The requirements for customer related process are reported in the section 7.2 of the ISO 13485:2016. Customer related processes are highly linked with other processes of the quality system, such as design and control, post-market surveillance and communication with competent authorities, for example during the field action process).
The ISO 13485:2016 provides three different sections related to the so-called customer related processes:
In this post we will go through all the main requirements associated with the customer related process, taking mainly in consideration what is mentioned in the ISO 13485:2016.
Determination of the Requirements related to the Product
The first section is related to the so-called “requirements related to the product”.
In fact, once the design process is concluded, the outputs of this design process are the product related requirements that need to be specified before selling the product to the customer.
Obviously, product related requirements are not only directly linked to the the product that is ready to be sold. For example, there might be specific requirements that are specified by the customer which need as well to be fulfilled.
Moreover, product related requirements shall take in consideration all the applicable regulatory requirements related to the product. The applicable requirements shall be identified during the design process to ensure all the device fulfils all the regulatory aspects and it is compliant with the general safety and performance requirements for the CE marking process according to EU MDR 2017/745 and EU IVDR 2017/746.
As part of the design process, the usability study needs to identify whether training to the patient or user is needed. In fact, the necessity to perform training as part of the sale process is considered a requirements related to the product that needs to be properly identified and fulfilled, if it is deemed applicable.
Any other additional requirements that is considered applicable by the organization shall also be included and be considered as an applicable requirement related to the product.
Review of requirements related to product
Section 7.2.2 of the ISO 13485 version 2016 deals with the requirements associated to the review of the requirements related to the product.
First of all all the identified product related requirements shall be accepted and this shall be done before the commitment to supply the product to a specific customer.
In this contest, there are different items that shall be addressed, as mentioned in the ISO 13485:
- Requirements need to be documented
- Any inconsistency in the order received by the customer shall be resolved
- All the applicable regulatory requirements shall be met
- User trainings, If deemed necessary, are properly planned
- The organisation is able to meet all the identified requirements.
Communication with Customers
The communication with customers also play an important role in the Quality Management System of a medical device organization. The standard identifies four areas where communication with customers may be involved:
a) product information;
b) enquiries, contracts or order handling, including amendments;
c) customer feedback, including complaints;
d) advisory notices.
In general the communication with customers need to be planned and specific process need to be in place to ensure an efficient communication.
What needs to be documented for the Customer Related Process
Customer related processes differ a lot from company to company, depending on the type of business model that it is used (B2C or B2B) and on the modalities by which the product is sold.
Typically, in the quality system there is a procedure for Customer Related Process where the main requirements associated to this process are covered.
Sometimes, it is necessary to document the presence of any additional requirements stated by the customer and the fact that this requirements are accepted by the organization. This can be done through a simple record form where it is documented:
a) Additional client requirements other than the ones already identified
b) Any non-stated requirements that need to be fulfilled
c) Any safety requirements or special applicable regulation
The organization shall then review these potential new requirements before the providing the product to the client.
Customer Related Process Procedure
4EasyReg has made available a specific procedure for Customer Related Process which is ready to be download through the 4EasyReg DocShop.
This is a 7 pages procedure, fully editable in word, that describes how it is possible to fulfil all the requirements associated to ISO 13485 that we have been discussing in this article.
Do not hesitate to download the procedure from our 4EasyReg DocShop.
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