ISO 13485:2016 Medical Device Quality Management System Certification

ISO 13485:2016 Certification ensures quality, safety, and regulatory compliance for medical devices while improving efficiency and global market access.

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WHAT IS ISO 13485:2016?

Ensure Quality Across Medical Device Lifestyle

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ISO 13485:2016 is the internationally recognized standard that defines quality management requirements for the medical device industry. It enables organizations to demonstrate their ability to design, manufacture, and deliver safe and reliable medical devices that meet strict regulatory and customer expectations. The certification applies to all stages of the device lifecycle, including design, production, storage, distribution, installation, and servicing, as well as to suppliers and service providers who support these activities.
Achieving ISO 13485:2016 certification shows a clear commitment to compliance, patient safety, and continuous improvement. It helps organizations strengthen process control, reduce risks, and ensure product consistency across global markets. By aligning operations with this standard, companies build trust with regulators and healthcare professionals while gaining a strong competitive advantage in the international medical device industry.
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WHY GET ISO 13485:2016 CERTIFIED?

Advance Your Business With Trusted Quality Management

Ensure Legal Compliance

Demonstrate that your quality management system fully meets international medical device regulations and standards.

Strengthen Brand Image

Build trust and credibility by proving your commitment to consistent quality and patient safety.

Enhance Customer Satisfaction

Understand customer needs, exceed expectations, and deliver reliable products that improve confidence and loyalty.

Improve Processes and Efficiency

Identify inefficiencies, reduce errors, and eliminate rework to achieve smoother, more effective operations.

Gain Competitive Advantage

Showcase certification to enter new markets, stand out from competitors, and boost your organization’s reputation.

Increase Employee Engagement

Empower employees through clear roles, stronger accountability, and a shared focus on delivering quality outcomes.

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HOW TO GET ISO 13485:2016 CERTIFIED?

Step By Step ISO 13485 Certification Process

Follow a clear, structured path to achieve and maintain ISO 13485 certification.

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Step 1 – Application

Submit your application for ISO 13485:2016 certification. Our team reviews your organization’s details, scope, and readiness to implement the Medical Devices Quality Management System.

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Step 2 – Offer Submission

After understanding your operations and product scope, IRQS prepares a tailored proposal outlining audit timelines, certification stages, and associated costs.

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Step 3 – Offer Acceptance

Once you approve the proposal, a formal agreement is signed between your organization and IRQS, confirming the audit plan and certification schedule.

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Step 4 – Certification Audit

IRQS conducts a two-stage audit.

Stage 1: Review of documentation, system structure, and readiness in line with ISO 13485 requirements.

Stage 2: On-site assessment to verify implementation effectiveness, process control, and regulatory compliance within the quality management system.

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Step 5 – Certification Approval

After successful completion of the audit and closure of any nonconformities, IRQS issues the Certificate of Approval, confirming compliance with ISO 13485:2016 requirements.

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Step 6 – Surveillance Audits

Annual surveillance audits ensure that your Medical Devices Quality Management System continues to meet ISO 13485 requirements and demonstrates continual improvement.

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Step 7 – Recertification

Every 3 years, a recertification audit is conducted to renew your certification and confirm sustained compliance with the latest ISO 13485:2016 standard.

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HOW TO GET ISO 13485:2016 CERTIFIED?

Step By Step ISO 13485 Certification Process

Follow a clear, structured path to achieve and maintain ISO 13485 certification.

Step 1 – Application
Step 1 – Application
Submit your application for ISO 13485:2016 certification. Our team reviews your organization’s details, scope, and readiness to implement the Medical Devices Quality Management System.
Step 2 – Offer Submission
Step 2 – Offer Submission
After understanding your operations and product scope, IRQS prepares a tailored proposal outlining audit timelines, certification stages, and associated costs.
Step 3 – Offer Acceptance
Step 3 – Offer Acceptance
Once you approve the proposal, a formal agreement is signed between your organization and IRQS, confirming the audit plan and certification schedule.
Step 4 – Certification Audit
Step 4 – Certification Audit
IRQS conducts a two-stage audit:
  • Stage 1: Review of documentation, system structure, and readiness in line with ISO 13485 requirements.
  • Stage 2: On-site assessment to verify implementation effectiveness, process control, and regulatory compliance within the quality management system.
Step 5 – Certification Approval
Step 5 – Certification Approval
After successful completion of the audit and closure of any nonconformities, IRQS issues the Certificate of Approval, confirming compliance with ISO 13485:2016 requirements.
Step 6 – Surveillance Audits
Step 6 – Surveillance Audits
Annual surveillance audits ensure that your Medical Devices Quality Management System continues to meet ISO 13485 requirements and demonstrates continual improvement.
Step 7 – Recertification
Step 7 – Recertification
Every 3 years, a recertification audit is conducted to renew your certification and confirm sustained compliance with the latest ISO 13485:2016 standard.
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TAKE A CLOSE LOOK AT ISO 13485:2016

