The organization shall determine and realize arrangements for communicating with its customers. One of the most common activities in organization is communicating with your customers. The ISO 13485 Standard knows it well. The customer wants the attention. The customer needs the attention.  The customer pays (also) for the attention…

The arrangements would refer to the next issues:

Communication with the customer may appear in various ways about various subjects:

• Information regarding the product – including the medical device components, and characteristics, and trainings regarding the use of the product. Changes of processes that may affect the characteristics of the medical device are included as well. At first, the organization must determine which information is required. The information shall also include changes within the medical device, improvements and problems regarding the medical device that the customer might not know about. The definition must refer to time frames (when the information must be distributed to the customer), and the organization must verify that the information reached its target. For example, if the organization decides to change some of the raw material used to produce the medical device; it is required to notice the customer. If it’s a software developing organization, and a change has been made on one of the components of the software provided to the customer, the organization must notify the relevant customers via means it defined (web site, e-mail message etc. In any case the customer is to be informed of any changes made in the product.
• Investigations or inquiries regarding the medical device or information regarding orders or contracts such as Progress of products' delivery, or orders status.  
• Feedback from the customers including customers' complaints – any income inquiry or complaint from a customer regarding the product.

The organization must determine which information is required and the way to distribute this information. The information should include: changes within the product (processes, materials or deliveries), improvements and problems regarding the product. The definition must refer to time frames and the organization must verify that the information reached its target.

The definition must include timeframes for answers regarding customers' complaints. The definition must also include activities that ensure that a corrective action was followed a customer's complaint and that the complaint is closed according to the customers' satisfaction.     

Customer's records shall be kept according to the needs. First the organization shall define (it is not required to document) the information the organization needs in order to communicate with the customer. Second, the organization shall define where, how, when and by whom.

So, what is the difference between the 9001?

Well, first additional requirement regards customers' feedback with reference to paragraph 8.2.1 – customers' feedback.  In paragraph 8.2.1 the organization is required to document the process of measuring customers' feedback (not satisfaction). The reason the ISO 13485 Standard requires measuring customers' feedback rather than customers' satisfaction is that satisfaction is  subjective to regulatory requirements, while feedback give a objective point of view whether the product was realized  according to the requirements or not.   The main issue of this process is to provide an early warning about quality problems – that the product was not realized according to requirements. This process would generate the inputs for corrective and preventive actions later on.

As for advisory notices, the organization is required to determine and document a process of communicating the customers and notifying them of any advisory notices. For example, if a medicine company discovers that one of its batches is disqualified for use for any reason or requirement, the company must notify all its customers. How? Using the media, sending massages – whatever suits the company. In Any way, this method must be documented including the responsible functions. Another example is to define a method for disqualified products. If the organization is required to clear products off the shelves (for any kind of reason, but you would be required to define the reason as well), it is required to define and document the process. Why it is required to clear the shelves, who shall approve, who shall perform, who shall be notified etc.