Purchase Audit

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7.4 Purchasing

7.4.1 Purchasing process

Does the organization document procedures (see 4.2.4) to ensure that purchased product conforms to specified purchasing information?
Does the organization establish criteria for the evaluation and selection of suppliers? Are the criteria:
a) based on the supplier’s ability to provide product that meets the organization’s requirements?
b) based on the performance of the supplier?
c) based on the effect of the purchased product on the quality of the medical device
d) proportionate to the risk associated with the medical device?
Does the organization plan the monitoring and re-evaluation of suppliers?
Is supplier performance in meeting requirements for the purchased product monitored?
Does the results of the monitoring provide an input into the supplier reevaluation process?
Are Non-fulfilment of purchasing requirements addressed with the supplier proportionate to the risk associated with the purchased product and compliance with applicable regulatory requirements?
Are records of the results of evaluation, selection, monitoring and reevaluation of supplier capability or performance and any necessary actions arising from these activities maintained (see 4.2.5)?

Does the purchasing information describe the product to be purchased? Does the information include, where appropriate ...
a) product specifications?
b) requirements for (approval of) product acceptance, procedures, processes and equipment?
c) requirements for qualification of personnel?
d) quality management system requirements?
Is the adequacy of specified purchase requirements ensured, prior to their communication to the supplier?
Does purchasing information include, as applicable, a written agreement that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements?
To the extent required for traceability given in 7.5.9, does the organization maintain relevant purchasing information in the form of documents (see 4.2.4) and records (see 4.2.5)?

Does the organization establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?
Is the extent of verification activities based on the supplier evaluation results and proportionate to the risks associated with the purchased product?
When the organization becomes aware of any changes to the purchased product, does the organization determine whether these changes affect the product realization process or the medical device?
Where the organization or its customer intends to perform verification at the supplier’s premises: are the intended verification activities (arrangements) and method of product release stated in the purchasing information?
Are the records of the verification maintained?