INSTITUTE FOR STANDARD AND QUALITY DEVELOPMENT STUDIES
The ISO 13485 standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide medical devices and related services that meet customer requirements and applicable regulatory requirements.
Such organizations may be involved in one or more stages in the life cycle of medical devices, including design and development, production, storage and distribution, installation, servicing of medical devices, as well as the design, development, or provision of related activities (e.g., technical support).
Medical devices and instruments play an especially important role in medical examination and treatment and have a direct impact on human life and health. Products in this sector must not only meet manufacturers’ standards but also comply with legal requirements to ensure that medical devices supplied to the market always meet quality and safety requirements for users.
ISO 13485:2016 is a globally recognized certification for quality management systems (QMS) related to medical devices. This standard focuses on maintaining the effectiveness of the QMS and meeting customer requirements. ISO 13485:2016 was developed to provide a globally harmonized model of QMS requirements for the international market.
All guidance for maintaining effective quality management processes specified in ISO 13485 certification aims to ensure the safe design, manufacture, and distribution of effective medical devices. In addition to being a regulatory requirement, a QMS compliant with ISO 13485 also offers sound business value by helping manufacturers reduce variability. This leads to economic benefits such as reduced waste and improved overall process efficiency.
Accordingly, the subjects of this certification include all organizations, regardless of type, location, or size. These may include facilities / companies / factories / distributors, etc., engaged in medical device business and integrated medical services (e.g., medical gloves, sterile medical products, syringes, infusion sets, feeding tubes, etc.). ISO 13485:2016 certification is a mandatory certification for medical device manufacturing facilities.
When an organization establishes and complies with ISO 13485:2016 and operates a safety management system, it can create a working environment that minimizes risks related to medical device safety. Products are produced safely and effectively, meeting customer needs as well as legal requirements.
ISO 13485 certification specifies essential requirements for a Quality Management System for enterprises that need to demonstrate their capability to provide medical devices and related services that meet customer needs and legal requirements.
Such organizations and enterprises may participate not only in one but in multiple stages of the product life cycle. These stages include activities such as design, development, production, storage, distribution, installation, supply, or maintenance of medical devices, as well as the design, development, and provision of other related activities.
According to Decree No. 36/2016/ND-CP, it is stipulated that:
“Medical device manufacturing facilities must complete the implementation of the ISO 9001 quality management system before January 1, 2018, and the ISO 13485 quality management system before January 1, 2020.”
Implementing ISO 13485:2016 certification brings many benefits to your organization. Although changes to your medical device quality management system will require greater implementation efforts across the organization, the results of adopting an ISO 13485-based QMS will bring numerous business benefits as well as customer satisfaction.
Helps enterprises affirm the safety and quality of products supplied to the market.
Creates competitive advantages and enhances brand reputation.
Reduces operating costs through continuous improvement and improved operational efficiency.
Ensures that products manufactured and supplied under a quality control system meet customer requirements and comply with legal regulations.
Enhances the capability to export medical equipment and supplies abroad and respond promptly to the demand for high-quality medical devices in epidemic situations.
When ISO 13485 certification is applied, each employee better understands their duties and responsibilities within the workflow chain, thereby becoming more proactive in their work and enabling enterprise leaders to focus on more strategic tasks.
The above are useful information about the overview of ISO 13485:2016 certification.
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Posted date: 12/11/2022
