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  • Writer's pictureKenko Soluciones

First steps into implementing a Quality Management System in your company

The implementation of a Quality Management System (QMS) in the Medical Devices sector is a very important issue and one that little is said about, until today it has not had the recognition required to demonstrate that its implementation is the main way of guaranteeing the quality of the products provided.

Quality Management System Definition

To delve a little into the subject, it is necessary to know what is a QMS, which is a set of tools related to each other, which are oriented to a way of working based on processes that allow the organization to plan, execute and control the activities necessary for the development of the company's mission, through the provision of services with high-quality standards.

The QMS in companies in the Medical Device sector seeks to achieve not only the quality requirements but those that have legal relevance and for this, processes, procedures, instructions, specifications, and records are implemented with tools that are intended to guide people in carrying out their tasks and be able to reduce errors related to miscommunication and product variations.

Stages of the implementation

We could divide the implementation of a QMS into eight stages, which will be developed below:

1. Prepare the organization

Once the decision to establish a QMS has been made, we need to understand the needs of the company to know under which standards we have to align ourselves and to inform ourselves about them. The issue of preparing the organization for change is very important because normally we tend to reject change and if the organization does not collaborate with us at the time of these changes, it will not be a successful implementation.

2. Planning of the QMS

Once we know the standards to comply with to implement the QMS, it is necessary to define the stages and activities to be carried out to comply with the regulations, assigning persons responsible to each of them, setting execution deadlines for each stage, and estimating the resources that will be required.

3. Design of the QMS and preparation of documentation

During this stage, it is necessary to define the quality objectives and the quality policy to which the company wants to align itself, as well as to establish the indicators with which the effectiveness of the implementation of our QMS will be measured.

It is also necessary to identify the processes required to achieve quality objectives, establishing a documentary structure for the QMS. Once the documents to be carried out have been identified, it is necessary to collect all the available documentation, including the applicable legal and regulatory ones, in order to prepare the QMS documentation.

4. Communication of the QMS

This stage consists of carrying out the execution of the proposed processes and informing the collaborators of the importance of correct implementation of these so that the QMS can be maintained. In my opinion, this stage is one of the most important, because, if a perfectly documented system is not followed in the correct way, we do not have a Quality Management System.

5. Implementación of the QMS

When the collaborators know the system and implement it, it is necessary to have all the documented information that evidences compliance with the established processes, so that, when conducting internal audits, we can verify the correct follow-up of the processes.

6. Certification

Once we have the Quality Management System implemented and its correct monitoring has been verified, we are ready for the certification stage before the health authorities, which will audit the processes implemented in the company.

7. Continuous improvement

As a result of each one of the audits, it suggests continuous improvement actions in the system, so that we can accomplish an improvement in the manufactured products and achieve total quality in the company.

8. Maintenance of the QMS

Continuous maintenance of the Quality Management System is important and to achieve this, it is necessary, in addition to periodic internal audits, the review of the QMS by Senior Management.

It is important to highlight that quality cannot be achieved without the commitment of all personnel, both managerial, operational, and administrative, and it is necessary that everyone recognize the importance of complying with the QMS and assume their responsibility for the success of the implementation or improvement of the system and together to achieve total quality.

If you are interested in implementing a Quality Management System in your company or would like some advice on this issue, contact us and we will gladly support you.

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