IATF16949認證要求修訂認可解釋SI5-6
IATF16949認證要求修訂認可解釋SI5-7.5.1.1 Quality management system documentation質量管理體系文件
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.
質量手冊至少應包括以下內容:
a)質量管理體系的范圍,包括任何刪減的細節和正當的理由;
b)為質量管理體系建立的形成文件的過程或對其引用;
c)組織的過程及其順序和相互作用(輸入和輸出),包括任何外包過程控制的類型和程度;
d)一個顯示組織質量管理體系內哪些地方滿足了顧客特定要求的文件(即矩陣,例如表格、列表或矩陣)。
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.
一些認證機構和組織要求澄清,矩陣不是一個強制性的文件。 矩陣只是可接受的多種方法之一。 使用什么格式取決于組織。
IATF16949認證要求修訂認可解釋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;
組織應采用多方論證方法來建立、形成文件并實施用于識別特殊特性的過程,包括顧客確定的以及組織風險分析所確定的特殊特性,應包括:
a)將所有特殊特性記錄進產品和/或生產文件圖紙(按要求)、相關風險分析(例如過程FMEA)、控制計劃和標準的工作/操作說明書;特殊特性用特定的標記進行標識,并且貫穿這些文件中的每一個; 記錄在為創造或控制這些特殊特性所需的制造文件中。
Rationale for change變化原理:
Clarifies the documentation of special characteristics in the product and/or manufacturing drawings.
明確將特殊特性記錄在產品和/或制造圖紙中。
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