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IAF-Audit practice group

IAF-Audit practice group
IAF-Audit practice group

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International Organization for Standardization

International Accreditation Forum

Date: 21 September 2004

ISO 9001 Auditing Practices Group

The ISO 9001 Auditing Practices Group is an informal group of quality management system (QMS) experts, auditors and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International

Accreditation Forum (IAF).

It has developed a number of guidance papers and presentations (see "QMS auditing topics" below) that contain ideas, examples and explanations about the auditing of QMSs. These reflect the process-based approach that is essential for auditing the requirements of ISO 9001:2000 Quality management systems - Requirements .

The guidance is primarily aimed at QMS auditors, consultants and quality practitioners, but is not definitive. The papers and presentations reflect a number of different views in QMS auditing. As such, their content may not always be consistent. It is not intended that the

guidance will be used as specified requirements, an industry benchmark, or as criteria that all QMS auditors, consultants or practitioners have to follow.

QMS auditing topics

? The need for a 2-stage approach to auditing 2阶段审核的必要性

? Measuring QMS effectiveness and improvements 测量QMS 的有效性及其改进

? Identification of processes 过程的识别

? Understanding the process approach 过程方法的理解

? Determination of the “where appropriate” processes 确定”适当的”过程

? Auditing the “where appropriate” requirements 审核”适当的”要求

? Demonstrating conformity to the standard 证明符合标准

? Linking an audit of a particular task, activity or process to the overall system

? Auditing continual improvement 审核持续改进

? Auditing a QMS which has minimum documentation 审核QMS 文件化的最低要求 ? How to audit top management processes 如何审核最高管理层

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?The role and value of the audit checklist 审核检查表的角色和价值

?Scope of ISO 9001:2000, Scope of Quality Management System and Defining Scope of Certification ISO9001:2000的范围,质量管理体系的范围和定义认证范围

?How to Add Value during the audit process审核过程如何增值

?Auditing competence and the effectiveness of actions taken审核能力要求和采取措施的有效性

?Auditing Statutory and Regulatory requirements审核法规和指令要求

?Auditing the Quality Policy and Quality Objectives审核质量方针和质量目标

?Auditing ISO 9001, Clause 7.6 Control of monitoring and measuring devices审核ISO9001,

7.6条款监视和测量装置的要求

?Making effective use of ISO 19011ISO19011的有效应用

?Auditing Customer Feedback processes审核顾客反馈过程

?Documenting a Nonconformity文件化不符合项

?Guidance for reviewing and closing nonconformities评审和关闭不符合项指南

?Auditing Internal Communications审核内部沟通

?Auditing Preventive Action审核预防措施

?Auditing Service Organizations审核服务组织

?Auditing the Effectiveness of the Internal Audit审核内部审核的有效性

?Auditing Electronic Based Management Systems审核电子管理体系

A "Zip" file of all the above documents is also available. 可获得以上文件的ZIP档。Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following email address: charles.corrie@https://www.doczj.com/doc/a811621180.html,.

The other papers and presentations may be downloaded from the web sites:

www.iaf.nu

https://www.doczj.com/doc/a811621180.html,/iso-tc176-sc2

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The need for a 2 stage approach to auditing

2阶段审核的必要性

Auditing ISO 9001:2000 requires auditors to obtain a good understanding of an auditee’s quality management system (QMS) and the nature of its business. This is why it is beneficial for an organization to be visited prior to its certification audit and for a1st stage audit to be conducted. 审核ISO9001:2000要求审核员很好地理解受审核方的质量管理体系和业务性质。这就是在认证审核前访问组织,建立第一阶段审核的好处。

This 1st stage audit is primarily for scoping and planning a certification audit (the stage 2 audit) and to allow the auditor to obtain an understanding of the organisation. For example, to gain knowledge of its QMS, policies, objectives, risks, processes, locations, etc. It is also may be used for the auditing body to communicate its needs and expectations to the auditee.第一阶段审核可初步确定认证审核(第二阶段审核)范围并进行策划,让审核员了解组织。如了解质量管理体系,方针,目标,风险,过程,现场等信息。也可用于审核机构与受审核方沟通需求和期望。

Activities performed at a preliminary 1st stage audit include第一阶段审核活动包括: ?Identification of the key risks of the business and related statutory, regulatory aspects and compliance

识别业务的主要风险和相关的法令法规及其符合性

?An assessment of whether the auditee's defined processes are adequate to meet its objectives and customer requirements

评价受审核方确定的过程是否充分,并满足目标和顾客要求

? Conducting a Documentation Review

进行文件审核

?This review should determine if the organisation's QMS documentation adequately covers all the requirements of ISO 9001:2000. The review would normally be carried out at the auditee's premises (unless otherwise requested and justified). As a result of this activity, a report should be provided that notes any deficient areas. As part of the

documentation review, the auditor should assess the extent and availability of supporting procedures and process descriptions. Collecting necessary information regarding the scope of the organization's management system, processes and location(s)

确定组织的质量管理体系文件是否充分覆盖了ISO9001:2000的要求。此评审通常基于受审核方的前提下进行(除非有另外的要求和证明)。结果应提供报告描述不足之处。作为文件评审的一部分,审核员应评价支持程序和过程描述的程度和可获得性。收集关于组织管理体系,过程和场所的必要信息。

?Drafting the future certification documentation, including the Scope statement 起草下一步认证文件,包括范围的确定

?Planning the certification (stage 2) audit, including the requirements for audit team selection

策划认证 (第二阶段) 审核,包括审核组选择的要求

?Obtaining evidence that internal audits and management reviews are being planned, or performed, effectively

获得内部审核和管理评审有效策划或实施的证据

?Checking that the QMS is implemented and ready for the stage 2 audit, including appropriate level of documents and supporting records.

