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 1 Assessment”, our auditor will conduct an initial review of your management system to determine your readiness for the certification audit, known as the “Stage 2 Assessment”. The Stage 1 Assessment will include reviews of the management system documentation and allocation of resources. It will also determine if management reviews, and internal audit processes are established and confirm the appropriate scope of the management system.
Gaps in your system will be documented as “Areas of Concern” that should be addressed prior to the Stage 2 Assessment.
When you are ready, an auditor will conduct a “Stage 2 Assessment” to establish if your organization meets the standard’s requirements. This is an in-depth review of each of your processes to verify the implementation and effectiveness of the management system. Where requirements are not met, the auditor will issue a nonconformity.
Nonconformities must be addressed prior to certification being granted. Once the responses for nonconformities are accepted, the auditor can recommend certification.
Following a review by our Compliance Team, a decision will be made as to whether your certification can be issued. Once certification is granted, we will conduct audits at least annually to ensure continued conformance to the requirements of the standard.
For more details about the certification process please click here.
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 1 Assessment”, our auditor will conduct an initial review of your management system to determine your readiness for the certification audit, known as the “Stage 2 Assessment”. The Stage 1 Assessment will include reviews of the management system documentation and allocation of resources. It will also determine if management reviews, and internal audit processes are established and confirm the appropriate scope of the management system.
Gaps in your system will be documented as “Areas of Concern” that should be addressed prior to the Stage 2 Assessment.
When you are ready, an auditor will conduct a “Stage 2 Assessment” to establish if your organization meets the standard’s requirements. This is an in-depth review of each of your processes to verify the implementation and effectiveness of the management system. Where requirements are not met, the auditor will issue a nonconformity.
Nonconformities must be addressed prior to certification being granted. Once the responses for nonconformities are accepted, the auditor can recommend certification.
Following a review by our Compliance Team, a decision will be made as to whether your certification can be issued. Once certification is granted, we will conduct audits at least annually to ensure continued conformance to the requirements of the standard.
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.
Download our ISO 13485 key requirements guide to find out more.
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.
