ISO 13485 is an internationally recognized quality management system for the design and manufacture of medical devices. It is based on the ISO 9001 standard, but with additional requirements specific to the medical device industry. There are a number of steps involved in get ISO 13485 certification.

Understand the requirements

The first step to getting an ISO 13485 certificate is to understand the requirements of the standard. You can purchase a copy of the standard from the ISO website or from a number of other sources. Once you have a copy of the standard, take some time to read through it and identify the requirements that are applicable to your organization.

Implement the quality management system

The next step is to implement a quality management system that meets the requirements of the ISO 13485 standard. This will involve developing policies and procedures, and putting in place the necessary infrastructure to support the quality management system.

Choose a certification body

Once you have implemented the quality management system, the next step is to choose a certification body. There are a number of certification bodies that offer ISO 13485 certification. When choosing a certification body, it is important to make sure that they are accredited by a recognized accreditation body.

Submit an application

Once you have chosen a certification body, you will need to submit an application. The application will include information about your organization and your quality management system.

Get Audited

After your application has been reviewed, you will be scheduled for an audit. The audit will be conducted by a team of auditors from the certification body. The purpose of the audit is to verify that your quality management system meets the requirements of the ISO 13485 standard.

Receive certification

If the assessors determine that your organization meets the requirements of ISO 13485, you will be issued a certificate. The certificate is typically valid for three years and can be renewed by undergoing another on-site assessment.

ISO 13485 Certification Cost

ISO 13485 certification cost can vary depending on a number of factors, such as the size and complexity of your organization, the number of sites that need to be certified, and the certification body that you choose. Generally speaking, ISO 13485 certification costs range from a few thousand dollars to tens of thousands of dollars.