WHAT IS ISO 13485?
ISO 13485:2016 is an international standard that specifies the requirements for a Quality Management System (QMS) for organizations involved in the medical device supply chain. The standard is designed to ensure that organizations can consistently provide products and services that meet customer requirements as well as applicable regulatory requirements.
ISO 13485:2016 focuses on risk management, production process control, product traceability, records management, and continual improvement to ensure the safety and effectiveness of medical devices.
WHAT IS ISO 13485 CERTIFICATION?
ISO 13485 certification is evidence that an organization has established, implemented, and effectively maintained a Quality Management System in accordance with the requirements of ISO 13485:2016.
As the medical device industry becomes increasingly regulated, ISO 13485 certification helps organizations enhance their credibility, comply with regulatory requirements, and facilitate the export of medical devices to international markets.
WHICH ORGANIZATIONS NEED ISO 13485 CERTIFICATION?
ISO 13485 certification is suitable for:
✓ Medical device manufacturers
✓ Manufacturers of medical consumables
✓ Medical instrument manufacturers
✓ Manufacturers of diagnostic devices
✓ Medical device distributors
✓ Medical device importers
✓ Medical device assembly companies
✓ Medical device maintenance and servicing providers
✓ Laboratories and testing centers
✓ Suppliers of components for the medical device industry
✓ OEM/ODM companies in the medical device sector
✓ Organizations involved in the medical device supply chain
WHEN SHOULD AN ORGANIZATION OBTAIN ISO 13485 CERTIFICATION?
✓ When establishing a Quality Management System for medical devices
✓ Before manufacturing, trading, or distributing medical devices
✓ To comply with legal and regulatory requirements for the medical device industry
✓ To become a supplier to domestic and international medical device companies and corporations
✓ To expand into international medical device export markets
✓ To enhance quality management capabilities and product risk control
✓ To increase the confidence of customers, hospitals, and regulatory authorities
BENEFITS OF ISO 13485 CERTIFICATION
► Effective Medical Device Quality Control
ISO 13485 helps organizations establish and maintain a Quality Management System specifically designed for medical devices, ensuring that products consistently meet quality, safety, and performance requirements.
► Risk Control Throughout the Entire Product Life Cycle
The standard requires organizations to control risks from the design, manufacturing, storage, and distribution stages through to after-sales service, ensuring the safety and effectiveness of medical devices.
► Compliance with Legal and Regulatory Requirements for the Medical Device Industry
ISO 13485 helps organizations comply with medical device regulatory requirements in Vietnam and many international markets, facilitating product registration and market approval.
► Easier Access to the Medical Device Supply Chain
Many manufacturers, importers, hospitals, and international partners require or give preference to organizations certified to ISO 13485 as evidence of their quality management capability.
► Enhanced Corporate Image and Reputation
ISO 13485 certification provides objective evidence of an organization's commitment to product quality and safety, increasing the confidence of customers, regulatory authorities, and other interested parties.
► Reduced Defects and Nonconformity Costs
Effective control of manufacturing processes, inspection activities, and product traceability helps reduce product defects, minimize corrective costs, and lower the risk of product recalls.
► Improved Access to International Markets
ISO 13485 is widely recognized worldwide and serves as an important foundation for organizations seeking access to medical device export markets with stringent requirements.
► Driving Continual Improvement
Through internal audits, risk management, complaint handling, and management review, organizations are able to continually improve the effectiveness of their Medical Device Quality Management System.
HOW DOES ISO 13485 MAKE A DIFFERENCE?
More than just a certificate, ISO 13485 helps organizations establish a Quality Management System specifically for medical devices, control product risks, comply with regulatory requirements, and enhance competitiveness in both domestic and international markets.
