质量管理系统（Quality Management System）

质量管理系统（Quality Management System）
ISO 9001 2000年版

质量管理系统 ─ 要求

1 范围

1.1 通则

当组织有下列要求时，本国际标准界定其质量管理系统的需求：

a.  须要展现其能力足以稳定地提供符合客户及适用法规要求之产品，和

b.  透过系统的有效运用，包括持续改善系统之过程与保证符合客户及适当法规要求，以增进客户满意。

备注　在本国际标准中，"产品"一词适用于预期提供予顾客或其所需要之产品。

1.2 应用

此国际标的所有要求乃通用性要求且期望能适用于所有组织，无论其行业、规模及所提供的产品。

本国际标准的任何要求若因组织或产品之特性而无法适用时可考虑予以排除。

当本国际标准的任何要求被排除时，则组织不得宣称其符合本国际标准，除非所排除的要求局限于本国际标准的第七节且不影响织组提供符合客户及适当法规要求产品的能力或责任。

2 引用标准

本国际标准引用下列标准的内容以构成本国际标准的条款。所引用的标准如具日期版次，则其后之修订或改版均不适用于本国际标准。然而依据本国际标准达成共识之各团体仍应探求使用下列引用标准最新版次的可能。引用的标准如未指定日期版次，则应使用最新的引用标准。ISO及IEC会员皆维持有最新有效国际标准的登录清单。

ISO 9000:2000 质量管理系统 - 基础与词汇

3名词与定义

ISO 9000:2000 中之名词与定义均适用于本国际标准。

本国际标准用来描述供应链之名词更动如下，以反映目前的用语习惯:

供货商 -> 组织 -> 顾客

本版次以"组织"取代先前1994版次使用的"供货商"，以表示采用本国际标准的单位。而"供货商"则用来取代之前版次的"分包商"。

本国际标准全文之中，"产品"一词亦等同于"服务"。

4 质量管理系统

4.1 一般要求

组织应遵照本国际标准的要求建立、文件化、执行、维持质量管理系统并持续改善其有效性。

组织应：

a.  鉴别质量管理系统所需的过程及其在组织中之运用(见1.2)，

b.  决定这些过程的顺序及相互关系，

c.  决定确保这些过程有效运作及管制的必要的准则及方法，

d.  确保提供支持这些过程的运作及监督必要的资源与信息，

e.  监控、量测及分析这些过程，和

f.  采取必要行动以达成这些过程的预期结果及持续攻善，

组织应遵照本国际标准的要求管理这些过程。

当组织选择将会影响产品符合要求的部分过程委外时，组织应确保其管制亦及于此等委外之过程，且在质量管理系统中界定其管制方式。

备注:　上述质量管理系统所须之过程包括管理活动、资源提供、产品实现与量测等过程。

4．2 文件化要求

4.2.1 通则

质量管理系统文件化应包括：

a.  质量政策与质量目标，

b.  品质手册，

c.  本国际标准要求的文件化程序，

d.  组织为确保其过程有效规划、运作及管制所需要的文件，及

e.  本国际标准要求之纪录(见4.2.4)

备注1  本国际标准中出现"文件化程序"之处，系要求该程序须被建立、文件化、实施及维持。

备注2　各组织其质量管理系统文件化的程度或有差别，端赖下列而定

a.  组织的规模及活动的型态，

b.  过程的复杂性及相互关系，

c.  员工的能力。

备注3　文件可能为任何形式或种类的媒体。

4.2.2 品质手册

组织应建立与维护质量手册，其内容包含

a.  质量管理系统的范围，包括对排除部份的细节与理由(见1.2)，

b.  质量管理系统所建立的文件化程序，或参考该等程序，及

c.  描述质量管理系统各过程的顺序及其彼此间之相互关系。

4.2.3 文件管制

质量管理系统运作所要求之文件应加以管制，记录为一特殊型态之文件应依据条文4.2.4之要求加以管制。

应建立文件化之程序用以管制

a.  文件发行前，核准其正确性，

b.  审查、必要的更新与再次核准文件，

c.  确保文件的改变及目前版次状态被标明，

d.  确保使用文件各场所，持有相应版次的适当文件，

e.  确保维持文件易于阅读及容易识别，

f.  确保外来原始文件被识别及管制其分发，和

g.  防止作废文件被误用，如因任何目的而留存时，应被适当的识别。

4.2.4 记录管制

质量管理系统所须之记录应被建立与维护，以证明符合质量管理系统的要求及有效运作。质量记录应易于阅读、识别及取用。应建立文件化程序以定义记录的识别、储存、取用、保护、保存期限与处置方式。

