top of page
  • Eng. Alejandra Cruz

First steps for the implementation of a Quality Management System

The implementation of a Quality Management System (QMS) in the medical device sector is a very important and little talked about topic. To date, it has not had the required recognition to demonstrate that its implementation is the main way to guarantee the quality of the products provided.

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

Definition of Quality Management System

To go a little deeper into the subject, it is necessary to know what a QMS is, which is a set of interrelated tools, which are oriented to a way of working based on processes that allows 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 requirements of quality 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 performing their tasks and to reduce errors related to miscommunication and variations in products.

Stages of implementation

We could divide the implementation of a QMS in 8 stages, which will be developed below:

1. Preparation of the organization.

Once the decision to establish a QMS has been taken, we need to understand the needs of the company to know under which standards we have to align ourselves and learn about them. The issue of the organization's readiness 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. QMS planning.

Once we know the standards to be met to implement the QMS, it is necessary to define the stages and activities to be carried out to comply with the regulations; assigning responsible for each of them, setting 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 the quality objectives, establishing a documentary structure for the QMS. Once the documents to be created have been identified, it is necessary to compile all the available documentation, including the applicable legal and regulatory documents, 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 importance of the correct follow-up of these to the collaborators, 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. Implementation of the QMS.

When the collaborators know the system and implement it, it is necessary the availability of all the documented information that evidences the fulfillment of the established processes, so that, at the moment of internal audits we can verify the correct follow-up of the processes.

6. Certification.

Once the Quality Management System has been implemented and its correct follow-up 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 of the audits, actions for continuous improvement in the system may be suggested, so as to have an improvement in the products manufactured and achieve total quality in the company.

8. Maintenance of the QMS.

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

Implementation of QMS in Soluciones Kenko

The implementation of our QMS at Soluciones Kenko was from scratch, from the creation of the organization chart to obtaining the NOM-241-SSA1-2012.

During this time the Quality and Regulatory team designed and implemented a QMS that allows us to create quality medical devices and products. Although the size of the team you have depends on the time it will take to create and implement a QMS in the company, it is not impossible and it is extremely important to start with its creation as soon as possible, since, as mentioned above, it is necessary that all employees of the company are committed to follow and comply with the requirements of the QMS and get used to the correct documentation processes. The success of the implementation of a QMS is a matter for all employees.

Today, we are able to help any small business successfully implement their QMS. If you would like to know more about how this could impact your company successfully, please do not hesitate to contact us.

14 views0 comments
bottom of page