Quality agreement is one of the most important documentation in a context of medical device quality management system, including QMS requirements for EU MDR 2017/745.
The ISO 13485:2016 specifically requires to have quality agreement with suppliers on different sections of the standard.
For example, section 4.1.5 deals with the requirements associated to outsources activities. The sections defines that the level of control towards external partners performing outsourced activities shall be proportional to the level of risks associated to these activities. There might be different types of controls associated to outsourcing activities and, as defined by the standard, the control shall include a written quality agreement.
The quality agreement usually defines the responsibilities between different parts in relation to activities that might have a direct impact on quality, safety and efficacy of the products on the market. This can include, for example, contract manufacturers and critical suppliers of medical device components but also other actors such as economic operators in the context of the EU MDR 2017/745 such as authorized representatives, importers and distributors.
We have already been talking extensively of several aspects related to requirements of quality management system such as quality plan, management representative, etc. In this article we will go for a deep dive in the understanding of the quality agreement documents, what should be detailed in these types of agreements and as well the requirements associated to quality agreement in a context of potential different regulations.
Quality agreements related requirements according to ISO 13485
As mentioned in the section before, the section 4.1.5 of the ISO 13485:2016 specifies the necessity to have a quality agreement set up as a form of control for people for the activities that are outsourced.
Furthermore, always in the context of ISO 13485, one more requirements related to quality agreement is defined in the section related to purchase control, specifically section 7.4.2. In fact, it is mentioned:
“Purchasing information shall include, as applicable, a written agreement that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements”.
This basically means that it is necessary to have a quality agreement with suppliers with a clear statement related to the obligation of the suppliers to notify the legal manufacturer (or anyway the responsible for the design of the device) of any changes performed on the product, or components supplied.
Similar requirements are as well mentioned in the 21 CFR 820 Quality System Regulation from FDA. Specifically, in the part related to Purchase Control, it is reported:
Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.
As you can see, the requirements are very similar and there is a specific demand on the necessity to notify the manufacturer of changes in the product or service.
Few comments on the contents of a Quality Agreements
Obviously the type of agreement it is possible to set up depends from the activities of the parties involved in the specific contract. However, in general, the following section shall be be properly defined within the text of a Quality Agreement.
Activities and Responsibilities of each parties
It is important to defines the activities and responsibilities related to each part. This includes the definition of a method to contact each part and contact person for each of both parts. It is important to defines the overall goal of the agreement and the expectations for each part involved.
Quality Management system Requirements
The specific requirements linked to a quality agreement are highly dependent from the responsibilities of each part involved. This means that if the agreement is with a supplier or a with a distributor, the agreements will have to mention different requirements based on the specific role of the involved parts and on the applicable regulatory and legal requirements.
Audit Requirements
Audit requirements are very important and will always have to be mentioned in the agreement. For critical suppliers or for contract manufacturers, there might be the possibility that the notified body is willing to audit the suppliers, according to the applicable requirements.
Among the audit requirements, unannounced audits shall also be mentioned as now they are becoming integral part of the audit methodologies.
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