GHTF—质量管理体系--过程验证指南中文版

GHTF—质量管理体系工艺验证指南中文版GHTF（全球医疗保健技术论坛）的质量管理体系工艺验证指南是一个重要的标准文件，用于指导医疗保健产品制造商在产品设计和生产过程中进行工艺验证。

该指南旨在确保医疗保健产品的质量和安全性，并要求制造商在产品生命周期的各个阶段执行工艺验证活动。

工艺验证是通过实际操作验证工艺的能力和有效性，以确保产品符合预期的要求。

该指南介绍了工艺验证的步骤、要求和方法，以帮助制造商开展有效的验证活动。

首先，该指南明确了工艺验证的目标和范围。

工艺验证的目标是验证工艺的适用性、一致性和稳定性，以确保产品在正常使用条件下的质量和性能符合设计和预期要求。

工艺验证的范围包括所有与产品质量和性能相关的制造和生产过程。

其次，该指南提供了实施工艺验证的步骤和要求。

制造商应在产品设计和开发的早期阶段就开始考虑工艺验证，并制定验证计划。

验证计划应包括验证的目标、方法、资源和时间计划等信息。

验证计划还应考虑产品的特性、使用情况和预期效果等因素。

然后，该指南描述了工艺验证的方法和技术。

工艺验证可以通过实验室测试、实地观察、数据分析和问题解决等方式进行。

制造商可以选择适当的方法和技术，以满足验证的要求。

此外，该指南还提供了一些常用的验证工具和技术，如故障模式和效应分析（FMEA）、统计过程控制（SPC）和实验设计等。

最后，该指南还强调了工艺验证的重要性和效益。

正确执行工艺验证可以帮助制造商发现和解决潜在的质量问题，提高产品的可靠性和安全性，降低制造成本，增加客户满意度。

因此，制造商应将工艺验证作为质量管理体系的重要组成部分，并持续改进验证活动。

总而言之，GHTF的质量管理体系工艺验证指南为医疗保健产品制造商提供了一套规范和指导，以帮助他们开展有效的工艺验证活动。

制造商应根据该指南的要求和方法，制定并执行适当的验证计划，以确保产品质量和性能符合预期要求。

GHTF特殊过程确认指南GHTF(全球医疗技术论坛)特殊过程确认指南是一个在医疗器械领域使用的国际标准指南，旨在帮助医疗器械制造商确定和管理特殊过程的合规性。

以下是对GHTF特殊过程确认指南的详细解析。

特殊过程在医疗器械的生产过程中起到至关重要的作用。

它们是生产过程中无法直接控制的步骤，但却直接影响着产品的质量和安全性。

特殊过程可能包括材料加工、表面处理、灭菌等一系列步骤。

由于这些过程的特殊性，制造商需要采取特殊的控制措施来确保产品的质量。

指南分为三个主要部分：前言、正文和附录。

前言部分详细介绍了特殊过程的定义、重要性和控制措施的目的。

它还列举了指南适用的产品范围，以及制造商在实施特殊过程控制方案时应考虑的因素。

正文部分是指南的核心内容，包括特殊过程的管理要求和实施细节。

它包括以下几个方面：1.特殊过程的分类：指南将特殊过程分为三个基本类别，每个类别有不同的管理要求。

这些类别分别是：关键特殊过程、验证特殊过程和巩固特殊过程。

2.特殊过程的管理要求：指南详细阐述了每个特殊过程类别所需的管理要求。

这些要求涉及特殊过程的控制、验证、记录和审计等方面。

3.特殊过程控制方案的实施：指南描述了制造商在实施特殊过程控制方案时应遵循的步骤。

这些步骤包括：制定控制计划、制定验证计划、执行验证和审计等。

附录部分提供了一些附加信息，例如：特殊过程控制计划的模板、验证计划的示例和特殊过程审计的指导。

总的来说，GHTF特殊过程确认指南是一个对医疗器械制造商非常实用的指南。

它提供了一种清晰的方法，帮助制造商确定和管理特殊过程的合规性。

通过遵循该指南，制造商可以确保特殊过程的有效控制，从而提高产品的质量和安全性。

标题：质量管理体系——过程确认指南编写：GHTF 第 3 研究组签署：全球协调任务组织日期：2004 年 1 月第 2 版Taisuke Hojo, GHTF 主席本文件由全球协调任务组织制作，该组织是一个志愿团体，由医疗器械管理机构和管理行业的代表组成。

本文件着重为管理机构提供关于医疗器械法规使用方面的非约束性指导，其撰写是经过多方面征求意见的。

本文件的印制、发售或使用是不受限制的。

但是，将本文件部分或全部引用到其它文件，或将它翻译成英语以外的其它语言，均不代表全球协调任务组织认同。

GHTF 第 3 研究组—质量管理体系过程确认指南— 2004 年 1 月第2页过程确认指南目录0 前言 (3)1 目的和范围 (5)1.1 目的 (5)1.2 范围 (5)2 定义 (5)3 质量管理体系范围内的过程确认 (5)3.1 过程确认的判定 (6)3.2 举例 (7)4 过程确认的统计方法和工具 (8)5 确认的实施 (8)5.1 准备阶段 (8)5.2 方案编制 (9)5.3 安装鉴定（IQ） (10)5.4 操作鉴定（OQ） (10)5.5 性能鉴定（PQ） (11)5.6 最终报告 (12)6 确认状态的保持 (12)6.1 监视和控制 (12)6.2 过程和（或）产品的改变 (12)6.3 连续的控制状态 (12)6.4 再确认原因举例 (12)7 过程确认中历史数据的使用 (13)8 活动小结 (13)附录A 过程确认的统计方法和工具 (15)B 确认的举例 (25)0 前言由于在 ISO 13485:2003 中内容有变化，修改后的“质量管理体系——过程确认指南”（原发表于 1999 年）重新发表名为“GHTF/SG3/N99-10:2004（第 2 版本）”的文件，它被使用于一些管理体系里。

过程确认指南从 0 到 3.4 部分、图一到附录B 都进行了修改。

修改分为两种类型：1）为符合 ISO 13485:2003，对术语进行编辑上的修改（例如，“质量体系”改为“质量管理体系”，“设计控制”改为“设计与开发控制”）；2）为反映 ISO 13485:2003 中 7.5.2 条的新过程确认要求，对图1 和相应文本所做的修改。

