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ISO 13485:2003, Medical Devices- Quality Management System – Requirements for Regulatory Purposes
A Brief Overview
ISO 13485 standard deals with the fundamentals of quality management systems with respect to the design and manufacture of Medical Devices
ISO 13485 standard is based on ISO 9001 standard with additional requirements related to regulatory compliances for the medical devices, but it has some exclusions from the ISO 9001 standard .
The ISO 13485 standard is specific in nature and is applicable to any organization providing medical devices regardless of type, size and product.
The ISO 13485 standard focuses more on the risk management, design controls, specific requirements for inspection and traceability for implantable devices, validation processes for sterile medical devices.
The ISO 13485 standard is basically adopted from the EN standards, later released as an ISO standard in 1996. First revision in 2003 (presently in use)
Main Clause Requirements of the ISO 13485 Standard
Clause 1. Scope
Clause 2. Normative References
Clause 3. Terms and Definitions
Clause 4. Quality Management System
Clause 5. Management Responsibility
Clause 6. Resource management
Clause 7. Product / Service Realization
Clause 8. Measurement, Analysis and Improvement
Advantages of ISO 13485 Certification
ISO 13485 certified organization has a better edge over increasing the profitability of making safe and effective medical devices.
ISO 13485 certification for an organization will meet the regulatory requirements and customer expectations.
Increased efficiency and cost saving is a key factor from an ISO 13485 certified organization
An ISO 13485 certificate enhances the marketing image of the organization.
ISO 13485 certification helps in more effective risk management and quality assurance.
An unique way of having a standardization process across the world with promotion of international trade.