Title Page

  • Organization

  • Conducted on

  • Auditor

  • Auditee

7.4 Purchasing

7.4.1 Purchasing process

  • Does the organization document procedures (see 4.2.4) to ensure that<br>purchased product conforms to specified purchasing information?

  • Does the organization establish criteria for the evaluation and selection<br>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<br>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<br>product monitored?

  • Does the results of the monitoring provide an input into the supplier reevaluation<br>process?

  • Are Non-fulfilment of purchasing requirements addressed with the supplier<br>proportionate to the risk associated with the purchased product<br>and compliance with applicable regulatory requirements?

  • Are records of the results of evaluation, selection, monitoring and reevaluation<br>of supplier capability or performance and any necessary<br>actions arising from these activities maintained (see 4.2.5)?

7.4.2 Purchasing information

  • Does the purchasing information describe the product to be purchased?<br>Does the information include, where appropriate ...

  • a) product specifications?

  • b) requirements for (approval of) product acceptance, procedures,<br>processes and equipment?

  • c) requirements for qualification of personnel?

  • d) quality management system requirements?

  • Is the adequacy of specified purchase requirements ensured, prior to<br>their communication to the supplier?

  • Does purchasing information include, as applicable, a written agreement<br>that the supplier notify the organization of changes in the purchased<br>product prior to implementation of any changes that affect the<br>ability of the purchased product to meet specified purchase requirements?

  • To the extent required for traceability given in 7.5.9, does the organization<br>maintain relevant purchasing information in the form of documents<br>(see 4.2.4) and records (see 4.2.5)?

7.4.3 Verification of purchased product

  • Does the organization establish and implement the inspection or other<br>activities necessary for ensuring that purchased product meets specified<br>purchase requirements?

  • Is the extent of verification activities based on the supplier evaluation<br>results and proportionate to the risks associated with the purchased<br>product?

  • When the organization becomes aware of any changes to the purchased<br>product, does the organization determine whether these<br>changes affect the product realization process or the medical device?

  • Where the organization or its customer intends to perform verification<br>at the supplier’s premises: are the intended verification activities (arrangements) and method of product release stated in the purchasing<br>information?

  • Are the records of the verification maintained?

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