GHTF—质量治理体系--工艺验证指南中文版〔可编辑〕GHTF—质量治理体系--工艺验证指南中文版GHRFSG3N99-102023 第 2 版最终文件标题质量治理体系过程确认指南编写 GHTF 第 3 争论组签署全球协调任务组织日期 2023 年 1 月第 2 版TaisukeHojo GHTF 主席本文件由全球协调任务组织制作该组织是一个志愿团体由医疗器械治理机构和治理行业的代表组本钱文件着重为治理机构供给关于医疗器械法规使用方面的非约束性指导其撰写是经过多方面征求意见的本文件的印制出售或使用是不受限制的但是将本文件局部或全部引用到其它文件或将它翻译成英语以外的其它语言均不代表全球协调任务组织认同GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第2 页过程确认指南名目0前言 31目的和范围 511目的 512范围 52定义 53质量治理体系范围内的过程确认5 31过程确认的判定 632举例 74过程确认的统计方法和工具 85确认的实施 851预备阶段 852方案编制 953安装鉴定 IQ 1054操作鉴定 OQ 1055性能鉴定 PQ 1156最终报告 126 确认状态的保持 1261监视和掌握 1262过程和或产品的转变 1263连续的掌握状态 1264再确认缘由举例 127过程确认中历史数据的使用 138活动小结 13附录A 过程确认的统计方法和工具 15B 确认的举例 25GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第3 页0 前言由于在 ISO 134852023 中内容有变化修改后的质量治理体系过程确认指南原发表于 1999 年重发表名为 GHTFSG3N99-102023 第2 版本的文件它被使用于一些治理体系里过程确认指南从 0 到 34 局部图一到附录B 都进展了修改修改分为两种类型 1 为符合 ISO 134852023 对术语进展编辑上的修改例如质量体系改为质量治理体系设计掌握改为设计与开发掌握 2 为反映 ISO 1348520com 过程确认要求对图1 和相应文本所做的修改本过程确认指南有助于厂商了解过程确认方面的质量治理体系要求它对医疗器械的生产过程包括修理和安装具备一般可应用性本指南为厂商预备和实施过程确认供给了一般性建议过程确认是医疗器械行业使用的一个术语它表示过程有经过认真的检查其结果产品效劳或其它输出是有保证的对于产品的预定要求仅能够通过破坏性试验来保证的过程确认起着相当重要的作用在进一步加工半成品或将成品投入使用后可能会暴露加工缺陷当过程在规定范围内进展操作时过程确认必需证明该过程将连续产出符合预定设计与开发要求的产品医疗器械行业包含了很多的技术和应用从简洁的手工工具到简单的数控外科仪器从嵌入式螺钉到人造器官从血糖试纸到诊断成像系统和试验室测试设备这些器材都是由各种规格构造产量生产过程和治理方法组合在一起生产出来的这些要素尤其是每样器材的产量和生产步骤的数目如焊接步骤在很大程度上影响了过程确认的实际应用由于存在多样性本指南不建议特定的过程确认的实施方法因此它不能用来评估器材是否符合质量治理体系要求本指南目的在于通过符合实际的解释和过程确认原理的举例来扩大质量治理体系要求的内容厂商可以也应当找出或选择特地的技术指南将过程确认应用到实际情形里本指南为厂商预备和实施过程确认供给了一般性建议或许还存在其它同样可行的方法有些治理要求将责任归到厂商身上即规定哪些要求确认的过程和操作确认过程的人员的资格除了用于过程确认的方法外全部确认活动的记录都应保持下来并将最终结果形成文件尽管过程确认的完成是一项治理要求厂商还可以通过确认的过程来提高总体质量消退废品降低本钱提高客户满足度等等结适宜当掌握的设计与开发活动一个经过确认的过程可以很好地缩短产品投入市场的时间GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第4 页一般说来过程确认是厂商用来筹划猎取数据记录数据和解译数据的机制或体系这些活动可分为三个阶段 1 第一个阶段对使用设备和必要效劳规定的一个初始鉴定也作安装鉴定 IQ2 对过程产生可承受的结果和建立过程参数限制范围最坏状况的一个证明也作操作鉴定 OQ 和3 长期过程稳定性的建立也作性能鉴定 PQ很多过程都是由电脑掌握的虽然电脑软件是过程中一个必要的局部但本指南不涉及软件确认尽管过程确认的原理是合理易懂的但是厂商打算评估每个潜在的过程确认可能会引起不确定性有些治理要求规定了全部的不能由后续的监控来验证或由措施来确认的过程由此供给了这样一份指南帮助打算是否要进展确认GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第5 页1 目的和范围11目的本过程确认指南有助于厂商了解关于过程确认的质量体系治理要求12范围本文件对医疗器械的生产过程包括修理和安装具备一般可应用性本文件提出了关于验证设计输出与设计确认的具体建议设计输出与设计确认见GHTF 文件中涉及设计掌握的局部2 定义对于本文件以下的定义均适用除了本文件所定义的术语外其它术语可在文件资料中找到21安装鉴定 IQ 有客观证据支持即正确地考虑到全部符合厂商规格的过程设备和关心安装系统的主要布置和设备供给商的说明22操作鉴定 OQ 有客观证据支持即使产品符合全部预定要求的过程掌握范围和作用程度23性能鉴定 PQ 有客观证据支持即在预期条件下过程连续地产出符合全部预定要求的产品24过程确认有客观证据支持即过程将连续地产出符合预定要求的结果或产品25过程确认方案说明如何实施确认的文件包含了测试参数产品特性生产设备和由什么构成可承受测试结果的推断要点26验证通过检查和供给客观证据来确定产品已符合规定的要求3 质量治理体系范围内的过程确认过程确认是质量治理体系总体要求的一局部它是通过一个系统来实施的该系统包含了设计与开发掌握质量保证过程掌握订正和预防措施对某些技术来说设计掌握和过程开发可能是严密相联的而对其它的则可能是不相关的产品的结实性应设计得足以承受住生产过程的变化生产过程的力量和稳定性应保证连续产出的安全产品运行正常这往往会使产品开发和过程开发活动相互猛烈影响GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第6 页日常测量和监控活动的实施是依据过程掌握方案的规定来进展的过程掌握方案往往在过程确认当中得到很大地改进订正措施往往确定了不完整的过程或过程确认每个应用于生产过程的订正措施应包含过程确认的实施或进展再确认的理由31 过程确认的判定以下图可能有助于判定一个过程是否需要进展确认ABCIs