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 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.
Welcome to the combined course on : I. ISM (International Safety Management), /ISPS (International Ship and Port Facility Security), /MLC (Maritime Labour Convention)., II. ISO (International Organization for Standardization) standards (ISO 9001, ISO 14001, ISO 45001), This course aims to provide you with a comprehensive understanding of various maritime industry standards and regulations that play a crucial role in ensuring safety, security, environmental protection, and quality management in the maritime sector. I. ISM,ISPS,MLC Maritime Auditor The International Safety Management (ISM) Code sets guidelines for the safe operation of ships and pollution prevention. It establishes a framework for ship management and requires companies to develop and implement a Safety Management System (SMS) to ensure the safety of ships and personnel. The International Ship and Port Facility Security (ISPS) Code is a set of measures designed to enhance the security of ships and port facilities. It aims to detect security threats and take preventive measures to protect ships, ports, and the maritime supply chain from acts of terrorism, piracy, and other criminal activities. The Maritime Labour Convention (MLC) is an international labor standardthat sets out seafarers' rights and working conditions. It covers a wide rangeof issues, including employment contracts, working hours, accommodation, healthand safety, and welfare, ensuring that seafarers are treated fairly and provided with adequate working and living conditions. II. ISO (International Organization for Standardization) standards (ISO 9001, ISO 14001, ISO 45001) ISO standards, including ISO 9001 (Quality Management System), ISO 14001 (Environmental Management System), and ISO 45001 (Occupational Health and Safety Management System), provide internationally recognized frameworks for organizations to manage their quality, environmental, and occupational health and safety responsibilities. These standards help companies establish efficient processes, minimize risks, and improve their overall performance. Throughout this course, you will delve into each topic, exploring their principles, requirements, and best practices. By the end of this combined course, you will have gained valuable insights into the key aspects of maritime safety, security, labor standards, quality management, and the role of the Designated Person Ashore
QMS Auditor/Lead Auditor (ISO 9001) Welcome to our online event where you can become a certified Quality Management System (QMS) Auditor/Lead Auditor for ISO 9001. Elevate your career with the skills to lead successful quality management system audits. This intensive 5-day course is for serious professionals seeking to: Plan and lead effective audit teams Conduct complex supplier and external audits Deliver accurate, valuable audit reports Drive continual improvement in organizations Join us for a comprehensive training session that will equip you with the necessary skills to audit quality management systems effectively. Learn from industry experts and gain valuable insights into ISO 9001 standards. Don't miss this opportunity to enhance your auditing capabilities and advance your career in quality management. Register now! Enroll Today and Take Your Career to the Next Level!
ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement. After completing this course, you can sit for the exam and gain "Certified ISO 13485 Foundation' Certification. This Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach. About This Course Learning Objectives Understand the elements and operations of a Medical Devices Quality Management System (MDQMS) Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Understand the approaches, methods and techniques used for the implementation and management of a MDQMS Course Agenda Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485 Day 2: Medical Devices Quality Management System requirements and Certification Exam Assessment Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice exam on Day 2 of the course. The overall passing score is 70%, to be achieved within the 60 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites None What's Included? Certification fees are included on the exam price Training material containing over 200 pages of information and practical examples will be distributed An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. Who Should Attend? Individuals involved in Medical Devices Quality Management Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS) Individuals interested to pursue a career in Medical Devices Quality Management Accreditation Provided by This course is Accredited by NACS and Administered by the IECB
The “ISO 42001:2023 Lead Implementer Course” is designed to provide participants with the knowledge and skills necessary to lead the implementation of an Artificial Intelligence Management System based on ISO 42001:2023. This comprehensive course covers the key principles, requirements, and best practices for establishing and maintaining an effective Artificial Intelligence management system. Participants will learn how to develop, implement, and manage processes that comply with the ISO 42001 standard.
Traibcert Awareness online course is a comprehensive package that delves into every nook and corner you deserve to know about ISO 17043 & ISO 19011, including all the erstwhile requirements and pragmatic impeccability for compliance. The course is durably defined for novices who exhibit great affinity towards Proficiency testing management and ISO standards.
Traibcert Awareness online course is a comprehensive package that delves into every nook and corner you deserve to know about ISO 31000, including all the erstwhile requirements and pragmatic impeccability for compliance. The course is durably defined for novices who exhibit great affinity towards Risk management and ISO standards.
Traibcert Awareness online course is a comprehensive package that delves into every nook and corner you deserve to know about ISO 22301, including all the erstwhile requirements and pragmatic impeccability for compliance. The course is durably defined for novices who exhibit great affinity towards Business continuity management and ISO standards.
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.