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ISO 13485

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ISO 13485

ISO 13485, published in 2003, is based on the ISO 9001 process model approach. Certification to ISO 13485:2003 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. ISO 13485 is an ISO standard, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.

Certification to ISO 13485 takes place when an accredited third party, such as BSI, visits an organization, assesses the quality management system and, if satisfactory, issues a certificate confirming that the organization’s quality management system meets the requirements of the standard.

The intent of ISO 13485 is to provide for the development of a Quality Management System that ensures to prospective customers and regulatory bodies that the goods and services offered by the organization will meet customer and regulatory requirements.

Who is ISO 13485:2003 applicable to?

Certification to ISO 13485:2003 is not only used by medical device manufactures as the foundation to their management system, it is also used by non-medical device companies as a first step to gaining new business opportunities within the medical device community

What are the benefits of registration?

The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide include:

How can ISO - Qatar help you to achieve ISO 13485:2003 Certification?

ISO Qatar will assist your organization in ISO awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485:2003 standard. ISO - Qatar is a result oriented professional training and certification service providers, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity by offering systematic approaches. Our main objective is to help you and your organization improve profitability, through better utilization of all of your resources


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