Section: |
7.4.1 |
Section Title: Purchasing Process |
9100 C Clause |
Purchasing Process: The organization shall ensure that the purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on the subsequent product realization or the final product.
The organization shall be responsible for the conformity of all products purchased from suppliers, including product from sources defined by the customer.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (AS9100 see 4.2.4 Control of Records). |
Generic Expectation |
The Seller is responsible for the quality of the material, supplies, and services that go into the product supplied. The type and extent of control applied depends upon the effect that the purchased product will have on subsequent production processes or the finished product. The Seller shall select suppliers based on their ability to supply product conforming to the organization's requirements and periodically measure and evaluate each supplier for necessary actions and maintain records of these evaluations. |
Product Type: |
COTS/Standards |
Raw Material |
Build-to-Print |
Supplier Design |
Specific Expectation |
Organization (Buyer) |
Buyer must ensure additions and/or exceptions to the requirements of this section be clearly stated as directed by contractual documents. |
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Buyer must review expectations for additional flowdown requirements in the contractual documents for quality assurance of raw materials included in the product. |
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Buyer must ensure contractual document includes all compliance specification requirements and expectations not listed on the drawing. |
Buyer should be aware of the order of precedence in regards to documentation and requirements. |
Supplier (Seller) |
Seller must understand and accept the requirements of this section as directed by contractual document. |
Seller is responsible for the quality of the material, supplies, and services that go into the product supplied. |
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Seller must ensure suppliers of raw material can meet physical, chemical, and certification requirements of the design and contractual documents. |
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Seller must ensure all contractual specification compliance requirements and expectations in addition to drawing requirements are complied with. |
Documentation to demonstrate conformance to expectation (what the auditor would look for) |
Organization (Buyer) |
Buyer to ensure contractual requirements flowdown requiring compliance to this section that includes all additions and/or exceptions to this section. |
Supplier (Seller) |
Seller to provide evidence that the type and extent of control applied to each supplier and the purchased product is dependent upon the effects that the purchased product will have on the subsequent production processes or the final product. |
Example (Best Practices) |
Organization (Buyer) |
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Supplier (Seller) |
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