5 管理责任

5.1 管理承诺

高阶管理者应透过下列方式，以证明对其质量管理系统的发展、实施与持续改善系统有效性之承诺：

a.  对组识内部沟通-符合客户及法令、法规要求的重要性，

b.  建立质量政策，

c.  确保质量目标被建立，

d.  执行管理审查，和

e.  确保提供必要的资源。

5.2 顾客为重

高阶管理者应确保顾客之需求已被决定且满足，以达到增进客户满意为目的(见7.2.1及8.2.1)。

5.3 质量政策

高阶管理者应确保其质量政策

a.  适合于组织的目地，

b.  包括符合质量管理系统需求及持续改善系统有效性之承诺。

c.  提供一个建立及审查质量目标之体制，

d.  于组织中被沟通及了解，

e.  审查其持续的适切性。

5.4 规划

5.4.1 质量目标

高阶管理者应确保组织内各相关机能及各层级之质量目标被建立，质量目标包含符合产品要求之各项需求(见7.1.a)。质量目标应可被量测，且必须与质量政策相一致。

5.4.2 质量管理系统规划

高阶管理者应确保：

a.  规划质量管理系统以符合条文4.1及质量目标之要求，和

b.  当质量管理系统计划将有或已有变化时，维持质量管理系统之完整性。
5.5 责任、授权与沟通

5.5.1 责任与授权

高阶管理者应确保组织内之责任、授权已被定义及沟通。

5.5.2 管理代表

高阶管理者应指派管理阶层中之一员，不受其它责任影响，明定其责任与授权包含下列

a.  确保质量管理系统中所需之过程被建立、实施与维持;

b.  向高阶管理者报告质量管理系统执行之成效及任何必要之改善；

c.  确保组织全员对客户需求认知的提升。

备注　管理代表的责任可以包括与外部机构对质量管理系统有关事务的联系。

5.5.3 内部沟通

高阶管理者应确保组织内之沟通过程已被建立，并且对于质量管理系统的有效性进行沟通。

5.6 管理审查

5.6.1 通则

高阶管理者应于事先计划的间隔期间审查组织的质量管理系统，以确保其持续的适切性、正确性与有效性。管理审查应包括评估改善的机会与质量管理系统修正的必要性，包括质量政策与目标。

管理审查的记录需加以维护(见4.2.4)。

5.6.2 管理审查的输入

管理审查的输入应涵盖下列信息

a.  稽核的结果，

b.  客户的回馈，

c.  过程的绩效及产品的符合性，

d.  各项矫正与预防措施的状态，

e.  前次管理审查决议事项的跟催，

f.  可能影响质量管理系统的变化，和

g.  改善的建议。

5.6.3 管理审查的输出

管理审查的输出应包括下列各项的决议与行动

a.  质量管理系统及其过程有效性的改善，

b.  与客户需求有关的产品改善，
c.  资源的需求。

6. 资源管理

6.1 资源的提供

组织应决定与提供必要的资源以

a.  执行和维护质量管理系统及持续改善其有效性，和
b.  藉由符合客户需求以增进客户满意。

6．2 人力资源

6.2.1 通则

人员从事足以影响产品质量之工作，必须依其适当教育、训练、技能和经历以胜任其工作。

6.2.2 资格、认知与训练

组织应

a.  界定从事足以影响产品质量工作者之资格需求，

b.  提供训练或其它措施以满足这些需求，

c.  评估所采取措施的有效性，

d.  确保员工认知本身作业的相关性与重要性及其对达成质量目标的贡献，和

e.  维护适当的教育、训练、技能及经验的记录(见4.2.4)。
6.3 基础设施

组织应决定、提供及维护为达成符合产品需求必要的基础设施。基础设施包括可行的下列

a.  建筑物、工作空间及附属的设施;

