It is the international standard determining the special requirements for the companies, operate in the medical device manufacturing industry (diagnostic and therapeutic products).
The ISO 13485 Certificate ensures the continuity of the ability to determine and meet the customer demands for each company operating in the operational processes such as production, sale and procurement of medical devices.
It ensure the customer confidence on the fact that the products are manufactured in a system that is safe for human health in all phases such as beginning from raw materials to design, production, storing and shipment.
The ISO 13485 Certificate is required for manufacturers of medical devices to meet the legal requirements and to obtain CE Mark.
How to Obtain ISO 13485 Certification and How Does the Process Work?
Medical device sector players wishing to obtain ISO 13485 certification must establish an internationally recognized Quality Management System (QMS) and prove it through audits conducted by third-party independent certification bodies. The first step of the process is current state analysis and scope determination. The organization's medical device design, manufacturing, storage, or technical service activities are examined, and the documentation infrastructure is revised from scratch according to ISO 13485 standard clauses.
During the documentation phase; quality policies, risk analysis procedures, traceability processes, and corrective and preventive action (CAPA) forms must be prepared thoroughly. The documented processes must be implemented within the organization for at least one audit cycle (Internal Audit). Following the implementation phase, an official application is submitted to the certification body.
The certification process is completed through a two-stage audit. The first stage checks documentation compliance, while the second stage consists of an on-site audit. Upon the successful outcome of the audits, the company is presented with the official ISO 13485 certificate. To maintain the validity of this certificate, annual surveillance audits are mandatory.
