ISO 13485:2016 Medical Devices (Quality Management Systems) Requirements for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device. ISO 13485 is based on ISO 9001 but the requirements are specific to design and manufacturing in medical device industry. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment.   ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.   An ISO 13485 Certification for Your Business Could

      ISO 9001:2015 Quality Management System Supporting an organization’s aims and objectives, an ISO 9001 quality management system (QMS) documents the processes, procedures, and responsibilities for achieving quality policies and objectives. Based on seven quality management principles, the ISO 9001:2015 certification defines the way an organization operates to meet the requirements of its customers and stakeholders   ISO 9001 certification will help your organization to develop and improve performance, as well as demonstrate high levels of service quality when bidding for contracts. Implementing a QMS benefits an organization by effectively identifying customers and stakeholders. This outward looking approach