An Overview: ISO 13485 Certification Clause 7.4

Businesses have much confusion about ISO 13485. One of these confusions is centered on clause 7.4. This article is going to discuss clause 7.4 of ISO 13485 to clear the confusions

When it comes to the sourcing of medical products, we pay attention to four basic elements. These basic elements are the nature of the purchase, the product cost, the product quality, and the last purchasing experience. Every business wants this workflow to be smooth. However, this is not the reality. Sometimes, businesses skip some vital areas of procurement. Some companies have amazing work processes designed for production and quality control while procurement is completely neglected. As an outcome, these companies may find the organization in a situation where verification can hardly be performed in response to the received product due.

Moreover, the updates to the products, which are associated with a modification to the initially purchased parts, might not be updated in the real agreement with the suppliers. It can highlight a potential flaw of the product in real time. This scenario is common in a number of companies.

Let’s have a glimpse of the steps in the procurement process of ISO 13485 certification (clause 7.4)

In most of the cases, the standard operating procedures or SOPS for procurement include these seven basic steps:

• Collect purchase requisition form
• Source for the suppliers (existing) in the company’s internal system
• Ask for the request quotes for the suppliers
• Assess the given quotes
• Issue the purchase orders
• Verify the received product against the issued order
• Issue the payment to the suppliers

If it is found that the received product deviates from the ordered product, it is important to issue a product return form. Upon receiving the product return form, the supplier will take the required initiatives, such as sending the right product once again. For this procedure, it is important to consider cost and previous purchasing experience with that particular supplier. Many entrepreneurs hire professional ISO certification services to deal with these steps.

Requirements for the Purchasing Process

Section 7.4.1 of ISO 13485 clause has mentioned two parts in the purchasing process. The business should set up certain requirements for the selection and evaluation of the suppliers, no matter whether the suppliers are new or existing. It is also important to determine the supplier’s ability to meet the specific requirements of an organization. In the case of the existing procedure, most of the businesses depend on two types of documents- a checklist for evaluation and the selection of the suppliers. It includes all the vital elements such as the suppliers’ capacity to meet the requirements. The second document is simple documentation that is meant for taking actions to address the non-fulfillment of an order. By implementing the additional appendix, it will allow an organization to identify a suitable supplier.

Section 7.4.2 of ISO 13485 certification is based on purchase information. It contains a reference for the purchased products. It needs to include vital information, such as limitations, part number, expiration date, and any other special requests that can cover the personnel, processes, and equipment. Apart from this, the 7.4.2 clause requires a written contract between the organization and the supplier for notification purposes in the event of any modification made to the primary purchased products.

The company, therefore, must put together a simple written contract that has listed the responsibilities of the company and the suppliers involved with this purchase process. It is highly suggested that the organization should review the written contract on an agreed timeline so that they can ensure only the latest information and communication. In this way, it will be possible to avoid any miscommunication between the organization and the suppliers. Every verification performed must be documented. These activities may include verifying through a certificate of analysis submitted by the suppliers.

Benefits of Implementing Clause 7.4

The advantages of implementing clause 7.4 into your existing procurement process are numerous-

• It offers a guideline for the company so that they can develop a smooth workflow in the purchasing process
• It describes the ISO 13485 requirements in the purchasing process between the suppliers and the organization
• It compels the organization to incorporate the purchasing process into the present risk management plan

A Final Takeaway

Implementation of clause 7.4 in the procurement workflow will make the existing SOP better rounded and firm. When a business has an enhanced SOP, it implies that the business has a thorough description that includes every step of the procurement process from the primary sage to the verification of the purchased goods.