IQC Training Courses for ISO 13485

Irish Quality Centre (IQC) is one of only two providers of IRCA Approved ISO 13485 Internal Auditor Training in Ireland and one of four for Europe as a whole. Its range of ISO 13485 training programs take life sciences professionals from basic familiarity with this important medical device standard to full Internal Auditor and Lead Auditor competence to conduct audits, assess remedial actions and ensure the effectiveness of all core business processes.

The IQC range of ISO 13485 learning and training programs are approved by Exemplar Global and the International Register of Certificated Auditors (IRCA).

The ISO 13485 Standard

ISO 13485:2016 Medical Device Quality Management Systems is a globally recognized benchmark standard for the design, production, and entire life cycle management of medical devices as defined by the International Standards Organisation (ISO), which is the global leader in setting, maintaining and validating industry-based quality standards.

The main objective of ISO 13485 is to impose consistency and uniformity on the quality, design, production, and usage of medical devices internationally and it is specifically adopted by organisations associated with the production, marketing and usage of medical devices. As well as manufacture, it also covers external suppliers and other associated services related to devices.

The ISO standards require organisations to determine the effectiveness of their quality management systems annually through external auditors, with a re-certification audit led by an ISO Certified or Notified Body every third year to ensure ISO 13485 compliance. The annual external audit is hugely important to organisations, making it critical to develop an internal audit team to ensure the organisation is conforming to ISO requirements.

ISO standards also require organisations to conduct their own internal audits with independent and competent auditors taking a Process and Risk Based approach. It is therefore essential that Internal Auditors are given the education, training, knowledge, and Skills to conduct these audits effectively, while Lead Auditors must be fully versed and understand the ISO 13485 Quality Standards to thoroughly manage the audit, and to be able to liaise effectively with external bodies and suppliers.

IQC ISO 13485 courses

IQC’s main offerings for ISO 13485 training are graduated in duration and complexity from basic familiarity to full Auditor expertise:

• ISO 13485 Fundamentals E-Learning: A self-directed, self-paced E-learning course that can be taken over 30 days that enables personnel involved in the development, implementation and auditing of medical device quality management systems, such as operational staff, quality teams, managers, supervisors, designers and engineers, to identify the ISO 13485 requirements. The Fundamentals course provides an ideal platform for those who are new to ISO 13485 or who are scheduled to attend IQC’s accredited Foundation and Internal / Lead Auditor training courses. The syllabus includes general requirements of the standards, management responsibilities, resource management, product planning, customer-related processes, design, development and purchasing.
• ISO 13485 Foundation Training: A one-day online ‘virtual classroom’ course facilitated by Quality Management experts designed to meet the needs of quality personnel, managers, supervisors and anyone responsible for QMS design, development, implementation, and auditing. It is highly useful for those who are new to ISO 13485 or are scheduled to attend IQC IRCA approved Internal Auditor and Lead Auditor training courses. The course learning objectives include being able to identify the principles of a medical device QMS, quality management system, the process approach and process management, how to conduct Gap analysis to address outstanding requirements, risk-based thinking and applicable regulatory requirements, potential implications of MDR regulatory changes, and impact of changes on the auditor role.
• ISO 13485:2016 Internal Auditor Training: Conducted over two day-long sessions, this course can be delivered via Virtual Classroom online or hosted onsite where requested. It includes physical training materials, pre-course study materials, registration with accreditation body, certification, and refreshments where applicable. This course will give those who audit internally against ISO13485 and cGMP to do so from a process-based perspective to check for effectiveness, conformance and identify Improvement opportunities. Syllabus includes ISO 13485-related QMS functions, the structure and key requirements of the ISO standards and regulations and their specific demands on audits, the roles and responsibilities of auditors and lead auditors, audit planning and auditor conduct, evidence gathering, interpretation, reporting and follow-up activities. Learners are given an opportunity to demonstrate their new knowledge in role-playing scenarios, with all key learnings confirmed by final examination to qualify for IRCA auditor certification.
• ISO 13485 Lead Auditor Training: A five-day training program via Virtual Classroom or on client site that evaluates the requirements of the ISO 13485 in detail and demonstrates best-in-class auditing practice in performing internal, supplier and third-party audits of related QMS. On completing an examination and continuous assessment, attendees receive a certificate of achievement that satisfies the formal training requirement for certification as an Exemplar Global and Chartered Quality Institute/IRCA auditor or lead auditor. The syllabus is focused on providing participants with the tools, knowledge, and skills needed to perform effective ISO 13485 management system audits, including planning and conducting an audit to ISO 19011 standards, analysis, interpretation and reporting, follow-up activities, liaison with external auditors, using Process Management methodology, establishing KPI’s, and conducting effective meetings.

Resources

Click on IQC ISO 13485 Auditor Training for further information.
Click on Introduction to IQC to watch video.