ISO 13485 Certification

ISO 13485 – Medical Devices

ISO 13485:2003, based on the ISO 9001:2000 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 9000:2000 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 thousands 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.

Improved communications, morale and job satisfaction – staff understand what is expected of them and each other.

Steps of getting ISO 13485 Certification

System Study & GAP Analysis
Documentation- Preparation of Quality Manual, Quality Procedure, Work Instructions, Formats
Records Generation, Implementation and Updating
Trainings- Management & Work Force Level
Internal Audit & MRM
Guidance through the Certification Audit
Closure of the Non-Conformities raised
Annual Maintenance Contract(Optional)

How can ASCENT World help you get ISO 13485 Certification?

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

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About Ascent World

We are based in South East Asia namely Ascent INDIA & Ascent LANKA. Overseas entities in the Gulf named Ascent SAUDIA have been serving a huge cluster of Corporate Customers since last one decade. In Africa, we exist as Ascent NIGERIA, Ascent TANZANIA, and were established about 5 years back had been serving the industries in the growing African nations. In the Far East as Ascent SINGAPORE and in the UK as Ascent UK have also been contributing heavily to the fame & achievements of the organization.