ProcessIs Verification VerifyOutput Yes YesSufficient Control theCost Effective ProcessVerifiableNo NoEDRedesignValidate ProductandorProcess图一过程确认判定的树状图上图描绘了一个判定的树状图依据上图厂商可打算什么时候过程是否需要进展确认上图表示的过程可能是最简洁的很多过程可能更大和或有简单的支干过程每个过程都应制定一个规格该规格规定了过程参数和期望的输出厂商应考虑该输出是否可通过后续的监控或测量来验证 A 假设可以那么应当考虑是否GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第7 页仅凭验证便足以消退不行承受的风险并且该验证是一个本钱效益方案 B 假设是应对输出进展验证并且正确地掌握该过程 C假设不能验证该过程输出那么应打算对该过程进展确认D或者明显的做法是重设计产品或过程来削减变化使产品或过程得到改进 E 同时生产过程的改进促进了对该过程进展确认的需要尽管之前该过程仅要求验证和掌握重设计产品或过程使得单一的验证成为可承受的打算这样的设计可能有助于降低风险或本钱 E32 举例以下内容是关于过程举例的清单 1 应确认的 2 可以阅历证便成功覆盖的和 3 可以被验证的过程但是出于商业目的可以选择确认或不确认1应确认的过程消毒过程清洁室的环境条件无菌填充过程无菌包装密封过程低压冻干过程热处理过程电镀过程注塑成形过程2可以阅历证便成功掩盖的过程手动切割过程溶液的颜色混浊度总 pH 值的测试方案印制板的目测检查电缆线束的制造和测试3以上模式中可能需要进展确认的过程清洁过程手工装配过程数控切割过程填充过程在验证某个过程输出的同时应确认用于该过程的软件应用确定软件符合其预期用途GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第8 页4过程确认的统计方法和工具用于过程确认的工具和方法有很多种附录 A 介绍了初步的统计和过程确认方法各个方法的根本概念可以作为一个指导其中包括了掌握图表力量争论试验设计容差分析强化设计方案故障状态效应分析抽样方案和反正法5确认的实施51 预备阶段首先考虑组建一个多功能小组来打算和监视确认活动制定一个小组工作步骤将有助于保证确认过程的顺当进展方案编制的全面性把最终确定的整个过程形成文件并便利追溯该小组应能够指出什么地方可能会出错同时对于主要的功能范围该小组要能够供给这样一个时机及早地就重要的产品改进产品和过程进展沟通并促进合作确认小组的成员可包含来自以下专业领域的代表或特地从事以下工作的人员质量保证工程生产其它取决于公司的组织和产品类型试验室技术效劳研发治理业务临床工程选购或打算一旦已组成确认小组下一步便是制定步骤和规定要求很多厂商都制定了主要确认方案该方案明确了哪些要确认的过程确认过程的进度表要求确认的过程和再确认过程时间选定上的相互关系一旦确定了上述内容清楚地规定确认的目的和范围并对外告知方案的编制便可以着手进展了以下是活动清单可用于对确认活动进展回忆形成确认的多功能小组制定步骤和规定要求确定和描述过程规定过程参数和期望的输出就验证和或确认做出打算GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第9 页制定一个主要确认方案选择确认的方法和工具编制确认方案执行 IQOQPQ 并将结果形成文件打算连续的过程掌握连续地掌握过程52 方案编制执行确认的具体方案对于保证过程的正确确认是相当重要的过程确认方案应包含以下内容要确认的过程标识在这个过程下产出的器材的标识一个成功确认的目标和可测量的准则确认的用时和有效期限过程中承受的轮班制操作人员和设备过程设备中使用器具 utilities 的标识和质量操作员标志和要求的操作员资格证过程的完整描述产品元件生产材料等的相关规格在过程确认中对先发生的过程所设置的任何特别掌握或条件要监控的过程参数和监控方法监视的产品特性和方法用来评估产品的主观准则以可测量准则和主观准则来定义由什么构成不合格性数据收集和分析的统计方法生产设备保养和修理方面的考虑再确认准则对于 IQOQ 和PQ 三个阶段以产品或过程为根底的要求打算验证或测量什么打算如何验证或测量打算验证或测量多少如统计量打算何时验证或测量规定承受或拒绝的标准规定要求的文件正确地了解产品的要求是什么和哪些主要参数是有必要测量的可测量参数包含了封装厚度密封强度压力测试和样品直观缺陷等GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第10 页承受统计学有效技术如抽样试验设计Taguchi方法特性曲线争论和元件交换来解答测量多少这个问题利用如国际或国内标准的标准测试方法来指导如何测量具体参数同样重要的一点是保证检测方法是模拟真实使用条件的在各个确认阶段的实施中该方案应规定出误差概率resolution已有方案里的某些偏差可能不会导致结果无效应规定和评估每个偏差并做出承受或拒绝结果的结论最终过程掌握程序可以要求修改所做的修改应作为整个过程的一部分来进展确认制定对全部产品和过程的要求规定对每个要求的具体标准以及以产品规格和现行标准为根底的上下范围这些都将有助于制定承受或拒绝标准53安装鉴定 IQIQ 意味着正确安装吗重要的 IQ 考虑事项包括设备设计特点如清洁装置的构造材料等安装条件布线有用性功能性等校准预防性保养清洁打算安全特性供给商文件印刷品图样和手册软件文件零部件清单环境条件如清洁室的要求温度和湿度有时候活动的实施是发生在设备供给商处设备发运前的设备供给商可在他们的机构内对设备进展测试并分析结果以打算该设备的发运供给商鉴定资料的拷贝应用作指导文件以猎取根底数据和补充安装鉴定但是仅立足设备供应商确实认结果往往是缺乏够的每个医疗器械厂商根本上要负责评估质疑和测试该设备并判定该设备是否能适用于生产特定的器械该评估可能会引起对设备或过程的修改54操作鉴定 OQ这个阶段过程参数应不断被调整以保证能产出一个在预定生产条件下的符合全部规定要求的产品如进展最坏状况测试在日常生产和过程掌握当中需要做的是测量过程参数和或产品特性以促进在各个作用程度上对生产过程进展调整并保持一个掌握状态为判定过程强度并防止趋向最坏状况条件应对这些作用程度进展评估和确立并形成文件OQ 考虑事项包括过程掌握范围时间温度压力线速度启动条件等GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第11 