IATF16949认证要求修订认可解释SI5-6
IATF16949认证要求修订认可解释SI5-7.5.1.1 Quality management system documentation质量管理体系文件
The quality manual shall include, at a minimum, the following:
a) the scope of the quality management system, including details of and justification for any exclusions;
b) documented processes established for the quality management system, or reference to them;
c) the organization’s processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes;
d) a document (i.e., matrix for example, a table, a list, or a matrix) indicating where within the organization’s quality management system their customer-specific requirements are addressed.
质量手册至少应包括以下内容:
a)质量管理体系的范围,包括任何删减的细节和正当的理由;
b)为质量管理体系建立的形成文件的过程或对其引用;
c)组织的过程及其顺序和相互作用(输入和输出),包括任何外包过程控制的类型和程度;
d)一个显示组织质量管理体系内哪些地方满足了顾客特定要求的文件(即矩阵,例如表格、列表或矩阵)。
Rationale for change:
Some CBs and organizations wanted clarification that a matrix was not a mandatory document. A matrix is just one of multiple methods that are acceptable. The format used is up to the organization.
一些认证机构和组织要求澄清,矩阵不是一个强制性的文件。 矩阵只是可接受的多种方法之一。 使用什么格式取决于组织。
IATF16949认证要求修订认可解释SI6-8.3.3.3 Special characteristics特殊特性
The organization shall use a multidisciplinary approach to establish, document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following:
a) documentation of all special characteristics in the product and/or manufacturing documents drawings (as required), relevant risk analysis (such as Process FMEA), control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents; documented in the manufacturing documents which show the creation of, or the controls required, for these special characteristics;
组织应采用多方论证方法来建立、形成文件并实施用于识别特殊特性的过程,包括顾客确定的以及组织风险分析所确定的特殊特性,应包括:
a)将所有特殊特性记录进产品和/或生产文件图纸(按要求)、相关风险分析(例如过程FMEA)、控制计划和标准的工作/操作说明书;特殊特性用特定的标记进行标识,并且贯穿这些文件中的每一个; 记录在为创造或控制这些特殊特性所需的制造文件中。
Rationale for change变化原理:
Clarifies the documentation of special characteristics in the product and/or manufacturing drawings.
明确将特殊特性记录在产品和/或制造图纸中。