Benefits of Achieving ISO 13485 Certification?
Achieving ISO 13485 certification can help your company open doors to untapped domestic and international business opportunities and reap benefits from:
- Expanded Market Access – National regulatory authorities require or prefer third-party audited and certified quality management systems for manufacturers marketing medical products in their countries. Investing in such a system accelerates access to those countries and facilitates market entry into others.
- Reduced Sales Costs – Your certification establishes your company’s credibility and commitment to quality. Explaining specific details and demonstrating the effectiveness of your quality system becomes easier, reducing the time needed to gain the trust and confidence of potential customers.
- Improved Performance – Based on a unified and widely accepted process control system, your certified quality management system will help improve your products and processes. This can foster better relationships with suppliers, business partners, and customers, giving you a real market advantage.
Competence of the Certification Organization GOOD VIỆT NAM
|
OPERATIONAL COMPETENCE DESIGNATED BY
THE MINISTRY OF SCIENCE AND TECHNOLOGY
|
COMPETENCE RECOGNITION BY BOA – IAF ACCREDITATION FORUM
INTERNATIONAL CERTIFICATION
|
 50+ EXPERTS NATIONWIDE
BRANCHES IN ALL THREE REGIONS
|
MULTI-SECTOR CERTIFICATION SERVICES
|
With the motto “Fast – Standardized – Friendly and Professional”: GOODVN always aims to minimize delays in the certification process to ensure businesses receive the ISO 13485 certificate as quickly as possible while fully complying with certification standards and procedures.
ISO 13485 Certification Process at Good Việt Nam
The certification process by GOODVN follows the steps below. These steps ensure that certification is objective and compliant with the standard’s requirements.
Step 1: Information Exchange Between Customer and GOODVN
The purpose of exchanging information between the certification organization and the customer is to ensure agreement on the previously discussed information. This exchange ensures that the certification assessment aligns with the standard’s and customer’s requirements.
Step 2: Preliminary Assessment and Review of ISO 13485 Documents
– The business submits to GOODVN: Certification application, plans, documents, and records related to ISO 13485:2016 implementation.
– GOODVN assigns experts in the relevant field to assess the actual status of ISO 13485 documents. Document assessment identifies any non-conformities with the requirements. After the preliminary review, experts must point out non-conformities for the business to address promptly. This preliminary assessment is highly beneficial as it serves as a guide for the formal assessment.
– ISO 13485:2016 documents will be evaluated for compliance with relevant laws and standards, specifically:
+ Reviewing the system’s compliance with standard requirements;
+ Reviewing compliance with legal and regulatory requirements.
+ Other documents and records related to management processes.
– After the formal review and assessment of documents and records, GOODVN’s assessors must prepare a report on the documents and provide a copy to the business.
– The business, upon receiving the document assessment report, is responsible for reviewing and correcting any issues.
Step 3: Formal Assessment and On-Site Verification
– The assessment team conducts on-site verification, reviewing the compliance of documents with reality and recommending corrections for any non-conformities.
– During the on-site certification audit, the effectiveness of the ISO 13485:2016 system is evaluated.
– The business must present documents, records, and the implementation of a system compliant with ISO 13485:2016.
– At the end of the on-site audit, the assessment team holds a closing meeting where the business can provide feedback on the findings.
Step 4: Document Review and Issuance of ISO 13485 Certificate
– The organization is issued a certificate if all documents are compliant with reality and all non-conformities have been satisfactorily addressed, as confirmed by the lead assessor.
– GOODVN will issue the certificate to the customer. The certificate is valid for 3 years.
Step 5: Periodic Monitoring of ISO 13485 Standard
The ISO 13485:2016 certificate is valid for 3 years. Annually, to maintain the certificate’s validity, the certification organization must conduct mandatory “surveillance assessments” as per legal requirements, at least once every 12 months.
Surveillance assessments evaluate compliance with and maintenance of the ISO 13485:2016 standard’s requirements.
Step 6: Recertification Assessment for ISO 13485
Upon the expiration of the initial 3-year certificate, the certification organization conducts a recertification assessment to issue a new certificate valid for another 3 years.
The recertification assessment follows the same evaluation procedures as the initial assessment.
Why Choose ISO 13485 Certification Services at Good Việt Nam
-
GOOD VIỆT NAM directly issues ISO 13485:2016 certificates valid nationwide.
-
GOOD VIỆT NAM is a reputable organization with a team of experts with over 10 years of experience and high competence, guiding and supporting customers until they receive the certificate.
- Hundreds of major customers nationwide, such as BONA Export Co., Ltd. and Rạn Biển Seafood Restaurant Co., Ltd., have been assessed and certified with ISO 13485:2016 by GOOD VIỆT NAM.
- The cost of conducting the assessment and certification process is always at the most competitive level.
- Maximum support to ensure businesses receive the ISO 13485:2016 certificate in the shortest time (only 1 week if the business meets the conditions).
The ISO 13485 certification standard emphasizes harmonizing quality management system requirements with regulatory requirements for the medical device industry. The ISO 13485 certification standard is widely accepted and applied by medical device manufacturers worldwide and is a necessary requirement today for organizations producing medical devices to have their products recognized globally.
ISO 13485 CERTIFICATION ORGANIZATION | GOODVN
 |
The National Certification Office – GOOD Việt Nam is an ISO 13485 certification organization licensed and designated by the Ministry of Science and Technology.
The ISO 13485 certification process, as well as other ISO certifications by GOODVN, complies with legal regulations and the rules of the International Organization for Standardization (ISO).
|
|
|
The ISO 13485 certificate issued directly by GOODVN is valid nationwide through its logo and certification mark.
Modern certificate with 4.0 technology
With the motto “One assessment -> One certificate -> Accepted everywhere” and following the 4.0 technology trend, GOODVN is a certification organization in Vietnam that establishes a certificate traceability system via QR code. This ensures that all customers and their partners can verify the certificate’s validity through a QR code scanning app on smartphones linked to GOODVN’s customer lookup system on their website. This promotes transparency and accessibility of the certificate’s value anytime, anywhere.
|
- Good Việt Nam’s certification is recognized nationwide.
- A network of branches across all three regions ensures responsiveness to business needs anytime, anywhere.
- Good Việt Nam guarantees fast assessment and certification timelines while fully complying with ISO/IEC standards.
- Good Việt Nam’s customers always receive the most competitive costs.
- A team of highly competent experts with over 10 years of experience, providing dedicated and professional consulting support.
