Quality management for manufacturers of medical devices

Medical devices are an important part of the healthcare system and must meet the highest standards of safety and performance. To ensure this, a quality management system (QMS) is essential. The following explains the basics of the QMS for manufacturers of medical devices and how BERNHARD & BERNHARD GmbH can support the implementation and optimization of a QMS.

What is quality management?

ISO 9000 defines quality as the ability to satisfy customers. However, this approach is not sufficient in the field of medical technology. The QMS includes activities through which the organization determines its goals and determines the processes and resources required to achieve the desired results. In particular, EN ISO 13485:2021 highlights that the main objective of any organization involved in one or more stages of the life cycle of a medical device is safety and performance and compliance with regulatory requirements.

The importance of the QMS for manufacturers of medical devices

Medical device manufacturers must implement a QMS to ensure regulatory compliancecertain requirements. The medical device goes through a specific phase with different requirements in each step of the product life cycle. This includes design and development, manufacturing, marketing, sales, installation and service. BERNHARD & BERNHARD GmbH supports manufacturers of medical devices worldwide with all questions and tasks relating to quality management.

Introduction of a complete quality management system

A complete quality management system (QMS) is critical to producing safe and effective medical devices. EN ISO 13485:2021 is the globally recognized standard for implementing a QMS in the life cycle of a medical device. The initial creation and implementation of a QMS presents many organizations with a major challenge. The greatest difficulty lies in writing down the normative and regulatory requirements in documented procedures that can nevertheless be implemented in practice and in everyday company life.

Identification of processes

EN ISO 13485:2021 describes in detail which processes you must implement documented procedures for. The first step is to identify the processes that are important to your company. On the one hand, this list describes the basis of your quality management manual and, on the other hand, is the basis of your project plan for the complete implementation of your QMS.

Documented procedures

In addition to the documented procedures, forms, checklists and work instructions are created that bring the QMS to life. According to the QM documentation, appropriate records must be kept that prove the effectiveness of the QMS. Employees must know the processes and be demonstrably trained. Top management must provide appropriate resources for both the implementation phase and continued effectiveness.

Maintaining the QMS

After the implementation phase, it is important to live and maintain the QMS processes. Evidence must be documented and archived. As part of internal audits, you put your system to the test. If your system complies with your internal as well as the regulatory and normative requirements, nothing stands in the way of certification by a notified body. When planning your project, remember to start communicating with a notified body early on; this is the only way you can secure your desired date at an early stage.

ISO 13485 - Requirements for a quality management system for medical devices

ISO 13485 is a standard that specifies quality management system (QMS) requirements for organizations involved in the development, production or delivery of medical devices. In contrast to the more general ISO 9001, ISO 13485 is specifically aimed at the area of medical devices. EN ISO 13485:2021, which was published in the European Official Journal at the beginning of 2022, defines the requirements for a complete QMS for medical devices and requires increased documentation effort for manufacturers and other organizations.

Basics of ISO 13485

Although ISO 13485 is based on the principles of ISO 9001, it contains far more requirements for a complete QMS for medical devices. The standard ensures that all processes required for the development, production or delivery of medical devices must be documented and maintained. ISO 13485 also establishes the PDCA (Plan-Do-Check-Act) cycle as an important principle for continuous QMS improvement.

Process-oriented approach

ISO 13485 places great emphasis on a process-oriented approach and requires that activities be understood and controlled as interrelated processes. This ensures that all processes in the QMS function as a coherent system and consistent and predictable results can be achieved more effectively and efficiently. The standard also explicitly requires that documented procedures for specific processes must be implemented and maintained to ensure compliance with the standard.

Scope of the QMS

The QMS according to ISO 13485 includes both supporting processes such as document control and value-adding processes that describe the entire life cycle of the medical device. This means that the standard is applicable not only to manufacturers, but also to suppliers and external parties who provide QMS-related services to medical device manufacturers. Suppliers can significantly reduce the audit effort required by their customers through their own certification, as they can already demonstrate conformity with ISO 13485 with their own certificate.