ISO 13485 Certification

What is ISO 13485:2016?

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.

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 is ISO 13485 applicable to?

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.

What are the benefits of certification?

Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
Improved stakeholder relationships - including staff, customers and suppliers
Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
Improved risk management - through greater consistency and traceability of products and use of risk management techniques
Proven business credentials - through independent verification against recognized standards
Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

Iso Certification body near by your Location?

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