ISO 13485 Medical Devices – Quality Management System Certification
With the ISO 13485 Medical Devices Quality Management System certificate, manage your medical devices in accordance with international legislation; increase patient safety by controlling your design, production and supply processes, comply with legal requirements and gain a strong position in the global market.
ISO 13485 Medical Devices – What is Quality Management System Certification?
Today, the importance of medical devices used in the health sector is increasing. Therefore, the reliability, sterility, effectiveness and quality of medical devices and equipment play a vital role in terms of patient health.
Therefore, ISO 13485 quality management systems are of great importance for medical device manufacturers and suppliers. ISO 13485 is an international quality management system standard developed specifically for the medical device and equipment sector.
This standard was created by ISO based on the ISO 9001 standard, but has been developed to meet the specific requirements of organizations engaged in the production and sale of medical devices and equipment. ISO 13485 helps manufacturers and suppliers of medical devices and equipment to ensure the safety and effectiveness of their products and meet regulatory requirements. The main objective of the standard is to maximize patient safety by meeting the requirements of medical device legislation.
The most current version of the standard published by ISO was published in 2016 as ISO 13485:2016.
ISO 13485 Medical Devices – Basic Principles of Quality Management System
The main purpose of the ISO 13485 standard is to ensure that medical devices and equipment are safe, effective and in compliance with legal requirements. This standard aims to keep all processes under control throughout the life cycle of medical devices, from design, development and production to disposal. In this way, risks that may arise from medical devices are minimized and patient, employee and environmental safety is ensured.
Legal Compliance
It ensures that medical device manufacturers and suppliers act in accordance with legal regulations and legislation. ISO 13485 certification is an important requirement, especially for entry into the European Union and other international markets.
Customer Satisfaction
Contributes to increasing customer satisfaction by offering quality and reliable products.
Quality Assurance
It guarantees quality in all processes from design to production, storage and distribution of medical devices. This increases the reliability and effectiveness of products.
Competitive Advantage
Having ISO 13485 certification gives organizations a competitive advantage in the market. The certificate enhances the reputation of the organization and helps it gain the trust of customers.
Risk Based Approach and Management
It guides processes for identifying and managing risks related to medical devices. This prevents or minimizes potential errors and non-conformities.
Continuous Improvement
It encourages continuous review and improvement of the quality management system. In this way, organizations can continuously optimize their processes.
Register Your Quality and Stand Out from the Competition
Manage your ISO 13485 certification process with confidence with our expert team. Contact us today to strengthen your regulatory compliance, solidify your quality infrastructure and gain a competitive advantage in the market for your medical devices.
ISO 13485 Medical Devices – Quality Management System Certification Process
ISO 13485 Medical Devices – After the organizations wishing to obtain Quality Management System Certificate have established the management system, certification is carried out as follows.
Certification Audit:
Completion of the certification audit in two phases;
Stage 1 Audit: General examination of the documentation prepared by the company within the scope of ISO 13485 Medical Devices – Quality Management System.
Stage 2 Audit: On-site control of the applications of the documentation prepared by the company within the scope of ISO 13485 Medical Devices – Quality Management System and identification of appropriate and possible inappropriate issues.
Corrective Actions, Follow-up Audit and Certification:
If nonconformity is detected in the Stage 2 Audit, ISO 13485 Medical Devices – Quality Management System Certificate of Conformity is issued after the nonconformity is closed by the organization applying for certification or by the certification body with a follow-up audit according to the type and size of the nonconformity detected.
Surveillance Audits:
Surveillance audits are partial audits and are conducted in the second and third years after the certification audit. In surveillance audits, the main processes of the organization are audited and certain parts of the support processes are checked.
Periodic surveillance audits are mandatory for the validity of the ISO 13485 Medical Devices – Quality Management System Standard Certificate and to determine that the organization’s management system continues to comply with the standard. These periodic surveillance audits are 1st Surveillance and 2nd Surveillance audits. The first of these surveillance audits must be completed within 12 months after the Stage 2 audit and the second within 24 months after the Stage 2 audit.
Recertification Audit:
It is a type of audit conducted in the fourth year after the Stage 2 audit and conducted to organizations that implement the ISO 13485 Medical Devices – Quality Management System Standard and have undergone the first certification audit. As in Stage 2, 1st and 2nd Surveillance Audits, an on-site audit is carried out, and the organization’s documentation and application control is carried out during the audit.
ISO 13485 Medical Devices – Why Buy Quality Management System?
- Providing the basic infrastructure for CE marking and international regulations
- Easier access to the European Union, North America and global markets
- Competitive advantage in public and private sector tenders
- Systematic management of compliance with legal requirements
- Demonstration of compliance of the quality management system with international standards
- Increased corporate credibility and stakeholder trust
- Increased operational efficiency through standardization of processes
- Reducing error rates through a risk-based approach
- Reducing costs in design, production and service processes
- Integrating continuous improvement culture into the organizational structure
- Decrease in customer complaints and increase in customer satisfaction
- Production of safer and more effective medical devices
- Monitoring and improving procurement and supply chain performance
- Effective management of production and after-sales service processes