b.  过程设备(包括软、硬设备)，和

c.  支持服务(例如运输、通讯)。

6.4 工作环境

组织应决定和管理为达到符合产品需求必要的工作环境。

7 产品实现

7.1 产品实现的规划

组织应规划与展开针对产品实现所需要的各项过程，产品实现过程的规划必须与质量管理系统其它过程的要求相一致。

在规划产品实现过程时，组织必须适当地决定下列要项：

a.  质量目标及产品的需求;

b.  针对产品所需过程、文件及资源的提供；

c.  针对产品必要的验证、确认、监控、检验与测试的活动及产品的允收标准;

d.  必要的记录以证明产品实现过程与最终产品符合要求(见4.2.4)。

此项规划产出的结果，其格式应适合其组织的作业方法。

备注1　针对特定产品、项目或合约用以描述其质量管理系统所有过程(包括产品实现过程)及所需资源的书面文件，可被称为质量计划。

备注2　组织亦可运用条文7.3的要求于产品实现过程的展开。

7.2 顾客相关的过程
7.2.1 决定产品相关的需求

组织应决定

a.  顾客已指明的需求，包括对交货与售后的需求，

b.  非顾客所明确指定，但对于已知特定或使用目的是必要的需求，

c.  与产品相关法令及法规的需求，和

d.  组织自订的任何额外需求。

7.2.2 产品相关需求的审查

组织应审查产品相关的需求。此项审查应该在向客户承诺提供产品之前完成(即:提出标单、接受合约或订单、接受合约或订单的变更)，并且确保

a.  产品的需求已被定义，

b.  合约或其它需求与先前表达有所不同处已被解决，和

c.  组织有能力满足各项已定义之需求。

审查结果及后续措施的记录必须加以维持(见4.2.4)。

当客户提供非文件化的需求叙述时，组织在接受客户需求前应加以确认。

当产品需求被改变时，组织应确保相关文件被修正，及相关人员都知道改变后的需求。

备注：　在某些情况下，例如网络营销，对每一张订单进行正式审查并不实际。取代的方式为对相关产品信息，例如型录、广告素材等加以审查。

7.2.3 客户沟通

组织应决定及实施有效的安排，以进行与客户有关下列的沟通:

a.  产品信息，

b.  询价，合约或订单的处理及修改，和

c.  客户回馈，包括客户的抱怨。

7.3 设计与开发

7.3.1 设计与开发的规划

组织须规划和管制产品的设计与开发活动。

在设计与开发规划时，组织必须决定

a.  设计与开发过程的各阶段，

b.  适合于各设计开发阶段的审查，验证和确认活动，和

c.  设计与开发活动的责任与授权。

组织需管理参与设计开发不同群组间的界面，确保有效的沟通和责任的分配。

规划的结果必须依据设计与开发的进展加以适当地更新。

7.3.2 设计与开发的输入

有关产品需求的设计输入必须加以决定和记录(见4.2.4)，这些必须包括

a.  功能与性能的需求，

b.  适用法规和法令的需求，

c.  可行时，得自先前类似设计的信息，及

d.  其它有关设计开发必要的需求。

这些设计输入应被审查其正确性。需求必须完整、明确且不与其它需求相冲突。

7.3.3 设计与开发的输出

设计与开发输出的格式必须能和设计与开发输入相验证，且在发出前被核准。

设计与开发的输出必须

a.  符合设计与开发的输入，

b.  提供采购、生产及服务提供的适当信息，

c.  包含或引述产品的允收标准，和

d.  明定对安全及正当使用必备的产品特性。

7.3.4 设计与开发的审查

于适当阶段，应依规划的安排(见7.3.1)执行系统化的设计与开发的审查

a.  评估设计与开发结果符合需求的能力，和

b.  指出问题并提出必要的措施。

参与此类审查者，应包含与该阶段审查有关功能的代表人员。必须维持设计审查其结果及任何必要措施的记录(见4.2.4)

