The importance of compliance with ISO 13485


Editor’s note: Halina explains how the international standard ISO 13485 defines the requirements for quality management systems of medical device manufacturers. If you want your medical devices to meet international quality requirements, you can turn to the ScienceSoft team healthcare IT consulting.

The global medical device market is steady expanding due to the increasing 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, high-quality medical devices for a variety of 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, in its version ISO 9001: 2008) which is independent of the industry. ISO 13485 was developed and published by ISO in 1996 and has since been revised several times. The last revision of the standard was published 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 the life cycle of a medical device. 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 the SGC of a medical device manufacturer to comply with ISO 13485: 2016.

ISO 13485: 2016 applies to organizations that have different functions in the life cycle of the production of medical devices, regardless of their size and type (public or private), unless expressly stated in the text of the norm. The requirements of the standard also apply to related services offered by the organization. For example, if a company that manufactures laboratory microscopes also offers calibration and repair services, the requirements of ISO 13485 are also covered in the services.

ISO 13485: 2016 consists of eight parts: parts 1-3 are introductory and parts 4-8 describe the mandatory requirements for the SGC of medical device manufacturers. Let’s take a look at parts 4-8 in more detail.

Part 4. Quality management system

This section of the standard establishes the general requirements of the GSC and its documentation, ie the quality manual and the file of the medical device.

Part 5. Management responsibility

According to this part of the standard, in addition to the implementation of the quality management system, company managers must establish the quality policy and objectives and periodically review the SGC processes to identify deficiencies. and fix them.

Part 6. Resource Management

The requirements of this section of the standard apply to all resources of an organization, including the infrastructure, buildings, personnel, work environment, and resources required for environmental control.

Have your medical device and software comply with ISO 13485-С

ScienceSoft’s healthcare IT team is ready to advise you on how to establish efficient quality management and achieve compliance with ISO 13485.

Part 7. Product realization

According to this part of the standard, the manufacturing organization must meet several important conditions for the realization of the product. First, the manufacturer must plan and control the stages of the life cycle of a medical device such as design and development (including analysis of each stage with an indication of participants and dates), verification, validation of the device and the procedure for managing changes. .

Part 8. Measurement, analysis and improvement

This section of the standard stipulates measures and processes to be applied to medical device production processes to ensure GSC compliance. It takes into account the level of customer satisfaction with the quality of the medical device purchased, internal audit (e.g., to check and evaluate risk management processes, assess employee satisfaction with working conditions), and so on.

ISO 13485 certification is voluntary, but compliance with the requirements of this standard offers medical device manufacturers a number of advantages. For example, the manufacturer’s intention to comply with the requirements of ISO 13485 shows the focus on quality, customer needs and, in general, improves the company’s image in the market.

Have your QMS comply with ISO 13485

A well-established quality management system helps to avoid quality problems, optimize the design and development of a medical device, and identify weaknesses in the production cycle. If you need expert help to establish an effective quality management system and achieve compliance with the latest revision of ISO 13485, do not hesitate to contact the ScienceSoft healthcare IT team.

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