What is ISO 13485:2016
ISO 13485 is the optimal device standard of the medical industry that ensures that all medical devices comply with the proper regulatory compliance and customer requirements. ISO 13485 certification is a valuable credential put in place to keep clinics, hospitals, and other medical settings safe for professionals.
ISO 13485:2016 is based on the ISO 9001 procedure model approach and is a management system standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized regulatory requirements for medical devices. The standard contains specific manufacturing, installation and servicing requirements and calls for:
Implementation of a system for quality management with several improvements
Approach to risk management in product development and product realization
Validation of procedures
Compliance with legal and regulatory requirements
Effective traceability of products and recall systems
The creation of more economical environments for work. As an internationally recognized quality and safety standard for the manufacture of medical devices, having ISO 13485 certification helps companies to be recognized as more reputable, trustworthy suppliers. Every five years, the most recent version of ISO 13485 is reviewed and revised according to new industry requirements and needs.
ISO 13485:2016 Cost
It sets out the quality management system criteria where a company demonstrates its ability to provide medical devices and related services that reliably comply with client and relevant regulatory requirements.You can visit our website ISO registrar and fill the ISO 13485:2016 application form to get the exact idea of ISO 13485 certification cost.
Steps to Obtain ISO 13485:2016 Certification
Create a quality plan- to meet the requirements of the standard, certification begins with the development of a quality plan. Plan out how your quality system will work, what roles are needed, and who will perform them.
Identify target markets and work towards compliance-determine where you want your medical devices to be marketed and establish compliance in those jurisdictions with other medical device regulations.
Implement design controls-from the beginning of the product development process, design controls are required and should be established and documented as early as possible.
Establish document controls-train your employees to update the QMS and maintain its compliance with ISO 13485 in a consistent and uniform system.
Build a CAPA system-CAPA forms the core processes of your QMS together with Design Controls. Ensure that the procedures for your CAPA are well defined and functional.
Schedule audits with Notified Bodies-The organizations known as Notified Bodies are assigned to audit the ISO 13485 compliance of medical device companies.
Certification audits are carried out in two phases and, following the Stage 2 audit, manufacturers are expected to be fully compliant with the standard.
Benefits of ISO 13485:2016
Check the ISO 13484 benefits below:
Increase efficiency, cut costs, and track the performance of the supply chain
Increase access to more markets worldwide with certification
Show that you manufacture safer and more effective medical devices
Outline how processes can be reviewed and enhanced across your organisation
Meet regulatory requirements and expectations for customers
Certification helps to win business, especially where procurement specifications require certification in a highly regulated sector as a condition for supply.
Document Required for ISO 13485:2016
Quality manual
Responsibilities and authorities
Medical device file
Procedure for document control
Procedure for design and development
How can we help you?
It can normally be very difficult to receive an ISO 13485 certificate on your own. But if you're trying to get through the sources with our help, we will help you get your ISO 13485 registration without any trouble. Our ISO Registrar company will help you to receive this credential, which will ensure that you comply with a set of regulations. Risks will be correctly measured for the good of the company. In order to achieve all these advantages, contact our company executive team to receive an ISO 13485 certificate for your organisation.
How to Apply for ISO 13485:2016 Certificate?
Follow these simple steps to get ISO 13485 Certificate
Step 1: Visit the ISO Certificate Registration Website.
Step 2: Fill out all the details of the ISO 13485:2016 Certification Registration Form.
Step3: Make your ISO 13485:2016 Registration Application online payment.
Step4: One of the ISO Registration Officers will process your official ISO Registration Certification work.
Step5: You will obtain your ISO 13485:2016 certificate in your registered email address within 5-7 working days.