|
Criteria |
Organizations Certified to ISO 13485 |
Organizations Without ISO 13485 |
|
Quality Management System |
Systematically established and controlled |
Relies on individual experience and management practices |
|
Risk Control |
Risks are assessed and controlled throughout the entire product life cycle |
Difficult to identify and manage risks effectively |
|
Regulatory Compliance |
Supports compliance with medical device regulations |
Higher risk of noncompliance |
|
Traceability |
Complete product traceability and record control |
Difficult to identify root causes when incidents occur |
|
Product Quality |
Consistent, stable, and tightly controlled |
Greater risk of defects and nonconformities |
|
Customers and Hospitals |
Increased confidence in product quality and safety |
Difficult to demonstrate quality management capability |
|
Supply Chain |
Easier participation in the medical device supply chain |
More difficult to access major customers and business partners |
|
Export Markets |
Better able to meet the requirements of international markets |
Limited opportunities for market expansion |
|
Complaints and Product Incidents |
Clear procedures for control, corrective action, and improvement |
More likely to respond reactively when incidents occur |
|
Continual Improvement |
Established mechanisms for evaluation and continual improvement |
Lack of data and systematic improvement methods |
ISO 13485 CERTIFICATION PROCESS AT KMRA
The ISO 13485 certification process at KMRA consists of 08 main steps:
Step 1: Certification Application
The organization provides the following information:
- Scope of business activities
- Types of medical devices
- Number of employees
- Locations where the management system is implemented
Step 2: Quality Management System Documentation Review
KMRA reviews the following information:
- Certification scope
- Information related to the medical device quality management system
- Applicable regulatory and legal requirements
- Conditions for conducting the certification audit
Step 3: Stage 1 Audit – Documentation Review and Readiness Assessment
This stage includes:
- Reviewing the QMS documentation
- Evaluating compliance with ISO 13485 requirements
- Assessing the initial implementation of the system
- Identifying issues that need to be addressed before the Stage 2 audit
Step 4: Stage 2 Audit – On-site Implementation Assessment
KMRA evaluates the practical implementation of the Quality Management System to verify conformity with the requirements of ISO 13485.
The audit includes:
- Product design and development process (where applicable)
- Production and quality control processes
- Medical device risk management
- Product traceability
- Document and record control
- Effectiveness of the Quality Management System
Step 5: Certification Review
The audit results are independently reviewed to:
- Ensure impartiality
- Verify compliance with certification requirements
- Make the certification decision
Step 6: ISO 13485 Certification
ISO 13485 certification is granted once the organization has:
- Fulfilled all applicable requirements of the standard; and
- Completed all required corrective actions (if any).
Step 7: Annual Surveillance Audits
During the three-year certification cycle, KMRA conducts periodic surveillance audits to verify that the organization:
- Maintains an effective Medical Device Quality Management System
- Continues to comply with ISO 13485 requirements
- Complies with applicable regulatory requirements
- Continually improves the effectiveness of its quality management system and product quality
Step 8: Recertification
At the end of the three-year certification cycle, the organization undergoes a recertification audit to maintain the validity of its ISO 13485 certificate.
CONTACT KMRA TO RECEIVE A QUOTATION WITHIN 24 HOURS
KMRA will provide advice on the certification scope, audit duration, and certification costs based on your organization's size.
HOW LONG DOES IT TAKE TO ACHIEVE ISO 13485 CERTIFICATION?
The time required to achieve ISO 13485 certification typically ranges from 2 to 6 months, depending on the organization's size, types of medical devices, certification scope, and the readiness level of the Quality Management System.
For most small and medium-sized enterprises, the implementation and certification process usually takes approximately 2–4 months.
|
Organization Size |
Reference Timeline |
|
Fewer than 50 employees |
2–4 months |
|
50–200 employees |
3–6 months |
|
More than 200 employees |
4–8 months |
The actual certification timeline depends on the maturity level of the Medical Device Quality Management System, the ability to meet applicable regulatory requirements, and the organization's readiness before the certification audit.
Factors affecting the ISO 13485 certification timeline include:
- Level of completeness of quality system documentation and records.
- Type of medical devices and product complexity.
- Applicable medical device regulatory and legal requirements.
- Risk management activities and product quality control.
- Number of employees and implementation locations.
- Results of internal audits and corrective actions for nonconformities.
- Coordination and cooperation progress between the organization and the certification body.
Organizations that already have a quality management system, controlled production processes, and complete technical documentation can significantly shorten the implementation and certification period.
Conversely, organizations that have not established a document system, have not implemented risk management, or have not fully met medical device regulatory requirements will need additional time to complete the system and train personnel.
In addition, a broader certification scope, multiple implementation sites, or products requiring stricter regulatory control may extend the preparation and audit timeline.
KEY HIGHLIGHTS
- 10+ years of experience in assessment and certification activities in Vietnam.
- 1,000+ organizations have been assessed and certified through various certification and conformity assessment programs.
- 100+ auditors and trainers.
- 100+ standards and assessment/training programs across multiple industries.
CERTIFIED CLIENTS
More than 1,000+ organizations have placed their trust in KMRA.
