IATF16949認證要求修訂認可解釋SI12-13
IATF16949認證要求修訂認可解釋SI12-5.1.1.2 Process effectiveness and efficiency過程有效性和效率
Top management shall review the product realization processes effectiveness and efficiency of the quality management system and support processes to evaluate and improve their effectiveness and efficiency the organization’s quality management system. The results of the process review activities shall be included as input to the management review (see Section 9.3.2.1.).
高層管理人員應審查 產品實現過程和質量管理體系的有效性和效率，并支持過程以評估和提高組織質量管理體系的有效性和效率 。過程審查活動的結果應作為管理審查的輸入(見第9.3.2.1節)。
Rationale for change改變原理:
Clarified that not every process requires an efficiency measure. The organization needs to determine which processes require efficiency measures within their quality management system. Additionally, the organization’s problem-solving processes need to have an effectiveness review conducted by the organization’s management.
闡明并不是每個過程都需要效率測度。組織需要確定在他們的質量管理體系中哪些過程需要效率測度。此外，組織的問題解決過程需要由組織的管理人員進行有效性審查。
IATF16949認證要求修訂認可解釋SI13-9.3.2.1 Management review inputs – supplemental管理評審輸入-補充
Input to management review shall include:
a) cost of poor quality (cost of internal and external nonconformance);
b) measures of process effectiveness;
c) measures of process efficiency for product realization processes, as applicable;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product (see Section 7.1.3.1);
f) customer satisfaction (see ISO 9001, Section 9.1.2);
g) review of performance against maintenance objectives;
h) warranty performance (where applicable);
i) review of customer scorecards (where applicable);
j) identification of potential field failures identified through risk analysis (such as FMEA);
k) actual field failures and their impact on safety or the environment.
管理評審的輸入應包括:
a) 不良質量成本 (內部和外部不符合的成本);
b) 過程有效性的測量;
c) 產品實現過程的過程效率測度, 如適用;
d) 產品符合性;
e) 對變更現有業務和新設施或新產品的制造可行性進行評估(見第7.1.3.1節);;
f) 客戶滿意度(見ISO 9001，第9.1.2節);;
g) 根據維護目標審查績效;
h) 保修績效 (如適用);
i) 審查客戶記分卡 (如適用);
j) 通過風險分析(如FMEA)識別潛在的現場故障;
k) 實際現場故障及其對安全或環境的影響。
Rationale for change改變原理:
Clarified that not every process requires an efficiency measure. The organization needs to determine which processes require efficiency measures within their quality management system.
闡明并不是每個過程都需要效率測度。組織需要確定在他們的質量管理體系中哪些過程需要效率測度。


樂清IATF16949認證（嵌入式）軟件開發項目管理清單
醫療器械FDA認證I，II或III類設備怎么區分？
鎮江GJB9001C對采購信息的控制要求
但行好事，莫問前程 ——話說ISO9001之中的“shall”
ISO14001-2004環境管理體系要求實施指南環境因素識別
申請注冊德國商標有什么需要了解的？
協同業務量系管理體系認證證書條件流程
辦理榮譽證書的要求和費用