What is ISO 13485:2016 Certification?
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
What are the benefits of 13485 certification?
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
- Improved customer perception of the organization’s image, culture
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
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
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.