SIO9001质量管理对照

四川检验检疫协会 曹跃武 2008-12-4Introduction and support package:Guidance on the documentation requirements of ISO 9001:2008 SIO9001：2008文件要求指南Document: ISO/TC 176/SC 2/N525R2October 20081. Introduction 说明Two of the most important objectives in the revision of the ISO 9000 series of standards have been ISO9000：2008标准的最重要的两个目标是： to develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and 开发一种简单并同时适用于小型、中型和大型企业的标准并 for the amount and detail of documentation required to be more relevant to the desired results of the organizations process activities. 使得文件的数量和详细程度更好和组织的过程活动结果相适应。ISO 9001:2008, Quality management systems Requirements has achieved these objectives, and the purpose of this additional guidance is to explain the intent of the new standard with specific regard to documentation. ISO9001：2008，质量管理体系要求已经达到了这一目标，本指南的目的是对新版标准中文件要求的意图进行解释。ISO 9001:2008 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. ISO9001：2008允许组织灵活选择文件化其质量管理体系（QMS）.允许每个独立的组织选择最小数量的文件描述其有效策划、运行并控制其过程并实施和持续改进其QMS效果。It is stressed that ISO 9001 requires (and always has required) a “Documented quality management system”, and not a “system of documents”.ISO9001强调（并一直要求）有一个“文件化的质量管理体系”，而不是“文件体系”。2 What is a “document”? - Definitions and references 2什么是“文件”？定义和参考The following are some of the main objectives of an organizations documentation, independent of whether or not it has implemented a formal QMS;下面是一些组织的文件的主要目标，不管其是否已经实施于一个正常的QMS；a) Communication of Information 信息沟通 as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organizations products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture. 一个信息传递和沟通的工具。其形式和内容取决于组织的产品和过程的本质，体系的规定和组织内部的沟通技能水平，及组织的文化 。b) Evidence of conformity 符合的证据 provision of evidence that what was planned, has actually been done. 提供什么列入策划，什么已经实际执行的证据。c) Knowledge sharing 知识共享 to disseminate and preserve the organizations experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product. 传播和保护组织的经验。一个典型的例子是一个可以用作新产品设计和开发基准的技术规范。A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2005). It must be stressed that, according to ISO 9001:2008 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:附录A（来自ISO9000：2005）给出了常用的与文件有关的术语。必须强调的是，根据ISO9001：2008第4.2条“文件要求”的规定，文件可以是任何形式的介质，ISO9000：2005第3.7.2条“文件”的定义给出了下来例子： paper 纸质 Magnetic 磁性记录 electronic or optical computer disc 电子或计算机光盘 photograph 照片 master sample 标准样品Users are also referred to ISO/TR 10013:2001, Guidelines for quality management systems documentation for further guidance. 用户还可参考ISO/TR10013 ：2001，文件化体系指南。3 ISO 9001:2008 Documentation Requirements ISO9001：2008文件化要求ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”ISO9001：2008第4.1 “总则”要求组织根据本国际标准的要求建立、文件化、实施、保持并持续改进其质量 管理体系的有效性。Clause 4.2.1 General explains that the quality management system documentation shall include:条款4.2.1总则给出质量管理体系文件化应包括： documented statements of a quality policy and quality objectives; 文件化的质量方针和质量目标； a quality manual 质量手册 documented procedures required by this International Standard 本国际标准要求的文件化的程序 documents needed by the organization to ensure the effective planning, operation and control of its processes, and 组织为确保有效策划、运行并控制其过程所需要的文件 records required by this International Standard; 本国际标准要求的记录；The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:4.2条的注释明确了在标准何处“文件化程序”必须建立，文件化，实施并维持。强调QMS文件范围根据组织的不同取决于： the size of organization and type of activities; 组织的规模和活动的形式 the complexity of processes and their interactions, and 过程的复杂程度和交互作用 the competence of personnel. 人员的能力。All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.根据ISO9001：2008第4.2.3条中要求所有形成QMS的文件或根据4.2.4要求的记录，必须受控。4 Guidance on Clause 4.2 of ISO 9001:2008 ISO9001：2008第4.2 条实施指南The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard. 下述说明的目的是帮助使用者理解本国际标准中文件化的基本意图。a) Documented statements of a quality policy and objectives: 文件化的质量方针和目标描述： Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3. Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g). 对ISO9001：2008标准5.3中定义的质量方针的要求。文件化的质量方针必须按照标准4.2.3条要求进行控制。备注：组织为满足ISO9001：2008标准而第一次对质量方针进行修改时应特别注意条款4.2.3的 (c)，（d）和（g） Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3. 对ISO9001：2008第5.4.1条定义的质量目标的要求。文件化的质量目标也要按照4.2.3条要求进行控制。b) Quality Manual: 质量手册 Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organizations size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS ISO9001：2008第4.2.2给出了质量 手册的最小范围。组织的手册形式和结构取决于组织的规模、文化和复杂程度。一些组织可能选择质量手册用于其他用途而非简单文件化QMS。 A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard. 一个小型组织可能选择一本质量手册描述其整个QMS，包括标准要求的文件化程序。 Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation. 大型跨国公司可能在全球、国家或区域内需要多个手册，更复杂的文件结构。 The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3. 文件化的手册必须按照标准4.2.3条要求进行控制。c) Documented procedures: 文件化程序 ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities: ISO9001：2008特别要求组织在下面6个活动必须有文件化程序4.2.3 Control of documents文件控制4.2.4 Control of records记录控制8.2.2 Internal audit内审8.3 Control of nonconforming product不符合控制8.5.2 Corrective action纠正措施8.5.3 Preventive action 预防措施 These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3 这些文件化的程序必须按照标准4.2.3条要求进行控制。 Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable. 一些组织可能发现将几个程序合并更合适（如，纠正措施和预防措施）。另外一些组织可能选择将一个活动分散到几个程序中（如，内审）。两者均可接受。 Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS. 一些组织（特别大的组织，或那些具有多个复杂过程的组织）可能需要附加的文件化程序（特别那些于产品实现过程有关的）来有效实施其QMS。 Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented. 一些组织可能需要附加程序，但组织的规模/文化可使其有效实施而不需要文件化。然而，为了符合ISO9001:2008标准，组织必须能够提供客观证据证明其QMS已经有效实施。d) Documents needed by the organization to ensure the effective planning, operation and control of its processes: 组织确保有效策划、运行和控制其过程所需的文件 In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are: 为了组织证明其QMS已经有效实施，可能需要建立文件而不是文件化程序。无论如何，ISO9001：2008中只特别提到以下文件：- Quality policy (clause 4.2.1.a)质量方针- Quality objectives (clause 4.2.1.a)质量目标- Quality manual (clause 4.2.1.b) 质量手册 There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include: 尽管标准中并没有对其提出特殊要求，ISO9001：2008中仍有些要求组织应增加其QMS价值，并通过文件证实其符合标准要求。例如：- Process maps, process flow charts and/or process descriptions过程图，流程图/过程描述- Organization charts组织机构图- Specifications 规格说明- Work and/or test instructions作业/试验指导书 - Documents containing internal communications包括内部沟通方式的文件- Production schedules生产计划- Approved supplier lists合格供方- Test and inspection plans试验/检验计划- Quality plans 质量计划 All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable 适用时，上述所有文件必须按照4.2.3/或4.2.2进行控制。e) Records: 记录 Examples of records specifically required by ISO 9001:2008 are presented in AnnexB. ISO9001：2008标准中特别要求的记录例子在附录B中给出。 Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system. 组织可以自行制定用于证实其过程、产品和质量管理体系符合性的记录。 Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008. 记录的控制要求与文件控制要求不同，所有记录的控制必须按照ISO9001：2008第4.2.4条进行。5 Organizations preparing to implement a QMS 组织实施QMS的准备For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.对实施QMS过程中，并希望符合IDO9001：2008标准要求，下列说明是有用的。 For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes: 对组织正在实施，但还没有实现QMS，ISO9001：2008强调过程模式。包括：- Identifying the processes necessary for the effective implementation of the quality management system 为有效实施质量管理体系进行过程识别- understanding the interactions between these processes. 了解这些过程之间的交互作用- documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.) 文件化过程范围确保其有效运行和控制。（用过程图描述过程，过程图强调的是文件化的过程图而不是ISO9001：2008要求） These processes include the management, resource, product realization and measurement processes that are relevant to the effective operation of the QMS. 与有效运行QMS相应的流程图，包括管理过程，资源，产品实现和测量过程。 Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that drives the processes. 分析流程并按照ISO9001：2008要求确定文件数量，而不是按照文件来确定过程数量。6 Organizations wishing to adapt an existing QMS 组织希望适用现存的QMSFor organizations that currently have a QMS the following comments are intended to assist in understanding the changes to documentation that may be required or facilitated by the transition to ISO 9001:2008对于已经有一个QMS的组织，下面的解释有助于理解其体系转换到ISO9001：2008时文件的变化要求。 An organization with an existing QMS should not need to rewrite all of its documentation in order to meet the requirements of ISO 9001:2008. This is particularly true if an organization has structured its QMS based on the way it effectively operates, using a process approach. In this case, the existing documentation may be adequate and can be simply referenced in the revised quality manual. 为了满足ISO9001：2008标准要求，一个已经具有QMS的组织不需要对文件进行重写。特别是组织的QMS已经高效运行，并按照过程模式建立时，现存的文件可以简单修订后进入质量手册。 An organization that has not used a process approach in the past will need to pay particular attention to the definition of its processes, their sequence and interaction. 没有适用过程模式的组织需要特别注意其过程的定义，顺序和过程之间的交互作用。 An organization may be able to carry out some simplification and/or consolidation of existing documents, in order to simplify its QMS. 组织可能需要简化/或强化现存的文件以简化其QMS。7 Demonstrating conformity with ISO 9001:2008 证明符合ISO9001：2008For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.对于以认证/注册，合同方要求，或其他原因，组织希望证实符合ISO9001：2008时，特别记住需要提供证实其QMS有效实施的证据。 Organizations may be able to demonstrate conformity without the need for extensive documentation. 组织可以证实其符合性而不需要扩充文件。 To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.” 声明符合ISO9001：2008，组织必须提供客观证据证明其过程和质量管理体系的有效性。ISO9000：2005第3.8.1中定义“客观证据”是“数据支持的存在或某些事物”并注明“客观证据可以通过观察，测量，试验，或其他方法”。 Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence. 除了ISO9001：2008特别提到的以外，客观证据不需要来自已经存在的文件化程序，记或其他文件。某些情况下（如，7.1（d）产品实现的策划和8.2.4产品的监视和测量），由组织决定需要什么样的证据来作为客观证据。 Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes. 当组织没有对一个特殊活动的详细内部程序，并且标准中没有要求的（如，5.6条管理评审），如果这样的活动是基于ISO9001：2008相关条款进行的时是可以接受的。这种情况，内审和外审均可以ISO9001：2008标准文本为准评价其符合性。Annex A Terms and Definitions relating to Documents 文件有关的术语和定义The following terms and definitions are taken from ISO 9000:2005:（下列术语和定义来自ISO9000：2005）Term （术语）ISO 9000:2005 Clause （条款）Definition 定义Document 文件3.7.2 information and its supporting medium Procedure 程序3.4.5 specified way to carry out an activity or a process (Note: Procedures can be documented or not) Quality Manual质量手册 3.7.4 document specifying the quality management system of an organization Quality Plan质量计划 3.7.5 document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract Record 记录3.7.6 document stating results achieved or providing evidence of activities performed Specification 规格说明3.7.3 document stating requirements Annex B Records required by ISO 9001:2008 （所需记录）Clause 条款Record required 所需记录5.6.1 Management reviews 管理评审6.2.2e) Education, training, skills and experience 教育，培训，技能和经验7.1 d) Evidence that the realization processes and resulting product fulfill requirements 过程实现和导致产品符合要求的证据7.2.2 Results of the