检查实施的质量管理体系及为第二阶段审核的准备,包括必要的文件和支持记录的水平。

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If the system is lacking in any way, the auditor should note this in the audit report, so that the organisation has an opportunity to rectify deficiencies prior to its certification (2nd stage) audit.

如果体系有缺失,审核员应记录在审核报告中,以便组织在认证(第二阶段)审核前矫正缺失。

?Agreeing a date for the stage 2 audit

确定第二阶段审核日期

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Identification of processes过程的识别

1. Distinguishing between the concepts of a process and an activity

过程和活动概念的区别

If an auditee cannot distinguish between the concepts of a process and an activity, the auditor can briefly explain the differences by using the guidance (clause 2.4) and definition ((3.4.1) in ISO 9000:2000 as background information. The auditor must be able to adapt to the auditee’s situation. It is the auditor’s responsibility to understand the auditee’s systems and approach.

如果受审核方不能区别过程和活动的概念,审核员可以ISO 9000:2000的指南和定义作为背景知识简要地解释其不同之处。审核员应有能力适应受审核方的状况。理解受审核方体系和方式是审核员的职责。

During the audit, the auditor should determine whether there is a problem of difference

of terminology only, or whether there is a lack of real implementation of the process approach by the auditee. There may be a need to issue an NCR if the auditee is not fully implementing the requirements stated in ISO 9001:2000, Clause 4.1. If this is simply a terminology problem, there should be no need to issue an NCR, if all the requirements of in Clause 4.1 are satisfied.

在审核期间,审核员应确定仅是术语不同的原因,还是受审核方过程方法实施的缺失。如果受审核方不能满足ISO 9001:2000条款4.1规定的要求,则需要发出NCR。如果满足了条款4.1的要求,仅是简单的术语问题,则不需要发出NCR,

The auditee has the right to use its own terminology, provided the requirements of the standard are met. The auditor should mentally develop a cross-reference list to ensure consistency and better understanding.

倘若满足标准要求,受审核方有权利使用他自己的术语。审核员应在心里建立一个对照表以确保一致性和更好地理解。

2. A process has defined objective(s), input(s), output(s), activities, and resources

定义的过程目标、输入、输出、活动和资源

If the auditee does not understand that a process must have defined (but not necessarily measurable) objective(s), input(s), output(s), activities, and resources, the auditor should try reformulating the questions to the auditee avoiding the use of QM jargon, e.g. Can you explain to me your operations here? What are the basic jobs carried out in your department? What information do you need to start your work? Where does it come from? Who receives the result of your work? How do you know if you’ve done your job correctly? etc..

如果受审核方不了解过程需定义(不适当可测量的)目标、输入、输出、活动和资源,审核员应试着换一种形式,以便受审核方避免使用质量管理行话,如你能向我解释你的运作吗?你部门的基本工作是什么?你开始工作需要哪些信息?这些信息从何处获得?谁接受你工作的结果?你如何理解正确的工作?等。

This should help the auditor to establish whether the processes (as per ISO 9001: 2000) are already defined, have clear inputs, outputs, objectives and so on.

这些帮助审核员确定是否已定义过程,有清晰的输入,输出,目标等。

3. Processes should be analysed, monitored and/or measured, and improved

应分析,监视和/或测量,改进过程

If after applying the audit techniques outlined above, there is an absence of any records or other proof to demonstrate that the processes are analysed, and/or monitored, and/or measured, and/or improved, there would appear to be non-conformity with part of ISO 9001:2000 Clause 4.1.

如果用以上的审核技术,发现记录的不足或不足以证明过程已分析、监视、测量、改进,这会成为ISO 9001:2000 条款 4.1的不符合项。

4. The auditee/auditor considers that each clause or sub-clause of ISO 9001:2000 must be defined as a separate process

受审核方和审核员认为ISO9001:2000的每个条款须定义为一个独立的过程

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If the auditor considers this as the right approach, he should refer to relevant ISO documents, (notably the ISO/TC 176/SC 2 document N544 ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach) which clearly indicates the contrary. If the auditee considers this as the right approach, it is recommended that the techniques outlined in section 2 (above) should be used.

如果审核员认为这是正确的方法,他应参考ISO文件(ISO/TC 176/SC 2文件 N544 ISO9000介绍和支持文件包:过程方法的使用和概念指南),规定正好相反。如果受审核方认为这是正确的方法,建议其使用第2节的技术。

5. Is the process approach as described in the 'Introduction' to ISO 9001:2000 a requirement of the standard?

过程方法是ISO9001:2000标准前言的一项要求吗?

The description of the process approach in the 'Introduction' to ISO 9001:2000 is purely informative and not a set of additional requirements.

ISO9001:2000前言描述的过程方法完全是正常的要求,不是附加要求。

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Understanding the process approach理解过程方法

Helping an auditor to interpret the process approach

帮助审核员解释过程方法

If an auditor does not understand or misunderstands the process approach, direct him or her to recognized information sources, such as the standard ISO 9000:2000 Quality management systems – Fundamentals and Vocabulary and the ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the Process Approach for management systems (document ISO/TC176/SC2/N544, available from

https://www.doczj.com/doc/a811621180.html,/iso-tc176-sc2).

