedAll others
External auditMajor NCMinor NC
Internal auditMajor NCRepeat minor NC
Product NCField failureTrend exceeds threshold
Process deviationSafety impactRepeated deviations
来源自动启动CAPA评估是否启动CAPA
顾客投诉安全相关其他所有情况
外部审核重大NC次要NC
内部审核重大NC重复次要NC
产品不合格现场失效趋势超出阈值
流程偏差安全影响重复偏差

Tools and References

工具与参考资料

Scripts

脚本

ToolPurposeUsage
qms_audit_checklist.pyGenerate audit checklists by clause or process
python qms_audit_checklist.py --help
Audit Checklist Generator Features:
  • Generate clause-specific checklists (e.g., 
    --clause 7.3
    )
  • Generate process-based checklists (e.g., 
    --process design-control
    )
  • Full system audit checklist (
    --audit-type system
    )
  • Text or JSON output formats
  • Interactive mode for guided selection
工具用途使用方法
qms_audit_checklist.py按条款或流程生成审核检查表
python qms_audit_checklist.py --help
审核检查表生成器功能：
  • 生成特定条款的检查表（如：
    --clause 7.3
    ）
  • 生成基于流程的检查表（如：
    --process design-control
    ）
  • 完整体系审核检查表（
    --audit-type system
    ）
  • 文本或JSON输出格式
  • 交互式引导选择模式

References

参考资料

DocumentContent
iso13485-clause-requirements.mdDetailed requirements for each ISO 13485:2016 clause with audit questions
qms-process-templates.mdReady-to-use templates for document control, audit, CAPA, supplier, training
文档内容
iso13485-clause-requirements.mdISO 13485:2016各条款详细要求及审核问题
qms-process-templates.md文档控制、审核、CAPA、供应商、培训等流程的即用模板

Quick Reference: Mandatory Documented Procedures

快速参考：必需成文程序

ProcedureClauseKey Elements
Document Control4.2.3Approval, distribution, obsolete control
Record Control4.2.4Identification, retention, disposal
Internal Audit8.2.4Program, auditor qualification, reporting
NC Product Control8.3Identification, segregation, disposition
Corrective Action8.5.2Root cause, implementation, verification
Preventive Action8.5.3Risk identification, implementation
程序条款核心要素
文档控制4.2.3审批、分发、作废控制
记录控制4.2.4标识、保留、处置
内部审核8.2.4审核计划、审核员资质、报告
不合格品控制8.3标识、隔离、处置
纠正措施8.5.2根本原因、实施、有效性验证
预防措施8.5.3风险识别、实施、验证

Related Skills

相关技能

SkillIntegration Point
quality-manager-qmrManagement review, quality policy
capa-officerCAPA system management
qms-audit-expertAdvanced audit techniques
quality-documentation-managerDHF, DMR, DHR management
risk-management-specialistISO 14971 integration
技能集成点
quality-manager-qmr管理评审、质量政策
capa-officerCAPA系统管理
qms-audit-expert高级审核技巧
quality-documentation-managerDHF、DMR、DHR管理
risk-management-specialistISO 14971集成