23 Courses

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.

Official BRCGS Food Safety Issue 9 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

Official BRCGS Food Safety Issue 9 Lead Auditor training course. Delivered online (Zoom) by a live BRCGS Approved Training Partner & Virtual Trainer. Exam and Certificate fee included in the price.

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.

This course provides the basic requirements for auditing IFD&FA systems to BS 5839-1 to certification bodies' standards. The course enables certified contractors to conduct objective auditing of their own systems.

This course provides the basic requirements for auditing I&HAS to PD 6662, EN 50131, BS 8243, and access control / CCTV systems to certification bodies' standards. The course enables certified contractors to conduct objective auditing of their own systems.

Course Information Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. Extending Expertise: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. Relevance and Value: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.  Key Benefits: Enrich your skill set to: Navigate audit processes encompassing planning, execution, reporting, and follow-up Embrace a personalised approach fostering positive audit outcomes Analyse evidence and present cohesive audit findings Recognise the pivotal role of audits in driving continual improvement. Interactive Learning: Structured to foster dynamic engagement, this course encourages delegates to: Engage in discussions, idea development, and problem-solving Exchange invaluable information and experiences. Hands-On Experience: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion View pop up Programme Please note timings may be subject to alteration. Day 1 08:45 Registration 09:00 Welcome and Course Objectives 09:10 What is 'Audit'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 Audits and their Purpose The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 Break 10:45 Audit Planning The requirements for an effective audit programme and individual audit plans. 11:30 Workshop 1 - Getting the Audit Started Planning for the audit. 12:25 Workshop 1 - Feedback 12:45 Lunch 13:30 Workshop 2 - Getting the Audit Started Arranging the opening meeting. 13:50 Workshop 2 - Feedback Audit initiation. Review and discussion of the role of the opening meeting. 14:25 Auditing Techniques (1) - Data and Documentation Techniques for the conduct of data and report audits are investigated. 14:55 Break 15:10 Workshop 3 - Data and Documentation Audit Conducting an audit of a data package and supporting documentation. 17:15 Close of Day Day 2 09:00 Auditing Techniques (2) - The People Questioning techniques which get the required information from the auditee. 09:45 Live Audit Role Play Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 Break 10:35 Audit Closing Meeting An exploration of audit closing meetings. 11:00 Workshop 4 - Audit Observations and Preparing for the Closing Meeting Reviewing and categorising your observations and getting ready to present your case. 11:45 Workshop 4 - Feedback 12:30 Audit Reports The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 Lunch 13:45 Workshop 5 - Audit Reports and Follow-up Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 Workshop 5 - Feedback 14:55 Corrective and Preventive Action and Follow-up The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 Panel Session An opportunity to get answers to outstanding questions. 15:30 Close of Course Extra Information Course material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. CPD Points 14 Points   Development Level Develop

Master the art of safety auditing and risk assessment with our comprehensive course! Explore topics such as safety culture, advanced auditing techniques, risk assessment, and COSHH compliance. Gain practical skills to conduct effective audits, implement corrective actions, and contribute to a safer workplace. Elevate your expertise in occupational health and safety with our expert-led training for continuous improvement and compliance. Join us now for a safer, healthier, and more secure professional environment!