7.3.5 计与开发的验证

设计与开发的验证应依规划的安排执行(见7.3.1)以确保设计与开发的输出符合设计与开发的输入。必须维持设计验证其结果及任何必要措施的记录(见4.2.4)

7.3.6 设计与开发的确认

设计与开发的确认应依规划的安排执行(见7.3.1)以确保最终产品能符合已知的特定应用或预期使用的需求。可行时，确认必须在产品交货或执行前被完成。必须维持确认的结果及任何必要措施的记录(见4.2.4)。

7.3.7 设计与开发变更的管制

必须鉴别设计与开发的变更并维持记录。此等变更必须被适当地审核、验证及确认且于执行前获得核准。设计与开发变更的审查必须包括对其组成零件和已交货产品的影响评估。

必须维持变更审查的结果及任何必要措施的记录(见4.2.4)。
7.4 采购

7.4.1 采购过程

组织须确保采购品符合规定的要求。对于供货商及采购品的管制方式及范围，应依采购品对后续产品的实现或最终产品影响的程度而定。

组织应根据供货商提供符合组织需求产品的能力来评估及选择供货商。用以选择、评估及定期评估供货商的标准应被建立。必须维持评估结果及任何后续必要措施的记录(见4.2.4)。

7.4.2 采购信息

采购信息必须清楚描述采购品，适当时，包括

a.  对产品、程序，过程及设备的要求，

b.  人员资格的要求．和
c.  质量管理系统的要求。

组织与供货商沟通前，应确保所规定需求内容的适当性。

7.4.3 采购品的验证

组织应建立及实施为确保采购品符合规定要求所需之检验及其它活动。

当组织或其客户准备于供货商处进行验证时，组织应于采购信息中说明计划验证的安排及产品放行的方法。　

7.5 生产及服务提供

7.5.1 生产及服务提供之管制

组织应在管制状态下计划及进行生产及服务的提供。管制状态包括了列可行的项目

a.  提供描述产品特性的信息，

b.  必要时，提供工作说明，

c.  使用适当的设备，

d.  具备及使用量测与监控设备，

e.  实施监控与量测，和

f.  实施放行、交货与售后之活动。

7.5.2 生产与服务提供过程的确认

当过程其结果输出无法被随后之监控或量测所验证时，组织应确认生产及服务过程，这包括过程的缺陷唯有在产品使用或是服务已提供后才会显现的任何过程。

过程的确认必须展现该过程具有达成计划结果的能力。

组织应建立此等过程确认的安排，可行时，应包括以下各项

a.  定义过程审核与核准的准则，

b.  设备与人员的资格的核准，

c.  使用规定的方法与程序，

d.  记录的需求(见4.2.4)，和

e.  再确认。

7.5.3 鉴别与追溯

适当时，组织于产品实现所有过程中应以适当的方式来鉴别产品。

组织应针对量测与监控要求的结果鉴别产品的状态。

当追溯为一项要求时，组织应管制及记录产品鉴别的特定方式(见4.2.4)。

备注　在某些产业中，型态管理为达到识别与追溯的一种方式。

7.5.4 客户财产

组织应注意被组织控管或使用的客户财产。组织须鉴别、验证、保护和维护客户所提供使用于或组装于产品之财产。任何客户财产如发生遗失、损坏或发现不适用时，须向客户报告并维持记录(见4.2.4)。