如果审核员不了解或误解过程方法,他或她应了解相关的信息资源,如标准ISO9000:2000质量管理体系-原理和术语和(ISO/TC 176/SC 2文件 N544 ISO9000介绍和支持文件包:管理体系的过程方法使用和概念指南,可从https://www.doczj.com/doc/a811621180.html,/iso-tc176-sc2网站获得)。

A certification body/registrar should ensure that all its auditors have received sufficient training regarding the new requirements in ISO 9001:2000, particularly those on the process approach. Thus, an auditor should realise that several steps are needed, including the following认证机构或注册方应确保其所有审核员都接受了足够的ISO 9001:2000新要求的培训,尤其是过程方法。因此审核员应清楚以下的几个步骤:

- determining the processes and responsibilities necessary to attain the quality objectives of the organisation确定必要的过程和职责以达成组织的质量目标;

- determining and providing the resources and information necessary确定并提供必要的资源和信息;

- establishing and applying methods to monitor and/or measure and analyse each process 确定并应用监视和测量和分析每个过程的方法;

- establishing and applying a process for continual improvement of the effectiveness of the QMS确定并应用持续改进质量管理体系的有效性的过程.

The process approach concept must be so well understood by auditors that they are not limited by the terminology in the standard; however, auditees may use their own “in-house” terminology. Auditors must be aware that the application of the process approach will be different from organisation to organisation, depending on the size and complexity of the organisation and its activities. Special consideration should be given to the situation in small and medium enterprises (SME’s), so that auditors should not expect so many processes in their QMSs.

审核员应清楚地理解过程方法的概念,不仅限于标准的术语;可是,受审核方可能用他们自己的术语。审核员应认识到不同组织的过程方法应用,基于组织及其活动的规模和复杂程度。尤其要考虑到中小型企业的情况,审核员不应期望在他们的质量管理体系有太多过程。

Helping an auditee to interpret the process approach

帮助受审核方说明过程方法

If an auditor is faced with a complete misunderstanding by an auditee, this situation should normally be identified at the 1st stage audit审核员面对完全误解的受审核方的情况通常在第一阶段审核中发现.

The auditor should refer the auditee to recognized information sources, such as those indicated in the section above. (In particular, the referenced ISO/TC 176/SC 2/N544 document sets out different steps in the process approach and provides useful guidance with examples)审核员应参考受审核方的信息资源,如以上章节显示的信息(通常参见ISO/TC

176/SC 2/N544文件设定的过程方法的步骤和提供的指南.

The auditee should also pay sufficient consideration to受审核方应充分考虑

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- the establishment of process objectives过程目标的建立,

- process planning过程策划,

- the availability of suitable records可获得适当的记录.

Auditees frequently identify too many processes; some or all of them are activities, which do not fulfil the requirements of a process, in the sense that ISO 9001:2000 uses the concept. In this situation, an auditor should (in the 1st stage audit) propose that the auditee performs a redefinition of its processes, based on e.g. the criticality of the activities. This might be particularly relevant for SME’s.

受审核方通常会识别许多的过程,其中一部分或全部是活动,不符合ISO 9001:2000中使用的过程要求。这种情况下,审核员应(在第1阶段审核中)建议受审核方基于活动的危险程度重新定义过程。通常在中小型企业可能遇到。

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Determination of the “where appropriate” processes确定适当的过程

Terminology术语

Where the terminology used by the auditee is different to that used by the auditor, the auditor should understand the concepts in ISO 9001:2000 using ISO 9000:2000 and make a mental or written cross reference between the terminology of the auditee and his/her own for the same concepts, avoiding the use of QM jargon当受审核方用的术语和审核员不同时,审核员应运用ISO 9000:2000理解ISO 9001:2000的概念,并在心里或写出书面的对照表,确定受

审核方和他自己对同一个概念所用的术语,避免使用质量管理行话.

The definition of process过程的定义

If the definition of process is not interpreted in the same way by the auditor and the auditee, the auditor should seek to understand the auditee’s point of view and not impose his own view unless it is clear (supported with enough objective evidence) that the requirements of the standard are not met. The same is true if the auditor believes that certain processes have not been correctly identified or are missing如果审核员和受审核方对过程的定义不能一致时,审核员应理解受审核方的观点,而不能强加他自己的观点,除非确定不能满足标准要求(足够

的客观证据.支持)。审核员确定过程识别不正确或遗漏时也同样处理.

Exclusions 删减

The auditor should refer to clause 1.2 of ISO 9001:2000, to the ISO/TC 176/SC 2/N524 document ISO 9000 Introduction and Support Package: Guidance on ISO 9001:2000, Clause 1.2 'Application' for further guidance, and the APG's guidance on Scopes.审核员宜参考ISO 9001:2000的1.2条款,ISO/TC 176/SC 2/N524文件ISO9000介绍和支持文件:ISO

9001:2000的1.2条款“应用”指南和APG的范围指南.

The auditor should obtain objective evidence that the auditee cannot exclude a specific requirement, before reaching a conclusion.

审核员应在做出审核结论之前获取受审核方不能删减要求的客观证据。

It is good practice for an auditor to utilize the standard ISO 9000:2000 Quality management systems - Fundamentals and vocabulary and ISO/TC 176/SC 2/N524 as support documents, to explain the arguments to the auditee.

审核员利用标准ISO 9000:2000质量管理体系-基础和术语和ISO/TC 176/SC 2/N524作为支持文件,解释和受审核方的争议是一个很好的办法。

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Auditing “where appropriate” requirements审核适当的要求The auditee should determine the application of the ISO 9001 “where appropriate" requirements, as this will affect its ability to satisfy its customers' requirements. (It may be useful to refer the auditee to ISO 9001:2000 clause 1.1 "… where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements”.)

受审核方应确定ISO9001”适当的”要求的应用,因为这些会影响到满足顾客要求的能力。(请受审核方参考ISO 9001:2000条款1.1“…当组织 A需要证明其持续提供满足顾客和适用法规要求产品的能力时”)。

An auditor should ensure that the "where appropriate" requirements are really ‘appropriate’ in relation to the proposed/actual scope of the auditee's quality management system. Therefore the basis of audit should be against this criterion, which should form the benchmark when deciding what is appropriate or not.

