2012年iris内审员教材.ppt

受审核方和审核方 受审核方职责: 审核方职责: CLAUSES 4 Quality Management System 质量管理体系 4.1 总要求General requirements In case of transfer of process or parts thereof, that affect product conformity to requirement within the execution of a contract, a documented procedure including: feasibility study, risk analysis, planning, communication to customer and first article inspections to the appropriate level shall exist. 在执行合同过程中如有转包(过程或产品)的情况发生，且影响到产品的 符合性时,组织必须有一个文件化的转包程序，其内容适当地包括：可行 性研究、风险分析、计划、顾客沟通和首件检验。 4.2.1 总述 General In addition to the ISO9001:2008, the business management system documentation shall include:除ISO 9001:2008要求外,企业系统文件应包括 e) documented statements of a technical safety policy and safety objectives.形成文件的技术安全方针和安全目标 f) Management system requirements imposed by the applicable regulatory authorities. 管理系统要求应包括适用的法规要求。 The organization shall (3)ensure that personnel have access to business management system documentation and are aware of relevant documents. Customer and /or regulatory authorities’ representatives shall (4) have access to the business management system documentation. 组织必须保证职员能获得企业管理系统文件，并且了解相关的文件，顾客和/或法规监管代表必须能获得企业管理系统文件。 4.2.2 质量手册 Quality Manual When referencing the documented procedures, the relationship between the requirements of this document and the documented procedures should (1)be clearly shown. 当参考文件化程序时，本标准中的要求和文件化程序要求之间的关系 应该清楚描述。 4.2.3 文件控制 Control of Documents The organization shall demonstrate effective management and control of all documents pertinent to the products it supplies. Names of personnel who authorize and carry out reviews of the necessary documentation shall be identified. 组织必须证实对与它供应的产品有关的所有文件进行有效管理和控制。 必须识别批准和执行必要的文件评审的人员的名字。 Effective systems shall be in place to review impact of documents of external origin. 必须建立有效的体系来评审外来文件的影响。 4.2.3 文件控制 Control of Documents The