IATF16949认证 新版ITAF16949:2016认证标准组织的环境理解与实施 发布时间: 2021-02-27 22:26 点击:
IATF16949认证 新版ITAF16949:2016认证标准组织的环境理解与实施
4 Context of the organization 组织的环境
4.1 Understanding the organization and its context 理解组织及其环境
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.组织应确定与其宗旨和战略方向相关并影响其实现质量管理体系预期结果的能力的各种外部和内部因素。
The organization shall monitor and review information about these external and internal issues.组织应对这些内部和外部因素的相关信息进行监视和评审。
NOTE 1 Issues can include positive and negative factors or conditions for consideration.注1:这些因素可能包括需要考虑的正面和负面要素或条件。
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.注2:考虑来自于国际、国内、地区和当地的各种法律法规、技术、竞争、市场、文化、社会和经济环境的因素,有助于理解外部环境。
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.注3:考虑与组织的价值观、文化、知识和绩效等有关的因素,有助于理解内部环境。
4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:由于相关方对组织稳定提供符合顾客要求及适用法律法规要求的产品和服务的能力具有影响或潜在影响,因此,组织应确定:
a) the interested parties that are relevant to the quality management system;与质量管理体系有关的相关方;
b) the requirements of these interested parties that are relevant to the quality management system.与质量管理体系有关的相关方的要求。
The organization shall monitor and review information about these interested parties and their relevant requirements.组织应监视和评审这些相关方的信息及其相关要求。
4.3 Determining the scope of the quality management system确定质量管理体系的范围
The organization shall determine the boundaries and applicability of the quality management system to establish its scope.组织应确定质量管理体系的边界和适用性,以确定其范围。
When determining this scope, the organization shall consider:在确定范围时,组织应考虑:
a) the external and internal issues referred to in 4.1; 4.1中提及的各种外部和内部因素;
b) the requirements of relevant interested parties referred to in 4.2; 4.2中提及的相关方的要求;
c) the products and services of the organization.组织的产品和服务。
The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system.如果本标准的全部要求适用于组织确定的质量管理体系范围,组织应实施本标准的全部要求。
The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system.组织的质量管理体系范围应作为成文信息,可获得并得到保持。该范围应描述所覆盖的产品和服务类型,如果组织确定本标准的某些要求不适用于质量管理体系范围,应说明理由。
Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.只有当所确定的不适用的要求不影响组织确保其产品和服务合格的能力或责任,对增强顾客满意也不会产生影响时,方可声称符合本标准的要求。
4.3.1 Determining the scope of the quality management system-supplemental 确定质量管理体系的范围–补充
Supporting functions, whether on-site or remote (such as design centers, corporate headquarters, anddistribution centers), shall be included in the scope of the Quality Management System (QMS).支持功能,无论其在现场或外部场所(例如:设计中心、公司总部和配送中心),应包含在质量管理体系(QMS)的范围中。
The only permitted exclusion for this automotive QMS standard relates to the product design anddevelopmentrequirements within ISO 9001, Section 8.3. The exclusion shall be justified and maintained asdocumented information (see ISO 9001, section 7.5.)本汽车QMS标准唯一允许的删减是ISO 9001第8.3条中的产品设计和开发要求。删减应以形成文件的信息(见ISO9001第7.5条)的形式进行声明和保持。
Permitted exclusions do not include manufacturing process design.允许的删减不包括制造过程设计。
4.3.2 Customer-specific requirements顾客特定要求
Customer-specific requirements shall be evaluated and included in the scope of the organizations qualitymanagement system.应对顾客特定要求进行评价,并将其包含在组织的质量管理体系范围内。
4.4 Quality Management System and its Processes质量管理体系及其过程
4.4.1 The organization shall establish, implement, maintain and continually improve a quality
management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.组织应按照本标准的要求,建立、实施、保持和持续改进质量管理体系,包括所需过程及其相互作用。
The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:组织应确定质量管理体系所需的过程及其在整个组织应的应用,且应:
a) determine the inputs required and the outputs expected from these processes;确定这些过程所需的输入和期望的输出;
b) determine the sequence and interaction of these processes;确定这些过程的顺序和相互作用;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;确定和应用所需的准则和方法(包括监视、测量和相关绩效指标),以确保这些过程的有效运行和控制;
d) determine the resources needed for these processes and ensure their availability;确定这些过程所需的资源并确保其可获得;
e) assign the responsibilities and authorities for these processes;分配这些过程的职责和权限;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1; 按照6.1的要求应对风险和机遇;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;评价这些过程,实施所需的变更,以确保实现这些过程的预期结果;
h) improve the processes and the quality management system.改进过程和质量管理体系
4.4.1.1 Conformance of products and processes产品和过程的符合性
The organization shall ensure conformacne of all products and processes, including service parts andthose that are outsourced, to all applicable customer, statutory, and regulatory requirements (see section8.4.2.2.).组织应确保所有产品和过程,包括服务件及外包的产品和过程,符合一切适用的顾客和法律法规要求(见第8.4.2.2条)。
4.4.1.2 Product Safety产品安全
The organization shall have documented processes for the management of the product-safety relatedproducts and manufacturing processes, which shall include but not be limited to the following, whereapplicable:组织应有形成文件的过程,用于与产品安全有关的产品和制造过程管理;形成文件的过程应包括但不限于(在适用情况下):
a) identification by the organization of statutory and regulatory product-safety requirement;组织对产品安全法律法规要求的识别;
b)customer notification of requirements in item a);向顾客通知a)项中的要求;
c) special approvals for design FMEA;设计FMEA的特殊批准;
d)identification of product safety-related characteristics;产品安全相关特性的识别;
e)identification and controls of safety-related characteristics of product and at the point of manufacture;产品及制造时安全相关特性的设别和控制;
f) special approval of control plans and process FMEAs;控制计划和过程FMEA的特殊批准;
g) reaction plans (see section 9.1.1.1);反应计划(见第9.1.1.1条);
h) defined responsibilities, definition of escalation process and flow of information, including topmanagement, and customer notification;包括最高管理者在内的,明确的职责,升级过程和信息流的定义,以及顾客通知;
i) taining identified by the organization or customer for personnel involved in product-safety relatedproducts and associated manufacturing processes;组织或顾客为与产品安全有关的产品和相关制造过程中涉及的人员确定的培训;
j) changesof product or process shall be approved prior to implementation, including evaluation ofpotential effects on product safety from process and product changes (see ISO 9001, Section 8.3.6.);产品或过程的更改在实施之前应获得批准,包括对过程和产品更改带给产品安全的潜在影响进行评价(见ISO 9001第8.3.6条);
k) transfer of requirements with regard to product safety throughout the supply chain, includingcustomer-designated sources ( see Section 8.4.3.1);整个供应链中关于产品安全的要求转移,包括顾客指定的货源(见第8.4.3.1条);
l) product traceability by manufactured lot (at a minimum) throughout the supply chain (see section8.5.2.1);整个供应链中按制造批次(至少)的产品可追溯性(见第8.5.2.1条);
m) lessons learned for new product introduction.为新产品导入的经验教训。
NOTE: Special approval of safety related requirements or documents may be required by the customer or the organization’s internal processes. 注:与安全有关的要求或文件的特殊批准可以由顾客或组织的内部过程要求。
4.4.2To the extent necessary, the organization shall:在必要的范围和程度上,组织应:
a) maintain documented information to support the operation of its processes;保持成文信息以支持过程运行;
b) retain documented information to have confidence that the processes are being carried out as planned.保留成文信息以确信其过程按策划进行。
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