ISO Standards

As medical device supply chains are rapidly globalizing, regulatory bodies have dealt with how to bridge the gap between domestic and foreign regulations. Without an integrated approach to regulations, implementing best practices to ensure that regulatory processes are followed and adequately documented is still more challenging.

ISO 9001 is the international standard for the quality management system (QMS). This certification showcases the organization’s commitment to providing products or services that meet customer and regulatory requirements and shows continuous improvement.

Today’s competitive business environment has placed tremendous pressure on medical devices manufacturing companies to lower operating costs, address complex product design, outsource development and seek global expansion plans.

An ISO 13485:2016 supported quality management system is applicable to the medical device industry and follows the ISO 9001 process model of Plan, Do, Check, Act designed for regulatory compliance. It is more prescriptive, requiring a demanding quality management system and documentation.

ISO 14001 was developed primarily to assist companies with a framework for better management control to reduce their environmental impacts. It applies to various industries, including aerospace and defense, automotive, consumer packaged goods, general manufacturing, hi-tech, and life sciences.

With increased environmental challenges in industry and society today, it is difficult to reduce environmental impacts from everyday activities. This challenge has encouraged industries to develop an Environmental Management System (EMS) and be certified to a standard to demonstrate their efforts for managing environmental impacts.

ISO 9001 training comes in numerous varieties, from internal auditor or ISO awareness training to assist the creation and support of a QMS for an organization to training individuals who will be certified for auditing the QMS of companies for certification bodies.

QMS ISO 9001 is the Global Standard for Quality Management Systems, published in 1987. ISO 9001 is a process approach and designed to help organizations ensure that they meet the needs of customers and other stakeholders by having a framework that helps to ensure the quality of goods and services.

ISO 9001 is a standard that facilitates the incorporation of best practices into an enterprise’s Quality Management System (QMS). Compliance to ISO 9001 needs automation and digital technology like ComplianceQuest’s holistic QHSE system.

ISO 45001 is an International Standard for Occupational Health and Safety Management Systems that provides a practical solution for organizations to improve the safety and health of employees and other personnel proactively and prevent injury and ill-health.