Communication with customers by ISO 13485 – explained

customer related processes iso 13485

Quality Management System for medical devices says that you and every other every medical device company must plan and document systems for communication with customers. How you will communicate with a customer depends on the type of medical device or the type of agreement that your company has with the customers. In some cases, communication with customers is controlled by third parties.

Few main goals are set as a standard (ISO 13485) for communicating with customers:

  • Product information
  • Inquiries, contracts or order handling, including amendments
  • Customer feedback, including complaints

Customer requirements should be the center of your attention. After a given request by the customer, the manufacturer should answer it and fulfill it. That might take place in several phases of the realization process, such as design and development, production, installation, marketing, service, and maintenance, etc. Your MedDev company should define proper response for each need or type of interaction: channel, responsibility, and information that will be handled.

Product information

On communication planning with the customer will affect any information related to the product or service which will be exchanged with the customer. The definition will be related to the following product information:

  • Description of the medical device
  • Intended use of the medical device
  • Training instructions or warnings regarding the use and operation of the medical device
  • Previous editions or versions of the medical device
  • The medical device materials, components, and characteristics
  • Processes and realization activities of the medical device (sterilization, storage, and delivery)
  • Warnings and advisory notices regarding the medical device

Information regarding the product including changes and updates to the medical device:

  • Changes that may affect the characteristics of the medical device
  • Improvements in the medical device
  • Problems regarding the medical device that the customer must not know about

Every medical device company is obligated to inform the customer about all updates, changes, and improvements of the medical device. Plus, they will define through which media ( e-mails, phone calls, or meetings) will keep informing the customers.

Inquiries, contracts or order handling

They will also define a system that will handle requests from the customers regarding the business collaboration between them and the customer (orders or contracts). The following information should be considered when defining the method:

  • Orders or contracts—the processes of submission orders or contracts, as well as inquiries or investigations
  • Status of orders—inquiries or investigations concerning production activities or the realization of the medical device, delivery dates, transportation, installation, and warranty
  • Technical support—how the support will be organized and the means of communication with the customer
  • Service and maintenance
  • Progress of activities that are under the responsibility of the customer
  • Reporting over present or future changes

To maintain the effectiveness of communication channels, the roles for each type of customer communication should be defined. Each role will be responsible for managing the communication channel according to the definition related to the specific case.

Customer feedback, including complaints

The customers’ feedback provides an objective point of view on whether the organization supplied the medical device according to the requirements. Providing early warning about potential quality problems is the main issue of this process. This process effectively creates inputs for improvement and initiates the necessary corrective and preventive actions. Feedback evaluation is maintained through the following:

  • Customer complaints—the organization must monitor customer complaints regarding the performance and functionality of the medical device.
  • User surveys—the manufacturer may conduct surveys regarding the functionality,  characteristics, and performances of the medical device.
  • Reviews—the manufacturer may order or initiate a review regarding their medical device.
  • Journal reviews—to research sector and industry tendencies.
  • Periodic postproduction preview phase—activities conducted after the product’s design is completed and the product had been manufactured.

For each of the mentioned actions should be defined communication channel. Besides this, the way how the medical device company deals with the customer’s complaints is highly significant. An important piece of customer complaints is the channel through which the customer can communicate with the organization and pass on a complaint.

Advisory Notice

It’s also required to determine and document a process for communicating with the customers, notifying them of any cases where a failure or deterioration in the characteristics of the medical device have happened or might potentially happen.

A good way to define and present the communication regarding advisory notices is to design a flow chart that specifies the interaction between medical device company and the relevant target groups, supported by the necessary documentation.

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