备注　客户财产可包含智慧财产。

7.5.4 产品保存

在内部实现过程及交运至指定地点中，组织应保存产品符合需求，此处的保存应包括识别、搬运、包装、储存及保护。此项要求亦适用于产品的零组件。

7.6 量测与监控设备的管制

组织应决定必需执行的监控与量测，以及用以证明产品符合规定要求所需的量测与监控设备(见7.2.1)。

组织应建立过程以确保监控与量测被执行，且其执行的方式相对监控与量测的需求是一致的。

当监控与量测的结果需确保正确时，量测的设备必须

a.  依规定周期或使用前加以校正或验证，比对的基准应可追溯至国际或国家的量测基准；如无此类标准存在时，应记录校正或验证所使用之基准；

b.  必要的调整或重复调整；

c.  足以识别其校正状态的标识；

d.  妥善防护免于不当调整而致量测结果失效；

e.  于搬运、维护与储存过程中加以保护以免造成损坏及劣化。

除此之外，当发现设备不符其要求时，组织应评估及纪录先前量测结果的有效性。组织应对该设备及受影响之任何产品采取适当之措施。应维持校正及验证结果的记录(见4.2.4)。

用于量测与监控规定需求的计算机软件，应于首次使用前确认其具备足够之能力满足预期之运用，且于必要时进行再确认。

备注　见 IS0 10012-1及IS0 10012-2 指导纲要

8 量测、分析与改善

8.1 通则

组织应规划与执行用以满足下列要求之监控、量测、分析及改善所需的过程：

a.  展现产品的符合，

b.  确保质量管理系统的符合，

c.  持续改善质量管理系统的有效性。

这应包括决定可行的方法，含统计技术，及其使用的范围。

8.2 监控与量测

8.2.1 客户满意

作为质量管理系统成效的量测之一，组织应监控客户所认知组织是否满足其需求的信息。取得及运用此等信息的方法应被决定。

8.2.2 内部稽核

组织应于规划的期间执行内部稽核以决定质量管理系统是否

a.  符合计划的安排(见7.1)，符合本国际标准的要求及组织所建立的质量管理系统要求，和

b.  有效地被执行与维持

稽核计划的规划应考虑被稽核过程与区域的状态及其重要性和前次稽核的结果。稽核的准则、范围、频率与方法必须加以定义。稽核人员的指派及稽核工作的执行必须确保稽核过程的客观与公平。稽核员不得稽核自身的工作。

规划稽核与执行及报告结果与维持纪录(见4.2.4)的责任与要求应被定义于文件化的程序。

被稽核区域的管理者应确保采取立即的矫正措施以消除所发现的不符合事项及其原因。后续追踪应包括矫正措施执行结果的验证及验证结果的提报(见8.5.2)

备注　见IS0 10011-1，IS0 10011-2及ISO 10011-3 指导纲要

8.2.3 过程的监控与量测

组织应对质量管理系统的各项过程运用适当方法加以监控及可行的量测。此等方法必须展现每项过程满足其预期结果的能力。当预期结果未达成时．必须采取纠正及矫正措施以确保产品的符合性。

8．2．4 产品的监控与量测

组织应监控与量测产品特性以验证产品的要求已被达成，此监控与量测应根据计划的安排(见7.1)，于产品实现的适当过程中执行。

符合允收准则的证据必须被维持。记录应包括产品放行的权责人员(见4.2.4)

除非获得相关权责及可行时客户的准许，否则产品放行及服务的提供必须等到所有计划的安排(见7.1)均已完成且符合要求。

8.3 不合格品管制

组织应确保不合格产品被识别与管制以防止非预期的使用或交货。不合格品的管制及处理的责任与授权，应被定义于文件化程序中。

针对不合格品，组织应该采取下列一项或多项措施：

a.  采取行动以消除所发现的不符合；

b.  获相关权责及可行时客户的特准其使用、放行或接收；

c.  采取行动以排除其预期之使用与运用。

应维持不符合的特性及其后续的任何措施，包括特采取得的纪录(见4.2.4)。

不合格品在纠正后应该再次验证以展现其符合各项要求。

当不合格品在交运后或开始使用才被发现，组织应相对不符合的影响或其潜在影响采取适当的行动。

8.4 资料分析

组织应决定、收集与分析适当的数据，以展现质量管理系统的适切性与有效性，并评估持续改善质量管理系统有效性的机会。这包括监控与量测结果及其它相关来源所产生之数据。

数据分析应提供下列相关信息

a.  客户满意(见8.2.1)，

b.  产品符合需求的程度(见7.2.1)

