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ISO 13485: 2003

What is ISO 13485: 2003 Medical devices -- Quality management systems ?

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. ISO 13485:2003 is the latest version of ISO 13485, published in July 2003. This standard is based on the ISO 9001:2000 process model approach. 

The standard contains specific requirements for manufacture, installation and servicing and calls for:

• Implementation of a Quality Management System with several enhancements 

• Risk Management approach to product development and product realization 

• Validation of processes 

• Compliance with statutory and regulatory requirements

• Effective product traceability and recall systems 

Who are the intended users ?

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

Benefits of ISO 13485 certification:-

• Demonstration of commitment to meet legal and regulation requirements 

• Guarantee of constancy of a production process and thus of a stable and high quality of services rendered and products supplied to customers 

• Demonstration of suitability, efficiency and effectiveness of the implemented quality management system by a third independent party

• Increase in quality of the management system, improvement of the organization’s organizational structure

• Improvement of order and an increase in effectiveness in the entire organization

• Optimization of costs - reduction in operating costs, decrease in costs of non-conforming products, savings in raw-materials, energy and other resources 

• Increase in confidence of public and state control bodies in manufacturer of medical devices

How can Lakshy Management Consultancy help to get ISO 13485 Certification ?

Lakshy Management Consultant assisted dozens of companies around the World and in India also establishing and implementing effective ISO 13485 2003 Quality Management Systems. Lakshy Management Consultant provides services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.

Lakshy Management Consultant offers

• Certification - Assessment and Certification against ISO 13485. 

• Internal Audit Assessments – We offer gap analysis, preliminary assessments to prepare you for certification. 

• Training –We offer training which will prepare you and your staff before and after the certification process. 

Lakshy Consultancy has in-depth knowledge of the dynamic global market; we provide our consultation services &solutions as per the requirements of our clients. We provide a combination of real-world business value through technology and process solutions delivered with exceptional quality that help you manage your risk, strengthen your controls.

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