页软件参数原材料规格过程操作程序材料处理要求过程修改掌握培训短期稳定性和过程力量横向争论或掌握图表可能的故障状态作用程度和最坏状况条件故障状态和效应分析缺陷分析统计学有效技术的使用照实行筛选试验来规定主要过程参数实行统计学试验设计来优化过程使其能在这个阶段中使用55性能鉴定 PQ这个阶段的主要目标是证明在正常操作条件下过程将连续产出可承受产品请关注过程稳定性方面的指导见附录 A 和B 的过程确认的方法和工具PQ 考虑事项包括OQ 阶段的真实产品过程参数和建立的程序产品的可承受性如OQ 阶段建立的对过程力量的保证过程的重复力量和长期过程的稳定力量过程调整应模拟真实生产条件下遇到的状况调整应包含如在OQ阶段建立的通过书面标准操作程序允许的作用程度所确立的条件范围该调整应重复进展足够的次数以保证结果的意义和全都性应对过程和产品数据进展分析以打算和过程输出相对应的变化的正常范围了解输出的正常变化对于打算过程是否在掌握状态下操作和能否连续产生规定输出是相当关键的OQ 和PQ 的输出之一是使连续监控和设备保养的好处得到进展同时应分析过程和产品数据来确定任何可以通过可掌握缘由进展调整的变化依过程性质和其灵敏性而定可掌握缘由包括了温度湿度电源转变振动环境污染加工水的纯度光线GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第12 页人的因素培训人机工程学因素压力等等材料的可变性设备的磨损和破坏应实行适当的措施来消退引起变化的可掌握缘由消退引起变化的可掌握缘由将削减过程输出的变化和形成更强的保证力度来保证输出全都符合规格56 最终报告确认活动完毕时应预备一份最终报告该报告总结并参考了全部的方案和结果应得出关于过程确认状态的结论最终报告应由确认小组和适宜的治理层来进展评审并审定6 保持确认状态61监视和掌握应监视过程的动向以保证过程始终保持在规定的参数范围里当质量特性的监视数据显示出一个相反的动向时应调查缘由可以实行订正措施并考虑进展再确认62过程和或产品的转变应评估过程和或产品的转变包括程序设备人员上的转变以确定这些转变所带来的效应并考虑再确认的范围63连续的掌握状态原材料和或过程可能发生各种各样的转变这些转变是觉察不到的或在不重要的时间里才会考虑到的例如消毒过程这些转变累积起来可以影响到过程确实认状态对于这类过程应考虑实行定期再确认64再确认缘由举例以下状况再确认可能是有必要的可能影响质量或其确认状态的真实过程的转变质量指示器的相反动向对过程有影响的产品设计上的转变从一台装置到另一台装置的过程转换过程应用的转变GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第13 页应对再确认的需要进展评估并形成文件该评估应包含产生于质量指示器产品转变过程转变外部要求法规或标准和其它类似环境转变的历史结果假设状况不要求重复原始确认的全部方面那么再确认的范围便可能没有初始确认掩盖的广泛假设为某个确认过程购置了一台设备那么很明显确认的 IQ 局部必需重复但是大多数的 OQ 内容已经确定 PQ 的某些内容可能还要重复确认这取决于设备的影响程度另外一个例子是假设原材料供给商消灭变化那么应考虑到这个转变对于过程和所产出产品的影响由于可能不能完全了解的原材料和过程的相互作用局部OQ 和PQ 可能要进展重确认7过程确认中历史数据的使用局部的过程确认是以累积历史生产测试掌握和其它与产品或过程相关的数据为根底的这些历史数据可在作业记录生产日志书批次记录掌握图表测试检查结果顾客反响地区故障报告效劳报告和评审报告中找到假设没有收集到全部适宜的数据或没有收集到进展充分分析所依据的适宜数据那么以历史数据为根底的完整确认便是不行能的一份合格或不合格的历史生产数据往往是不充分的假设历史数据被判定为充分而具代表性的那么便可依据书面方案进展分析来判定过程是否在受控状态下进展操作并连续地产出符合预定要求的产品该分析应形成文件常常使用到这样的术语可追溯性确认全都确认和预期确认不管使用什么术语任何确认都可以使用到上述的历史数据8活动小结初始的考虑事项包括确定和描述该过程打算验证和或确认制定一个主要确实认方案GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第14 页假设打算要确认形成多功能确实认小组打算步骤和规定要求确定和描述该过程规定过程参数和期望的输出制定一个主要确实认方案选择确认的方法和工具编制确认方案执行 IQOQPQ 并将结果形成文件打算连续的过程掌握预备最终报告由治理层审定连续地掌握过程保持确认状态连续地监视和掌握过程如需要进展再确认GHTF 第 3 争论组质量治理体系过程确认指南 2023 年 1 月第 15 页附录 A 过程确认的统计方法和工具A1 前言过程确认要求建立一个完全符合要求的过程然后进展争论并证明该过程过程的进展和优化可直接引起对过程确实认换句话说可使用进展和优化过程的方法和进展的数据来证明过程的力量和稳定性因此过程进展和过程确认之间往往不存在明显的区分但是很多过程已经很好地建立起来并且受到了日常过程确认的掌握这些过程可能已经使用到这里所描述的方法和工具已经对现有的过程确认方法和工具进行了评审其中的一些可能有助于改进确认方案和进展过程本附录描述了很多可用于确认的统计方法和工具每个以粗体字表达的工具将在附录 A 的 A3 中做进一步阐述由于所造成的错误和存在过多的变化不合格状况常常消灭要获得一个完全符合要求的过程需要使用一个结合了防故障法和削减变化工具的平衡方案当某个错误引起不合格状况发生时应使用到防故障法防故障法着重于使错误不行能发生或至少能够被觉察但是很多不合格状况并不是由错误引起的而是过多的变化和脱离目标的过程造成的削减变化和制定适宜的过程目标要求确定主要的输入变量并掌握这些输入以保证输出符合要求过程确认的其中一个输出就是编制掌握方案确认的最终阶段要求证明该掌握方案起效例如它使过程能够完全符合要求这里使用到的一个主要工具便是力量争论力量争论测定的是过程完全符合规格的力量它对变化和脱离目标条件下产生的不合格状况的可测量特性是适用的所进展的测试应不仅是名义上的同样还要在最坏状况的条件下进展在潜在故障状况下应执行盘问测试以证明防故障法特地用于觉察或防止同类错误的方法起效了承受抽样方案可能有利于优化被测试的样品数量并证明产品的规格全都性A2 初步统计和过程确认每个产品间都存在着些许的差异这些差异无论多小都称为变化变化的特点可通过测定产品中的某个样品并将其绘制成矩形图来表现例如一个将电线切成 100cm 的操作其容差是 100?5cm 随机选出一个由 12 条电线组成的样品以下是所获得的结果987 993 1004 976 1014 10201002 964 1034 1020 980 1005。

