GOOD VIETNAM EVALUATES ISO 13485 STANDARD: MEDICAL EQUIPMENT MANAGEMENT SYSTEM – TRAPHACO CNC JSC

In the context of the pharmaceutical and medical equipment industry increasingly requiring standardization and strict quality control, the application of international standards such as ISO 13485 has become an essential requirement for manufacturing enterprises. Recently, Traphaco CNC High Technology Joint Stock Company has been assessed by GOOD Vietnam Certification Organization for its quality management system according to ISO 13485.

ISO 13485 – the foundation for ensuring medical device quality

ISO 13485 is an international standard specifically for quality management systems of organizations that manufacture and trade medical devices. This standard specifies strict requirements for risk management, production process control, product traceability and effectiveness to ensure safety and effectiveness throughout the entire life cycle of medical products.

During the assessment process, the GOOD Vietnam expert team conducted a comprehensive review of all aspects of the management system at Traphaco CNC, including: organizational structure, record control, measurement equipment management, risk assessment, clean production environment, product quality control process and compliance with legal requirements. The assessment activities were carried out seriously and closely but still ensured support, construction and created conditions for the enterprise to improve in the process of operating the quality system.

The result of the effort

Traphaco CNC’s achievement of ISO 13485 certification is not only a testament to its quality management capacity and strict compliance with technical requirements in the production of medical equipment, but also demonstrates the company’s strong commitment to ensuring safety for users. Thereby, Traphaco CNC enhances its reputation in the medical equipment supply chain, while creating a solid foundation for expanding domestic and foreign markets.

GOOD Vietnam representative shared: “We appreciate the thorough preparation, professionalism and commitment from the Traphaco CNC team. This is a typical model in applying international standards to practical management, especially in high-demand fields such as healthcare and pharmaceuticals.”

ISO 13485 certification is not the final destination but the foundation for Traphaco CNC to continue to improve and maintain the quality management system in a sustainable manner. At the same time, this is also an important milestone in the journey to affirm the position of the enterprise in the healthcare industry in Vietnam and the region.

ISO 13485 assessment steps at the enterprise

The assessment of the quality management system according to ISO 13485 is carried out through a standardized and scientific process, ensuring that it accurately reflects the actual operating status of the enterprise. At Traphaco CNC, the assessment process carried out by the GOOD Vietnam certification organization has gone through the following steps:

1. Preliminary assessment

This is the first step to check the readiness of the enterprise before entering the official assessment. The team of experts reviews documents such as quality policy, quality manual, procedures, forms, legal documents, production licenses, etc. to ensure that the management system has been built in accordance with the requirements of ISO 13485.

2. Formal certification assessment

In this step, the assessment team visits the facility to inspect the actual implementation of the quality management system. Activities include:

Interviewing personnel at multiple levels;
Observe production, packaging and testing processes;
Check the calibration of measuring equipment;
Consider risk management and product traceability;
Compare actual records with published procedures.

The objective is to assess the effectiveness and compliance of the management system in operation.

3. Reporting and handling non-conformances

After the assessment, the certification body will compile the findings, including any non-conformities (if any). Traphaco CNC will have time to develop a plan of action for correction and improvement. The evidence of implementation will be sent back for review by the assessment expert.

4. ISO 13485 certification

When the system fully meets the requirements, the enterprise will be granted ISO 13485 certificate, which is valid for 3 years. During this period, the certification body will conduct annual surveillance assessments to ensure the system remains effective.

5. Recertification Assessment

After a 3-year cycle, the business will be comprehensively re-evaluated to re-certify, ensuring continued compliance with ISO 13485 standards in the next phase.