c.  过程及产品的特性及趋势，包括预防措施的机会，和

d.  供货商

8.5 改善

8.5.1 持续改善

组织应透过质量政策、质量目标、稽核结果、数据分析、矫正与预防措施及管理审查的运用，以持续改善质量管理系统的有效性。

8.5.2 矫正措施

组织应采取矫正措施消除不符合的原因以防止再度发生，矫正措施应适切于所遇不符合的影响程度。

应建立矫正措施的文件化程序以定义下列

a.  审查不符合事项(含客户抱怨)，

b.  决定不符合事项的原因，

c.  评估为确保不符合事项不会再度发生必要的措施，

d.  决定及执行必要的矫正措施，

e.  记录矫正措施执行结果(见4.2.4)，和

f.  审查已执行的矫正措施。

8.5.3 预防措施

组织应决定预防措施以消除潜在不符合的原因，以防止其发生。预防措施应适切于潜在问题的影响程度。

应建立预防措施的文件化程序以定义下列

a.  决定潜在不符合事项及其原因，

b.  评估预防不符合事项发生的必要措施，

c.  决定及执行必要的预防措施，

d.  记录预防措施执行结果(见4.2.4)，和

e.  审查已执行的预防措施。

 

Quality management systems - Requirements

1.Scope

1.1 General

This International Standard specifies requirements for a quality management system where an organization

a.  needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and

b.  aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.

NOTE  In this International Standard, the term "product" applies to the product intended for, or required by, a customer.

1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Were any requirement(s) of this international Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

2 Normative reference

The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.

ISO 9000:2000, Quality management systems - Fundamentals and vocabulary.

3 Terms and definitions

For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.

The following items, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:

supplier -> organization -> customer

The term "organization" replaces the term "supplier used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term "supplier" now replaces the term "subcontractor".

Throughout the text of this International Standard, wherever the term 'product" occurs, it can also mean "service".

4 Quality management system

4.1 General requirements

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.

The organization shall

a.  identify the processes needed for the  quality management system and their application throughout the organization (see 1.2),

b.  determine the sequence and interaction of these processes,

c.  determine criteria and methods needed to ensure that both the operation and control of these processes are effective,

d.  ensure the availability of resources and information necessary to support the operation and monitoring of these processes,

e.  monitor, measure and analyse these processes, and

f.  implement actions necessary to achieve planned results and continual improvement of these processes. 

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

NOTE Processes needed for the quality management system referred to above should 'include processes for management activities, provision of resources, product realization and measurement.

4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include

a.  documented statements of a quality policy and quality objectives,

b.  a quality manual,

c.  documented procedures required by this

International Standard. 

d.  documents needed by the organization to ensure the effective planning, operation and control of its processes, and 

e.  records required by this International Standard (see 4.2.4)

NOTE 1 Where the term 'documented procedure" appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

a.  the size of the organization and type of activities,

b.  the complexity of processes and their interactions, and

c.  the competencies of personnel 

NOTE 3 The documentation can be in any form or type of medium.

4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes

a.  the scope of the quality management system, including details of and justification for any exclusions (see l.2.),

b.  the documented procedures established for the quality management system, or reference to them, and

c.  a description of the interaction between the processes of the quality management system.

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed

a.  to approve documents for adequacy prior to issue,
b.  to review and update as necessary and re-approve documents,

c.  to ensure that changes and the current version status of documents are identified,

d.  to ensure that relevant versions of applicable documents are available at points of use,

e.  to ensure that documents remain legible and readily identifiable,

f.  to ensure that documents of external origin are identified and their distribution controlled, and

g.  to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

5 Management responsibility

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

a.  communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,

b.  establishing the quality policy

c.  ensuring that quality objectives are established,

d.  conducting management reviews, and

e.  ensuring the availability of resources

5.2 Customer focus

Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).