审核员应确保”适当的”要求对于提议或实际的受审核方的质量管理体系范围确实是”适当的”。因些确定是否适当时,审核基准应基于标准。

Issues that should be considered include应考虑的问题包括:

- Does this requirement add value to this element of confidence, without the ‘where appropriate’ being addressed?

没有确定“适当”时,此条款的要求是否可增值?

- Does it increase the risk that the organisation cannot meet its customer requirements?

(This may be more than a specific set of customer requirements, as it can include the demands and expectations of end users, consumers, or the supply chain).

是否增加组织不能满足顾客要求的风险?(这可能超过一组特定顾客的要求,因为也包括最终使用者、消费者或供应链的要求和期望)。

Need for experience to make a judgement on a technical issue 技术问题判定的经验需求。

An auditing body should be able to demonstrate that its auditor has the necessary sector knowledge, competence and auditing skills. The auditor needs to be able to demonstrate knowledge of a process that is being examined and to be able to apply their skill in evaluating whether the ‘where appropriate’ requirements are appropriate or not.

审核机构应有能力证明其审核员具备必要的知识、能力和审核技能。审核员需证明过程相关的知识经过测试,有能力应有其技能评价”适当的”要求是否适当。

The auditor will need to understand how the ‘where appropriate’ requirements fit into the context of how a process is established and its expected outcomes. When the requirements are not considered to be "appropriate", the audit should provide objective evidence to demonstrate that the system is effective and that customer requirements are being consistently met.

审核员需要理解适当的要求如何适合建立的过程及其期望的输出。当这个要求认为“不适当”时,审核应提供客观证据以证明体系是有效的,并可持续满足顾客要求。

An auditing body should have the necessary processes in place to ensure that an auditor has the specific skills for the organisation that is to be audited.

审核机构应有必要的过程以确保审核员对于受审核组织具备所需的特定技能。

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Demonstrating conformity to the standard证明符合标准“Performing the audit to the standard's clauses” versus “Performing the audit to the auditee’s processes”审核标准条款和审核受审核方过程

When assessing conformity to the standard, audit checklists may not be sufficient评

价标准符合性时,审核检查表可能不充分

At the end of an audit, the auditor should be in a position to know whether all requirements of the standard are satisfied or not.

审核结束时,审核员应确定标准所有要求是否都能满足。

Trying to show compliance to a standard often brings people back to using checklists, where an auditor is able to check-off the requirements of the standard one-by-one, making sure that all the requirements have been covered. This basic approach of filling out a checklist is an easy way to ensure that all requirements of the standards have been checked. However, considering the approach of the ISO 9001:2000, performing an audit from a generic checklist might prevent an auditor from collecting evidence of effective interfacing between processes. 当审核员能逐个检查标准要求时,确保已覆盖了标准所有要求时,常使用检查表显示符合标准要求。填写检查表是确保标准所有要求都已检查的基本方法。但是,考虑到ISO9001:2000

的方法,用普通的检查表可能会妨碍审核员收集过程接口有效性的证据。

In some situations, completely moving away from the checklist (or audit question list) might not be possible, particularly if the organization needs to provide evidence of compliance to the standard to third parties (e.g. regulators, conformity assessment bodies).

有些情况下,显然组织需要向第三方(如调节方,符合性评价机构)提供符合标准的证据时,完

全使用检查表(或审核问卷)可能是不行的。

It is important to use a checklist in an appropriate way and at an appropriate time, i.e. as a tool to help keep track of the requirements of the standard to be covered.

用适当的方式、在适当的时间使用检查表是很重要的,如作为帮助跟进标准要求是否覆盖的工具。

What is adequate sampling?足够的抽样

There is no statistical or mathematical formula to establish the right number of samples to be taken during an audit. Defining the number of samples (e.g. one, five, or even more samples of records for a particular requirement) to be taken to confirm conformity to the requirements is not efficient and does not ensure conformity. It is of course a fact that by increasing the number of samples taken, an auditor will have greater confidence regarding the actual status of the implementation of the QMS. "Adequate" sampling in this context would refer to a level of sampling taken during on-site interviews and record reviews that give sufficient confidence that the auditee's QMS is implemented as described.

没有统计或数学公式来确定在审核期间抽样的正确数量。确定抽样数量来确认与标准的符合性是效率低下的,且不能确保其符合性。当然增加抽样数量,审核员对质量管理体系实施的真实状态更具信心。抽样的适量会涉及到现场面谈和记录评价的抽样水平,对受审核方质量管理体系实施性充满信心。

Multi-site sampling, or sampling of the organizational units of a company, are covered in Annex II of the IAF's Guidance on the Application of ISO/IEC Guide 62, along with the required on-site auditor days and sampling formula for multi-sites.

多现场抽样或公司的组织单位抽样,在IAF的ISO/IEC导则62应用指南文件中规定,包括了多现场审核人天要求和多现场的抽样公式。

The auditor needs to perform interviews and check records and evidence during the interview. The number of samples to be taken depends on the complexity of the process being audited, and on the quality of information received from the auditee during the interview. It is also important that the auditor maintains the schedule outlined in the audit plan.

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At the end of the day, the auditor needs to feel comfortable that the samples and the objective evidence seen are representative, in order to draw appropriate conclusions regarding the implementation of the QMS.

