Customer Requirements

As customers are the driving force behind any business, it makes sense to make sure they are taken care of. Does your company have processes and/or procedures in place to identify your customer’s requirements? For medical device companies, there are regulations in place from the FDA and ISO to make sure there are practices in place to meet the customers’ needs.

To start with, 21 CFR 820.160 has a requirement for each manufacturer to establish and maintain procedures that control the finished product to ensure the customer receives only product that has been approved for release. They also require a step be in place to review all purchase orders to eliminate any ambiguities and/or errors before the product is released to the customer. The FDA also states that “Each manufacturer shall maintain distribution records which include or refer to the location of: (1) The name and address of the initial consignee; (20 The identification and quantity of devices shipped; (3) The date shipped; and (4) Any control number(s) used.”

Both ISO 9001 and ISO 13485 also contain customer-related requirements. In ISO 9001, section 7.2 discusses Customer-related processes. Here, you are required to identify (in procedures) how your company will define customer requirements. This information can be captured in customer agreements, quotes or specifications. This is also where you will need to review the requirements related to the product. Prior to committing to produce the device, your company will need to determine if you’re able to make the requested product and if you can provide it in the time requested. You will also need to proceduralize how any changes the customer’s requests are handled, and to verify that you are still able to meet those needs. Your goal as a manufacturer should be to identify customer requirements, as well as to work towards enhancing their satisfaction in your company and the product(s) provided.

In ISO 13485, customer-related requirements are also discussed in section 7.2, as well as section 5.2. The requirement in the latter section is that top management needs to be able to ensure customer requirements can be determined and are met. In section 7.2, it is stated “The organization shall determine a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization.”