5.3 Quality policy

Top management shall ensure that the quality policy

a.  is appropriate to the purpose of the organization

b.  includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,

c.  provides a framework for establishing and reviewing quality objectives,

d.  is communicated and understood within the organization, and

e.  is reviewed for continuing suitability.

5.4 Planning

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent

with the quality policy.

5.4.2 Quality management system planning

Top management shall ensure that

a.  the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and

b.  the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

Top management shall ensure that the responsibilities, authorities are defined and communicated within the organization.

5.5.2 Management representative

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes

a.  ensuring that processes needed for the quality management system are established, implemented and maintained,

b.  reporting to top management on the performance of the quality management system and any need for improvement, and

c.  ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE  The responsibility of a management representative can include liaison with external parties

on matters relating to the quality management system.

5.5.3 Internal communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

5.6 Management review

5.6.1 General

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management review shall be maintained (see 4.2.4).

5.6.2 Review input

The input to management review shall include information on

a.  results of audits,

b.  customer feedback,

c.  process performance and product conformity

d.  status of preventive and corrective actions

e.  follow-up actions from previous management reviews,

f.  changes that could affect the quality management system, and

g.  recommendations for improvement

5.6.3 Review output

The output from the management review shall include any decisions and actions relate to

a.  improvement of the effectiveness of the quality management system and its processes,

b.  improvement of product related to customer requirements, and

c.  resource needs.

6. Resource management

6.1 Provision of resources

The organization shall determine and provide the resources needed

a.  to implement and maintain the quality management system and continually improve its effectiveness, and

b.  to enhance customer satisfaction by meeting customer requirements.

6.2 Human resources

6.2.1 General

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

6.2.2 Competence, awareness and training

The organization shall

a.  determine the necessary competency for personnel performing work affecting product quality,

b.  provide training or take other actions to satisfy these needs,

c.  evaluate the effectiveness of the actions taken,

d.  ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and

e.  maintain appropriate records of education, training, skills and experience (see 4.2.4).

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable

a.  building, workspace and associated utilities;

b.  process equipment (both hardware and software) and

c.  supporting services (such as transport or communication).

6.4 Work environment

The organization shall determine and manage the the work environment needed to achieve conformity to product requirements.

7 Product realization

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

In planning product realization, the organization shall determine the following, as appropriate:

a.  quality objectives and requirements for the product;

b.  the need to establish processes, documents, and provide resources specific to the product;

c.  required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;

d.  records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization's method of operations.

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.

NOTE 2 The organization may also apply the requirement given in 7.3 to the development of product realization processes.

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

The organization shall determine

a.  requirements specified by the customer, including the requirements for delivery and post-delivery activities,

b.  requirements not stated by the customer but necessary for specified or intended use, where known.

c.  statutory and regulatory requirements related to product, and

d.  any additional requirements determined by the organization.

7.2.2 Review product of requirements related to the

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission offenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that

a.  product requirements are defined

b.  contract or order requirements differing from those previously expressed are resolved, and

c.  the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

NOTE: In some situations, such as in internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

7.2.3 Customer communication

The organization shall determine and implement effective arrangements for communicating with customers in relation to:

a.  product information,

b.  enquiries, contracts or order handling, including amendments, and

c.  customer feedback, including customer complaints

7.3 Design and development

7.3.1 Design and development planning

The organization shall plan and control design and development of product.

During the design and development planning, the organization shall determine

a.  the design and development stages,

b.  the review, verification and validation that are appropriate to each design and development stage, and
c.  the responsibilities and authorities for design and development.

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

Planning output shall be updated, as appropriate, as the design and development progresses.

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These shall include

a.  functional and performance requirements

b.  applicable statutory and regulatory requirements

c.  where applicable, information derived from previous similar designs, and

d.  other requirements essential for design and development.

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
7.3.3 Design and development outputs

The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.

Design and development outputs shall

a.  meet the input requirements for design and development,

b.  provide appropriate information for purchasing

production and for service provision,

c.  contain or reference product acceptance criteria

and

d.  specify the characteristics of the product that are essential for its safe and proper use.

