医疗器械质量管理体系内审 Internal Audit of Medical Device Quality Management Sys

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医疗器械质量管理体系内审（Internal Audit）是企业依据法规和标准（如ISO 13485、KGMP、FDA QSR等）对自身质量管理体系（QMS）进行的系统性、独立的检查与评估。其核心目的是验证体系的符合性、有效性与持续改进性，为管理评审提供输入，并为外部审核（如认证机构、药监局检查）做好准备.



Internal Audit of Medical Device Quality Management System is a systematic and independent inspection and evaluation of a company's Quality Management System (QMS) based on regulations and standards such as ISO 13485, KGMP, FDA QSR, etc. Its core purpose is to verify the compliance, effectiveness, and continuous improvement of the system, provide input for management reviews, and prepare for external audits (such as certification bodies and drug regulatory inspections)

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医疗器械内审的重要性作用说明
合规性验证确保体系符合ISO 13485、MDD/MDR、FDA 21 CFR Part 820、KGMP等法规要求。
问题发现与预防主动识别流程漏洞、执行偏差和潜在风险，防止问题升级。
持续改进驱动通过发现不符合项（NC）和改进建议（Opportunity for Improvement），推动CAPA。
外部审核准备模拟药监局（如NMPA、FDA、MFDS）或公告机构检查，降低不通过风险。
管理层决策支持为管理评审提供客观证据，评估体系整体绩效
The Importance of Internal Audit in Medical Devices
Function Description
Compliance verification ensures that the system complies with regulatory requirements such as ISO 13485, MDD/MDR, FDA 21 CFR Part 820, KGMP, etc.
Proactively identify process vulnerabilities, execution deviations, and potential risks to prevent problem escalation.
Continuous improvement drives CAPA by identifying non conformities (NCs) and providing opportunities for improvement.
Prepare for external audits to simulate inspections by drug regulatory agencies (such as NMPA, FDA, MFDS) or notified bodies, in order to reduce the risk of failure.
Management decision support provides objective evidence for management review and evaluates the overall performance of the system

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审的核心依据

• ISO 13485:2016：医疗器械质量管理体系的国际通用标准。
• 适用的法规要求：
  • 中国：《医疗器械生产质量管理规范》（GMP）
  • 美国：FDA 21 CFR Part 820（QSR）
  • 欧盟：MDR (EU) 2017/745 / IVDR (EU) 2017/746
  • 韩国：KGMP
  • 日本：J-GMP
    
• 企业内部文件：
  
  • 质量手册（Quality Manual）
  • 程序文件（SOPs）
  • 作业指导书（WI）
  • 记录表格
  • 已批准的计划（如：验证计划、培训计划）
    

The core basis of the review
ISO 13485:2016: International standard for quality management systems for medical devices.
Applicable regulatory requirements:
China: Good Manufacturing Practice (GMP) for Medical Device Production
United States: FDA 21 CFR Part 820 (QSR)
EU: MDR (EU) 2017/745/IVDR (EU) 2017/746
South Korea: KGMP
Japan: J-GMP
Internal documents of the enterprise:
Quality Manual
Program Files (SOPs)
Homework Instruction Book (WI)
Record Form
Approved plans (such as validation plans, training plans)

