PT 264 ISO 13485:2016 Internal Auditor Training Course

Yes, this is a CQI-IRCA Certified Internal Auditor Training Course under Course ID 2481. The course is aligned to recognised Internal Auditor learning requirements for ISO 13485 in the medical devices context. Successful completion supports learners who are seeking to meet the training requirement for CQI-IRCA Internal QMS Auditor registration, subject to the CQI-IRCA registration criteria in force at the time of application.

This course is intended for professionals who need to plan, conduct, or participate in first-party internal audits of a Medical Device Quality Management System against ISO 13485. It is suitable for individuals responsible for auditing a process, activity, department, or function within an organisation’s QMS, rather than carrying out a full third-party certification audit. Learners should have a basic understanding of ISO 13485, which may be gained through prior workplace exposure, existing QMS knowledge, or successful completion of a Fundamentals course.

Yes, learners should already be familiar with the requirements of ISO 13485, or should have successfully completed a Fundamentals course beforehand. This is a recommended prerequisite for attending the course, as it provides the essential background knowledge needed for Internal Auditor training. Having this prior understanding will help ensure that you can fully engage with the audit lifecycle activities covered during the course, including planning, conducting, reporting, and following up internal audits.

This course is the right level if your goal is to become competent to perform internal audits within a Medical Device QMS against ISO 13485. The course is practical and skills-based, covering audit planning, evidence gathering, findings writing, and reporting. If you are completely new to ISO 13485, a Fundamentals course may be the best first step before progressing to Internal Auditor training.

The delivery format for your course will be confirmed at the time of registration. If your cohort is delivered virtually, the training will take place on the Zoom platform, and you will receive the relevant joining instructions, access details, and platform guidance in advance. To participate effectively, you will need a stable internet connection and a laptop, desktop, iPad, or other tablet device that supports the required platform, together with working audio and an active web camera.

The course is practical and interactive, with a strong focus on applying audit methods in realistic medical device QMS audit scenarios. It includes consultant-facilitated activities aligned to the ISO 19011 audit lifecycle. There is also a strong emphasis on auditor behaviours, audit tools, and evidence-based evaluation throughout the programme.

No, this Internal Auditor course does not include a final written or online certification exam. Instead, the learning consultant carries out regular in-class assessment during the course through activities, participation, and performance evaluation. Full attendance is required, and successful completion is based on attendance together with satisfactory in-class assessment outcomes.

After completing the course, you will be able to plan and conduct internal audits against ISO 13485 for a process, activity, department, or function within an organisation. You will also be able to gather, verify, and evaluate objective evidence using a range of audit methods, rather than relying on interviews alone. In addition, you will be able to write clear audit findings and contribute effectively to audit reporting and follow-up activities.

You will receive structured learning materials, including access to the relevant standards and content aligned to Internal Auditor competence development. You will also be provided with practical audit tools and templates, such as audit plans, audit scope documents, and audit protocols or checklists, to support the learning process. The course also includes scenario-based exercises designed to help you develop confidence in evidence gathering, writing audit findings, and contributing to audit reporting.

This course places a strong focus on process effectiveness and how QMS performance links to product quality, regulatory compliance, and operational control in the medical devices sector. It develops auditor capability using wider audit methods, including interviews, document review, and analysis of process, product, and operational records. The course follows a practical, structured approach aligned to the ISO 19011 audit lifecycle, rather than relying on theory alone.

At Kelmac Group, we recommend this ISO 13485 internal auditor training for professionals involved in quality assurance, regulatory affairs, manufacturing, engineering, supplier management and compliance. It is also valuable for anyone responsible for internal or supplier audits within a medical device organisation.

Our ISO 13485 internal auditor training helps organisations address challenges such as maintaining regulatory compliance, fulfilling audit requiremens, managing risk, managing audit findings and supporting corrective actions. It also helps develop a more structured approach to audit planning, evidence gathering and reporting.

Internal auditing helps your organisation assess whether its QMS is effectively implemented and maintained, identify areas for improvement and support ongoing compliance with ISO 13485 requirements. At Kelmac Group, we focus on developing auditors who can conduct process and risk based audits systematically and objectively based upon ISO 13485 and regulatory requirements.

ISO 13485 requires organisations to conduct regular internal audits, with the audit programme determined according to the organisation's previous history, needs, processes risks and opportunities and previous audit results. At Kelmac Group, we recommend using a performance and risk-based approach when establishing the audit frequency rather than applying the same schedule to every organisation.

Professionals who have completed ISO 13485 training and demonstrated the required knowledge, auditing skills and competence can be considered for internal auditor responsibilities. At Kelmac Group, we also emphasise gaining practical audit experience and developing an understanding of applicable medical device regulations before undertaking audits independently. The organisation should ensure that auditors have appropriate competence for the audits they perform and that auditors are selected to maintain objectivity and impartiality throughout the audit process.