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2023年度内部审核计划
Annual Internal Audit Plan

审核计划编号: 2023-01 编号:ZL-JL-042 版本E1.0
Audit Plan Number: 202 3-0 1 Number: Z L-JL-042 Rev. E1.0

审核目的:
Purpose of Audit:

主要是检查本公司质量管理体系运行是否符合欧盟《医疗器械第2017/745法规》(MDR)、EN ISO13485:2016(GB/T42061-2022)《医疗器械质量管理体系 用于法规的要求》、EN ISO 11135-1:2014《医疗保健产品灭菌-环氧乙烷-第1部分:医疗器械灭菌过程开发、确认和常规控制要求》标准的要求、乌克兰《КАБІНЕТ МІНІСТРІВ УКРАЇНИ ПОСТАНОВА《医疗器械监督管理条例》、《医疗器械生产质量管理规范》等质量管理体系法规要求及相关标准的要求
It is mainly to check whether the operation of the company's quality management system complies with the EU Medical Device Regulation 2017/745 (MDR) and EN ISO13485:2016 (GB/T42061-2022). Requirements of the standard "Quality Management Systems for Medical Devices – Requirements for Regulation", EN ISO 11135-1:2014 "Sterilization of healthcare products – Ethylene oxide – Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices", КАБІНЕТМІНІ І Н І of Ukraine СТРІВУКРАЇНИПОСТАНОВА", "REGULATIONS ON THE SUPERVISION AND ADMINISTRATION OF MEDICAL DEVICES", "GOOD MANUFACTURING PRACTICES FOR MEDICAL DEVICES", ETCRequirements of quality management system regulations and related standards.

审核范围(包括部门、场所、过程 和活动):
Scope of the audit (including department, site, process, and activity):

质量管理体系覆盖下的手术包类、手术衣类、手术单、手术膜、医用口罩类、医用帽、医用隔离鞋套、隔离衣医用检查手套、医用垫单、洁净服、负压引流器等产品,质量管理体系覆盖的所有部门和要素。
All departments and elements covered by the quality management system include surgical kits, surgical gowns, surgical sheets, surgical membranes, medical masks, medical caps, medical isolation shoe covers, isolation gowns, medical examination gloves, medical pads, clean clothes, negative pressure drainage devices and other products covered by the quality management system.

审核依据:
Audit basis:

欧盟《医疗器械第2017/745法规》(MDR)、EN ISO13485:2016(GB/T42061-2022)《医疗器械质量管理体系 用于法规的要求》、EN ISO 11135-1:2014《医疗保健产品灭菌-环氧乙烷-第1部分:医疗器械灭菌过程开发、确认和常规控制要求》标准的要求、乌克兰《КАБІНЕТ МІНІСТРІВ УКРАЇНИ ПОСТАНОВА《医疗器械监督管理条例》、《医疗器械生产质量管理规范》、《医疗器械生产质量管理规范无菌医疗器械现场检查指导原则》(以下简称:《指导原则》)公司质量手册及相关质量管理体系文件、产品标准。
EU Medical Device Regulation 2017/745 (MDR), EN ISO13485:2016 (GB/T42061-2022) "Medical Device Quality Management System – Requirements for Use in Regulations", EN ISO 11135-1:2014 "Sterilization of Healthcare Products – Ethylene Oxide – Part 1: Development of Sterilization Process for Medical Devices, REQUIREMENTS FOR CONFIRMATION AND ROUTINE CONTROL", UKRAINIAN КАБІНЕТМІНІСТРІВУКРАЇНИПОСТАНОВА", "Regulations on the Supervision and Administration of Medical Devices", "Good Manufacturing Practice for Medical Devices", "Guiding Principles for On-site Inspection of Sterile Medical Devices under Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Guiding Principles"), the company's quality manual and related quality management system documents, Product standards.

审核类型:内部质量管理体系的集中审核。
Audit Type: Centralized audit of the internal quality management system.

审核组组长、成员:
Audit Team Leader and Members:

审核组长:陈淑玲 审核组员: 刘容、胡娟、赵菡
Audit team leader: Chen Shuling Audit team members: Liu Rong, Hu Juan, Zhao Han

审核时间: 2023年1213日-15
Review time: January 13-15, 2023

注:各部门审核要素和审核日程安排计划。
Remarks: Elements of the review and audit schedule of each department.

