ISO 13485 Medical Device Quality Management System Certification

I. INTRODUCTION TO ISO 13485:2016

ISO 13485:2016 is the international standard for quality management systems in the medical device sector, designed to assist organizations in establishing, implementing, and maintaining quality-assurance processes that meet regulatory requirements and ensure the safety of medical products. This standard emphasizes risk management, production process control, and product lifecycle monitoring to maximize quality and safety for end-users. ISO 13485:2016 not only helps organizations achieve production efficiency but also ensures compliance with international standards, building trust among customers and partners in the healthcare industry.

Introduced in 1996, ISO 13485 provided a specialized quality management framework for medical devices with a focus on safety and risk management. The standard was updated in 2003 to meet the demands of major markets and to implement stricter process controls. The current ISO 13485:2016 version, released in March 2016, further optimizes quality management processes, enhances risk management, and requires continuous improvement, making it the most widely adopted standard in the industry.

ISO 13485:2016 establishes essential requirements for a quality management system, covering leadership commitment, risk management throughout the product lifecycle, and rigorous control of production processes, services, and resources. Additionally, the standard mandates continuous evaluation, improvement, supplier management, and product verification before market release, all contributing to the increased credibility and reliability of certified organizations.

As of the end of 2023, 32,963 ISO 13485 certificates have been issued globally, with 133 certified companies in Vietnam.

Implementing and certifying ISO 13485 offers numerous benefits for organizations in the medical device industry, from enhancing reputation and meeting international regulatory requirements to improving risk management, optimizing processes, and minimizing waste. ISO 13485 also provides a significant competitive advantage in international bidding and partnerships, enabling organizations to continuously improve product and service quality for sustainable development.
 
II. CERTIFICATION PROCESS

1. Certification registration: To obtain ISO 13485:2016 certification, organizations need to contact GIC Vietnam for registration guidance. Organizations then complete the application and submit it to GIC Vietnam with the required certification documents.

2. Audit program and auditor assignment: GIC Vietnam develops an assessment program, clearly defining the activities needed to confirm that the organization’s medical device quality management system meets certification requirements. Auditors are selected based on expertise relevant to the assessment field, with additional technical auditors added as necessary.

3. Assessment process: Conducted in two stages:
Stage 1: Review documentation, conditions, scope, and the organization's readiness for stage 2 assessment.
Stage 2: Evaluate the implementation and effectiveness of the management system, including the following steps: Opening Meeting → Department/Unit Evaluation → Assessment Report Preparation → Closing Meeting.

4. Assessment report and corrective actions: The organization must implement corrective actions for errors and deficiencies found during the assessment, ensuring all requirements are fully met.

5. Review and certification issuance: The Certification Council reviews the assessment records to decide on certification approval or denial. ISO 13485:2016 certification is issued once the organization fully meets the requirements and is valid for three years, with periodic monitoring required to maintain validity.
 
III. GIC CERTIFICATION BENEFITS

- International recognition: GIC is a globally recognized certification body, endorsed by prestigious organizations such as CPSC (USA), UKAS (UK), JAS-ANZ (Australia - New Zealand), SAAS (SAI), VICAS (Vietnam), SAC (Singapore), CNAS (China), and others. GIC certification offers national and international credibility, recognized by the International Accreditation Forum (IAF) and Asia-Pacific Accreditation Cooperation (APAC), helping businesses expand markets and increase global reputation.

- High-quality certification service with competitive cost: GIC Vietnam provides certification services to strict European and North American standards, ensuring that the business’s products and services meet international requirements. Alongside excellent service quality, GIC offers competitive, reasonable costs, helping businesses optimize expenses while achieving international recognition, facilitating participation in major markets and sustainable development.
 
For ISO 13485:2016 certification inquiries, please contact:
 
GIC VIETNAM
12F, 14 Lang Ha Building, Ba Dinh District, Hanoi
Tel: 024.6275 2268, Fax: 024.6275 2269, Email: tuandm@gicvn.vn
Ho Chi Minh City Office: R502, 160 Nam Ky Khoi Nghia, Tel: 028.39307936