审核员在审核中应进行面谈,并检查记录和证据。抽样的数量取决于受审核过程的复杂程度和在面谈时从受审核方处获得的信息质量。审核日结束时,审核员应觉得抽样是适当的,客观证据具有代表性,以便对质量管理体系实施状态作出结论。

Recording audit information记录审核信息

ISO 19011 and the IAF Guidance on the Application of ISO/IEC Guide 62 explain what an audit report should contain. However, it is important that the audit reports to the auditee only contain important information for the auditee, e.g. information on possible improvements, positive observations, and non-conformities to the standard. Merely reiterating and explaining the requirements of the standard is unlikely to be what the auditee is looking for.

ISO19011和IAF文件ISO/IEC导则62的应用说明了审核报告应包含的内容。但是,重要的是给受审核方的审核报告仅包括一些重要信息,如可改进的信息,正面的观察和不符合项。仅重复和解释标准的要求不是受审核方所需要的。

There may also be a requirement for the auditor to demonstrate the sequence in which the audit was performed, sometimes called the audit trail. Using audit notes is a very efficient way for an auditor to record the audit. The main disadvantage of using audit notes is that they tend to be a very personal way of recording information during an audit, and the levels of recording detail and styles will vary greatly from one auditor to another.

这也是对审核员的要求,证明执行审核的顺序,有时叫审核路线。对于审核员记录审核,使用审核笔记是很有效的方法。使用审核笔记主要不足是趋向于非常人个化的方法记录审核信息,每个审核员的记录详细程度和类型都有很大的不同。

A checklist can ensure some uniformity in the performance of the auditors. However, auditors should never forget to spend their time auditing, not filling out checklists or taking notes.

检查表可确保审核员的一致性。但是,审核员不应忘记时间的分配,而不是填写检查表或审核笔记。

Linking an audit of a particular task, activity or process to the overall system体系特定的任务、活动或过程的审核

The auditor should not lose sight of the overall direction of the audit, and get side-tracked by superfluous details. It is important that the auditor keep a close eye on the information provided by the auditee in the quality manual or documentation where the auditee has defined the interaction of processes. Interviews should also be performed in such a way that the auditors should determine the input and output of the process being audited. Keeping in mind the auditee's process map should ensure that the auditor will be able to determine the importance of the process he is auditing at any time, and will therefore be able to keep sight of the overall direction of the audit. This will also help the auditor to understand the linkage between the processes.

审核员不能忽视审核的全面趋势,获取边缘资料。重要的是审核员应密切关注质量手册或定义过程接口的文件中受审核方提供的信息。审核员应确定受审核的过程输入和输出。关注受审核方的过程图,以确保审核员任何时候都有能力确定过程的重要性,因而能够看到审核的全面趋势。这样也有助于审核员理解过程间的联系。

During an audit, the auditor has an opportunity to check the auditee's description of the interrelation of its processes. The auditor should take some samples to see if the descriptions are a proper reflection of the actual interrelation of the processes, as this will help determine if the process description is adequate.

在审核期间,审核员有机会检查受审核方对过程相互关系的描述。审核员应抽样看描述是否反映过程的相互关系,以便确定过程描述是否充分。

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Auditing continual improvement审核持续改进

How much improvement is “enough”?多少改进才“足够”

It should be emphasised that the requirement in ISO 9001:2000 is for continual improvement of the effectiveness of the QMS.

ISO 9001:2000强调持续改进质量管理体系的有效性。

Continual improvement emanates from the objectives set by top management, which should (at least) address: the improvement of internal efficiency (for the organization to remain economically competitive), individual customer needs, and the level of performance that the market normally expects.

持续改进源于最高管理者设定的目标,(至少)说明:内部效率(组织保持经济竞争力)的改进,

单个顾客需求和市场正常期望的业绩水平。

For example, in the aeronautical sector, the “acceptable rate” of non-conforming delivered product is zero percent, so it would not be useful for the organization to set objectives for an “improvement“ in this rate. However, it would be useful for the organization to have objectives aimed in improving its internal efficiency and its competitiveness (e.g. through innovation).

例如,对于航空业,交付不合格品的接受率为零,所以组织不能用此作为目标改进。但是,组织可以改进其内部效率和竞争力作为目标(如通过创新)。

The auditor should seek to determine if the auditee has attempted to set objectives that establish the correlation between the 3 factors of: corporate objectives, customer needs, and market expectations. Thereafter, it is up to the organization to balance the need for improving internal efficiency and the need to progress with external performance (although the two are very often closely related). No one in isolation can ever be considered as being “enough” or “not enough”.

审核员应确定受审核方设定目标建立以下3方面的关系:公司目标,顾客需求和市场期望。随后组织平衡其内部效率改进需求和外部业绩(这两项通常紧密相关)发展需求。不可孤立地考虑是否足够。

One area which can be problematic for the auditor is to know what is a reasonable market benchmark. Continuing the above aeronautical example, if the organization announced that it had improved from a level of 50% non-conforming product delivered to 40%, this would demonstrate continual improvement, but would hardly be acceptable, given the industry sector's zero percent normal rate. However, if it announced that it had set an objective to improve its performance from 0,50% to 0,40%, this would be much nearer the market norm. 对于审核员有一处问题是什么是合理的市场绩效。继续上面航空的例子,如果组织告知从50%的交付不良品率改进到40%,这可证明持续改进,但是对于行业内零缺陷却是不能接受的。但是,告知其绩效从0,50%改进到0,40%,这样就比较接近行业正常水平。

The only real solution for the auditor is to verify how the organization has determined this proposed rate of improvement, how it has evaluated the associated risks, and how this relates to customer requirements and the monitoring of feedback on customer satisfaction. It would be almost impossible to issue an NCR that stated “There was not enough continual improvement”.

审核员最真实的解决方法就是验证组织如何确定其改进比率,如何评价其关联风险,如何考虑顾客要求和顾客满意反馈的监视。几乎不可能开出NCR“持续改进不够”。

What sort of information is relevant and where can we find it?相关信息和何处可发现?The auditor has to verify how the overall corporate objectives have been translated into internal requirements throughout the appropriate processes, and how these requirements are communicated and monitored. So, the auditor should look for evidence that the organization is analysing data from process monitoring, and is then taking the results forward for evaluating process efficiency and/or improving process output. One point that should be

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specifically examined, is the consistency of the way in which the improvement of any one process contributes to meeting the overall objectives, in order to ensure that this will not cause conflict in the achievement of other objectives.

审核员须验证公司目标如何通过必适当的过程转化为内部要求,以及这些要求如何沟通和监视。因此,审核员应寻找组织分析过程监视数据,并利用结果评价过程效率和/或改进过程输出的证据。有一点要特别注意,任何一个过程对满足目标的贡献的改进,以确保不会引起达成目标的抵制。

The type of information that an auditor needs to look for, is evidence of how the corporate objectives are translated into specific QMS objectives. For example: an organization could set an objective to reduce customer complains by 30%. The top management analysis shows that 50% of the complaints concern overdue deliveries. The auditor should then look for evidence that the organization is monitoring and analysing key aspects of its scheduling and planning activities, throughout its processes, and the process interfaces, to reduce delays.

审核员要寻找的信息类型是如何将组织目标转为具体的质量管理体系目标的证据。如:组织可设定目标降低顾客投诉30%。最高管理者分析50%投诉和延迟交货有关。审核员应寻找的证据有组织通过过程、过程的接口监视和分析其排程和策划活动的关键因素,以降低延迟交货率。

Improvement of the process or improvement of the QMS?过程改进或QMS改进

An auditor should remember that it would be unrealistic to expect an organization to make progress all potential improvements simultaneously. Each improvement will require the commitment of resources, which may need prioritisation by top management, especially where investments are needed. Instead, the auditor should seek to ensure that the improvement objectives are consistent overall, and are coherent with the trilogy of factors mentioned above. However, an organization that does not have a policy and objectives relating to continual improvement is clearly not complying with the standard. Similarly, the absence of any evidence of improvement on at least one of these aspects would have to be considered as indicating that an organization's quality policy is not in line with ISO 9001: 2000.

审核员应记住期望组织同时进行所有的改进机会是不切实际的。每项改进都要求承诺资源,尤其是需要投资时,最高管理者就需要优先选择。相反,审核员应寻求确保改进目标符合整体目标,和上面提到的三个方面相一致。但是,组织没有关于持续改进的方针和目标是明显不符合标准的。相同的,这些方面有一项的改进缺乏证据则显示组织的质量方针和ISO 9001: 2000不一致。

One word of warning: There is no requirement that the organization should set objectives for improvement of all its processes at any one time. As in the above example on reducing customer complaints, some processes may not be deemed by top management to contribute significantly to the reduction of delays, and it is only normal therefore, that the organization would not concentrate on these areas.

注意:没有要求组织应在任何时间所有过程都设定改进目标。如以上降低顾客投诉率的例子中,最高管理者可能不认同一些过程对降低延迟的能力,认为这是正常的,所以组织也没有集中关注到这些区域。

If the top management has set a (realistic) objective for a process, and there is no evidence of improvement, this information must be fed back into the management review so that top management can decide what type of action is appropriate - for example, re-adjusting the objective or providing other means to impact on the process.

如果最高管理者已设定了过程的(现实)目标,但是没有改进的证据,这个信息应反馈到管理评审以便最高管理者能决定适当的措施-如,再调整目标或提供其它方法影响此过程。

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Auditing a QMS which has minimum documentation审核文件化最少的QMS

There can be disagreement between an auditor and an auditee on the absence of certain documented procedures, when the auditee presents only a quality manual and the six documented procedures specifically required by ISO 9001:2000.

当受审核方呈出的仅有质量手册和ISO 9001:2000明确要求的6份程序文件时,审核员和受审核方之间对于必要的文件化程序可能存在争议。

The differences in view between the auditor and the auditee can arise from differences in the interpretation of the ISO 9001 requirements contained in Clause 4.2.1, and the related Note, which state:

观点的不同在于审核员和受审核方对于ISO9001条款4.2.1要求及相关说明的解释不同,规定是:

"4.2.1 General总则

The quality management system documentation shall include质量管理体系文件应包括:

….

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

组织确保过程有效策划、运作和控制所需的文件

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to注2 组织的质量管理体系文件化程度不同,取决于

a) the size of organization and type of activities组织的规模和活动类型,

b) the complexity of processes and their interactions, and过程及其接口的复杂程度,和

c) the competence of personnel."人员的能力

The auditor should requests information on the auditee's operating processes and subsequently ask questions, record answers and observe staff at all levels (including administrative personnel, process owners and operators), to confirm that the actual working status conforms to the descriptions given.

审核员应要求受审核方提供过程运作的信息,随后提问题,记录回答和在各阶层观察员工(包括管理人员,过程拥有者和操作员)以确认实际工作状态是否符合所给出的描述。Thereafter, the necessity for any documentation should be evaluated in the light of the observed need for consistency, and the role that any documentation could play in avoiding any significant, identified risks.

此后,结合观察到的一致性的需要评价所必需的文件,文件化可以避免重大的识别的风险。The reader is referred to the advice given in document referenced “ISO/TC 176/SC 2/N 525, ISO 9000 Introduction and Support Package: Guidance on the Documentation Requirements of ISO 9001:2000”可参见“ISO/TC 176/SC 2/N 525, ISO 9000介绍和支持文件包: ISO 9001:2000文件化要求指南”

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How to audit top management processes如何审核最高管理过程

Recognizing that the auditing of top management is a sensitive issue, this document provides guidance for this category of auditing.

审核最高管理层是一个很敏感的话题,本文件提供了此类审核的指南。

Auditors should involve top management in the audit, i.e. invite them to opening and closing meetings, allow sufficient time in the audit plan for interviewing top managers, discuss audit findings directly with them, seek evidence of their commitment, etc.. It is important to change the focus of attention from just the quality manager to the top management of the organization.

审核应包括最高管理者,如邀请他们参加首末次会议,审核计划中安排足够的时间与最高管理者面谈,与他们直接讨论审核发现,寻求他们承诺的证据等。将关注焦点从质量经理改变到组织的最高管理者是非常重要的。

The auditor should consider top management activities to be processes, and should auditing them accordingly.

审核员应视管理活动为过程,对他们进行审核。

Planning stage策划阶段

The auditor needs to identify top management processes, and审核员需识别最高管理过程

a) understand the organization and its management structure, by reviewing information

such as organization charts, annual reports, business plans, company profiles, press releases, websites,

通过评审信息如组织结构图,年度报告,业务计划,公司档案,新闻发布,网站了解组织及其管理结构

b) make provision on the audit plan for gathering relevant information regarding top

management commitment, directly from and by interviewing top management,

审核计划安排直接与最高管理者面谈收集有关最高管理者承诺的信息

c) understand the culture of the organization and its top management, in order to

determine its impact on the audit plan – and make appropriate adjustments.

了解组织及其最高管理者文件,以确定对审核计划的影响-并做适当的调整

d) take a professional approach in the auditor's own appearance, by determining the

dress code of the organization.

审核员的专业能力确定组织的专业代码

e) plan the timing of the top management interview, to ensure convenience and

punctuality.

计划与最高管理者面谈的时间表,以确保方便准时。

An auditor with limited auditing experience should not be assigned to interview top management,

不宜分配审核经验有限的审核员和最高管理者面谈。

Conducting the audit审核实施

Common methods of evaluating top management commitment are:

评审最高管理者承诺的通用方法是:

1. Interviews with top management

和最高管理者面谈

The auditor can, by utilising business terminology appropriate for the top management, ask relevant questions that

审核员能用适当的业务术语向最高管理者询问问题

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a) seek to obtain evidence of top management’s awareness of and commitment to quality

and its relevance to the organization's overall objectives and management system,

寻求最高管理者的质量意识和承诺,组织的整体目标和管理体系的证据,

b) establish evidence of conformity to the ISO 9001 requirements for management

responsibility.

建立符合ISO9001管理职责要求的证据

2. Collecting and corroborating evidence 收集并确认证据

The auditor/audit team should be constantly looking for opportunities to corroborate the answers received from top management when interviewed.

审核员/审核组宜不断寻找机会确认与最高管理者面谈时获取的信息。

This includes包括

a) the availability and relevance of policies and objectives

方针和目标的可获得和适宜性

b) the establishment of linkage between the policies and objectives

方针和目标的关联性

c) obtaining the evidence that these policies and objectives are effective and understood

throughout the organization

收集方针和目标有效性并为组织全员理解的证据

d) determining if the policies and objectives are appropriate for continual improvement of

the quality management system and for the achievement of customer satisfaction.

确定方针和目标是否适合于质量管理体系的持续改进和实现顾客满意

e) determining if top management are involved in management reviews.

确定最高管理者是否参与管理评审。

Additional interviewing and gathering of evidence may be needed to provide the necessary corroboration.

或能需要附加的面谈和收集证据以进行必要的验证。

The audit team should ensure that any additional evidence of top management commitment

is also collected.

审核组宜确保最高管理者承诺的证据已收集。

The auditor/audit team should review the collected evidence, to ensure the completeness

and accuracy of the information, and to provide confidence in the conclusions drawn.

审核员/审核组应评价所收集的证据以确保信息的完整正确性,为作出结论提供信心。

Audit reporting审核报告

Auditors should prepare their audit reports in order to make them appropriate for presentation to the top management of organizations. It may be appropriate to present an executive summary of the audit report, suitable for presentation to the top management and key interested parties of the organization. The executive summary should highlight the key findings, both positive and negative, and identify opportunities for improvement.

审核员应编制审核报告便于向组织的最高管理者传达。应适于向组织的最高管理者和关键相关方传达执行状况。执行状况应突出主要审核发现,包括正面和负面和改进机会的识别。

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The role and value of the audit checklist审核检查表的角色和价值

Introduction简介

This document provides information on the role and use of audit checklists to actively support the audit process本文介绍了用以支持审核过程的检查表角色和应用.

Whilst the document is primarily directed to external auditing organizations (including registration and certification bodies), the information can also equally be used by any organization conducting internal audits本文主要用于外部审核组织(包括注册和认证机构),同时也可用于任何组织实施内部审核.

Need for checklists检查表的需要:

In looking at current auditing standards, ISO 19011 makes reference to “Preparing work documents” in Clause 6.4.3. The following is an extract from this clause依据目前的审核标准ISO19011条款6.4.3“准备工作文件”。以下是摘录自此条款:

“The audit team members should review information relevant to their audit assignment and prepare work documents as necessary for reference and for recording audit proceedings. Such documents may include审核组成员宜评审其审核任务的相关信息,准备必要的工作文件以参考和记录审核发现

?Checklists and audit sampling plans, and检查表和审核抽样计划,和

?Forms for recording information, such as supporting evidence, audit findings and records of meetings记录信息表格,如支持证据,审核发现和会议记录.

