ISO 13485

What is ISO 13485 Certification?
ISO 13485 is an international standard that defines the requirements for a Quality Management System for organizations involved in the manufacturing of medical devices and supplies.
It is specifically developed to ensure the safety and quality of medical products and their compliance with international and local regulatory requirements.
The standard covers the entire product lifecycle—from design and development, through production and distribution, to post-market activities.

What is the importance of ISO 13485 certification?
ISO 13485 is suitable for all entities involved in the medical supply chain, such as manufacturers of medical devices and supplies, companies involved in distribution, storage, sterilization of medical equipment, and suppliers of raw materials used in medical devices.
The ISO 13485 certification aims to:
• Ensure the quality and safety of medical devices at every stage of production and supply.
• Achieve compliance with legal and regulatory requirements in global markets.
• Reduce risks associated with the use of medical products.
• Enhance customer and user confidence in products and the services of manufacturing companies.
• Open access to global markets, as the certification is often a prerequisite for entry into markets such as the EU, Canada, and others.
• Strengthen regulatory and commercial trust in the organization.
• Reduce the likelihood of product recalls or failures through strict quality control.
• Improve operational efficiency and reduce costs caused by defects.
• Boost competitiveness in a highly sensitive sector like the medical field.

How to obtain ISO 13485 certification?

1. Conduct a Gap Analysis between the current situation and the standard’s requirements.

2. Develop a medical quality management system according to ISO 13485.

3. Train employees and document procedures.

4. Perform internal audits and prepare for the external audit.

5. Contract with an accredited certification body and receive the certificate upon successful audit.

What is the validity period of ISO 13485 certification?
ISO 13485 certification is granted for a period of three years from the date of issuance, provided the organization maintains and effectively applies the management system throughout this period.
During the certification period, the organization is subject to:
Surveillance Audits
• Usually conducted once a year by the accredited certification body.
• Aim to ensure the ongoing proper application of the standard’s requirements.
Recertification Audit
• Conducted before the end of the third year to renew the certification for a new term.
• Involves a comprehensive review of the entire management system.