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    How can ISO 13485 clause 7.4, Purchasing, enhance procurement?

    We often cover four basic elements in sourcing a product for the company. These include the nature of the purchase, the cost of the product, the quality of the product, and previous purchasing experience. This workflow is not always as smooth as we want it to be. Could it be that we are neglecting a certain area of the procurement? In many cases, companies have fantastic work processes established for production and quality control, but not for procurement. This has resulted in a common situation in which verification is hardly performed against the received product due to having an established relationship with the supplier.

    In addition, updates to the product that involve a modification to the initial purchased part may not be communicated or updated in the original agreement with the supplier. This can fuel the situation of a potential defect of the product in real time. The above scenario could potentially happen to many companies.

    Steps in the procurement procedure

    Most standard operating procedures (SOPs) for procurement cover these seven basic steps:

    1. Receive purchase requisition form.
    2. Source for existing suppliers in the company’s own system.
    3. Request quote from supplier.
    4. Review provided quote.
    5. Issue purchase order.
    6. Verify received product against purchase order issued.
    7. Issue payment to supplier.

    If the product deviates from the purchase order, a product return form will be issued. The supplier will take the necessary corrective action, such as sending the correct goods. The above procedure only takes into account cost and previous purchasing experience with an existing supplier. For more about this topic, check out this article: How to comply with ISO 13485:2016 requirements for handling complaints.

    So, let us now look at the requirements in each section of 7.4, Purchasing, in the ISO 13485:2016 standard and see how it can help to improve your existing workflow in your daily procurement process.


    Requirements for the purchasing process

    In Section 7.4.1 (Purchasing process), there are two parts: a need to establish a set of criteria for selection and evaluation of new or existing suppliers, and also to evaluate the supplier’s ability to solve the non-fulfillment of an agreed purchase order. To the existing procedure, we can append two types of documents. The first one is a checklist used for evaluation and selection of suppliers. It should cover important elements such as the supplier’s ability to meet the organization’s requirements, as well as the effect of the purchased product on the quality of the medical device. The second document should be a simple form for documenting the action taken to address nonfulfillment of an order. By implementing the additional appendix, it will enable the organization to easily identify a suitable supplier, as well as those “difficult” suppliers that are non-compliant with the requirements specified in the purchasing process. This can build up the company’s reputation as being the one that takes quality seriously in its daily operation.

    Section 7.4.2 (Purchasing information) requires a reference for the purchased product. It needs to include important information, such as specifications, part number, expiration date, and any special requests covering personnel, processes, and equipment. The other part of this section requires a written agreement to be in place between the organization and the supplier for notification purposes in the event of changes made to the initial agreed purchased product. The organization should put together a simple written agreement to list out the responsibilities of the company and the supplier in this purchasing process. The written agreement should also include the purchasing information. It is recommended to review the written agreement on an agreed timeline to ensure that only the latest information and communication are updated. By doing so, it can minimize any miscommunication between both parties, and ensure that the quality of the product received from the supplier’s end will be maintained as agreed. This improvement also facilitates a need for the supplier to maintain its own Quality Management System (QMS). To learn how to put your QMS in place, read this article: How to structure Quality Management System documentation according to ISO 13485.

    In Section 7.4.3 (Verification of purchased product), the organization should verify the received product against what was agreed with the supplier. Any verification activities performed must be documented. Such activities could include verifying through a Certificate of Analysis provided by the supplier. When conducting supplier audits, it is a good idea to check any verification activities that the supplier performs on products made for you.

    Advantages of implementing clause 7.4

    The benefits of incorporating clause 7.4 into your existing procurement process are numerous:

    • It provides a guideline for the company to establish a smoother workflow in purchasing.
    • It defines requirements in the purchasing process between the organization and its suppliers.
    • It enables the company to have an established workflow for selection and monitoring of existing or new suppliers.
    • It allows for traceability in the event of a Field Safety Notice issued by the supplier.
    • It reminds the company to include the purchasing process into the existing risk management plan.

    For the negative effects of not implementing ISO 13485, check out this article: What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices?

    So, by implementing clause 7.4 as part of your procurement workflow, the existing SOP is more well-rounded. Now you have an improved SOP that covers every step of the process, from the initial stage of purchasing to the verification of purchased goods, in detail. For the initial stage of purchasing, the company takes into account the selection and monitoring of suppliers. By documenting the requirements of the purchase and defining roles and responsibilities, this can minimize miscommunication and allow changes to be incorporated smoothly. With a verification system in place, the company can now systematically check the product against the requirements and reduce any risk that might arise prior to production. Lastly, do not forget to carry out periodic reviews on the existing workflow for improvement and document any changes.

    If you plan to implement ISO 13485 in your business, check out this free ISO 13485 Project Plan o find out the best way to do so.