The ISO 13485 certification cost is dependent on several factors such as (1) the complexity and the type of medical device manufactured, (2) the scope and size of your business, (3) the number of employees, and (4) the certification body selected. Other factors that may have an effect on the ISO 13485 Certification Cost are the number of locations you have and where your organization is in terms of your current quality management system in relation to ISO 13485 requirements.
Liberty Management Group (LMG) will quote you a fixed total fee at the beginning of the process so that you can budget your ISO 13485 certification journey without any surprises. For example, the total cost of ISO 13485 Certification could be as low as $8,500 if you decide to go with the certification body we recommend.
Our services include everything from preparing all the necessary documents such as the Quality Manual, Procedures, and templates, to implementing the quality management system, ISO Awareness Training, performing Internal Audits, and certification body audit support, and obtaining the ISO 13485 Certification.
The ISO 13485 certification process involves three kinds of expenses: ISO 13485 consultation cost, ISO 13485 certification body fees, and ISO 13485 recertification cost.
ISO 13485 CONSULTATION COST
Most small and medium-sized companies do not have the resources and expertise to properly implement a quality management system that meets all the requirements of ISO 13485. Trying to reduce the ISO 13485 certification cost by doing it yourself will often end up with a poor implementation of the standard or problems with documentation. A well-experienced ISO 13485 consultant can help you to navigate through the process by providing assistance with internal audit, management review meetings, identifying non-conformities, correcting any non-conformities, and support with the certification audit.
ISO 13485 consultation cost is the expense involved in employing a consultant to prepare all the necessary and mandatory documentation such as the Quality Manual, procedures, templates and guide you through the process of implementing a quality management system across your organization.
ISO 13485 consultation cost can vary based on your existing quality management system and the amount of service required to implement a system that meets the ISO 13485 requirements.
ISO 13485 consultation involves several onsite visits, and it is recommended that you choose a consultant who is not too far from the location of your site. This will save you unnecessary expenses like the travel, lodging, or other expenses of a consultant.
ISO 13485 CERTIFICATION BODY FEES
ISO 13485 Certification Cost involves certification body fees. These are the fees that you pay to the third-party certification body (registrar). ISO 13485 certification cost can vary depending on your business’s scope and the credibility of the certification body selected.
The International Standardization of Organizations (ISO) develops standards such as ISO 9001, ISO 13485, etc, but ISO is neither involved in the certification of any standards nor do they issue any certificates. ISO Certifications are issued by third-party certification bodies after conducting certification audits. ISO certification bodies are categorized accredited and non-accredited
To be accredited is neither mandatory nor are non-accredited registrars all non-reputable.
It is always recommended that you do your due diligence by reaching out to multiple certification bodies and comparing their audit fees and audit process prior to choosing one. The location of the consultant and or certification body is important as having a consultant who is close to your location reduces your overall ISO 13485 certification cost significantly by reducing the travel and other lodging expenses.
Liberty Management Group works closely with various certification bodies and helps you to find the right one that meets your unique needs.
ISO 13485 RECERTIFICATION COST
ISO 13485 certification cost involves recertification and surveillance audit fees. Although ISO 13485 certification is valid for three years, they must go through an annual onsite surveillance audit by the certification body during this time. This is to establish that your organization is consistent and still meets the requirements of ISO 13485 standards. After the third year, a new cycle will start and a recertification audit is required by the certification body to validate the original certificate issued. Recertification audits are more or less like the certification audit. ISO 13485 surveillance audit fees could be 25 – 35 % less than the original ISO 13485 certification fees as you have already established a quality management system and a process.
FREE ISO 13485 CONSULTATION: Liberty Management Group (LMG) offers a free, onsite ISO 13485 consultation. Whether you are just starting out on building a quality management system from scratch or need to evaluate your existing system for ISO 13485 Certification, our experienced consultants will be able to give advice and guide you through the entire process of implementation and certification of ISO 13485.
After the initial onsite visit, we will provide you with an estimate of the cost and time frame of the ISO 13485 Implementation and Certification process. No contract or commitment is required unless LMG is selected to provide any further service.