Editor’s note: Alena explains how the international standard ISO 13485 defines the requirements for the quality management systems of medical device manufacturers. If you want your medical devices to meet international quality requirements, you are welcome to turn to ScienceSoft's team for healthcare IT consulting.
The global market of medical devices is steadily expanding due to the rising incidence of chronic diseases and the growing awareness of telemedicine among the general public. Compliance with the ISO 13485 standard allows a medical device manufacturer to produce and sell safe and high-quality medical devices for various purposes.
ISO 13485 is the international quality management standard for medical devices, issued by the International Organization for Standardization (ISO). It is based on the general quality management standard ISO 9001 (more specifically, on its version ISO 9001:2008) which is industry-independent. ISO 13485 was developed and published by ISO in 1996 and has been revised several times since then. The latest revision of the standard was released in March 2016.
ISO 13485:2016 applies to medical device manufacturers who want to adjust their quality management systems (QMS) and processes in accordance with international requirements throughout all stages of a medical device life cycle. The stages include design, development, production, storage, delivery, technical support, and disposal of a medical device. Here, you can review the list of documents required for a medical device manufacturer's QMS to comply with ISO 13485:2016.
ISO 13485:2016 applies to organizations having various roles in a medical device production life cycle, regardless of their size and type (public or private), unless expressly indicated in the text of the standard. The requirements of the standard are also applicable to the related services provided by the organization. For example, if a company that manufactures laboratory microscopes also provides the services of their calibration and repair, the ISO 13485 requirements span to the services as well.
ISO 13485:2016 consists of eight parts: parts 1-3 are introductory, and parts 4-8 describe the mandatory requirements for the medical device manufacturers’ QMS. Let's take a look at parts 4-8 in more detail.
This section of the standard sets out the general requirements for the QMS and its documentation, namely, the quality manual and the medical device file.
According to this part of the standard, in addition to the implementation of the quality management system, the company executives must establish the quality policy and objectives and regularly review the QMS processes to identify deficiencies and fix them.
The requirements of this section of the standard apply to all resources of an organization, including infrastructure, buildings, personnel, work environment, and resources needed for environmental control.
According to this part of the standard, the manufacturing organization should fulfill several important conditions of product realization. First, the manufacturer needs to plan and control such stages of a medical device life cycle as design and development (including the analysis of each stage with an indication of its participants and dates), the device verification, validation, and the procedure for managing changes.
This section of the standard stipulates measures and processes that need to be applied to the medical device production processes to ensure QMS conformity. It takes into account the level of customer satisfaction with the quality of the purchased medical device, internal audit (e.g., for checking and assessing the processes of risk management, evaluating employee satisfaction with the working conditions), etc.
ISO 13485 certification is voluntary, but compliance with the requirements of this standard provides medical device manufacturers with a number of benefits. For example, the intention of the manufacturer to comply with the ISO 13485 requirements shows the focus on quality, customer needs, and generally improves the image of the company on the market.
Make your QMS compliant with ISO 13485
A well-established quality management system helps avoid quality problems, optimize design and development of a medical device, and identify weaknesses in the production cycle. If you need expert assistance in establishing effective QMS and achieving compliance with the latest revision of the ISO 13485, feel free to contact ScienceSoft’s healthcare IT team.