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The ISO 13485:2016 revision was launched on March 1, 2016, and the 2003 version certificate was no longer valid as of March 1, 2019.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