7.3.4 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)

a.  to evaluate the ability of the results of design and development to meet requirements, and

b.  to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and development stage (s) being reviewed. Records of the result of the reviews and any necessary actions shall be maintained (see 4.2.4)

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4)

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

7.3.7 Control of design and development changes

Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent- parts and product already delivered.

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4)

7.4 Purchasing

7.4.1 Purchasing process

The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4)

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate

a.  requirements for approval of product, procedures,processes and equipment,

b.  requirements for qualification of personnel, and

c.  quality management system requirements

The organization shall ensure the adequacy of specified requirements prior to their communication to the supplier.

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

7.5 Production and service provision

7.5.1 Control of production and service provision

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable

a.  the availability of information that describes the characteristics of the product,

b.  the availability of work instructions, as necessary,

c.  the use of suitable equipment,

d.  the availability and use of monitoring and measuring devices,

e.  the implementation measurement, and of monitoring and

f.  the implementation of release, delivery and post-delivery activities.

7.5.2 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicable

a.  defined criteria for review and approval of the processes,

b.  approval of equipment and qualification of personnel,

c.  use of specified methods and procedures,

d.  requirements for records (see 4.2.4), and

e.  revalidation

7.5.3 Identification and traceability

Where appropriate, the organization shall identify the product by suitable means throughout product realization.

The organization shall identify the product status with respect to monitoring and measurement requirements.

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

NOTE In some industry sectors, configuration management is a means by which identification and

traceability are maintained.

7.5.4 Customer property

The organization shall exercise care with customer property while it is under the organization's control or being use by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).

NOTE Customer　property　can include　intellectual property.

7.5.5 Preservation of product

The organization shall preserve the conformity of product during internal processing and delivery to the　intended destination. This preservation shall include　identification, handling, packaging, storage and protection. Preservation shall also apply to the constitute parts of a product.

7.6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall

a.  be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded:

b.  be adjusted or re-adjusted as necessary;

c.  be identified to enable the calibration status to be determined;

d.  be safeguarded from adjustments that would invalidate the measurement result;

e.  be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).

When used in the monitoring and measurement ofspecified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

NOTE  See ISO 10012-1 and ISO 10012- 2 for  guidance.

8 Measurement, analysis and improvement

8.1 General

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed

a.  to demonstrate conformity of the product, 

b.  to ensure conformity of the quality management system, and

c.  to continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

As one of the measurement of the performance of the quality management system, the organization shall monitor information relating to customer perceptions as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

8.2.2 Internal audit

The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a.  conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and

b.  is effectively implemented and maintained

An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

NOTE  See ISO 10011-1. ISO 10011-2 and ISO 10011-3 for guidance.

8.2.3 Monitoring and measurement of processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

8.2.4 Monitoring and measurement of product

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4)

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable, by the customer.

8.3 Control of nonconforming product

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

The organization shall deal with nonconforming product by one or more of the following ways:

a.  by taking  action to eliminate the detected nonconformity;

b.  by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer:

c.  by taking action to preclude its original intended use or application.

Records of the nature of the nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.

8.4 Analysis of data

The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as q result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to

a.  customer satisfaction (see 8.2.1), 

b.  conformance to product requirements (see 7.2.1),

c.  characteristics and trends of processes and products including opportunities for preventive action, and
d.  suppliers

8.5 Improvement

8.5.1 Continual improvement

The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

8.5.2 Corrective action

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered.

A documented procedure shall be established to define requirements for

a.  reviewing nonconformities (including customer complaints);

b.  determining the causes of nonconformities,

c.  evaluating the need for action nonconformities do not recur,

d.  determining and implementing the action needed,

e.  records of the results of action taken (see 4.2.4), and

f.  reviewing corrective action taken

8.5.3 Preventive action

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

A documented procedure shall be established to define requirements for

a.  determining potential nonconformities and their causes,

b.  evaluating the need for action to prevent occurrence of nonconformities,

c.  determining and implementing action needed,

d.  records of results of action taken (see 4.2.4), and

e.  reviewing preventive action taker