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.
Orion Registrar is accredited for ISO 13485 by the ANSI National Accreditation Board (ANAB).
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.
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.
Then 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.
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Our auditors are professionally qualified with distinguished backgrounds and experience.
Orion Registrar is dedicated to earning your loyalty with our consistent, cost-effective service.
With Orion Registrar, you can customize your certification needs to suit your organization.
We guarantee no application fees, no annual fees, and a fixed price per service for certification
Orion Registrar understands the importance of maintaining impartiality in achieving certification.
Orion Registrar sets a goal to be open, honest, and approachable, working in partnership with clients.
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.
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.
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.
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.
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 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.
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.
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.
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.