标题：质量管理体系——过程确认指南编写：第3 研究组签署：全球协调任务组织日期：2004 年1 月第2 版, 主席本文件由全球协调任务组织制作，该组织是一个志愿团体，由医疗器械管理机构和管理行业的代表组成。

本文件着重为管理机构提供关于医疗器械法规使用方面的非约束性指导，其撰写是经过多方面征求意见的。

本文件的印制、发售或使用是不受限制的。

但是，将本文件部分或全部引用到其它文件，或将它翻译成英语以外的其它语言，均不代表全球协调任务组织认同。

第3 研究组—质量管理体系过程确认指南— 2004 年1 月第2页过程确认指南目录0 前言 (3)1 目的和范围 (5)1.1 目的 (5)1.2 范围………………………………………………………...………………………. .52 定义 (5)3 质量管理体系范围内的过程确认 (5)3.1 过程确认的判定 (6)3.2 举例 (7)4 过程确认的统计方法和工具 (8)5 确认的实施 (8)5.1 准备阶段 (8)5.2 方案编制 (9)5.3 安装鉴定（） (10)5.4 操作鉴定（） (10)5.5 性能鉴定（） (11)5.6 最终报告 (12)6 确认状态的保持 (12)6.1 监视和控制 (12)6.2 过程和（或）产品的改变 (12)6.3 连续的控制状态 (12)6.4 再确认原因举例 (12)7 过程确认中历史数据的使用 (13)8 活动小结 (13)附录A 过程确认的统计方法和工具 (15)B 确认的举例 (25)第 3 研究组—质量管理体系过程确认指南—2004 年 1 月第3页0 前言由于在13485:2003 中内容有变化，修改后的“质量管理体系——过程确认指南”（原发表于1999 年）重新发表名为“399-10:2004（第2 版本）” 的文件，它被使用于一些管理体系里。

过程确认指南从0 到3.4 部分、图一到附录B 都进行了修改。

修改分为两种类型：1）为符合13485:2003，对术语进行编辑上的修改（例如，“质量体系”改为“质量管理体系”，“设计控制”改为“设计与开发控制”）；2）为反映13485:2003 中7.5.2 条的新过程确认要求，对图1 和相应文本所做的修改。