Typical industries applying ISO 13485 include:
- Medical device manufacturing
- Medical device import and distribution
- Diagnostic and testing equipment
- Dental equipment
- Orthopedic and rehabilitation equipment
- Medical consumables
- Medical electronic devices
- Surgical and healthcare equipment
- Packaging and components for medical devices
- Medical device outsourcing services
- Biotechnology and medical technology
- Organizations within the medical device supply chain
FREQUENTLY ASKED QUESTIONS (FAQ)
1. How long is an ISO 13485 certificate valid?
An ISO 13485 certificate is valid for 3 years from the date of issuance. During this period, organizations must undergo periodic surveillance audits to maintain certification validity.
2. Is ISO 13485 certification internationally recognized?
Yes. ISO 13485 is an international standard for Quality Management Systems specifically designed for medical devices and is widely recognized and applied worldwide. The recognition of certification depends on the accreditation system and requirements of each market.
3. Which organizations should apply ISO 13485?
ISO 13485 is suitable for organizations involved in the medical device supply chain, including manufacturers, importers, distributors, outsourcing companies, component suppliers, material suppliers, and organizations providing related medical device services.
4. Is hiring an ISO consulting organization mandatory?
No. Organizations can independently develop and implement an ISO 13485 Quality Management System if they have sufficient resources and technical expertise.
5. If nonconformities are identified, can certification still be granted?
Yes, it is possible. The organization must implement corrective actions and demonstrate their effectiveness before the certification body makes the certification decision.
6. What is a surveillance audit?
A surveillance audit is a periodic assessment conducted during the certification cycle to verify that the organization continues to maintain and effectively implement its Medical Device Quality Management System.
7. Is recertification required after 3 years?
Yes. At the end of the certification cycle, the organization must undergo a recertification audit to maintain the validity of the ISO 13485 certificate.
8. Can an ISO 13485 certificate be suspended or withdrawn?
Yes. The certificate may be suspended or withdrawn if the organization fails to maintain conformity of its Quality Management System or does not meet surveillance requirements.
9. Who performs ISO 13485 certification audits?
Certification audits are performed by qualified auditors with appropriate competence in the medical device sector and appointed by the certification body according to the applicable certification process.
10. Does ISO 13485 replace legal requirements for medical devices?
No. ISO 13485 does not replace legal requirements. Organizations must still comply with applicable regulations related to medical device management, registration, manufacturing, import, and distribution in relevant markets.
11. What is the difference between ISO 13485 and ISO 9001?
ISO 9001 is a Quality Management System standard applicable to all industries, while ISO 13485 is specifically developed for the medical device sector, with additional requirements related to risk management, traceability, technical documentation control, and regulatory compliance.
12. Does ISO 13485 certification support medical device export?
Yes. ISO 13485 is considered an important foundation for accessing many international markets and is often a requirement or competitive advantage when working with international partners, importers, and regulatory authorities.
13. Can medical device trading or distribution companies achieve ISO 13485 certification?
Yes. ISO 13485 applies not only to manufacturers but also to organizations involved in importing, distributing, maintaining, installing, or providing services related to medical devices if these activities are included within the scope of the Quality Management System.
14. What is the greatest value of ISO 13485?
The core value of ISO 13485 is not only the certificate itself, but the establishment of a specialized Quality Management System for medical devices, helping organizations control risks, ensure product quality, meet regulatory requirements, and enhance customer and regulatory confidence.
15. Is ISO 13485 mandatory for medical device companies?
It depends on the requirements of each country, customer, or medical device regulatory program. In many cases, ISO 13485 is an important or almost mandatory requirement to demonstrate quality management capability in the medical device industry.
16. Can newly established companies apply ISO 13485?
Yes. Building an ISO 13485 Quality Management System from the early stages helps organizations standardize operations, meet regulatory requirements, and create a strong foundation for product development and future market expansion.
KMRA – ISO 13485 CERTIFICATION PARTNER FOR MEDICAL DEVICE ORGANIZATIONS
KMRA is developed based on more than 10 years of experience in management system assessment and certification activities in Vietnam.
We support organizations involved in medical device manufacturing, importing, distribution, and related services in establishing Quality Management Systems according to ISO 13485, meeting regulatory requirements, improving product quality, and enhancing competitiveness in the market.
With a team of experienced experts in the medical device sector, KMRA accompanies organizations in risk control, meeting customer requirements, regulatory expectations, and international market requirements.
RECEIVE AN ISO 13485 CERTIFICATION QUOTATION FROM KMRA WITHIN 24 HOURS
Contact KMRA for consultation on certification scope, audit duration, and certification costs suitable for your organization's size, medical device type, and operational scope.
