In the medical device sector, quality and safety are of the utmost importance because they are directly related to human health. One of the most important standards proving that businesses in this field produce in compliance with international standards is the ISO 13485 Medical Devices Quality Management System. So, what is ISO 13485 and how can it be obtained?
What is ISO 13485?
ISO 13485 is an international standard that defines the quality management system for the design, production, installation, and servicing processes of medical devices. This certificate ensures that products are manufactured in accordance with legal requirements and customer expectations.
Having ISO 13485 certification allows businesses to be recognized not only in Turkey but also in the European Union and other international markets as reliable manufacturers.
Who Needs ISO 13485 Certification?
-
Medical device manufacturers
-
Sub-supplier companies
-
Businesses providing sterilization services
-
Companies developing medical device software
-
Distribution and logistics firms
How to Obtain ISO 13485 Certification?
Certain steps are followed to obtain ISO 13485 certification. While the process may vary according to the business’s current status and field of activity, the general stages are as follows:
1. Current Situation Analysis
The company’s quality management system and processes are compared with ISO 13485 standards, and deficiencies are identified.
2. System Implementation
Quality management system documentation, procedures, and processes are established in line with ISO 13485 requirements.
3. Application and Monitoring
The system is integrated into the business and applied for a period to test its effectiveness.
4. Internal Audit and Management Review
Internal audits are conducted to address deficiencies and increase the maturity of the system.
5. Certification Application
An application is submitted to an accredited certification body, and an audit plan is prepared.
6. Certification Audit
Authorized auditors visit the business to check compliance with ISO 13485 requirements.
7. Certificate Issuance and Surveillance Audits
If compliance is achieved after the audit, the ISO 13485 certificate is granted. Its validity is maintained through regular surveillance audits.
Advantages of Obtaining ISO 13485 Certification
-
Ensures reliability in international markets.
-
Guarantees safety and quality in medical devices.
-
Facilitates compliance with legal requirements.
-
Increases corporate reputation and competitive power.
-
Strengthens trust with customers and business partners.
Where Can You Obtain ISO 13485 Certification?
ISO 13485 certification can only be issued by accredited certification bodies. The process and cost may vary depending on the size, field of activity, and existing systems of your business.
Key Kalite offers ISO 13485 certification services specifically for businesses operating in the medical device sector. If you want to securely obtain ISO 13485 certification for your company, you can contact us for detailed information and pricing.
ISO 13485 certification is one of the most important indicators of quality and safety for businesses operating in the medical device sector. To obtain the certificate, the stages of system implementation, application, internal audit, and certification audit must be followed.
If you want to increase your reliability both in the domestic and international markets, you can obtain ISO 13485 certification in the most accurate way with the certification services of Key Kalite.