ISO 13485

Medical Device Quality Management System

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Key benefits of the ISO 13485

Organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related

services to such organizations.

It provides a systematic framework for to define, implement, measure and analyze the process of business operation and customer opinion.

It provides a systematic framework on monitored base that resulting in less waste and fewer complaints.

Reduction of operating costs, reduction of nonconforming products costs, raw materials, energy and other resources saving.

This standard focused to improve the performance in areas such as sales, product delivery, and process efficiency.

It reduce costs as a result of minimizing product failures.

Through ISO 13485 standard organization access to the competitive edge with our independently.

Certification Journey

The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to stage 2

This second assessment determines the effectiveness of the system and seeks to confirm that the management system is implemented and operational

At this point in the process we review any corrective action taken to address findings raised at stage 1 & 2. Certification may be recommended

The organisation’s file are reviewed by an independent and impartial panel and the certifxication decision is made

Successful certification is communicated to the client. Certificates are issued

About

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