SCIE H5R03: Quality Management Systems (QMS) have a supreme role in the operation of each company fabricating a medical device: Product Programme Management, Vigilance, Surveillance and Risk Management Assignment, Ireland

Give a brief summary of the significance of the Quality Management system.

Quality Management Systems (QMS) have a supreme role in the operation of each company fabricating a medical device. The design and manufacture must be precise as the impact on the user’s life is immersed. Quality standards need to be met to reach a high-quality level of production along with its reliability.

QMS’s scope of control applies to more than just the production line. It involves each aspect of the manufacturing body and all its actions. It includes the production process, employees, and the product itself.

QMS provides numerous benefits to the organization. The significance of it shouldn’t be undermined. Compliant and regularly revised QMS will help get the product out on the market.

When following QMS, the company can always be sure of the highest standards achieved at all times, where quality is key. The quality of medical devices is a crucial variable for both customers and stakeholders.

Medical Device industry needs to adhere to numerous quality standards and regulations. Medical devices need to adhere to ISO 13485 international standards in order to meet QMS. ISO 13485 is based on the ISO9000 family of standards, but it is used specifically to regulate the medical device industry.

ISO13485 is the main document for QMS released by the Food and Drug Administration (FDA).QMS system compliant with ISO13485 will be approved globally. In the EU there is a regulation 2017/745 which calls out all medical device companies to implement a compliant QMS.

Annex IX of the document states that the manufacturing body needs to ensure that documentation along with QMS is kept effective and highest level throughout the device’s lifecycle.

The importance of creating and updating all documents and records related to the device is huge. Without documentation, there’s no proof or record of the device. These documents will help improve the device along with patients’ quality of life.

The management is also responsible for the decisions regarding the policy and the resources used to produce the device. The QMS touches on each part of the medical device life cycle, from design to implementation and manufacture.

It also covers analysis and improvement. All variables come together when the company is ready to sell its product to the customers and can be sure that all measures were taken to ensure its safety and best possible quality.