WHAT IS ISO 13485 - QUALITY MANAGEMENT SYSTEM (QMS)
ISO 13485 Certification is a Management Systems Standard specifically developed for the manufacture of Medical Devices. ISO 13485 sets regulatory requirements or, when specified, customer requirements for a management system for medical devices or services. The primary objective of ISO 13485 is to harmonize medical device regulatory requirements for quality management systems. The standard is specific to organizations providing medical devices or services, regardless of the type or size of the organization. Based on the ISO 9001 process approach to quality management, ISO 13485 focuses on what manufacturers must do to provide safe and effective medical devices.
HOW TO GET CERTIFIED IN 5 SIMPLE STEPS
Fill the Certification Intent Form and send it to us.
We will do a FREE GAP analysis of your organisation with respect to ISO 13485 Standard and give you a quote.
Get Trained and Finish the Documentation work.
Once you have agreed to our quotation, Our team will provide the required trainings to you and will complete the documentation work required for ISO 13485 certification.
Pre-assessment and Internal Audit.
We will then conduct a pre assessment audit to ensure that you organisation meets the desired certification requirements.
Final Audit by Certification body – Guaranteed Success !
We will provide assistance during final certification audit to ensure that your organisation achieves certification successfully!
Receive Certificate and Make Payment !
We are a quality conscious organisation and believe in Total Customer Satisfaction. So if you are 100% satisfied and happy with our service, make payment to us.