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ISO 13485:2003 (Quality Management System for Medical Devices)

ISO 13485:2003, based on the ISO 9001:2008 Certification process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this International

Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.
The standard strongly infers that clients should consider using ISO 9001:2008 to ensure understanding of the Process Model, definitions and other items of concern, too.

ISO 13485 Certification – Benefits
The benefits of an ISO 13485:2003 Certification compliant quality management system to the many of companies worldwide include:

    • Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing
      medical device design and manufacturing regulatory requirements.
    • Controlled consistency of manufactured products
    • Managed productivity and efficiency, controlling costs
    • Competitive advantage and increased marketing and sales opportunities.
    • Improved customer perception of the organization’s image, culture and performance.

    How do you implement ISO 27001:2005?

    • First know the requirements by ISO 27001:2005 Standard and how to apply for it
    • Select a Registrar
    • Hand over a document list that specifies the scope of compliance
    • Create a management framework for information
    • Identify the security risk
    • Selection and implementation of controls
    • Implement a security awareness program
    • Make sure that the security procedures documented and implemented
    • Regularly review the risk assessment plan for continual improvement
Improved communications, morale and job satisfaction – staff understand what is expected of them
and each other.

How can BICC help you get ISO 13485 Certification?

BICC consists of full-time trainers and certification having huge international experience and exposure in ISO 13485 Consulting, implementation and training.

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