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ISO 13485 Certification

ISO 13485 is a globally recognized quality standard which defines the requirements of the quality management system for designing and manufacturing of medical devices. In short, ISO 13485 standard defines the requirement of medical devices for regulatory purpose. The ISO 13485 quality standard was originally developed during 1996 and then the standard was revised again in 2003. Approval to this standard shows the company or organization capability to constantly meet customer requirements for medical devices and services

To receive ISO 13485 certification, a company or organization must implement a strict quality management processes for product development, marketing and delivery so that it will completely meet the customer requirements.

ISO 13485 certification process

First of all, an organization needs to educate itself on the requirements of medical device customers and the ISO 13485 quality management system. After that, an organization must create a quality manual which demonstrates the organizational goals, processes and procedures for compliance and quality management.

This quality manual helps organization to implement a quality management system. An organization can implement quality management system by themselves or by hiring a professional consultant with an expertise in the 13485 market from outside.

After creating a quality manual and procedures, they implement the quality management system in their organization. Then they audit themselves for a period of 3 months or more to ensure the procedures are being followed – correcting any non-conformances they find. After they feel the system is running satisfactorily, they invite a registrar to audit their QMS. If they pass the audit, the registrar will recommend the organization for ISO 13485 certification.

If your organization wants to implement ISO 13485 standard, we can help you. We have a tools and products related to ISO 13485. We at the 13485store.com provide ISO 13485 quality manual and procedures package for sale. This package contains all the processes and documents you need to become ISO 13485 certified. Apart from this quality manual, you can also buy employee training package to train your employees and let him know how to implement the ISO 13485 standard in the organization. Contact Us to know more about our products and services.