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What is ISO 13485:2003?

ISO 13485:2003 is a quality management system which is internationally recognized for maintaining and following the standards for manufacturing of medical devices or medical services.

It helps the customers to have reliability and trust as medical devices are used for sensitive process and also to save life.

ISO 13485:2003 also give value to the company in exporting his goods in the global market.

The production of the company gets increased by following the standard process as it helps company to manage and upgrade their products life and quality. It can also be used by the organization in product designing, development and in production process.

The main objective of ISO 13485:2003 is to maintain clear, safe and genuine production and documentation to meet medical legal requirements in the management systems.

ISO 13485:2003 can be obtained by all size of manufacturing and service providing sectors.

Benefits of ISO 13485:2003

Global reorganization in market as a medical device manufacturers or service provider

Quality and standard of products are assured

Increase in customer satisfaction

Increase in growth of Business

Increase in export order business

Value for money by reducing cost

Benefit customers, vendors, management and employees

Fulfills customer and regulatory needs.

Smoother and transparent documentation

Efficient steps towards effective risk management