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很多人同您想得一样。本指南可以概述性地帮助您了解 ISO 9001 为组织带来的利益,了解 ISO 9001 的要求,了解您获得认证所需的实际步骤。
ISO 9001 是由国际标准化组织(ISO)发布的质量管理体系(QMS)国际标准。该标准最后一次更新于 2015 年,被称为 ISO 9001:2015。ISO 9001 的发布和更新必须得到多数成员国的同意,这样它才能成为一个国际认可的标准,为全世界大多数国家所接受。
2017年底对ISO 9001认证的调查显示,尽管全球经济衰退,但已实施ISO9001质量管理标准的公司数量仍然在全球范围内保持稳定。以下是过去6年的结果。
2017 年 ISO 调查数据
此外,ISO 9000 系列还包括其他支持 ISO 9001 的要求的标准:ISO 9000 规定 ISO 9001 使用的术语和原则,ISO 9004 则为 ISO 9001 质量管理体系的改进提供指导。
质量管理体系通常称为 QMS,是一整套方针、过程、形成文件的程序和记录。整个文档定义了一套指导企业如何创建产品或服务并将其交付给顾客的内部规则。质量管理体系必须结合您的企业和您所提供的产品或服务的需求量身打造,但 ISO 9001 标准提供了一组基本原则,确保您不会遗漏任何一个成功的质量管理体系所必备的重要因素。
如上所述,ISO 9001:2015 是一个用于创建、实施和保持质量管理体系,为国际认可的标准,可用于任何企业。它当初的宗旨,就在于可以让任何规模或行业的组织使用,并且可以让任何企业使用。任何一家企业要想建立一个体系,来确保客户满意和改进,ISO 9001 作为一个国际标准,是公认的基础,正因如此,许多企业将符合 ISO 9001 作为挑选供应商组织的最低要求。
因为您的各个过程有您自己的审核,加上还有认证机构的审核,所以您的顾客不需要亲自审核您的企业。正因如此,ISO 9001 已成为众多企业参与市场竞争的一种必要手段。
此外,您的顾客可以放心认为,您已根据 ISO 9001 的七项质量管理原则建立了质量管理体系。质量管理原则形成 ISO 9001 标准的基础,在这篇文章中有详细介绍:Seven Quality Management Principles behind ISO9001 requirements。
事实上,因为 ISO 9001 标准非常基本而且影响巨大,各行业团体以它为基础,添加特定的行业需求,从而建立自己的行业标准,如用于航空航天行业的 AS 9100、医疗器械行业的 ISO 13485、汽车行业的 IATF 16949。
ISO 9001结构分为10个章节。 前面3个章节是介绍性的,后面7个章节包含质量管理体系的要求。 以下是7个主要章节的内容:
第4节:组织的环境 —— 本节讨论了理解组织的要求,以实施质量管理体系。 它包括识别内部和外部因素,识别相关方及其期望,定义质量管理体系范围以及确定过程及其相互作用的要求。
第5节:领导作用 —— 领导作用要求涵盖了最高管理者在实施质量管理体系方面发挥作用的必要性。最高管理者需要通过确保以顾客为关注焦点,确定和传达质量方针以及在整个组织中分配角色和职责来证实对质量管理体系的承诺。
第6部分:策划 —— 最高管理者还必须策划质量管理体系的持续有效。需要评估质量管理体系在组织中的风险和机遇,并且需要确定改进的质量目标并制定计划以实现这些目标。
第7节:支持 —— 支持这一节规定质量管理体系所有资源的管理,涵盖控制所有资源的必要性,包括人力资源、建筑和基础设施,工作环境,监测和测量资源以及组织的知识。 该章节还包括有关能力、意识、沟通和成文信息(过程所需的文件和记录)的控制要求。
第8节:运行 —— 运行要求涉及策划和建立产品或服务的所有方面。本节包括对策划、产品要求评审、设计、外部供方的控制、产品或服务的提供和放行以及不合格过程输出控制的要求。
第9节:绩效评价 —— 本节包括确保监控质量管理体系是否运行良好所需的要求,包括监视和测量过程、评估客户满意度、内部审核以及对运行中的质量管理体系进行管理评审。
第10节:改进 —— 最后一节包括使质量管理体系持续改进的要求。这包括需要评估不合格过程并采取纠正措施。
这些章节的基础是计划-执行-检查-处理循环,该循环使用这些元素,实施组织过程的变更,以推动并保持过程中的改进。
对于计划-执行-检查-处理循环如何在 ISO 9001 标准中发挥作用,博文 ISO 9001 和计划-执行-检查-处理模式(PDCA)有更进一步的解释。
ISO 9001 的好处说得再大也不过分;大大小小的企业使用它,得益良多,大大节省了成本,提高了效率。以下仅是其中的几个益处:
提高您的形象和信誉 ——当顾客看到您被认可的认证机构认证,他们会明白,您已经实施了一个以满足顾客要求和改进为关注焦点的体系。他们会更加相信您的承诺。
提高顾客满意 ——ISO 9001 质量管理体系的一项主要原则是识别并满足顾客要求和需要,以提高顾客满意为关注焦点。顾客满意度提高了,顾客的回头率也就相应提高。
全面整合的过程 ——通过使用 ISO 9001 的过程方法,您不仅看到组织中的各个过程,也看到这些过程的相互作用,这样就更容易找到组织内需要改进和节约资源的领域。
使用基于证据的决策 ——确保在证据充分的基础上作出决策,是 ISO 9001 质量管理体系成功的关键。确保决策有充分的证据支持,就可以把资源用到刀口上,以最好的效果,纠正问题,改进组织的效率和效益。
创造持续改进的企业文化 ——以持续改进作为质量管理体系的主要输出,您在时间、资金和其他资源上的节省可见日益增加。将持续改进作为企业文化,可将员工的工作重点放到对他们直接负责的过程的改进。
员工参与 ——在某个过程中工作的员工,是改进该过程的最好帮手。调整员工的工作重点,让他们不仅管理,而且还参与改进过程,他们会更加与组织休戚与共。
什么是 ISO 9001 认证?认证有两种类型:一种是对企业的质量管理体系符合 ISO 9001 要求的认证,另一种是对个人能够依据 ISO 9001 的要求实施审核的资格认证。本节讨论的内容是关于企业步步实施 ISO 9001 质量管理体系,并最后通过认证的过程。
ISO 9001 企业认证包括先基于 ISO 9001 的要求实施质量管理体系,然后聘请认可的认证机构审核,确认该质量管理体系符合 ISO 9001 标准的要求。
对于质量管理体系,您需要从管理支持和确定顾客要求开始,首先定义质量方针和质量目标,这些方针和目标共同定义质量管理体系的总体范围和实施。在这一阶段,首先要确立质量方针、质量目标和质量手册,它们共同确定了质量管理体系的总体范围和实施。除了这些,您需要创建组织必需的强制性和附加的过程和程序,以正确地创建和交付产品或服务。ISO 9001 需要的强制性文件共有六个,其他的可根据企业需要加入。想要更好地了解这这些,请参阅ISO 9001:2015所要求的强制性文档清单白皮书 ISO 9001:2015 强制性文件列表。
您可使用企业内部资源创建文件,也可聘请咨询师或购买标准文档。请访问 ISO 9001 免费下载s 页面,查看文档样品。
一旦所有的过程和程序全部到位,就需要让质量管理体系运行一段时间,以此收集必要的记录,迎接下面的步骤:对体系进行审核和审查,并获得认证。
在完成文档并加以实施后,组织需要采取以下措施,确保认证成功:
内部审核 ——内部审核的作用是审查质量管理体系,其目的是确保记录齐全,以确认过程的符合性,发现隐藏的问题和不足。
管理评审 ——管理评审是管理层对质量管理体系的正式审查,以评价管理体系过程的相关事实,从而作出适当的决策,分配资源。
纠正措施 ——继内部审核和管理评审之后,您需要从根源上纠正发现的任何问题,并记录其解决经过。
企业认证过程分为两个阶段:
第一阶段(文件审核——您选择的认证机构选派审核员进行文件审核,确保文件符合 ISO 9001 的要求。
第二阶段(现场审核——认证机构审核员审查文件、记录和企业实际工作,判定企业实际活动是否符合 ISO 9001 和企业本身文件的要求。
在 ISO 9001 概念方面的个人培训机会不难找,并有一系列的课程可以选择。在下列课程中,只有第一种的资格证书持有人可为认证机构担任审核工作。但作为在企业内部使用,其它课程所提供的技巧非常有用:
ISO 9001 审核组长课程 ——这是一个四至五天的培训课程,重点是了解 ISO 9001 质量管理体系标准,并且能够用它来依据标准要求审核管理体系。课程最后有一个测验,来验证学员的知识和能力。学员必须选读得到认可的课程,方可成为审核认证机构的审核员。
ISO 9001 内部审核员课程——该课程一般为二至三天,以审核组长课程为基础,但没有能力测验。所以,它最适用于刚刚开始为企业做内部审核的个人。
ISO 9001 意识和实施课程——该课程有好几种,内容是 ISO 9001 有关知识和实施方法。这些课程可为一或两天,甚至可以包括网上学习章节,作为教学方法之一。这些课程适用于需要大概了解 ISO 9001 标准的个人,或是将会参与企业内部实施工作的个人。对于其参与程度在这个水平的个人,许多这类课程比审核组长课程更为合算。
世界各地有许多经过认可的培训机构,可颁发 ISO 9001 个人资格证书。
要了解有关ISO 9001实施的更多信息,请访问我们的ISO 9001免费下载页面。 你会发现许多有用的资源。