GHTF/SG3/N99-10:2004 (Edition 2)FINAL DOCUMENTTitle: Quality Management Systems - ProcessValidation GuidanceAuthoring Group: SG3Endorsed by:The Global Harmonization Task Force Date: Edition 2 - January 2004Taisuke Hojo, GHTF ChairThe document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry. The document is intended to provide n on-binding guidance to regulatory authorities for use in the regulation of medical devices, and has been subject to consultation throughout its development.There are no restrictions on the reproduction, distribution or use o f this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.GHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance – January 2004Page 2Process Validation Guidance Contents0 Introduction1 Purpose and scope1.1 Purpose1.2 Scope2 Definitions3 Processes that should be validated3.1 Special processes3.2 Process validation within the quality management syste m3.3 Process validation decision3.4 Examples4 Statistical methods and tools for process validation5 Conduct of a validation5.1 Getting started5.2 Protocol development5.3 Installation qualification (IQ)5.4 Operational qualification (OQ)5.5 Performance qualific ation (PQ)6 Maintaining a state of validation6.1 Monitor and control6.2 Changes in process and/or product6.3 Continued state of control6.4 Examples of reasons for revalidation7 Use of historical data in process validation8 Summary of activitiesAnnexesA Statistical methods and tools for process validationB Example validationGHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance– January 2004Page 3 0Introduction“Quality Management Systems – Process Validation Guidance”, originally finalized in 1999, is beingrepublished as “GHTF/SG3/N99-10:2004 (Edition 2)” after revisions due to the changes in ISO 13485:2003, which is utilized in some regulatory systems. The Process Validation Guidance has beenrevised in sections 0 through 3.4, Figure 1 and Annex B. The revisions can be generalized in twocategories: 1.) Editorial revision of terminology to be consistent with ISO 13485:2003 (i.e., “quality system” to “quality management system” and “design controls” to “design and developmentThis process validation guidance is intended to assist manufacturers in understanding quality management system requirements concerning process validation and has general applicability to manufacturing (including servicing and installation) processes for medical devices. The guidance provides general suggestions on ways manufacturers may prepare for and carry out process validations.Process validation is a term used in the medical device industry to indicate that a process has been subject to such scrutiny that the result of the process (a product, a service or other outcome) can be practically guaranteed. This is vitally important if the predetermined requirements of the product can only be assured by destructive testing.Processing deficiencies may only become apparent after an intermediate component is further processed or the finished product is in use. Validation of a process entails demonstrating that, when a process is operated within specified limits, it will consistently produce product complying with predetermined (design and development) requirements.The medical device industry encompasses a wide range of technologies and applications, ranging from simple hand tools to complex computer-controlled surgical machines, from implantable screws to artificial organs, from blood-glucose test strips to diagnostic imaging systems and laboratory test equipment. These devices are manufactured by companies of varied size, structure, volume of production, manufacturing processes and management methods. These factors, especially production volume and number of manufacturing steps per unit (e.g. soldering or welding steps) significantly influence how process validation is actually applied. Given this diversity, this guidance does not suggest particular methods of implementation, and therefore, must not be used to assess compliance with quality management system requirements. Rather the intent is to expand on quality management system requirements with practical explanations and examples of process validation principles. Manufacturers can and should seek out/select technology-specific guidance on applying process validation to their particular situation.This guidance provides general suggestions on ways manufacturers may prepare for and carry out process validations. Other ways may be equally acceptable; some regulatory requirements place the responsibility on the manufacturer to specify those processes which require validation and the qualification of personnel who operate validated processes. Regardless of the method used to validate the process, records of all validations activities should be kept and the final outcome documented.While the completion of process validation is a regulatory requirement, a manufacturer may decide to validate a process to improve overall quality, eliminate scrap, reduce costs, improve customer satisfaction, or other reasons. Coupled with properly controlled design and development activities; a validated process may well result in a reduced time to market for new products.In general, the validation of a process is the mechanism or system used by the manufacturer to plan,GHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance – January 2004Page 4obtain data, record data, and interpret data. These activities may be considered to fall into three phases: 1) an initial qualification of the equipment used and provision of necessary services – also know as installation qualification (IQ); 2) a demonstration that the process will produce acceptable results and establishment of limits (worst case) of the process parameters – also known as operational qualification (OQ); and 3) and establishment of long term process stability – also known as performance qualification (PQ).Many processes are controlled by computers. While the computer software may be considered an integral part of the process, this guideline does not cover software validation.While the theory of process validation is reasonably straightforward, the decision of the manufacturer to evaluate every process for potential validation may lead to uncertainty. Some regulatory requirements state that every process that cannot be verified by subsequent monitoring or measurement be validated. Guidance is provided for reaching decisions on whether to validate or not.GHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance– January 2004Page 5 1Purpose and scope1.1Purpose This process validation guidance is intended to assist manufacturers in understanding quality management system requirements concerning process validation.1.2Scope This document has general applicability to manufacturing (including servicing and installation) processes for medical devices. Specific recommendations for verification of design output and design validation is included in the GHTF document covering design control.2 DefinitionsFor this document, the following definitions apply. Terms other than those defined herein may be found in the literature.2.1Installation qualification (IQ): establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.2.2Operational qualification (OQ): establishing by objective evidence process control limits and action l evels which result in product that meets all predetermined requirements.2.3Performance qualification (PQ): establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.2.4Process validation: establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements.2.5Process validation protocol: a document stating how validation will be conduc ted, including test parameters, product characteristics, manufacturing equipment, and decision points on what constitutes acceptable test results.2.6Verification: confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled.3 Process validation within the quality management systemProcess validation is part of the integrated requirements of a quality management system. It is conducted in the context of a system including design and development control, quality assurance, process control, and corrective and preventive action.GHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance – January 2004Page 6The interrelationship of design control and process development may, for some technologies, be very closely related. For others the relationship may be remote. The product should be designed robustly enough to withstand variations in the manufacturing process and the manufacturing process should be capable and stable to assure continued safe products that perform adequately. Often this results in a very interactive produ ct development and process development activity.Daily measuring and monitoring activities are conducted as specified by the process control plan which is often largely developed during process validation.Corrective actions often identify inadequate processes/process validations. Each corrective action applied to a manufacturing process should include the consideration for conducting process validation/revalidation.3.1Process validation decisionThe following model may be useful in determining whether or not a process should be validated:Figure 1: Process validation decision treeThe model shown describes a decision tree that a manufacturer can follow when deciding on whether a process needs to be validated. The process under consideration in this model is the simplest possible - many processes may be large and/or a complex set of sub-processes.GHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance– January 2004Page 7 Each process should have a specification describing both the process parameters and the output desired. The manufacturer should consider whether the output can be verified by subsequent monitoring or measurement (A). If the answer is positive, then the consideration should be made as to whether or not verification alone is sufficient to eliminate unacceptable risk and is a cost effective solution (B). If yes, the output should be verified and the process should be appropriately controlled (C).If the output of the process is not verifiable then the decision should be to validate the process (D); alternatively, it may become apparent that the product or process should be redesigned to reduce variation and improve the product or process (E). Also, a change in a manufacturing process may result in the need for process validation even though the process formerly only required verification and control.The risk or cost may also be reduced by redesigning the product or process to a point where simple verification is an acceptable decision (E).3.2ExamplesThe following table is a list of examples of processes which: (1) should be validated, (2) may be satisfactorily covered by verification, and (3) processes which may be verifiable, but for business purposes, validation can be chosen.(1) Processes which should be validated•Sterilization processes•Clean room ambient conditions•Aseptic filling processes•Sterile packaging sealing processes•Lyophilization process•Heat treating processes•Plating processes•Plastic injection molding processes(2) Processes which may be satisfactorily covered by verification•Manual cutting processes•Testing for color, turbidity, total pH for solutions•Visual inspection of printed circuit boards•Manufacturing and testing of wiring harnesses(3) Processes for which the above model may be useful in determining the need for validation•Certain cleaning processes•Certain human assembly processes•Numerical control cutting processes•Certain filling processesGHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance – January 2004Page 8While the output of a process may be verifiable, application of software used in that process should bevalidated for its intended use.4 Statistical methods and tools for process validationThere are many methods and tools that can be used in process validation. A primer on statistics andprocess validation is provided in Annex A as a guide through the basic concepts. Control charts,capability studies, designed experiments, tolerance analysis, robust design methods, failure modes andeffects analysis, sampling plans, and mistake proofing are some of the examples.5 Conduct of a validation5.1Getting startedA consideration should be given to form a multi-functional team to plan and oversee the validationactivities. A team approach will help assure the validation processes are well thought out, the protocols are comprehensive and that the final packages are well documented and easy to follow. Theteam should advise “what could go wrong”. The team also provides an opportunity for key functionalareas to communicate early about important new and changed products and processes and can fostercooperation.Members of the validation team could include representatives from or personnel with expertise in:•Quality Assurance•Engineering•Manufacturing•Others depending on company organization and product types:•Laboratory•Technical Services•Research & Development•Regulatory Affairs•Clinical Engineering•Purchasing/PlanningOnce the validation team has been formed, the next step is to plan the approach and define therequirements. Many manufacturers develop what is referred to as a master validation plan whichidentifies those processes to be validated, the schedule for validations, interrelationships betweenprocesses requiring validation and timing for revalidations. Once these have been established, and thepurpose and scope for validations are clearly stated and known, protocol development can commence. Following is a list of activities which may be used as a checklist to review validation activity: •Form multi-functional team for validation•Plan the approach and define the requirements•Identify and describe the processes•Specify process parameters and desired output•Decide on verification and/or validation•Create a master validation plan•Select methods and tools for validation•Create validation protocols•Perform IQ, OQ, PQ and document results•Determine continuous process controlsGHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance– January 2004Page 9 •Control the process continuously5.2Protocol developmentDetailed protocols for performing validations are essential to ensure that the process is adequately validated. Process validation protocols should include the following elements:•Identification of the process to be validated•Identification of device(s) to be manufactured using this process•Objective and measurable criteria for a successful validation•Length and duration of the validation•Shifts, operators, equipment to be used in the process•Identification of utilit ies for the process equipment and quality of the utilities•Identification of operators and required operator qualification•Complete description of the process•Relevant specifications that relate to the product, components, manufacturing materials, etc.