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医疗器械内审全流程（PDCA循环）
🔹 阶段1：策划（Plan）
制定年度内审计划
确定审核频率（通常每年至少一次全面审核，关键部门可增加频次）。
覆盖所有部门、过程和场所。
考虑上次审核结果、变更、投诉、不良事件等风险因素。
组建审核组
选择经过培训且独立于被审核部门的内审员。
指定审核组长，负责整体协调。
确保内审员具备医疗器械行业知识和审核技巧。
编制审核检查表（Checklist）
基于ISO 13485条款和企业SOP，逐项列出审核内容。
发布审核通知
提前1-2周通知被审核部门，明确时间、范围、审核员。
🔹 阶段2：执行（Do）
首次会议（Opening Meeting）
介绍审核组成员、目的、范围、方法、日程。
确认审核计划，澄清疑问。
现场审核（现场+文件）
方法：“查、看、问、记”
抽样原则：基于风险，关注关键过程、高投诉环节、新员工/新设备。
重点审核过程（根据ISO 13485）：
管理职责（4-5章）
资源管理（6章）
产品实现（7章）：特别是设计开发、采购、生产与服务提供、过程确认
测量、分析与改进（8章）：监控与测量、不合格品控制、CAPA、内部审核、管理评审
审核发现整理
将收集的证据与审核准则对比，判断是否符合。
识别不符合项（Nonconformity, NC） 和观察项/改进建议（Observation/OFI）。
🔹 阶段3：报告（Check）
末次会议（Closing Meeting）
审核组长口头通报审核发现，包括：
审核过程概述
不符合项（明确条款、事实描述、证据）
观察项/改进建议
初步结论（如：体系整体有效，但需改进XX）
允许被审核方澄清事实。
编制《内部审核报告》
报告内容：
不符合项清单（必须包含）：
不符合条款（如：ISO 13485 7.5.1.1）
审核结论（体系是否有效运行）
🔹 阶段4：改进（Act）
不符合项整改（CAPA）
根本原因：培训计划未及时更新，HR未通知QA新员工入职。
纠正：立即安排该员工补训并考核
管理评审输入
将内审报告、整改情况作为管理评审的重要输入，由最高管理者评估体系整体绩效。
知识沉淀
将典型不符合项和整改经验纳入培训教材或“经验教训库”，防止重复发生。

Medical Device Internal Audit Process (PDCA Cycle)
🔹  Stage 1: Planning
Develop an annual internal audit plan
Determine the audit frequency (usually at least once a year for comprehensive audits, and key departments may increase the frequency).
Covering all departments, processes, and locations.
Consider risk factors such as the results of the previous audit, changes, complaints, and adverse events.
Establish an audit team
Select trained internal auditors who are independent of the audited department.
Designate an audit team leader responsible for overall coordination.
Ensure that internal auditors possess knowledge and audit skills in the medical device industry.
Prepare an audit checklist
List the audit contents item by item based on ISO 13485 clauses and enterprise SOP.
Publish audit notification
Notify the audited department 1-2 weeks in advance, specifying the time, scope, and auditor.
🔹  Stage 2: Execution (Do)
Opening Meeting
Introduce the members, purpose, scope, methods, and schedule of the audit team.
Confirm the audit plan and clarify any doubts.
On site audit (on-site+document)
Method: "Search, Look, Ask, Record"
Sampling principle: Based on risk, focus on key processes, high complaint areas, and new employees/equipment.
Key audit process (according to ISO 13485):
Management Responsibilities (Chapters 4-5)
Resource Management (Chapter 6)
Product Implementation (Chapter 7): Especially Design and Development, Procurement, Production and Service Provision, Process Confirmation
Measurement, Analysis, and Improvement (Chapter 8): Monitoring and Measurement, Nonconforming Product Control CAPA、 Internal audit, management review
Review findings and organization
Compare the collected evidence with the audit criteria to determine if it meets the requirements.
Identify nonconformity (NC) and observation/improvement suggestions (Observation/OFI).
🔹  Stage 3: Report (Check)
Closing Meeting
The audit team leader verbally reported the audit findings, including:
Overview of the Audit Process
Non conformities (clear terms, factual description, evidence)
Observation items/improvement suggestions
Preliminary conclusion (e.g. overall effectiveness of the system, but improvement is needed for XX)
Allow the audited party to clarify the facts.
Prepare the Internal Audit Report
Report content:
Non conformance list (must include):
Does not comply with the terms (e.g. ISO 13485 7.5.1.1)
Audit conclusion (whether the system is effectively operating)
🔹  Stage 4: Improvement (Act)
Corrective Action for Nonconformities (CAPA)
Root cause: The training plan was not updated in a timely manner, and HR did not notify QA of the new employee's onboarding.
Correction: Immediately arrange for the employee to receive supplementary training and assessment
Management review input
Take internal audit reports and rectification situations as important inputs for management review, and have the top management evaluate the overall performance of the system.
Knowledge accumulation
Include typical non conformities and rectification experiences in training materials or "experience training libraries" to prevent recurrence.

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