Course Objectives
Note: All attendees must study the current published version of ISO 13485 before attending class. Evening study recommended. A 2-hour final exam is required.
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Quality Management System (QMS) Basics – Describe the core components of an effective QMS.
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QMS Requirements – Describe the ISO 9000 standard series as well as analyze requirements of and relationship between ISO 9001:2015 and ISO 13485:2016.
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Auditing Basics – Describe the audit cycle, auditor responsibilities, and identification of audit-related risks and opportunities.
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Process- and Risk-Based Approach to Auditing – Describe how to use a process- and risk-based approach to increase the value of your audits.
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Audit Planning – Learn how to plan all aspects of an audit, including creating working documents.
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Performing the Audit – Learn how to conduct the opening meeting, collect and verify information (including sampling concepts), listen/question effectively, and generate audit findings.
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Recording and Following Up on the Audit – Learn how to present audit results, conduct a closing meeting, and do needed follow-up.
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QMS Certification – Describe the third-party QMS certification process.
Course Topics
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Interpretation and use of ISO 13485:2016 as audit criteria
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The audit cycle and ISO 19011:2018
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Audit planning activities
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Process and risk-based auditing techniques
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Interviewing and listening techniques
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Evidence collection techniques and sampling
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Nonconformity reporting
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Audit follow-up and corrective action
Who Should Attend
This course was originally designed to train third-party auditors, but most attendees lead their company’s QMS implementation and/or audit programs. Ideal for anybody involved in a supplier quality assurance program who has auditing experience and/or has completed an internal auditor course.
Exemplar Global-Certification
Oriel STAT A MATRIX is a registered training provider with Exemplar Global and this virtual instructor-led ISO 13485 Lead Auditor training course provides evidence of knowledge and skills aligned with their auditor personnel certification schemes. To successfully complete the course, you must earn a passing grade in the course assessments and pass the final online examination. To enroll in an Exemplar Global auditor personnel certification program, you will need to register with Exemplar Global and may need to complete additional requirements such providing an audit log.
Course Pre-Work
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In advance of the workshop, course participants are required to complete one short (~ ½ hour) eLearning module covering basic topics related to ISO 13485. Completion of this module helps to level-set course attendees, ensuring familiarity with key course topics and an ability to hit the ground running on the first day of class. Access to the eLearning module is provided to course participants the week before the start of the class.
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All participants must read – and be familiar with the contents of – the ISO 13485:2016 standard before attending this course.
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We strongly encourage participants to bring a personal copy of the ISO 13485:2016 standard that you can mark up during the class. We can provide the standard electronically for your use during the training (if needed), but due to copyright restrictions we cannot give out a downloadable file.
Course Schedule
Virtual Class Days: The first 8 days run 1:00-5:00 p.m. Eastern time (ET); the final session runs 11:30 a.m.- 5:00 p.m. ET to allow time for administering the final exam.
Virtual Half-Days:
9
In-Person Full-Days:
5
CEUs:
4.4