What is ISO 13485:2016 Certification?

ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers, suppliers, contract service and distributors of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector.

 ISO 13485 Standard has been based on the requirements of ISO 9001 standard and has the same structure in terms of clauses. Even some clauses of ISO 13485 have been referred to ISO 9001.This standard 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 requirements and regulatory requirements applicable to medical devices and services

Why 13485 certification is important? 

The ISO 13485 standard is for medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most global markets. Exporting medical Devices to various countries is mandatory. ISO 13485 Certification is an objective evidence of compliance of the requirements, regardless of the type or size of the organization.

It is the "de facto" standard for global medical device QMS compliance for medical devices, and is a prerequisite for access to most major markets worldwide.

 What are the benefits of 13485 certification?

• Recognition by regulators around the world of ISO 13485 as a good basis for addressing medical device design and manufacturing regulatory requirements
•  Demonstrate that medical devices are produced safely & Communicate your high standards of quality
•  Gain a competitive edge
•  Reducing operating costs
•  Establishing business credentials
• Controlled consistency of manufactured products
• Competitive advantage and increased marketing and sales opportunities.
• Improved customer perception of the organization’s image, culture and performance

Who can acquire 13485 certification?

ISO 13485:2016 applies to all manufacturers, suppliers, contract service and distributors of medical devices and equipment.

Is 13485 certification a mandatory?

ISO 13485 is a voluntary standard.  But as above, it closer meets requirements in the regulation and may better meet the requirements of your customers if they manufacture medical devices.

What is the validity of ISO 13485 certificate?

The cycle of the certificate is valid for 3 years from the date of certification, subject to the successful conduct of surveillance audits before completion of the 1st & 2nd year respectively.