What is quality?
According toISO 9000, quality is "the ability of a set of intrinsic characteristics of an object to satisfy requirements". It is then possible to define the quality of a product, a service, the care given to people, etc.
In the medical device industry, quality refers to the ability of a device to satisfy :
- customer requirements,
- the requirements imposed by the regulations,
- the requirements relating to the environment in which the device is located
- requirements related to the safety of the patient or user of the device.
These requirements may be obligations or needs stated or induced by these entities.
Why implement a quality approach?
What we are looking for above all, as manufacturers, is customer satisfaction. To achieve this, it is important to be able to identify customer requirements, to know how to implement them in our products and to have the ability to measure this satisfaction in order to evaluate our ability to identify and implement these requirements.
The identification of these three elements finally constitutes the basis of a quality approach. To this will be added methods of traceability, documentation and improvement of our activities.
The quality approach is mainly oriented around three axes:
- Competitiveness: through research and development, sustainable development, outsourcing of activities, etc.
- Organization: by sorting, controlling, improving, etc.
- Adaptability: through the conquest of new markets, knowledge of the regulatory environment, knowledge of the market, etc.
The quality management system
Quality management within organizations is standardized by the ISO 9000 series of standards, including ISO 9001, which describes the requirements for quality management systems. These systems aim not only to ensure the quality of the products and services distributed by an organization, but also to promote the continuous improvement of these products and services, the organization and the quality management system itself!
A quality management system is based on 7 principles defined in ISO 9001 :
Quality in health
In our sector, quality is both a regulatory and ethical imperative. If the regulation, in this case the EU Regulation 2017/745 on medical devices, requires the implementation of a quality management system, it is primarily to ensure the effectiveness of care provided to patients. Through this quality approach, we seek to ensure that the products, services, drugs, employed to improve the health condition of patients actually achieve the objectives, but also do not generate unexpected adverse effects.
The ISO 13485 standard provides additional requirements compared to the criteria of the ISO 9000 series of standards applicable, in particular, to manufacturers in the medical device sector. Its implementation, as for ISO 9001, is sanctioned by a renewable cycle of three annual audits carried out by a certification body leading to the issue of an ISO certificate. For devices above class I, the notified body is responsible for this task and a fourth unannounced audit is added to the cycle.
The ISO 13485 standard is voluntary, meaning that there is no regulatory obligation to follow this standard. However, the implementation and maintenance of a quality management system is mandatory and the audit of this system is also mandatory for all devices above class I.
Quality at exolis
At exolis, we have chosen to apply the ISO 13485 standard and to have our quality management system certified by Afnor, the French organization that represents France at ISO (International Organization for Standardization, the international organization responsible for producing ISO standards).
Our quality management system covers all our activities, whether or not they concern the connected monitoring module of the engage solution (medical device module). This choice allows us to provide a guarantee of quality to our customers and commitment to provide products and services in constant improvement, following the state of the art and in compliance with regulatory requirements.
The certification audit took place at the end of the first half of 2022 and the certificate was issued on July 21, 2022. This certificate attests that the quality management system implemented by exolis for the activities of design, manufacturing, marketing, installation and maintenance of systems, software for planning and organization of care pathways, deployed on our site of activity has been assessed and found to be in compliance with the requirements of the ISO 13485 standard version 2016.
This audit evaluated the internal organization of exolis, the quality of our processes, our ability to monitor and improve them and the quality of the post-marketing follow-up of our products and services.
As for the rest, we are currently implementing the requirements of the QHN (Qualité Hôpital Numérique) standard, but this will be the subject of a new article!
Article written by :
Camille MERINI, Quality and Regulatory Affairs Manager at exolis