IsO9001:2000E) 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements(see 7.3. 1)to ensure that the design and development outputs have met the design and development input requirements, Records of the results of the verification and any necessary actions shall be maintained(see 4. 2. 4) 7.3.6D and development validation Design and development validation shall be performed in accordance with planned arrangements(see 7.3.1)to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actins shall be maintained (see 4.2.4 7.3. 7 Control of design and development changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained( see 4.2. 4 ). 7. 4 Purchasing 7.4.1 Purchasing process The organization shall 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 purchase 3d 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 form the evaluation shall be maintained(see 4.2. 4) 7. 4.2Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate al of product, procedures, proces equipment, b)requirements for qualification of personnel, and c)quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of purchased product The organization shall establish and implement the inspection or other activities necessary for en suring that purchased product meets specified purchase requirements. Where the organization or its customer intends to performs verification at the suppliers premises, the organization shall state the intended verification arrangements and method of product release in the urchasing information OISO2000-All rights reservedISO 9001： 2000(E) ©ISO2000 – All rights reserved 9 7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4) 7.3.6 Design and development validation Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actins shall be maintained (see 4.2.4) 7.3.7 Control of design and development changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). 7.4 Purchasing 7.4.1 Purchasing process The organization shall 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 purchase3d 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 form the evaluation shall be maintained (see 4.2.4) 7.4.2Purchasing information Purchasing information shall describe the product to be purchased, including where appropriate a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c)quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. 7.4.3 Verification of purchased product The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to performs verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information