ISO13485 - 7.4.1 Purchasing process

7.4.1 Purchasing process

The organization shall establish documented procedures to ensure that 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 subsequent product realization or the final product.

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 (see 4.2.4).