Medical devices have a significant impact on human life and health, so they must ensure higher stability, quality and safety than other products. Therefore, the medical equipment industry will always be justified by internal monitoring systems, international standards and other practical requirements.
ISO 13485: 2016 standard is a quality management system (QMS) based on the ISO 9001 standard for companies operating in the medical equipment production. This standard ensures the organization's commitment to a process approach regarding design, safety and quality of medical equipment. All the requirements of the medical equipment production are met in this standard, which is the basis for CE certification of these products.
این استاندارد بین المللی علاوه بر تعریف الزامات مربوط به سيستم مديريت كيفيت سازمان هاي تولید کننده تجهیزات پزشکی، ضوابطی کاربردی برای سازمان های فعال در زمینه طراحي و توسعه، نصب و خدمات این حصولات نیز ارائه کرده است. علاوه بر این، دامنه کاری ISO 13485:2016 می تواند شامل نهاد های خارجی ارائه دهنده خدماتی نظیر استریل سازی، کالیبراسیون و فروش شود.
Implementing a system based on the ISO 13485: 2016 standard has several benefits for your organization, such as:
- Increase Customer Satisfaction: provide products with lasting quality
- Improving working Environment Conditions: Increasing the level of awareness and knowledge of employees
- Reduce operating costs: Increase constant process efficiency
- Identifying occupational risks: Establishing a system for tracking products and services
- Authentication of business through obtaining international certifications
- Expanding International Trade: Meeting the needs of global markets
Iranian Govah Cosar Co. as a well-known institution in the field of issuing system standards, using the knowledge of the audit team consisting of experienced and qualified evaluators, covers a wide range of specialized areas to assess the compliance of your management system with ISO 13485:2016.