What is ISO 13485
ISO 13485 is an internationally recognized standard that specifies the requirements for the quality system of organizations operating in the medical device sector, ensuring that the medical device or service provided complies with the legal and regulatory framework and leads to final products/services that are safe for the end user.
Which organizations can adopt ISO 13485
ISO 13485 is aimed at manufacturers of medical devices, as well as organizations that support manufacturers. It emphasizes their obligation to comply with regulatory requirements, setting goals for their fulfillment.
Why you should get ISO 13485 certified
- Contributes to cost and time reduction, limiting errors and enhancing operational efficiency
- Increases customer satisfaction by providing products that fully meet their requirements
- Strengthens communication and collaboration between departments and staff, promoting a culture of continuous improvement, encouraging employees to actively contribute to improving the quality system
- Reduces liability risks through the existence of a documented and reliable Quality Management System
- Demonstrates the organization's compliance with international regulatory requirements, such as the FDA's QSR regulation for medical devices in the United States
- Facilitates access to international markets, enhancing the organization's competitiveness and reputation
ISO 13485 Certification Process
The initial assessment for obtaining ISO 13485 certification is carried out through a structured and transparent two-stage process:
Initial Assessment: Stage I Audit
Review of the completeness and adequacy of the organization's documented Occupational Health and Safety Management System
Initial Assessment: Stage II Audit
Review of the implementation and effectiveness of the management system. The audit examines all relevant information, performance targets, internal controls and processes, assessing the organization's full compliance with the selected ISO standard, and serves as the final step in achieving the organization's certification.
After a successfull evaluation, the company receives their ISO Certification, valid for 3 years.
Surveillance Audits
During the certificate's validity period, surveillance audits (2 in total) are conducted annually to confirm the seamless and continued implementation of the Management System.
Recertification is achieved by re-evaluating the Management System before the current certificate expires.
Relevant Documents
Management Systems Certification Regulation
Management Systems Certification Application
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