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.
Before The Classroom Modules
- Complete the online course modules and obtain 70% or higher in the final assessment (2 Online MCQ-based Assessments) by the required deadline set in advance of the given classroom dates you are registered for
During The Classroom Modules
- Fully attend the classroom element as 100% attendance is required
- Obtain 70% or higher in the course continuous assessment during the classroom element
- Obtain 70% or higher in a 2-hour CQI & IRCA set final examination
- The Plan, Do, Check, Act (PDCA) Cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
- Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
- Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course & final examination may be very challenging.
Fluency in spoken and written English
- For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.
Printed Copy of ISO 13485:2016
- Each participant should bring a printed clean copy of the standard with them to the course. This is not provided by Comply Guru.
E-Learning System RequirementsThe below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Recommended Operating SystemsWindows 7/10, Mac OSX Sierra, iPad IOS10
Mobile DevicesComply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.
Internet SpeedWe recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content
Recommended Internet Browsers
- Google Chrome 32 bit version 50 or later
- Safari 10 or later
Recommended SettingsWe recommend that the following settings are enabled:
- Pop-ups (in both Internet Browser and security software)
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader