2008 版ISO9001标准的主要变化
Version 2008 standard ISO9001 main changes
相对 于ISO 9001:2000 版标准，ISO/DIS 9001:2008 标准的主要变化包括：
Relative to ISO 9001: 2000 version of the standard, ISO / DIS 9001 : 2008 standard of the major changes include:
　　(1) 有关法律法规的要求方面。在 “引言”中，将“本标准能用于内部和外部 ( 包括认证机构 ) 评价组织满足顾客、法律法规和组织自身要求的能力 ”改为“本标准能用于内部和外部 ( 包括认证机构 ) 评价组织满足顾客、适用产品的法律法规和组织自身要求的能力 ”。对满足法律法规要求的范围作了明确的限定，并与 7.2.1 与产品有关的要求的确定 C) 相一致。
( 1) the relevant laws and regulations aspect. In the" Introduction"," this standard can be used by internal and external ( including certification bodies ) evaluation organization to meet customer requirements, laws and regulations and the organization's own ability" is changed to" this standard can be used by internal and external ( including certification bodies ) evaluation organization to meet customer product, applicable laws and regulations and the organization's own requirements. Ability". To meet the requirements of the laws and regulations of the range were clearly defined, and with the 7.2.1 determination of requirements related to the product C ) consistent.
　 　(2) 有关产品范围的方面。在“ l 范围”的注中，将“在本标准中，术语‘产品’仅适用于预期提供 给顾客或顾客所要求的产品”改为“在本标准中，术语‘产品’适用于预期提供给顾客或顾客所要求的产品， 也包括采购产品和产品实现过程的中间产品”，明确了产品范围。
( 2) in relation to the products of. In" L" the note," in this international standard, the term ' product ' is only applicable to expected provided to the customer or customer requirements of product " to " in this standard, the term ' product ' is suitable for the intended for or required by a customer 's products, including the procurement of products and product realization process of intermediate products", a clear product range.
　　(3) 有关外包过程方面。在 “ 4.1 总要求”中，将“对此类外包过程的控制应在质量管理体系中加以识别”改为“对此类外包过程 控制的类型和程度应在质量管理体系中加以规定”，并增加了“注 2 ：虽然所识别的外包过程作为组织的质量管理体系所 需的一部分，但由组织的外部方选择运作”和“注 3 ：应用于外包过程的控制类型和特点可能受下列因素影响： a) 外包 过程对组织提供满足要求的产品能力的潜在影响； b) 共享过程的控制程度； c) 通过应用 7.4 条款获得的所需控制的能力。确保控 制外包过程不免除组织满足顾客和法律法规要求的责任。”进一步明确了对外包过程的控制要求。
( 3) on the outsourcing process. In total 4.1 " requirements"," control of such outsourced processes shall be identified within the quality management system" to " on the outsourcing process control the type and extent of the quality management system shall be stipulated in", and added" Note 2: Although the identification of the outsourcing process as the organization's quality management system requirements for the part, but by the organization of the external side of the operation of choice" and" note 3: applied to outsourcing process control types and features may be affected by the following factors: a ) the outsourced process on the organization to meet the requirements of the product potential effects; b ) shared process control through C ); the application of clause 7.4 to get the required control ability. Ensure the control system outsourcing process does not absolve the organization to meet customer and legal requirements of liability." To further clarify the 's control of the outsourced process requirements.
　　 (4) 有关形成文件的程序方面。在“ 4.2.1 文件要求总则 注 l ”中，增加了“一个文件可包括一个或多个程序的 要求。一个形成文件的程序的要求可以包含多个文件”，进一步明确了对程序文件编写数量要求的灵活性。
( 4) the documented procedures. In the" 4.2.1 file requirement for L injection", adding" a file may include one or more program requirements. A documented procedure requirements can contain multiple files", made clear further on the program file write quantity flexibility.
　　(5) 有关外来文件方面。在“ 4.2 .3 文件控制 f) ”中，将“确保外来文件得到识别，并控制其分发 ”改为“确保策划和运行质量管理体系所需的外来文件得到识别，并控制其分发”，限定了所需控制的外来文件的范 围。
(5 ) related to external files. In the" 4.2 . 3 file control f )"," to ensure that documents of external origin are identified, and their distribution controlled" changed to" ensure that the planning and operation of the quality management system for foreign documents are identified, and their distribution controlled", defines the required control of foreign document fan wai.
　　(6) 有关管理者代表方面。在“ 5.5.2 管理者代表”中，将“最高管理者应指定一 名管理者”改为“最高管理者应指定一名本组织的管理者”，明确管理者代表应是组织的内部人员。