•Any special controls or conditions to be placed on preceding processes during the validation •Process parameters to be monitored, and methods for controlling and monitoring•Product characteristics to be monitored and method for monitoring•Any subjective criter ia used to evaluate the product•Definition of what constitutes non-conformance for both measurable and subjective criteria •Statistical methods for data collection and analysis•Consideration of maintenance and repairs of manufacturing equipment•Criteria for revalidationFor all three phases, IQ, OQ, and PQ, based on product/process requirements:•Determine what to verify/measure•Determine how to verify/measure•Determine how many to verify/measure, i.e. statistical significance•Determine when to verify/measure•Define acceptance/rejection criteria•Define required documentationKnowing exactly what the product requirements are and what key parameters will be necessary to answer the questions of what to measure. Seal thickness, seal strength, pressure testing and visual defects of samples are examples of measurable parameters.Utilizing statistically valid techniques such as sampling, design experiments, Taguchi methods, response surface studies and component swapping are statistically valid techniques to answer the questions of how many to measure. Utilization of standard test methods such as such as those contained in international or national standards will provide guidance in how to measure specific parameters. Also, it is important to ensure test methods replicate actual use conditions.During the conduct of various phases of validation, the protocol should address the resolution of discrepancies. Some deviations in established protocol may not negate the results. Each deviation should be addressed, evaluated and a conclusion drawn as to acceptance or rejection of the results. As a result, process control procedures may require modification and those modifications should be validated as part of the overall process.Addressing all product and process requirements and the establishment of specific criteria for each requirement, upper and lower limits based on product specifications and established standards will help define the acceptance/rejection criteria.GHTF Study Group 3 - Quality Management SystemsProcess Validation Guidance – January 2004Page 105.3Installation qualification (IQ)Simply put, IQ means is it installed correctly? Important IQ considerations are:•Equipment design features (i.e. materials of construction cleanability, etc.)•Installation conditions (wiring, utilities, functionality, etc.)•Calibration, preventative maintenance, cleaning schedules•Safety features•Supplier documentation, prints, drawings and manuals•Software documentation•Spare parts list•Environmental conditions (such as clean room requirements, temperature, humidity)Sometimes activities are conducted at the equ ipment supplier’s site location prior to equipment shipment. Equipment suppliers may perform test runs at their facilities and analyze the results to determine that the equipment is ready to be delivered. Copies of the suppliers’ qualification studies should be used as guides, to obtain basic data, and to supplement installation qualification. However, it is usually insufficient to rely solely upon the validation results of the equipment supplier. Each medical device manufacturer is ultimately responsi ble for evaluating, challenging, and testing the equipment and deciding whether the equipment is suitable for use in the manufacture of a specific device(s). The evaluations may result in changes to the equipment or process.5.4Operational qualification - (OQ)In this phase the process parameters should be challenged to assure that they will result in a product that meets all defined requirements under all anticipated conditions of manufacturing, i.e., worst case testing. During routine production and process control, it is desirable to measure process parameters and/or product characteristics to allow for the adjustment of the manufacturing process at various action level(s) and maintain a state of control. These action levels should be evaluated, established and documented during process validation to determine the robustness of the process and ability to avoid approaching “worst case conditions.”OQ considerations include:•Process control limits (time, temperature, pressure, linespeed, setup conditions, etc.)•Software parameters•Raw material specifications•Process operating procedures•Material handling requirements•Process change control•Training•Short term stability and capability of the process, (latitude studies or control charts)•Potential failure modes, action levels and worst-case conditions (Failure Mode and Effects Analysis, Fault Tree Analysis)•The use of statistically valid techniques such as screening experiments to establish key process parameters and statistically designed experiments to optimize the process can beused during this phase.5.5Performance qualification - (PQ)In this phase the key objective is to demonstrate the process will consistently produce acceptableproduct under normal operating conditions. Please note the guidance for process stability in Annexes A and B “Methods and tools for process validation”.PQ considerations include:•Actual product and process parameters and procedures established in OQ•Acceptability of the product•Assurance of process capability as est ablished in OQ•Process repeatability, long term process stabilityChallenges to the process should simulate conditions that will be encountered during actual manufacturing. Challenges should include the range of conditions as defined by the various action levels allowed in written standard operating procedures as established in the OQ phase. The challenges should be repeated enough times to assure that the results are meaningful and consistent. Process and product data should be analyzed to determine what the normal range of variation is for the process output. Knowing the normal variation of the output is crucial in determining whether a process is operating in a state of control and is capable of consistently producing the specified output. One of the outputs of OQ and PQ is the development of attributes for continuous monitoring and maintenance. Process and product data should also be analyzed to identify any variation due to controllable causes. Depending on the nature of the process and its sens itivity, controllable causes of variation may include:•Temperature•Humidity•Variations in electrical supply•Vibration•Environmental contaminants•Purity of process water•Light•Human factors (training, ergonomic factors, stress, etc.)•Variability of materials•Wear and tear of equipmentAppropriate measures should be taken to eliminate controllable causes of variation. Eliminating controllable causes of variation will reduce variation in the process output and result in a higher degree of assurance that the output will consistently meet specifications.5.6Final reportAt the conclusion of validation activities, a final report should be prepared. This report should summarize and reference all protocols and results. It should derive conclusions regarding the validation status of the process. The final report should be reviewed and approved by the validation team and appropriate management.6 Maintaining a state of validation6.1Monitor and controlTrends in the process should be monitored to ensure the process remains within the establishedparameters. When monitoring data on quality characteristics demonstrates a negative trend, the cause should be investigated, corrective action may be taken and revalidation considered.6.2Changes in processes and/or productAny changes in the process and /or product including changes in procedures, equipment, personnel, etc. should be evaluated to determine the affects of those changes and the extent of revalidation considered.6.3Continued state of controlVarious changes may occur in raw materials and/or processes, which are undetected, or considered at the time to be inconsequencial. (An example of this type of process is sterilization.) These changes may cumulatively affect the validation status of the proc ess. Periodic revalidation should be considered for these types of processes.6.4Examples of reasons for revalidationRevalidation may be necessary under such conditions as:•change(s) in the actual process that may affect quality or its validation status•negative trend(s) in quality indicators•change(s) in the product design which affects the process•transfer of processes from one facility to another•change of the application of the processThe need for revalidation should be evaluated and documented. This evaluation should include historical results from quality indicators, product changes, process changes, changes in external requirements (regulations or standards) and other such circumstances.Revalidation may not be as extensive as the initial validation if the situation does not require that all aspects of the original validation be repeated. If a new piece of equipment is purchased for a validated process, obviously the IQ portion of the validation needs to be repeated. However, most of the OQ aspects are already established. Some elements of PQ may need to be repeated, depending on the impact of the new equipment.Another example might be if a raw material supplier is changed, the impact of that change on the process and resultant product should be considered. Parts of OQ and PQ might need to be redone, as the interaction between the new raw material and the process may not be fully understood.7 Use of historical data for validationValidation of a process can be partially based on a ccumulated historical manufacturing, testing, control, and other data related to a product or process. This historical data may be found in batch records, manufacturing log books, lot records, control charts, test and inspection results, customer feedback, field failure reports, service reports, and audit reports. A complete validation based on historical data is not feasible if all the appropriate data was not collected, or appropriate data was not collected in a manner which allows adequate analysis. Historical manufacturing data of a pass/fail nature is usually not adequate.If historical data is determined to be adequate and representative, an analysis can be conducted per awritten protocol to determine whether the process has been operating in a state of control and has consistently produced product which meets its predetermined requirements. The analysis should be documented.The terms “retrospective validation”, “concurrent validation” and “prospective validation” are often used. Any validation can use historical data in the manner described above, regardless of the term used.8 Summary of activitiesInitial considerations include:•Identify and describe the processes•Decide on verification and/or validation•Create a master validation planIf the decision is to validate:•Form multi-functional team for validation•Plan the approach and define the requirements•Identify and describe the processes•Specify process parameters and desired output•Create a master validation plan•Select methods and tools for validation•Create validation protocols•Perform IQ, OQ, PQ and document results•Determine continuous process controls•Prepare final report and secure management approval•Control the process continuouslyMaintaining a state of validation:•Monitor and control the process continuously•Revalidate as appropriate。

