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IATF16949認證要求修訂認可解釋SI7-9

   日期:2024-09-27 23:13:32     來源:IATF16949認證     作者:中企檢測認證網     瀏覽:912    評論:0
核心提示:IATF16949認證要求修訂認可解釋SI7-9IATF16949認證要求認可解釋SI7-8.4.2.1 Type and extent of control -

IATF16949認證要求修訂認可解釋SI7-9

IATF16949認證要求認可解釋SI7-8.4.2.1 Type and extent of control - supplemental

The organization shall have a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity of externally provided products, processes, and services to internal (organizational) and external customer requirements.

The process shall include the criteria and actions to escalate or reduce the types and extent of controls and development activities based on supplier performance and assessment of product, material, or service risks.

Where characteristics or components “pass through” the organization’s quality management system without validation or controls, the organization shall ensure that the appropriate controls are in place at the point of manufacture.

組織應有一個形成文件的過程,以識別外包過程并選擇控制的類型和程度,用于驗證外部提供的產品、過程和服務對內部(組織的)要求和外部顧客要求的符合性。

該過程應包括根據供應商績效和產品、材料或服務風險評估,增加或減少控制類型和程度以及開發活動的準則和措施。

如果特性或組件在沒有確認或控制的情況下“通過了”組織的質量管理體系,組織應確保在制造地點實施適當的控制。

Rationale for change變化原理:

Clarifies the documentation of special characteristics in the product and/or manufacturing drawings.

明確組織對特性通過的責任

IATF16949認證要求認可解釋SI8-8.4.2.3 Supplier quality management system development供應商管理體系開發

The organization shall require their suppliers of automotive products and services to develop, implement, and improve a quality management system (QMS) with the ultimate objective of eligible organizations becoming certified to this Automotive QMS Standard.

Using a risk-based model, the organization shall define a minimum acceptable level of QMS development and a target QMS development level for each supplier.

certified to ISO 9001, unless otherwise Unless otherwise authorized by the customer [e.g., item a) below], a QMS certified to ISO 9001 is the initial minimum acceptable level of development. based on current performance and the potential risk to the customer, the objective is to move suppliers through the following QMS development progression: with the ultimate objective of becoming certified to this Automotive QMS Standard. Unless otherwise specified by the customer, the following sequence should be applied to achieve this requirement:

a) compliance to ISO 9001 through second-party audits;

b) certification to ISO 9001 through third-party audits; unless otherwise specified by the customer, suppliers to the organization shall demonstrate conformity to ISO 9001 by maintaining a third-party certification issued by a certification body bearing the accreditation mark of a recognized IAF MLA (International Accreditation Forum Multilateral Recognition Arrangement) member and where the accreditation body’s main scope includes management system certification to ISO/IEC 17021;

c) certification to ISO 9001 with compliance to other customer-defined QMS requirements (such as Minimum Automotive Quality Management System Requirements for Sub-Tier Suppliers [MAQMSR] or equivalent) through second-party audits;

d) certification to ISO 9001 with compliance to IATF 16949 through second-party audits;

e) certification to IATF 16949 through third-party audits (valid third-party certification of the supplier to IATF 16949 by an IATF-recognized certification body).

NOTE: The minimum acceptable level of QMS development may be compliance to ISO 9001 through second-party audits, if authorized by the customer.

組織應要求其汽車產品和服務供應商開發,實施和改進質量管理體系(QMS),最終目標是合格的組織獲得本汽車質量管理體系標準的認證。

使用基于風險的模型,組織應為每個供應商確定可接受的QMS開發最低水平和QMS開發目標水平。

ISO9001認證,除非顧客另行授權[如:下文的a)項],ISO 9001認證的質量管理體系是開發可接受的最低水平。 根據當前績效和顧客的潛在風險,目標是將供應商轉移到以下質量管理體系開發進程:最終目標是通過本汽車QMS標準的認證。除非顧客另有規定,應當根據以下順序來達成本要求:

a)由第二方審核符合ISO 9001;

b)經由第三方審核通過ISO 9001認證;除非顧客另有規定,組織的供應商應通過保持認證機構出具的第三方認證證明來證實對ISO 9001的符合性,證明上應有被承認的IAF MLA(國際認可論壇多邊相互承認協議)成員的認可標志,其中,認可機構的主要范圍包括ISO/IEC 17021管理體系認證

c)經由第二方審核通過ISO 9001認證,同時符合其它顧客確定的質量管理體系要求(例如:次級供應商最低汽車質量管理體系要求[MAQMSR]或等效要求);

d)通過ISO 9001認證,同時經由第二方審核符合IATF 16949;

e)經由第三方審核通過IATF 16949認證(IATF認可的認證機構進行的有效的供應商IATF 16949第三方認證)。

注:如果顧客授權,QMS開發可接受的最低水平可以是通過第二方審核符合ISO 9001。

Rationale for chang改變原理e:

Clarified the expected supplier quality management system development progression. This approach supports the “Risk based Thinking” concept emphasized throughout Section 8.4 of the standard. Additional clarification added with “as applicable” in the first paragraph to address those organizations that are not eligible for IATF 16949 certification (examples including but not limited to the following: scrap metal suppliers, trucking companies who provide transport and logistics support, etc.).

明確預期的供應商質量管理體系開發進程。 這種方法支持標準第8.4節強調的“基于風險的思維”概念。在第一段中增加了“適用”的附加說明,以說明那些沒有資格獲得IATF 16949認證的組織(包括但不限于以下例子:廢金屬供應商、提供運輸和后勤支持的卡車公司等)。

IATF16949認證要求修訂認可解釋SI9-Customer authorization for concession客戶批準

The organization shall obtain a customer concession or deviation permit prior to further processing whenever the product or manufacturing process is different from that which is currently approved.

The organization shall obtain customer authorization prior to further processing for “use as is” and rework for repair (see 8.7.1.5) dispositions of nonconforming product. If sub-components are reused in the manufacturing process, that sub-component reuse shall be clearly communicated to the customer in the concession or deviation permit.

無論何時,當產品或制造過程與當前批準的不同時,組織在進一步加工之前應獲得顧客的讓步或對偏離的許可。組織應在進一步加工之前,獲得顧客對不合格品“照現狀使用”和返工返修(見8.7.1.5)處置的授權。如果在制造過程中有子部件的再使用,應在讓步或偏離許可中向顧客清楚傳達該子部件的再使用。

Rationale for change變化原理:

Clarify requirements and eliminate contradiction in relation to customer approval associated with rework.

明確要求并消除關于顧客批準返工的矛盾。

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