ISO 13485 (Medical Devices Quality Management System)

What is Medical Devices - Quality Management Systems?
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What is the purpose of ISO 13485?
The purpose of ISO 13485 certification is sometimes misunderstood. ISO 13485 certification does not fulfill the requirements of ISO 9001, nor is it equivalent to or have the ability to take the place of any country-specific requirement for medical device manufacturers.

ISO 13485 is a Quality System for Medical Device and adopt a risk management approach to identify risk throughout the medical device product realization and such identified risks are managed to eliminate hazardous situations in medical device.

ISO 13485 Standard clauses and requirement are applicable to all types of organizations irrespective of size or nature and applicable to all like Hospital, Health Care, Trading, Manufacturing, Service Companies, Software, Construction and Medical Devices.

Medical Devices - Quality Management Systems Advantages
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
- Increase access to more markets worldwide with certification
- Outline how to review and improve processes across your organization
- Increase efficiency, cut costs and monitor supply chain performance
- Demonstrate that you produce safer and more effective medical devices
- Meet regulatory requirements and customer expectations
- guarantees high quality of provided services and products
- reduces production loss rate
- reduces operational costs
- increases effectiveness across the whole organisation
- increases your customers- trust in you as a safe supplier or producer

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