ISO 13485 Certification in Vietnam

About ISO 13485 

ISO 13485 is a medical device and equipment quality management system standard. The standard mandates that an organization applies in one or more phases of a medical device's life cycle in order to meet the Medical Device Regulatory Compliances. ISO 13485 stipulates that medical devices must be free of pollutants, disinfected, and kept clean during their entire life cycle. ISO 13485:2016 is the latest version of this standard, updated frequently to ensure continuous quality improvement. We Provide ISO 13485 Certification for Medical devices.

ISO 13485 provides enterprises with guidance on how to effectively implement a quality management system in medical device manufacturing or medical service-related organizations. The ISO 13485 standard assures that medical devices are designed, developed, manufactured, installed, and delivered in a consistent manner for their intended functions.

What is ISO 13485 Certification?

ISO 13485 certification assures that medical device manufacturers satisfy stringent quality and safety standards. Professionals and patients in clinics, hospitals, and other medical facilities are protected by companies that have acquired ISO 13485. The requirements for creating and maintaining a quality management system for enterprises that design and produce medical devices and equipment are covered by ISO 13485. The US Food and Drug Administration requires ISO 13485 certification for medical device makers before shipping their products to the US.

Importance of ISO 13485 Certification

ISO 13485 certification ensures that all requirements and specifications are met to satisfy customers’ expectations. It not only improves QMS performance but also ensures consistent improvements in the quality of medical devices and equipment. Most importantly, achieving ISO 13485 certification ensures adherence to all directives, regulations, and responsibilities that manufacturers must follow while designing and assembling medical devices. Overall, ISO 13485 helps improve the quality and performance of medical equipment.

Organizations Eligible to Apply for ISO 13485 Certification

All companies/industries that manufacture and distribute medical devices and equipment, regardless of size, can obtain ISO 13485 certification. ISO 13485 also applies to industries that provide related services across the medical device supply chain.

Advantages of ISO 13485 Certification

• Improves the quality of medical devices and equipment to international standards
• Provides directives, regulations, and responsibilities for medical products’ manufacture
• Enhances QMS performance and profit of the organization.
• Ensures customers satisfaction
• Reduces product malfunctioning and associated risks
• Expands business resources to get global recognition

Procedure to Apply for ISO 13485 Certification through IAS

• Contact IAS by sending the completed ISO 13485 Certification Application Form 
• Prepare your organization ready for ISO 13485 by implementing, practicing, and monitoring the standard’s requirements for continual improvement.
• The process of ISO 13485 certification includes 2 audit stages:

1. Stage 1 Audit: Readiness Audit
2. Stage 2 Audit: Verifying the Effectiveness of the System

• The organization applying for ISO 13485 will be audited based on an extensive sample of its sites, services, process, products & functions.
• If any deviation is observed during the audit, a deviation report will be submitted along with the detailed audit report. According to the grading of the deviations, IAS determines the time required for its closure including the correction and corrective actions which have to be approved by IAS.
• After the effective closure of non-conformities, ISO 13485 certification will be issued by IAS.

Online ISO 13485 Certification Audits by IAS

IAS also conducts ISO 13485 certification audits through the use of online web testing tools. Going through the online test scenarios for your system documentation, as well as testing all policies and other relevant procedures, are among the steps. After the audit is completed successfully, IAS issues ISO 13485 certification confirming that your company is compliant with the relevant ISO 13485 standards.

Why Choose IAS for ISO 13485 Certification?

IAS is a major ISO 13485 Certification body in Vietnam, assisting businesses in assuring the effectiveness of their ISO 13485 quality management system for medical devices by conducting conformity assessments with qualified specialists and experienced auditors. IAS assesses your activities against the requirements of the standard to ensure that you receive ISO 13485 certification in a timely manner.

Contact IAS today to learn more about ISO 13485 Certification, or visit our ISO 13485 Certification frequently asked questions page!