Management via International Standards
ISO (The International Organization for Standardization), is a worldwide federation for national standards which OS Biomedical has been governed by since its certification. OS Biomedical currently has ISO 9001:2015 Quality Management System and ISO 13485-2017.
Our main corporate policy is to engage in business within the framework of the regulations and legislations, staying in line with the economic needs of the business world, producing efficient and rational solutions, and doing work that encourages the future generations into becoming a part of the sector.
We regularly improve our quality assurance systems
Our Quality Goals
- Constant improvements to our technological infrastructure.
- Becoming the preferred destination in the industry.
- Ever improving service times.
- Advancing our personnel's academic and educational formation.
- Maintaining perpetual training for our clients and employees.
Information Security Goals
- Ensuring the continuity of OS Biomedical's operational and support processes with the least number of interruptions.
- Guiding the personnel towards maintaining information security at all times.
- Minimizing risk through established and mindfully adhered to protocols.
- Improving job-related awareness and actively turning the occasional information security related issues into case studies to learn from.
- Generating, storing, and accessing information exactly the way prescribed by law.
ISO 9001:2015 Quality Management System
The application of ISO 9001:2015 Quality Management System that are company is subject to is a strategic decision made in order to increase our overall performance as well as building a strong foundation for our development initiatives.
Our ISO based quality management system offers our company the benefits listed below
- The ability to continuously provide products and services in accordance with customer and applicable primary and secondary regulatory requirements
- To gain maximum customer satisfaction by enabling opportunities to increase customer satisfaction and being customer-oriented
- Identifying risks and opportunities related to its context and objectives
- Ability to demonstrate compliance with specified quality management system requirements
- Continuous improvement of service quality by achieving the quality targets set for the processes
- Making situational analyzes in line with data and statistical measurements and thus enabling strategic decision-making dynamics to benefit from the analysis results
OS Biomedical’s ISO 9001:2015 Quality Management System is audited every year by an independent institution.
ISO 13485:2017 Medical Devices
At OS Biomedical, we are dedicated to providing secure, efficient, and reliable storage solutions for medical devices and other critical assets. Achieving ISO 13485:2017 certification affirms our ability to handle medical devices and healthcare-related assets with the utmost care and precision, ensuring compliance with industry regulations and providing our clients with peace of mind.
What is ISO 13485:2017?
ISO 13485:2017 is an international standard that sets the requirements for a quality management system (QMS) specifically designed for the medical device sector. This certification ensures that organizations meet regulatory requirements, maintain high standards of quality, and prioritize safety and effectiveness in the management and storage of medical devices.
- Secure Storage Processes: We have implemented best practices for storing medical devices, ensuring they are kept in controlled environments that meet stringent safety and regulatory standards.
- Traceability and Documentation: Our storage systems are fully traceable and documented, ensuring that all medical devices are accurately tracked from receipt to delivery.
- Risk Management and Safety Protocols: We’ve established effective risk management strategies to minimize potential risks to the integrity of stored devices and ensure their safety and compliance.
- Regulatory Compliance: We strictly adhere to relevant national and international regulations regarding the storage of medical devices, guaranteeing compliance at all stages.
- Employee Training: Our team is highly trained in the management and storage of medical devices, with a strong focus on maintaining the quality and safety of all stored products.
* OS Biomedical's ISO 13485:2017 certification is audited every year by an independent institution.