ISO 13485
Medical Devices

ISO 13485 shows your commitment to the quality management of medical devices and related services in the medical industry.

  • Demonstrate compliance.
  • Build client confidence.
  • Access markets and tenders.
  • Realize cost savings.


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What is ISO 13485?

ISO 13485 is a global standard set by the International Organization for Standardization (ISO) that establishes a Quality Management System (QMS) for the medical industry providing medical devices and related services.

The standard ensures organizations consistently meet clients and applicable regulatory requirements. It offers a framework for quality design, manufacture, and installation of medical devices worldwide.

ISO 13485 helps organizations meet medical regulations to demonstrate their commitment to high-quality products and efficient services.

Find out about the benefits of ISO 13485, the certification journey, FAQs and more, below.

Orion Registrar is accredited for ISO 13485 by the ANSI National Accreditation Board (ANAB).

ISO 13485 Medical devices – Group of ventilator machines

Benefits of ISO 13485

Implementing a QMS for medical devices is beneficial for organizations, large and small, that specialize in the medical device industry.

ISO 13485 certification enables medical device businesses to prove their commitment to excellence, whether it’s associated with developing, producing or installing medical devices.

The medical appliance industry comprises a complex range of regulatory systems and international standards, so your organization must consistently deliver safe and effective devices.

Achieving ISO 13485 certification helps prevent risks associated with poor-quality design, products or services.

ISO 13485 helps build and retain client confidence and satisfaction and mandates a process of continuous improvement, helping businesses increase efficiencies and reduce costs.

To gain potential new business within the medical device sector, ISO 13485 certification can also be obtained by non-medical device companies, such as organizations throughout the supply chain.

  • Improve detection of manufacture faults.
  • Build client trust and satisfaction.
  • Enhance supply chain quality and reliability.
  • Boost production quality and reduce waste.
  • Meet medical safety standards.
  • Gain competitive advantage.
  • Exceed client requirements.
ISO 13485 Medical devices - carrying out audit

How to Become Certified

It’s an easy process to become ISO 13485 certified.

Implementing a QMS is the pivotal step to achieving ISO 13485 accreditation for your organization.

Once established, an ISO 13485 certification audit will take place, and Orion’s knowledgeable auditors will assess whether your organization complies with ISO 13485 requirements through an assessment of your QMS.

If your business meets the requirements for the international standard, you will be issued with ISO 13485 certification.

This certification is yours to promote to clients and business partners to illustrate your commitment to producing safe and efficient medical equipment.

Want to learn more? Learn about the ISO Standards For Medical Devices.

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Why You Should Choose Orion

Why Choose Orion

ANAB Accredited

Our certificates are ANSI National Accreditation Board (ANAB) accredited, which are recognized and accepted, worldwide.

Qualified Expertise

Our auditors are professionally qualified with distinguished backgrounds and experience.

Cost-Effective Service

Orion Registrar is dedicated to earning your loyalty with our consistent, cost-effective service.

Customized Approach

With Orion Registrar, you can customize your certification needs to suit your organization.

Fixed Price Guarantee

We guarantee no application fees, no annual fees, and a fixed price per service for certification.

Contract Flexibility

You are not tied in with Orion, provided you cancel your agreement at least 4 weeks ahead of your pre-booked assessment date.

High Quality Service

94% of Orion clients have said they are ‘likely’ or ‘very likely’ to recommend us.

Impartial Certification

Orion Registrar understands the importance of maintaining impartiality in achieving certification.

On Your Side

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The ISO 13485 Certification Journey

Get in touch for a free quote from one of our experienced team to get your ISO certification journey underway. Our quotes reflect your organization's specific requirements.

Help You Prepare

Our team will get in touch to outline the process and explain the plan for your initial assessment. We can also signpost you to any resources that you might find useful on your journey to becoming certified.


Step One – Identify Gaps

Referred to as a “Stage one assessment”, our auditor will conduct an initial review of your management system to determine if the core requirements of the standard are being met. We will provide a detailed report outlining the areas you need to focus on in order to comply with the requirements.


Step Two – In-Depth Review

When you are ready, an auditor will conduct a “Stage two assessment” to establish if your organisation meets the requirements of the standard. We review any actions taken to address findings raised at Stage one and our auditor will make a recommendation as to whether certification can be issued, based on the audit outcomes.

Please note: It is typical for gaps to be identified during the audit, which will need to be addressed through corrective actions before certification can be approved.

Step Three – Certification Issued

Following a review by our Compliance Team, a decision will be made as to whether your certification can be issued.

For more details about the certification process please click here.

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ISO 13485 FAQs

How Long Does the ISO 13485 Certification Last?

ISO 13485 certification expires three years after certification and will need to be renewed. Your organization will need to undergo a reassessment audit to obtain the standard for an additional three years.

Compulsory audits will be conducted annually to ensure your organization maintains QMS standards.

What are the Requirements for ISO 13485?

Unless explicitly stated otherwise, ISO 13485 contains requirements essential for any organization operating at any rank in the medical device and pharmaceutical field, including design, manufacture, fitting, storage, progress, and service.

The requirements may alter based on the type of medical device, whether it be low-level devices such as bandages and non-electric wheelchairs to more high-level devices like pacemakers and infusion pumps.

How Can ISO 13485 Help Grow My Business?

ISO 13485 can help your business grow in custom and attain new tenders. By implementing ISO 13485, you will be confident knowing all medical devices have traceability, identification, risk assessment, and meet cleanliness requirements.

An ISO 13485 accreditation will help medical device manufacturers feel confident working with such devices and services.

What Is ISO 13485:2016 and Why Was It Revised?

The ISO 13485:2016 revision was launched March 1, 2016, and the 2003 version certificate was no longer valid as of March 1, 2019.

All ISO standards are reviewed every five years to establish if a revision is required to keep them current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including technological changes, regulatory requirements, and expectations.

What are the key improvements? The new version emphasizes risk management and risk-based decision-making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.

Get Started on Your Certification Journey Now

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