How is the ISO 13485 Standard for Medical Devices Structured?

There is a vast range of medical devices designed, manufactured, and used. While some can be as simple as a blood pressure machine, some can be as complex as a heart failure sensor, but one thing that is common in all medical devices is that they benefit the health of people and immensely contribute to their wellness. Safety along with quality must be the primary concern for every medical device manufacturer and achieving the ISO 13485 certification helps them address that.

ISO 13485 is the most acclaimed and globally recognized standard for medical devices. It focuses on increasing the effectiveness of the Quality Management System (QMS) in the medical device industry and obliges the manufacturers to meet a range of regulatory requirements. With different countries having their own standards for medical devices, ISO (International Organization for Standardization) wanted to introduce a globally uniform model of medical device QMS for all countries. ISO 13485 was hence developed by ISO to provide the standardized requirements of a QMS to all the medical device businesses.

The next section discusses how ISO 13485 is structured to help medical device businesses to implement it.

Structure of the ISO 13485 Standard for a Medical Device QMS (Quality Management System)

The structure of the ISO 13485 standard is made up of eight sections.

Scope

Scope describes the key purpose of the standard in a medical device manufacturing business. It must be followed for implementing an effective QMS. The QMS should help in supervising the design and manufacturing of medical devices for assuring their quality and safety.

Normative References

Normative references are the introductory information and nomenclature that medical device organizations need to understand to form and implement their QMS.

Definition and Terminology

The standard also defines the various specific terms or terminology that is to be used in the QMS of the medical device manufacturing process.

Quality Management System

The standard outlines the general requirements including the documentation requirements of a QMS for medical device manufacturing. It explicitly specifies that a quality management manual must be written, adhered to, and produced to the auditors in the certification stage.

General QMS requirements include procedures that manufacturers need to adopt for their various tasks including designing, procuring materials, product development, and product realization. They also include the methods that are to be used for risk identification and risk management. Lastly, the standard also needs organizations to determine the sequence of their manufacturing and their interactions with each other.

Documentation requirements of the standard specify the key documents and records that have to be controlled by the manufacturers. Documentation control also includes reviewing of documents, getting approval from management, incorporating changes, and ensuring that all the latest versions of documents are available whenever needed.

Management Responsibility

The management team of the medical device organization must be involved right from the start in the implementation of the QMS. They should establish the quality policy, affirm the organization’s objectives, and direct the QMS implementation process. The provisioning of resources for the implementation task is also the responsibility of the management team. They must plan consciously and make sure to communicate the quality policy and QMS requirements to employees at all levels of the organization.

Resources Management

The resources and facilities that are used in the manufacturing of the medical device such as mechanical tools, hardware, computers, and even the building need to be maintained properly for quality assurance. The standard specifies that these resources should be maintained through their lifecycle so that they can produce quality medical devices which successfully meet the customer requirements.

Product Realization

A part of the QMS requirements includes the day-to-day activities or tasks of the employees that help to realize the final product or device from the inputs. They include all the tasks including designing, developing, evaluating, and installing a device. The tasks of risk assessment and risk mitigation are also included in the product realization criteria. Therefore, the QMS must be able to control all aspects of product realization to affirm the quality of devices.

Measurement, Analysis and Continual Improvement

The ISO 13485 standard’s requirements also include continuous reviewing, monitoring, and measuring of the quality performance of the devices. It is necessary to identify inefficiencies or issues in the devices and improve the QMS further to correct them. Collection of customer feedback, performing internal audits, data analysis, and measuring conformances in the devices and CAPA (Corrective and Preventive Actions) are the key requirements needed for improving the effectiveness of the QMS.

All medical device businesses including the original manufacturers of devices, suppliers of equipment/parts, and even providers of a related service are eligible to get the ISO 13485 certification. The standard is based on ISO 9001, the world’s leading and general QMS standard. However, it is different from ISO 9001 in its structure in mainly two ways: it gives more importance to the risk management aspect, and secondly, it places more emphasis on the documented procedures.