ISO 13485:2016
COMPREHENSIVE QUALITY MANAGEMENT STANDARD FOR THE MEDICAL DEVICE INDUSTRY
Trusted by over 27,000 organizations worldwide, ISO 13485 enables medical device companies to elevate operational standards, ensure product safety, and strengthen trust with international partners.
TIGHTENING MARKET
ORGANIZATIONS MUST STANDARDIZE
As regulatory requirements and inspections become increasingly stringent, ISO 13485:2016 has become a mandatory standard for medical device companies to ensure compliance and eligibility for participation in the international supply chain.
Europe (EU): Serves as the primary basis for obtaining the CE mark under the MDR regulations.
United States (FDA): ISO 13485 is directly integrated into the national QMS system.
MDSAP: Canada, Japan, Australia, Brazil, and the US only accept organizations with internationally recognized ISO 13485 certification.
ISO 13485 demonstrates operational competence according to international standards – providing a solid foundation for medical device companies to expand their markets legally, safely, and sustainably.
WHY ISO 13485:2016 IS MANDATORY IN THE MEDICAL DEVICE INDUSTRY
ISO 13485 is a core management standard that enables medical device companies to control risks and maintain quality throughout the entire product lifecycle.
This standard establishes a closed-loop operational system, ensuring that every stage – from design and manufacturing to distribution – is scientifically controlled and transparently traceable.
Beyond being a regulatory requirement, ISO 13485 shapes management thinking based on prevention and social responsibility – providing a foundation for organizations to build sustainable trust with regulators, partners, and end-users.
Risk prevention from the outset
Specialized quality system for medical devices
Foundation for building sustainable trust
WHICH ORGANISATIONS ARE REQUIRED
TO OBTAIN ISO 13485:2016 CERTIFICATION?
This standard applies not only to manufacturers but also to the entire medical device supply chain, including:
ARES VIETNAM – ISO 13485:2016 CERTIFICATION PARTNER
GLOBALLY RECOGNIZED
As an internationally accredited consulting and certification body, ARES Vietnam provides comprehensive support to organizations throughout the entire journey of establishing, operating, and maintaining an ISO 13485 system in a practical and effective manner.
3 Reasons to Choose ARES Vietnam
CAPABILITIES OF THEARES VIETNAM CERTIFICATION BODY
We are proud to be an internationally accredited certification body, recognised by leading global authorities in the field of management system assessment and certification
This recognition serves as proof of:
Strong professional expertise
Transparent and independent assessment activities
And the international legal validity of certifications issued by ARES Vietnam
The United Kingdom’s national accreditation body, representing global trust in the field of certification
Taiwan’s national accreditation body, supporting certification activities in compliance with international standards
The U.S. accreditation body, an IAF member, ensuring the global validity of certifications
EXPERT TEAM - THE FOUNDATION FOR DIFFERENCE
Bringing together experienced experts, internationally trained and accredited, ARES Vietnam is committed to supporting organisations on their journey toward standardisation and sustainable development
ISO 13485:2016 CERTIFICATION PROCESS
AT ARES VIETNAM
A 6-step standardised process, accompanying organisations from consulting to certification
CONTACT ARES VIETNAM
Please contact ARES Vietnam via our hotline or official social media channels
RECEIVING REQUIREMENTS
Based on the information provided by the organisation, we prepare a quotation and sign a contract
CONDUCT ASSESSMENT
Assess the current system and propose adjustments to operational processes
SUPERVISING EXPERT
Support organisations in addressing non-conformities to ensure compliance with assessment requirements
CERTIFICATION ISSUANCE
Organisations that meet the requirements will be granted certification through ARES Vietnam’s recommendation to the certification body
REASSESSMENT
During the 3-year validity period, annual surveillance must be conducted to maintain the certification
SAMPLE ISO 13485:2016 CERTIFICATE
ISSUED BY ARES VIETNAM
ISO 13485:2016 certificates issued by ARES Vietnam bear the IAS and IAF marks – guaranteeing their value and global recognition
*Illustrative image of an ISO 13485:2016 certificate issued by ARES Vietnam
FREQUENTLY ASKED QUESTIONS ABOUT ISO 13485:2016 CERTIFICATION
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Is ISO 13485:2016 certification mandatory for device commercialization?
Not always mandatory, but ISO 13485 is often a prerequisite for medical device registration in many countries – especially for higher-risk products classified as Class B, C, or D.
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Can ISO 13485:2016 replace CE or FDA approval?
No. ISO 13485 provides a quality management system framework that supports compliance with the technical requirements of CE (Europe) and FDA (USA), but it does not replace the legal approval processes of individual markets.
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Can ISO 9001 be used instead of ISO 13485 in the medical device industry?
No. ISO 13485 is specifically designed for medical devices, with specialized requirements for safety, traceability, and risk management – significantly more stringent than ISO 9001.
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Do distributors who do not manufacture need ISO 13485:2016?
Yes. Medical device distributors – particularly those involved in importing, relabeling, or maintaining products – require a quality management system compliant with ISO 13485 to meet regulatory requirements and satisfy international partners.
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Is the certification and recertification process complicated?
Recertification does not require starting from scratch, but the system undergoes a comprehensive assessment to ensure continued suitability, validity, and compliance with new requirements (if any). Continuous improvement facilitates a smooth recertification process.
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What is the cost of ISO 13485:2016 certification?
Costs depend on the organization’s size, number of sites, and current system status. ARES Vietnam will conduct an on-site assessment and provide a transparent, tailored quotation – ensuring an optimized roadmap for each organization.
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How long does it usually take to implement ISO 13485:2016?
Depending on readiness, organizations can complete the system and obtain certification in 2–5 months. ARES Vietnam provides full support to shorten implementation time and optimize resources.
EXCLUSIVE OFFERS FOR BUSINESSES
ISO 13485:2016 CERTIFICATION
With practical incentive policies, ARES Vietnam supports medical device companies in implementing ISO 13485:2016 quickly, cost-effectively, and sustainably.
- Certification fee reduction for organisations implementing ISO for the first time
- Special incentives for registration integrating two or more standards
- Receive 10 Internal Auditor Certificates
- Free Pre-audit Consultation – Reviewing the System Prior to Assessment
- Priority scheduling for early assessment and support for fast certificate issuance
*Service incentives applicable to organisations registering via the Website
