Blended ISO 13485:2016 Lead Auditor Training (CQI & IRCA Pending)
This blended course (online & classroom) is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain the knowledge and skills required to perform first, second and third-party audits of QMS against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015
Did you know? This course is delivered both online & in a classroom. Each learner must complete an 16hr online training course before attending a classroom-based 2.5-day skills-based training session. The major benefit to this approach is that it offers each Learner the flexibility to learn at their own pace and reduce the overall time spent in a classroom!
If you are interested in this course, we recommend having a look at our free online ISO 13485:2016 introduction course. Check it out today!
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- 40 Hours
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An application has been made to CQI & IRCA for certification of this course!
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Includes Online ISO 13485:2016 Pre-Course Assignment [Additional]
Each Learner will receive access to an additional Online ISO 13485:2016 Pre-Course Assignment that focuses on the Learners knowledge of the ISO 13485:2016 requirements and other key prior learning topics! This online assignment is included FREE & to ensure each Learner is well prepared, meets the prior learning requirements & gets the most out of their training!
Module 0 - Course Introduction [Online]
In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.
Module 1 - Introduction to Quality Management Systems (QMS) [Online]
In this module we will explore the purpose and benefits of a QMS, Structure of ISO 13485:2016, key terminology related to auditing, Plan-Do-Check Act (PDCA) Cycle, application of risk-based thinking, process approach & controls and the significance of these for the QMS auditor.
Module 2 - Introduction to Auditing [Online]
In this module we will explore the different types of audits including MD-SAP, benefits of accreditation, principles of auditing, audit program management and the audit lifecycle.
Module 3 - Planning the Audit [Online]
In this module we will explore the criteria for selection of the audit team, roles and responsibilities throughout the audit, desired auditor behaviors, determining audit scope, objectives and criteria.
Module 4 - Audit Initiation and Preparation [Online]
In this module we will explore the activities associated with the first two phases of the audit lifecycle. Topics to be covered will include, establishing contact with the auditee, audit feasibility, document review and finally preparation of a risk-based audit plan and development of the audit checklists.
Module 5 - Conducting the Audit [Online]
In this module we will explore the activities associated with the first third phases of the audit lifecycle. Topics to be covered will include, opening meeting, communication, auditee reactions and conflict resolution, audit methods and audit evidence.
Module 6 - Generating Audit Findings and Closing Meeting [Online]
In this module we will explore the final audit team meeting, the steps required to generate and document the audit findings and the process for determining the audit conclusion. We will also review the purpose and agenda for the closing meeting.
Module 7 - Audit Reporting, Completion and Follow-Up [Online]
In this module we will explore the final three phases of the audit lifecycle including coverage of the audit report, steps required to complete the audit and requirements for following-up on the audit.
Module 8 - Course Introduction [Classroom]
In this module, an introduction to the classroom element of the blended course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & training delivery.
Module 9 - Planning the Audit [Classroom]
In this module we will explore the key steps that are required to plan the audit using a risk-based approach. We will also conduct a document review in preparation for the audit and practice the skills required to prepare the necessary documents for the audit including the audit checklist.
Module 10 - Conducting the Audit [Classroom]
In this module we will practice the skills required to effectively conduct an audit using a sample QMS case study. A variety of audit methods will be practiced during this session including interview, document review and data analysis.
Module 11 - Generating Audit Findings and Closing Meeting [Classroom]
In this module we will practice the skills required to write and grade non-conformities and determine audit conclusions. We will also practice the skills required to conduct a closing meeting
Module 12 - Audit Report and Follow Up Activities [Classroom]
In this module we will practice the skills required to prepare the audit report and to evaluate audit responses including differentiating between a correction and corrective action.
This course is fully certified by Comply Guru™. An application is being made to CQI & IRCA for this “variant” course.
What is a variant? The core Blended QMS Lead Auditor Course is CQI & IRCA Certified (No. 2192) – but we are working on the “variant” which specifically focuses on ISO 13485:2016 and this is being submitted to CQI & IRCA for approval.
In order to successfully complete this blended course, each Learner will need to:
- Complete the online course and obtain 70% or higher in the final assessment (part 1 of 2)
- Fully attend the classroom element, obtain 70% or higher in the continuous assessment & obtain 70% or higher in a 2-hour CQI & IRCA set final examination (part 2 of 2)