编制/日期: 刘容/ 2023年12月07日 批准/日期:
Prepared / Date: Liu Rong / 07 December 2023 Approved / Date:

2023内部审核日程安排计划
2023 Internal Audit Schedule

审核日期
Date of review

2023年1213日-15
2023 1February 13-15

受审核部门
Audited department

总经理、管理者代表、人事行政部、技术部、生管部、质量部、制造部、设备部、销售部
General Manager, Management Representative, Personnel Administration Department, Technology Department, Production Management Department, Quality Department, Manufacturing Department, Equipment Department, Sales Department

审核要求标准要求
Audit requirements, standard requirements

欧盟《医疗器械第2017/745法规》(MDR)、EN ISO13485:2016(GB/T42061-2022)《医疗器械质量管理体系 用于法规的要求》、EN ISO 11135-1:2014《医疗保健产品灭菌-环氧乙烷-第1部分:医疗器械灭菌过程开发、确认和常规控制要求》标准的要求、乌克兰《КАБІНЕТ МІНІСТРІВ УКРАЇНИ ПОСТАНОВА、《医疗器械监督管理条例》、《医疗器械生产质量管理规范》、《医疗器械生产质量管理规范无菌医疗器械现场检查指导原则》(以下简称:《指导原则》)公司质量手册及相关质量管理体系文件、产品标准
EU Medical Device Regulation 2017/745 (MDR), EN ISO13485:2016 (GB/T42061-2022) "Medical Device Quality Management System – Requirements for Use in Regulations", EN ISO 11135-1:2014 "Sterilization of Healthcare Products – Ethylene Oxide – Part 1: Development of Sterilization Process for Medical Devices, REQUIREMENTS FOR CONFIRMATION AND ROUTINE CONTROL", UKRAINE КАБІНЕТМІНІСТРІ В УКРАЇНИПОСТАНОВА", "Regulations on the Supervision and Administration of Medical Devices", "Good Manufacturing Practice for Medical Devices", "Guiding Principles for On-site Inspection of Sterile Medical Devices under Good Manufacturing Practice for Medical Devices" (hereinafter referred to as the "Guiding Principles"), the company's quality manual and related quality management system documents, product standards

日 期
Date

时 间
Time

内审员
Internal auditors

受审核部门
Audited department

审核依据章节及条款号
The review is based on the chapter and clause number

12月13日
December 13th

13:00-13:40

首次会议
First meeting

14:00-15:00

胡 娟
Hu Juan

总经理
managing director

4.1/5.1/5.2/5.3/5.4/5.5/5.6/6.1及相对应的《指导原则》
4.1/5.1/5.2/5.3/5.4/5.5/5.6/6.1 and their corresponding Guiding Principles

14:00-16:00

赵菡
Zhao Han

管理者代表
Representatives of managers

4.1/4.2.1/4.2.2/5.4/5.5/5.6

/8.1/8.2.3/8.2.4/8.2.5/8.5及相对应的《指导原则》
/8.1/8.2.3/8.2.4/8.2.5/8.5 and corresponding Guiding Principles

法规符合性负责人
Head of Regulatory Compliance

MDR第15条法规符合性负责人/第 84条(质量手册9.6.1)上市后监管计划
Head of Regulatory Compliance of Article 15 of the MDR / Article 84 (Quality Manual 9.6.1) Post-Market Regulatory Planning

MDR 第10.9条/附录(9)IX第2.2条MDR合规战略性计划、确保器械符合MDR法规的质量管理体系
MDR Article 10.9 / Annex (9) IX Article 2.2 MDR Compliance Strategic Plan, Quality Management System to Ensure Device Compliance with MDR Regulations

14:00-15:30

刘 容
Liu Rong

人事行政部
Department of Personnel Administration

5.5/6.2/6.3/6.4及相对应的《指导原则》
5.5/6.2/6.3/6.4 and their corresponding Guiding Principles

15:10-17:30

胡 娟
Hu Juan

技术部
Technical Department

4.2.3/7.1/7.3/7.3.4/7.3.5//7.3.6/7.3.7/7.3.8//7.3.9/7.3.10/7.5.1/7.5.6/7.5.7及相对应的《指导原则》
4.2.3/7.1/7.3/7.3.4/7.3.5//7.3.6/7.3.7/7.3.8//7.3.9/7.3.1/7.5.1/7.5.6/7.5.7 and their corresponding Guiding Principles

