APG-“重要的是结果!”

日期：2006年12月8日

ISO 9001审核实践组指南

“重要的是结果！”

1. 介绍

针对不断增加的对获证组织没有交付一致的、符合顾客要求的产品的关注（参见ISO 9001:2000条款1.1），ISO 9000顾问组（由ISO/TC 176, ISO/CASCO, ISO/COPOLCO, IPC和IAF的代表组成）最近提出了一系列建议。

下文由杰克·维斯特撰写，最初刊登在2006年7月出版的《质量文摘》杂志。这片文章对上述问题进行了论述，并强调了“重要的是结果！”这一主题思想。

符合ISO 9001:2000的单个要求是重要的，例如文件控制、记录控制、人员能力、测量设备的校准，但不应当是质量管理体系的中心关注点。应当把满足这些要求看作实现所期望的结果的手段，这个结果就是一致的、合格的产品。 2. 杰克·维斯特的文章

人们常说一个组织可以有符合ISO 9001的很好的质量管理体系，然而仍生产“垃圾”。这种观点产生于第三方QMS认证和产品认证之间所存在的很大的但又是合理的区别。对QMS进行认证并不是绝对保证获证组织生产的产品将符合要求。然而，把ISO 9001中的许多要求结合在一起，应当为体系的输出符合顾客要求提供合理的保证。

ISO 9001要求组织的质量方针包含对符合要求和持续改进QMS的承诺。标准要求对产品设计进行确认以确保它们符合特定的使用要求。ISO 9001还要求对产品进行验证以确保其符合要求。识别和满足顾客要求是

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始终贯穿ISO 9001的主题。例如，管理评审的期望输出之一就是对不满足顾客要求的产品做出决定。

ISO 9001中证明“重要的是结果”的条款

1.1 范围

本标准为有下列需求的组织规定了质量管理体系要求： a)需要证实其有能力稳定地提供满足顾客和适用的法律法规要求的产品；

b)通过体系的有效应用，包括体系持续改进的过程以及保证符合顾客与适用的法律法规要求，旨在增强顾客满意。

最高管理者应以增强顾客满意为目的，确保顾客的要求得到确定并予以满足(见7.2.1和8.2.1)。 最高管理者应确保质量方针： ……

b)包括对满足要求和持续改进质量管理体系有效性的承诺；管理评审的输出应包括与以下方面有关的任何决定和措施： ……

b)与顾客要求有关的产品的改进；

组织应确定并提供以下方面所需的资源： ……

b)通过满足顾客要求，增强顾客满意。 组织应确定：

a)顾客规定的要求，包括对交付及交付后活动的要求； b)顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求；

c)与产品有关的法律法规要求； d)组织确定的任何附加要求。

应确定与产品要求有关的输入，并保持记录(见4.2.4)。这些输入应包括：

a)功能和性能要求；

为确保产品能够满足规定的使用要求或已知的预期用途的要求，应依据所策划的安排 (见7.3.1)对设计和开发进行确认。 作为对质量管理体系业绩的一种测量，组织应对顾客有关组织是否已满足其要求的感受的信息进行监视，并确定获取和利用这种信息的方法。

组织应对产品的特性进行监视和测量，以验证产品要求己得到满足。这种监视和测量应依据所策划的安排(见7.1)，在产品实现过程的适当阶段进行。

5.2 以顾客为关注焦点

5.3 质量方针

5.6.3评审输出

6.1资源提供

7.2.1与产品有关的要求的确定

7.3.2设计和开发输入 7.3.6设计和开发确认

8.2.1顾客满意

8.2.4产品的监视和测量

我们需要打破这样的“神话”：组织在实实在在地符合ISO 9001的同时，仍然可以生产出不满足顾客要求的产品。获得ISO 9001认证的组织和审核员都趋向于关注ISO 9001的细节，而经常忽视了最基本的要求。

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一定不要忽视产品！如果声称一个组织符合ISO 9001，应当对顾客意味着这个组织能够一致地提供符合顾客要求的产品。

我们必须肯定我们的体系向我们的顾客交付合格的产品。标准要求做到这一点，ISO 9001的可信性要求做到这一点。对我们的顾客来说，重要的是我们的QMS输出的结果。

注：这篇文章总结了几个与ISO 9001:2000有关的重要概念，这些概念在《解释ISO 9001:2000》（第2版，Charles A. Cianfrani, Joseph J. Tsiakals and John E. (Jack) West著，ASQ质量出版社2001年出版）中做了详细解释。 关于作者

杰克·维斯特（John E. (Jack) West）是一位咨询师、商业顾问和作家，在许多行业有着超过30年的覆盖多个行业的经验。 - 3 -

Date:

8 December 2006

ISO 9001 Auditing Practices Group Guidance on:

“Output matters!”