GHRF/SG3/N99-10:2004 (第2版)最终文件标题：质量管理体系——过程确认指南编写：GHTF 第3研究组签署：全球协调任务组织日期：2004年1月第2版Taisuke Hojo, GHTF主席本文件由全球协调任务组织制作，该组织是一个志愿团体，由医疗器械管理机构和管理行业的代表组成。

本文件着重为管理机构提供关于医疗器械法规使用方面的非约束性指导，其撰写是经过多方面征求意见的。

本文件的印制、出售或使用是不受限制的。

但是，将本文件局部或全部引用到其它文件，或将它翻译成英语以外的其它语言，均不代表全球协调任务组织认同。

过程确认指南目录0前言 (3)1 目的和范围 (5)1.1目的 (5)1.2 范围 (5)2 定义 (5)3 质量管理体系范围内的过程确认 (5)3.1 过程确认的判定 (6)3.2 举例 (7)4 过程确认的统计方法和工具 (8)5 确认的实施 (8)5.1 准备阶段 (8)5.2 方案编制 (9)5.3 安装鉴定〔IQ〕 (10)5.4 操作鉴定〔OQ〕 (10)5.5 性能鉴定〔PQ〕 (11)5.6 最终报告 (12)6 确认状态的保持 (12)6.1 监视和控制 (12)6.2 过程和〔或〕产品的改变 (12)6.3 连续的控制状态 (12)6.4 再确认原因举例 (12)7 过程确认中历史数据的使用 (13)8 活动小结 (13)附录A 过程确认的统计方法和工具 (15)B 确认的举例 (25).0前言由于在ISO 13485:2003中内容有变化，修改后的“质量管理体系——过程确认指南〞〔原发表于1999年〕重新发表名为“GHTF/SG3/N99-10:2004〔第2版本〕〞的文件，它被使用于一些管理体系里。

过程确认指南从0到3.4局部、图一到附录B都进行了修改。

修改分为两种类型：1〕为符合ISO 13485:2003，对术语进行编辑上的修改〔例如，“质量体系〞改为“质量管理体系〞，“设计控制〞改为“设计与开发控制〞〕；2〕为反映ISO 13485:2003中7.5.2条的新过程确认要求，对图1和相应文本所做的修改。