1 Educators providing Courses in London

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

The “ISO 42001:2023 Lead Auditor Course” integrates the principles of ISO 42001:2023, the International Standard for Artificial Intelligence Management, with the methodologies outlined in ISO 19011:2018, the Guidelines for Auditing Management Systems. The course equips participants with the skills and knowledge required to lead Artificial Intelligence audits effectively, ensuring compliance with ISO 42001:2023, and applies the principles of ISO 17011:2017 for conformity assessment bodies.

The "ISO 14298:2021 Lead Auditor Course" integrates the principles of ISO 14298:2021, the International Standard for Security Printing Management, with the methodologies outlined in ISO 19011:2018, the Guidelines for Auditing Management Systems. The course equips participants with the skills and knowledge required to lead security printing audits effectively, ensuring compliance with ISO 14298:2021, and applies the principles of ISO 17011:2017 for conformity assessment bodies. It covers audit planning, execution, and reporting while emphasizing risk management and continual improvement.

ISO 7101 Healthcare Quality Management System Lead Auditor Course provides participants with the knowledge and skills necessary to lead audits of quality management systems within healthcare organizations. This comprehensive training program covers the principles, processes, and practices of auditing healthcare quality management systems, focusing on key standards and regulations applicable to the healthcare industry.

The “ISO 20387 Lead Assessor Course” is a comprehensive program designed to equip individuals with the knowledge and skills needed to assess and evaluate biobanking systems in accordance with ISO 20387:2018. This course focuses on the principles of assessment, audit methodologies, and the specific requirements of ISO 20387. Participants will learn how to lead and conduct assessments of biobanking facilities and organizations to ensure compliance with the standard.

ISO 30401 sets requirements and provides guidelines for establishing, implementing, maintaining, reviewing and improving an effective management system for knowledge management in organizations. All the requirements of this standard are applicable to any organization, regardless of its type or size, or the products and services it provides. Knowledge management is the intentional process of defining, structuring, retaining, and sharing an organization’s employees’ knowledge and experience.