ISO 13485:2016 for medical devices in Bangalore

ISO 13485: 2016

ISO 13485: 2016 for medical devices

Quality management system

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What is the ISO 13485 standard?

Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved within the medical device industry. Companies are using compliance to the present standard to get the certification of their Quality Management System. The first purpose of the ISO 13485:2016 a standard is that the Harmonization of the Medical Device regulatory requirements for Quality Management Systems.

What is the value of ISO 13485?

It costs less to adopt the audit mechanism through ISO 13485 clauses within the medical field because the ISO 13485 standards are easy to suit the needs. Whatever it costs, it can ultimately recover an equivalent by assuring the less error within the entity and by utilizing the resources at its optimum level.

 ISO 13485:2016 represents the needs for a comprehensive management system for the planning and manufacture of medical devices. All requirements of this International Standard are specific to organizations providing medical devices, no matter the sort or size of the organization. This standard supersedes earlier documents like EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (1996). ISO 13485:2016 is a quality system standard designed specifically for medical device companies. The standard is applied by most Class II and III (plus Class IV in Canada) medical device manufacturers to satisfy the quality system requirements of Europe, Canada, Australia, Japan, India and other parts of the world.

Compliance with ISO 9001:2015 is usually seen because the initiative in achieving compliance with ISO 13485:2016, which is predicated on the ISO 9001:2015 process model, suggests that the appliance and management of a system of processes is efficient to ensure good quality management. All requirements of this International Standard are specific to organizations providing Medical Devices, no matter the sort or size of the organization.

ISO 13485:2016 partially designed to supply a management system that facilitates compliance to the needs of consumers and various global regulators. While being certified to ISO 13485 doesn’t fulfill the wants of either the FDA or foreign regulators, the certification aligns an organization’s management system to the wants of the FDA’s Quality System Regulation (QSR) requirements also as many other regulatory requirements found throughout the planet. Therefore, ISO 13485 certification serves to make a management system which will be thought of as a framework on which to create compliance to vary regulatory and customer requirements.

The ISO 13485:2016 standard supplements ISO 9001 and has many of equivalent requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer satisfaction and more. All countries will have additional requirements necessary to satisfy their specific regulations.

Though supported ISO 9001, ISO 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is a stress on meeting regulatory customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

Benefits of ISO 13485:2016 Certification

Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and authorized management system. Investing in such a system speeds access into those countries that need 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 – supported a consistent and widely-accepted system of process control, your company’s certified management system helps you improve your products and processes. This will foster improved relationships together with your suppliers, business partners, and customers, and provides you a true advantage within the marketplace.

Advantages of ISO 13485:2016 Certification with Expert Certifier:-

  • Demonstration of responsibility to satisfy legitimate and control necessities
  • Guarantee of consistency of a creation procedure and during this way of a gentle and high caliber of managements rendered and items provided to clients
  • Demonstration of appropriateness, proficiency and adequacy of the actualized quality management framework by a 3rd autonomous gathering
  • Increase in nature of the management framework, enhancement of the organization’s hierarchical data structure
  • Improvement of request and an expansion in viability within the whole organization
  • Optimization of expenses – decrease in working costs, diminish in expenses of non-acclimating items, investment in crude materials, vitality and different assets
  • Increase in certainty of open and state control bodies in producer of restorative equipments

ISO 13485:2016 contains necessities that are fundamental for any organization performing at any level within the medicinal gadget and pharmaceutical inventory network. ISO 13485 Certification in Bangalore with Expert Certifier would be a right option for the developments of your organization and to succeed in subsequent level.

Following are key requirements of ISO 13485:2016 medical devices quality system certifications

  • Preparation of quality manual and quality procedures
  • Preparation of quality policy and quality objectives
  • Appointment of specific responsibilities as per national / international legal rules
  • Review of legal requirements
  • Providing clean ,hygienic & product – production adequate work environment
  • Reverting on advisory notices
  • Clinical evaluations of product under development
  • Control of product installation and services
  • Validation of software’s
  • Validation of sterile medical devices
  • Maintaining specific identification and traceability
  • Risk management as per relevant risk management standard like ISO 14971

How to get ISO 13485:2016 certification in Bangalore – Consultants in Bangalore?

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