ISO 13485:2016 - Quality Management System for Medical Devices

ISO 13485:2016 - Quality Management System for Medical Devices

Introduction to ISO 13485

Manoria Associates is one of the largest and leading ISO 13485 consultants in India. We are a transnational ISO certification consultants with clients in India. We provide quick, result oriented and easy to implement consulting and training for ISO 13485 Certification.

We have been associated with organizations across the world for their ISO 13485 certification project. Whether you a small organization or a multinational corporate, our proven consulting solutions will ensure that you implement ISO 13485 standard in the most effective manner with timely project completion.

ISO 13485 quality management system implementation with the consultants and experts of Manoria Associates not only assures 100% successful ISO 13485 certification but also improves process performance and business operations.

Consultants of our organization partner your company in your quality management initiative through ISO 13485 certification to get your company ISO 13485 certified quickly with ease of implementation and in the most cost effective manner. We make sure that ISO 13485 standard implementation does not become just a documentation activity but it becomes a way of life for the organization that lays a foundation for Total Quality Management and quality conscious organizational culture.

We offer onsite consulting solutions and online consulting solutions for ISO 13485 certification. Our customers have been utilizing our services not only for initial certification consulting but also post certification consulting to ensure that our consultants regularly add value to the business processes of our customers and their process & quality standardization initiatives.

Our ISO 13485 certificate consulting services include awareness training, quality policy - objectives workshop, gap analysis, documentation design including manuals, procedures, work instructions, formats etc, implementation assistance & training, internal auditor training, lead auditor training, assistance in conducting internal audit, pre-assessment audit and everything required to ensure a 100% successful ISO 13485 certification audit within scheduled project completion time period.

Biggest benefit an organization gets out of ISO 13485 QMS is improved business process control through process standardization. No matter what benefits you are looking from ISO 13485 certification, we will make sure that your organization benefits from ISO 13485 implementation and certification.

What is ISO 13485:2016 :-

ISO 13485:2016 is a quality management system requirements for medical devices and related services.

The organization should meet with customer and legal requirements the related to manufacturing medical devices and related services.

Recently, this standard was revised and released in the year 2016.

How to upgrade to new standard :

If you are already certified with old revision, just update the requirements/documents and implement 2016 new revision and get certified during surveillance or recertification audit.

Major reasons for revision:

  • 1. Adapt to new global changes
  • 2. To provide consistent basement in future
  • 3. To improve customer satisfaction
  • 4. To identify context and interested parties needs
  • 5. To integrate with other management system.

Requirements for ISO 13485

ISO 13485 requirements are based on ISO 9001:2015 standards.

  • 1. Systematic requirements
  • 2. Management requirements
  • 3. Resource requirements
  • 4. Realization Requirements
  • 5. Remedial Requirements

Benefits of ISO 13485:2016

  • Increased productivity
  • Customer satisfaction improved
  • Well defined and documented procedures improve the consistency of output
  • Quality is constantly measured
  • Procedures ensure corrective action is taken whenever defects occur
  • Non conformity rates decrease
  • Non conformity are caught earlier and are corrected at a lower cost
  • Defining procedures identifies current practices that are obsolete or inefficient
  • Documented procedures are easier for new employees to follow
  • Organizations retain or increase market share.
  • Increasing sales or revenues.

What we offer for ISO 13485 Certification for your Organization?

With a team of highly qualified consultants and trainers having vast industrial experience, Manoria Associates organize across the world to implement and achieve ISO 13485 certification. Our consulting approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client organization.

We offer ISO 13485 training, implementation, consulting, gap analysis, documentation, internal audits, reassessment audits, certification audit through best of the certification bodies and post certification enhancement / maintenance services to enable your organization get the best out of ISO 13485 MDQMS. quality management system. Our services are globally accepted, authoritative and benchmarked in the field of ISO 13485 MDQMS:

Contact us at to get your organization ISO 13485 certified.