ISO 13485-2016 医疗器械-质量管理体系-用于法规的要求 中文版

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INTERNATIONAL
STANDARD ISO
13485
第3版
2016-03-01
医疗器械 —
质量管理体系—
用于法规的要求
Dispositifs médicaux — Systèm es de management de la qualité —
Exigences à des fins réglementaires
Reference number
ISO
13485:2016(E)
© ISO
2016
ISO 13485:2016(E)
2
© ISO 2016 – All rights reserved
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Tel. +41 22 749 01 11
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copyright@iso.org
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ISO 13485:2016(E)
3
© ISO 2016 – All rights reserved
目录 Page
前言
........ ..................................................................................................................................................................................................................................................v
引言................................................................................ ...... ..................................................................................................................................................................vi
1 范围 ..... ... .............................................................................................................................................................................................................................. 1
2 规范性引用文件........................................................................................................................................................................................................... 1
3 术语和定义 ......................................................................................................................................................................................................................... 1
4 质量管理体系.................................................................................................................................................................... ……………………………...……..6
4.1 总要求 ....................................................................................................................................................................... …………………………..…...6
4.2 文件要求........................................................................................................................................................................................................... 7
4.2.1 总则.................................................................................................................................................................................................. 7
4.2.2 质量手册 .................................................................................................................................................................................... 7
4.2.3 医疗器械文件 ........................................................................................................................................................................ 7
4.2.4 文件控制
.................................................................................................................................................................................... 8
4.2.5 记录控制 .................................................................................................................................................................................... 8
5 管理职责 ............................................................................................................................................................................................................................. 9
5.1 管理承诺........................................................................................................................................................................................................... 9
5.2 以顾客为关注焦点.................................................................................................................................................................................... 9
5.3 质量方针........................................................................................................................................................................................................... 9
5.4 策划....................................................................................................................................................................................................................... 9
5.4.1 质量目标...................................................................................................................................................................................... 9
5.4.2 质量管理体系策划 ............................................................................................................................................................. 9
5.5 职责、权限与沟通................................................................................................................................................................................. 10
5.5.1 职责与权限 ............................................................................................................................................................................. 10
5.5.2 管理者代表............................................................................................................................................................................. 10
5.5.3 内部沟通................................................................................................................................................................................... 10
5.6 管理评审 ........................................................................................................................................................................................................ 10
5.6.1 总则.............................................................................................................................................................................................. 10
5.6.2 输入评审................................................................................................................................................................................... 10
5.6.3 输出评审 ................................................................................................................................................................................... 11
6 资源管理...........................................................................................................................................................................................................................11
6.1 资源提供 ........................................................................................................................................................................................................ 11
6.2 人力资源 ........................................................................................................................................................................................................ 11
6.3 基础设施........................................................................................................................................................................................................ 12
6.4 工作环境和污染控制
..............................................................................................................................................................................
12
6.4.1 工作环境
.....................................................................................................................................................................................
12
6.4.2 污染控制................................................................................................................................................................................. 12
7 产品实现...........................................................................................................................................................................................................................12
7.1 产品实现的策划 ..................................................................................................................................................................................... 12
7.2 与顾客有关的过程................................................................................................................................................................................ 13
7.2.1 与产品有关的要求的确定
………………………………………...................................................................................
13
7.2.2 与产品有关的要求的审评…………………………... ................................................................................................. 13
7.2.3 顾客沟通
…………..
.............................................................................................................................................................. 14
7.3 设计和开发 .................................................................................................................................................................................................. 14
7.3.1
总则
............................................................................................................................................................................................... 14
7.3.2 设计和开发策划................................................................................................................................................................. 14
7.3.3 设计和开发输入................................................................................................................................................................. 14
7.3.4 设计和开发输出 ................................................................................................................................................................ 15
7.3.5 设计和开发评审
..................................................................................................................................................................
15
7.3.6 设计和开发验证................................................................................................................................................................ 15
7.3.7 设计和开发确认................................................................................................................................................................ 15
7.3.8 设计和开发转化
.................................................................................................................................................................
16
7.3.9 设计和开发更改的控制
...............................................................................................................................................
16
7.3.10 设计和开发文件................................................................................................................................................................ 16
ISO 13485:2016(E)
4
© ISO 2016 – All rights reserved
7.4
采购
..................................................................................................................................................................................................................... 17
7.4.1 采购过程 ................................................................................................................................................................................... 17
7.4.2 采购信息 ................................................................................................................................................................................... 17
7.4.3 采购产品的验证.................................................................................................................................................................... 17
7.5 生产和服务提供....................................................................................................................................................................................... 18
7.5.1
生产和服务提供的控制
............................................................................................................................ ....... .........
18
7.5.2
产品清洁................................................................................................................................. ………………………................ 18
7.5.3
安装活动 ............................................................................................................................................................................... ….18
7.5.4
服务活动
......................................................................................................................................................................................
19
7.5.5
无菌产品特殊要求
...............................................................................................................................................................
19
7.5.6
生产和服务提供过程的确认
..........................................................................................................................................
19
7.5.7
灭菌和无菌屏障系统的特殊要求
………………………………………............................................................................................................................................ 19
7.5.8
标示................................................................................................................................................................................................ 20
7.5.9
可追溯性 .................................................................................................................................................................................... 20
7.5.10
顾客财产.................................................................................................................................................................................... 20
7.5.11
产品防护 .................................................................................................................................................................................... 20
7.6
监视和测量装置的控制
......................................................................................... ....................................................................... 22
8 测量、分析和改进 ............................................................................................................................................................................................22
8.1
总则
..................................................................................................................................................................................................................... 22
8.2 监视和测量................................................................................................................................................................................................... 22
8.2.1 反馈
.................................................................................................................................................................................................
22
8.2.2 投诉处理 .................................................................................................................................................................................. 22
8.2.3 法规机构报告 ...................................................................................................................................................................... 23
8.2.4 内部审核 ................................................................................................................................................................................... 23
8.2.5 过程的监视和测量
.............................................................................................................................................................
23
8.2.6 产品的监视和测量
.............................................................................................................................................................
23
8.3 不合格品的控制
........................................................................................................................................................................................
24
8.3.1
总则
............................................................................................................................................................................................... 24
8.3.2 交付前发现不合格品的应对措施........................................................................................................................ 24
8.3.3 交付后发现不合格品的应对措施......................................................................................................................... 24
8.3.4 返工 ............................................................................................................................................................................................... 24
8.4 数据分析......................................................................................................................................................................................................... 24
8.5
改进
..................................................................................................................................................................................................................... 25
8.5.1
总则
................................................................................................................................................................................................ 25
8.5.2 纠错措施 ................................................................................................................................................................................... 25
8.5.3 防护措施.................................................................................................................................................................................... 25
附录 A (资料性附录) ISO 13485:2003 和 ISO 13485:2016 对照………………………………………………………………….......27
附录 B (资料性附录) ISO 13485:2016 and ISO 9001:2015 对应关系 ....................................................................................30
参考资料
.............................................................................................................................................................................................................................................36
(ISO 13485-2016 医疗器械-质量管理体系-用于法规的要求 中文版,(共43页),pdf,1.06MB,https://bjxwk.com/doc/150307/)
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