The use of checklists and forms should not restrict the extent of audit activities, which can change as a result of information collected during the audit检查表和表格的使用不能限制可能改变审核过程收集信息的结果审核活动的范围”

The use of audit checklists审核检查表的使用:

Whilst not always required in management system standards, audit checklists are just one tool available from the “auditors toolbox”. Many organizations will use them to ensure that the audit at a minimum will address the requirements as defined by the scope of the audit审核检查表仅是审核员所用的工具,随时可获得,管理体系标准中无明确的要求。许多组织用以确保审核范围的至少的审核要求.

An example auditing approach is shown below审核方法案例如下:

management

9001:2000

requirements.

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It is beneficial to audit from the organization's quality management system up to the requirements.

A checklist may be used to ensure that all relevant ISO 9001 requirements addressed对于按要求审核组织的质量管理体系是有益的。检查表可用于确保所有ISO9001的要求都可以覆盖。

Advantages优点:

Literature available in the marketplace notes the following with respect to the use of audit checklists以下关系到检查表使用的要点:

1. Checklists if developed for a specific audit and used correctly为特定的审核制定检查

表并正确使用:

a. Promote planning for the audit利于审核策划.

b. Ensure a consistent audit approach确保审核过程的一致性.

c. Act as a sampling plan and time manager用于抽样计划和时间管理.

d. Serve as a memory aid想备忘录作用.

e. Provide a repository for notes collected during the audit process (audit field

notes)审核过程中提供关注点收集的指引

2. Audit checklists need to be developed to provide assistance to the audit process制定

审核检查表为审核过程提供帮助.

3. Auditors need to be trained in the use of a particular checklist and be shown how to

use it to obtain maximum information by using good questioning techniques审核员需接受常用检查表使用的培训,并展示如何应用提问技巧获取最多的信息.

4. Checklists should assist an auditor to perform better during the audit process检查表

应可帮助审核员更好地实施审核过程.

5. Checklists help to ensure that an audit is conducted in a systematic and

comprehensive manner and that adequate evidence is obtained检查表帮助审核的系统性和全面性,并获得足够的证据.

6. Checklists can provide structure and continuity to an audit and can ensure that the

audit scope is being followed检查表能提供审核的结构及连续性,并能确保覆盖审核

范围.

7. Checklists can provide a means of communication and a place to record data for use

for future reference检查表可提供沟通工具和记录为以后提供参考的数据区域.

8. A completed checklist provides objective evidence that the audit was performed完成

后的检查表可提供审核实施的客观证据.

9. A checklist can provide a record that the QMS was examined检查表可提供QMS检查

的记录.

10. Checklists can be used as an information base for planning future audits检查表可用

于以后审核的信息基础.

11. Checklists can be provided to the auditee ahead of the on-site audit检查表可在现场

审核前提供给受审核方.

Disadvantages缺点

In contrast, when audit checklists are not available, or poorly prepared, the following

issues/concerns are noted相比之下,没有检查表或过于缺乏,应注意以下问题:

1. The checklist can be seen as intimidating to the auditee检查表看起来对受审核方可能

造成压力.

2. The focus of the checklist may be too narrow in scope to identify specific problem

areas过份关注检查表可能缩小识别问题区域的范围.

? ISO & IAF 2004 – All rights reserved www.iaf.nu; https://www.doczj.com/doc/a811621180.html,/iso-tc176-sc220

3. Checklists are a tool to aid the auditor, but will be restrictive if used as the auditor’s

only support mechanism检查表是审核员的帮助工具,但如果当做审核员的支持设施使用的话,可能会限制审核活动.

4. Checklists should not be a substitute for audit planning检查表不能代替审核策划.

5. An inexperienced auditor may not be able to clearly communicate what he/she is

looking for, if they depend too heavily on a checklist to guide their questions一个没有经验的审核员如果过份依赖检查表指导审核,可能不能清楚地沟通他所需查找的内容.

6. Poorly prepared checklists can slow down an audit due to duplication and repetition

因简单复制检查表,过份缺乏可能导致审核缓慢.

7. Generic checklists, which do not reflect the specific organizational management

system, may not add any value and may interfere with the audit没有反映出组织管理体系的检查表,不能增值,并对审核造成困扰.

8. Narrow focused checklists minimize unique assessment questions/approach关注检

查表可能影响审核问题/方法。

Conclusion结论

There are advantages and disadvantages in using audit checklists. It depends on many factors, including customer needs, time and cost restraints, auditor experience and sector scheme requirements. Auditors should assess the value of the checklist as an aid in audit process and consider its use as a functional tool.

这些是使用检查表的优点和缺点。取决于很多方面,包括顾客需求,时间和成本控制,审核员经验,部分要求。审核员应评价用作工具的检查表在审核过程中的价值。

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高级英语写作1-10课翻译

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(3).设计网站 using System; using System.Collections; using System.Configuration; using System.Data; using System.Linq; using System.Web; using System.Web.Security; using System.Web.UI; using System.Web.UI.HtmlControls; using System.Web.UI.WebControls; using System.Web.UI.WebControls.WebParts; using System.Xml.Linq; using System.Data.SqlClient; namespace web { public partial class_Default : System.Web.UI.Page { protected void Page_Load(object sender, EventArgs e){} protected void Button1_Click(object sender, EventArgs e) {try {SqlConnection coon = new SqlConnection(); coon .ConnectionString =" Server =localhost; uid = sa;pwd=; database=studb109"; coon .Open (); Label1 .Text ="连接成功"; } catch { Label1 .Text ="连接失败"; }}}}

翻译的归化与异化

万方数据

万方数据

万方数据

万方数据

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