1. Introduction

The ISO 9000 Advisory Group (comprising representatives from ISO/TC 176, ISO/CASCO, ISO/COPOLCO, IPC and the IAF) has recently made a number of recommendations to address increasing concerns that certified organisations are not delivering consistent, conforming product complying with customer requirements (ref. ISO 9001:2000 clause 1.1.)

The following paper by Jack West, first published in the July 2006 issue of Quality Digest magazine, addresses this topic and emphasises the theme that “Output matters!”

Conformity to individual requirements of ISO 9001:2000 such as document control, control of records, personnel competence and calibration of measuring equipment are important, but should not be the central focus of a quality management system. They should be seen as a means of achieving the desired output, which is consistent, conforming product.

2. Jack West's Paper

It's often said that an organization can have a good quality management system (QMS) that conforms to ISO 9001 and yet still produce \"junk.\" This observation derives from the perfectly valid distinction between third-party registration of a QMS and product certification. Certifying a QMS is no absolute guarantee that the product produced by the certified organization will be in conformance with requirements. Nonetheless, ISO 9001 contains many requirements that, taken together, should provide reasonable assurance that a system's output will meet customer requirements.

ISO 9001 requires that an organization's quality policy include commitments to meeting requirements and continually improving its QMS. The standard requires that product designs be validated to ensure they will meet requirements for given applications. ISO 9001 also requires that a product be verified to ensure it meets requirements. Identifying and meeting customer requirements is a consistent theme throughout ISO 9001. For example, one of the expected outputs of a management review is a decision regarding product that doesn't meet customer requirements.

ISO 9001 Clauses Demonstrating That Output Matters

1.1 \"Scope\"

\"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

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customer and applicable regulatory requirements.\"

5.2 \"Customer \"Top management shall ensure that customer requirements are determined focus\" and are 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 …

b) includes a commitment to comply with requirements and continually

improve the effectiveness of the quality management system …\"

5.6.3 \"Review \"The output from the management review shall include any decisions and output\" actions related to

b) improvement of product related to customer requirements …\"

6.1 \"Provision of \"The organization shall determine and provide the resources needed resources\" b) to enhance customer satisfaction by meeting customer

requirements.\"

7.2.1 \"Determination \"The organization shall determine of requirements a) requirements specified by the customer, including the requirements related to the for delivery and post-delivery activities, product\" b) requirements not stated by the customer but necessary for specified

or intended use, where known,

c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization.\"

7.3.2 \"Design and \"Inputs relating to product requirements shall be determined and records Development inputs\"maintained (see 4.2.4). These inputs shall include

a) functional and performance requirements …\"

7.3.6 \"Design and \"Design and development validation shall be performed in accordance with development planned arrangements (see 7.3.1) to ensure that the resulting product is validation\" capable of meeting the requirements for the specified application or

intended use, where known. …\"

8.2.1 \"Customer \"As one of the measurements of the performance of the quality management satisfaction\" system, the organization shall monitor information relating to customer

perception as to whether the organization has met customer requirements. …\"

8.2.4 \"Monitoring \"The organization shall monitor and measure the characteristics of the and measurement of product to verify that product requirements have been met. …\" product\"

Material quoted from ISO 9001:2000, used by permission of ISO

We need to stop perpetuating the myth that organizations can truly be in conformance with ISO 9001 and still produce product that doesn't meet customer requirements. ISO 9001-registered organizations and auditors alike tend to focus on conforming to the details of ISO 9001 and often lose sight of the basic requirements. Never lose sight of the product! A claim that an organization conforms to ISO 9001 should mean to the organization's customers that it can consistently provide product that meets customer requirements.

We must make certain our systems deliver conforming product to our customers. The standard requires it, and the credibility of ISO 9001 registration demands it. It's the output of our QMS that matters to our customers.

Note: This article summarizes several important concepts related to ISO 9001:2000 that are explained in more detail in ISO 9001:2000 Explained, Second Edition by Charles A. Cianfrani, Joseph J. Tsiakals and John E. (Jack) West (ASQ Quality Press,2001).

About the author

John E. (Jack) West is a consultant, business advisor and author with more than 30 years of experience in a wide variety of industries.

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