附录I第III章产品随附信息 (质量手册9.2.1)MDR附录(8)Ⅷ产品分类规则/(质量手册9.4.1)/MDR 第83/84/89上市后监管、警戒和市场监督(质量手册9.6)
Appendix I, Chapter III, Information accompanying products (Quality Manual 9.2.1) MDR Appendix (8) VIII. Product Classification Rules/(Quality Manual 9.4.1)/MDR Article 83/84/89 Post-Market Surveillance, Vigilance and Market Surveillance (Quality Manual 9.6)

12月14日
December 14th

8:20-11:00

陈淑玲
Chen Shuling

生管部
Department of Health Management

7.4//7.5.1/7.5.10/7.5.11及相对应的《指导原则》
7.4//7.5.1/7.5.10/7.5.11 and their corresponding Guiding Principles

8:20-11:00

胡 娟
Hu Juan

制造部
Manufacturing Department

6.4/7.5.1/7.5.2/7.5.4/7.5.5/7.5.7/7.5.8/7.5.9//7.5.11/8.3及相对应的《指导原则》
6.4/7.5.1/7.5.2/7.5.4/7.5.5/7.5.7/7.5.8/7.5.9//7.5.11/8.3 and their corresponding Guiding Principles

08:00-09:00

刘 容
Liu Rong

设备部
Equipment Department

6.3/6.4及相对应的《指导原则》
6.3/6.4 and their corresponding Guiding Principles

12月14日
December 14th

08:00-11:00

赵 菡
Zhao Han

质量部
Quality Department

4.2.4(法规MDR -第10条附录9(IX)第III章)/4.2.5/6.4/7.4/7.6//7.5.8/7.5.9/7.6/8.2.1/8.2.2/8.2.3(MDR第87 报告严事件和现场安全纠正措)/8.2.4/8.2.5/8.2.6/8.3/8.4/8.5及相对应的《指导原则》
4.2.4 (Regulation MDR - Regulation 10, Appendix 9(IX) Chapter III) / 4.2.5/6.4/7.4/7.6//7.5.8/7.59/7.6/8.2.1/8.2.2/8.2.3 (MDR No. 87 reporting of critical incidents and on-site safety corrective actions)/8.2.4/8.2.5/8.2.6/8.3/8.4/8.5 and corresponding Guiding Principles

MDR 第 24/27条(UDI标识)(手册9.3.1)/MDR 第90条(手册9.6.3)警戒/MDR 第83/84/89/(质量手册9.6)上市后监管、警戒和市场监督/MDR 第34条Eudamed数据库(质量手册9.2.2)、MDR第19条(质量手册9.2.5符合性声明)
MDR Article 24/27 (UDI Marking) (Manual 9.3.1) / MDR Article 90 (Manual 9.6.3) Vigilance / MDR Article 83/84/89 / (Quality Manual 9.6) Post-Market Regulation, Vigilance and Market Surveillance / MDR Article 34 Eudamed database (Quality Manual 9.2.2), MDR Article 19 (Quality Manual 9.2.5 Declaration of Conformity).

12月14日
December 14th

13:00-1430

刘 容
Liu Rong

销售部
Sales Department

7.2/8.2.1/8.2.2/8.3.3((MDR 第95条)对健康和安全带来不可接受风险的器械的处理程序产品召回
7.2/8.2.1/8.2.2/8.3.3 ((Article 95 MDR) Procedures for the handling of devices that pose an unacceptable risk to health and safety (product recalls).)

12月14日
December 14th

15:00-17:00

审核组整理资料、内部会议
The audit team organizes materials and holds internal meetings

12月15日
December 15th

09:30-11:00

末次会议
Final meeting

说明:
Illustrate:

1. 审核要素标准条款号为EN ISO13485:2016(GB/T42061-2022)条款号。
1. The standard clause number of the audit element is EN ISO13485:2016 (GB/T42061-2022) clause number.

2.《医疗器械生产质量管理规范无菌医疗器械现场检查指导原则》条款号与EN ISO13485:2016(GB/T42061-2022)对应条款见附件。
2. The article number of the "Guiding Principles for On-site Inspection of Sterile Medical Devices in Good Manufacturing Practice for Medical Devices" and the corresponding clauses of EN ISO13485:2016 (GB/T42061-2022) are shown in the annex.

3.《医疗器械第2017/745法规》(MDR)章节要求
3. Requirements of the Medical Device Regulation 2017/745 (MDR) chapter.