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ISO 13485

Medical Devices

ISO 13485 is the internationally recognized global standard for quality management for medical devices. It shows your commitment to the quality management of medical devices and related services in the medical industry.

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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, which provides 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.

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

what is iso 13485

What Are the Benefits of ISO 13485?

improved quality management - ISO 13485

Improved Quality
Management

customer satisfaction - ISO 13485

Enhanced Customer
Satisfaction

Strong Internal Processes - ISO 27001

Employee
Engagement

better decision making - ISO 13485

Better
Decision-Making

consistency standardisation - ISO 9001

Consistency &
Standardization

increased efficiency - ISO 27001

Increased
Efficiency

Improved reputation - ISO 13485

Continuous
Improvement Culture

regulatory compliance - ISO 45001

Regulatory
Compliance

Risk Management - ISO 13485

Risk
Management

Strong Supplier Relationships - ISO 13485

Strong Supplier
Relationships

Global Recognition - ISO 13485

Global
Recognition

Market competitive advantage - ISO 13485

Market &
Competitive Advantage

Key Requirements of ISO 13485

The ISO 13485 standard outlines a number of requirements that organizations must meet to demonstrate their commitment to quality. These include:

tick-icon - ISO 9001

Customer focus

Organizations need to show an understanding of how to meet their customers’ needs and expectations while striving to enhance customer satisfaction.

tick-icon - ISO 9001

Continual improvement

Regular assessments are required to improve the effectiveness of a QMS to achieve better results and enhance performance. These should be both internal and external assessments.

tick-icon - ISO 9001

Leadership

Senior leaders and top management need to provide strong guidance and commitment to the QMS in place, promoting a culture of quality throughout the organization.

tick-icon - ISO 9001

Evidence-based decision making

Informed decisions should be made based on the analysis and evaluation of data and information within the organization, to enhance overall quality.

tick-icon - ISO 9001

Process approach

To achieve the desired outcomes and improve their overall performance, an organization should identify, understand and manage its processes and procedures.

tick-icon - ISO 9001

Relationship management

As well as internal processes and procedures meeting the quality standard, a focus should be put on establishing and managing strong relationships with high-quality suppliers, partners and stakeholders.

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 Amtivo’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.

How to become certified

Why You Should Choose Amtivo

Our team of experts are with you every step of your certification journey.
 
  • Our accreditation by ANAB guarantees that your ISO certificate will be recognized worldwide
  • Our US-based team will provide solutions to suit your individual needs
  • Our auditors are qualified, experienced and experts within their field
  • We have no hidden costs and do not charge admin or registration fees
  • We offer flexible contracts so you are not tied in
  • 94% of Amtivo clients have said they are ‘likely’ or ‘very likely’ to recommend us
  • We are open, honest, and approachable – we work in partnership with our clients
why choose amtivo - ISO 9001

The ISO 13485 Certification Journey

Get in touch for a free quote from one of our experienced team to get your ISO 13485 certification journey underway. Our quotes will reflect your organization's specific requirements.

STEP 1
STEP 2
STEP 3
STEP 4
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.

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.

In-Depth Review

When you are ready, an auditor will conduct a “Stage two assessment” to establish if your organization meets the standard’s requirements. We review 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.

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.

The ISO 13485 Certification Journey

Get in touch for a free quote from one of our experienced team to get your ISO 13485 certification journey underway. Our quotes will reflect your organization's specific requirements.

STEP 1
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 2
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 3
In-Depth Review

When you are ready, an auditor will conduct a “Stage two assessment” to establish if your organization meets the standard’s requirements. We review 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.

STEP 4
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.

Free ISO Certification Software

Available from Q4 2024

  • Available for ISO 9001, ISO 14001, ISO 27001 and ISO 45001.
  • Detailed user guides and videos explain the requirements of the standard
  • No ISO experience necessary – simply follow step-by-step instructions
  • Built-in templates are easy-to-follow and personalize for your business
  • Store, link to, and manage important documentation all in one place
  • Track your progress and identify important actions
  • Simplify the auditing process through easy access to critical information
iso certification software

ISO 13485 FAQs

What is ISO 13485:2016 and why was it revised?

The ISO 13485:2016 revision was launched on 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 determine whether a revision is required to keep them current and relevant to 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.

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 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 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.

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