ISO 13485:2016

Medical Devices

What is ISO 13485?

Benefits of implementing ISO 13485:2016 in your business?

ISO 13485:2016 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore it is more prescriptive in nature and requires a more thoroughly documented QMS.

Importance of ISO 13485:2016 in your business?

ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certification in order to do business with a vendor.

How to get your ISO certificate ?

Application to KRISHTECH- Application for registration is made by completely updating KRISHTECH Application Form & submitting to KRISHTECH office. This provides information about your organization to KRISHTECH & so KRISHTECH can accurately define the scope of assessment.
Get a Quote - We'll give you a clear indication of the costs of gaining and maintaining certification.
Assessment to ISO 13485 is undertaken by KRISHTECH - this consists of two mandatory visits that form the Initial Certification Audit (Stage 1 Audit + Stage 2 Audit). Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.
Certification to ISO 13485 is issued by KRISHTECH and maintained through a program of annual surveillance audits and a three yearly recertification audit.

Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that require it, and expedites market entry into the others.

Reduced cost of sales – Your certification establishes your company’s credibility and commitment to quality. Because the task of explaining the specifics and demonstrating the effectiveness of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence.

Improved performance – Based on a uniform and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This can foster improved relationships with your suppliers, business partners, and customers, and give you a real advantage in the marketplace.

ISO 13485 is the world’s most recognised quality management standard used by millions of organizations all over the world to continuously improves performance. By becoming certified your organisation by KRISHTECH is making a statement about your commitment to continually and consistently meet the expectations of your customers through the improved efficiency and effectiveness of your business processes