Start Your ISO 13485:2016 Certification Journey

Considering ISO 13485:2016 but unsure where to start? This guide explains the certification process, key requirements and how the standard improves compliance, product quality and customer trust.
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What Our Learner Say

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“IRQS delivered a structured and impartial audit experience, helping us validate our medical device quality system. Their certification added credibility without offering consultancy.”
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“The auditors demonstrated strong expertise in ISO 13485 and guided us through a transparent assessment process. Their approach reinforced our confidence in compliance readiness.”
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“IRQS conducted a rigorous yet fair evaluation of our QMS. Their independent certification enhanced stakeholder trust in our medical device processes.”
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“The audit process was professional and well-coordinated. IRQS helped us understand our maturity level while maintaining full neutrality.”
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“IRQS’s clear audit methodology and objective reporting strengthened our assurance in quality management. Their certification brought value without any conflict of interest.”
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“We appreciated the competence and independence of IRQS auditors. Their certification reinforced the credibility of our systems in a regulated healthcare environment.”
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ADVANCE YOUR EXPERTISE WITH ISO 13485:2016 Certification

Learn from Experts. Strengthen Your Skills

Build expertise with ISO 13485 training to implement and audit medical device Quality Management Systems. Strengthen compliance, improve product quality and enhance patient safety.

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Frequently Asked Questions

Quick Guide to ISO 13485:2016 Certification

ISO 13485:2016 is the global quality management standard for the medical device industry. It defines the systems and processes needed to design, manufacture, and deliver medical devices that are safe, reliable, and meet regulatory expectations. This certification helps organizations maintain consistent product quality and patient safety.

Any organization involved in the medical device lifecycle can benefit from this certification, including manufacturers, suppliers, distributors, and service providers supporting design, production, installation, or maintenance.

It demonstrates a strong commitment to quality and patient safety, ensuring compliance with international regulations. The certification reduces risks, improves operational efficiency, and builds trust with regulators, customers, and healthcare professionals.

While ISO 9001 applies to general quality management, ISO 13485 is tailored specifically for medical device manufacturing. It places greater emphasis on regulatory compliance, risk management, and traceability throughout the product lifecycle.

Although ISO 13485 certification is technically voluntary, it has become a practical requirement in many markets. Regulatory authorities and clients often expect certified systems as a condition for approvals and partnerships, making it essential for global market access.

ISO 13485 requires organizations to establish a documented quality management system that defines clear policies and procedures for every stage of the medical device lifecycle. Key requirements include risk management, product realization, traceability, regulatory compliance, internal audits, and continuous improvement to ensure safety and reliability.

The certification process usually takes between three and six months, depending on the size of the organization, system maturity, and the complexity of its medical device operations.

Once achieved, ISO 13485 certification remains valid for three years. During this period, annual surveillance audits are conducted to verify ongoing compliance with the standard’s requirements.

No. Holding ISO 13485 certification does not exempt a company from FDA inspections or other regulatory audits. However, it can help demonstrate robust quality management and streamline the inspection process.

IRQS provides comprehensive support throughout the ISO 13485 certification journey. Its experienced auditors and industry specialists guide organizations through every stage—from gap analysis and system implementation to audit preparation and certification. IRQS helps ensure full compliance with international regulatory requirements, strengthens quality processes, and promotes continuous improvement in safety and performance across the medical device lifecycle.

Get Certified with Confidence!

Start your journey today with trusted experts in certification, assurance and training who make the process simple seamless and stress free.

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