ISO 13485 Lead Auditor Course
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Language
English
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Duration
30 hours
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CPE
36
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Course type
Online self-paced + live online workshop
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This ISO 13485 Lead Auditor training is accredited by ASIC and allows you to become a certification auditor for ISO 13485. The course was created to help you start working for certification bodies or expand your consulting
After passing the exam, you will receive an ISO 13485 Lead Auditor certificate, accredited by ASIC, which proves your ability to perform certification audits and lead audit teams.
The ISO 13485 Lead Auditor course is divided into three parts:
- A video library: includes lessons and practical information about the standard and how to prepare for the ISO 13485 audit, lead the audit team, perform the audit and prepare the final audit report
- An interactive workshop: helps you practice the concepts necessary for auditing the standard guided by an Advisera top expert
- ISO 13485 Lead Auditor certification exam: upon successful completion of the exam, you will get a certificate and a badge for your LinkedIn profile to highlight your qualifications
Who should attend:
- Novice consultants/auditors seeking to acquire new expertise and perform medical device QMS certification audits
- Experienced consultants/auditors needing proof of their competence as ISO 13485 lead auditor
- Quality managers that need to prepare for a medical device QMS audit
Prerequisites:
- There are no prerequisites to attend the ISO 13485 Lead Auditor course.
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Introduction
Introduction to the course
Module 1 - Introduction to ISO 13485
Introduction & suggested reading
What is ISO 13485:2016?
What is the QMS?
Why is ISO 13485:2016 important?
What is the structure of ISO 13485?
Key principles of quality management
Key interested parties in ISO 13485
Implementing ISO 13485 using The Plan Do Check Act Process
The ISO 13485 Project
Certification FAQs
Recap quiz
Module 2 - Management and Supporting Processes
Introduction & suggested reading
What is a process?
Top management commitment (clauses 5.1 and 5.2)
Quality Policy and objectives (clauses 5.3 and 5.4)
Roles and responsibilities (clause 5.5)
Management review (clause 5.6)
Documentation process (clauses 4.1 and 4.2)
Quality Manual (clause 4.2.2)
Medical Device File (clause 4.2.3)
Handling the QMS documentation (clause 4.2.4)
Records for the QMS (clause 4.2.5)
Importance of Resources management process (clause 6.1)
Managing human resources (clause 6.2)
Managing infrastructure resources (clause 6.3)
Managing work environment (clause 6.4.1)
Managing contamination (clause 6.4.2)
Managing monitoring and measuring equipment (clause 7.6)
Related documentation
Recap quiz
Module 3 - Product Realization Planning, Contract Review, and Design & Development
Introduction & suggested reading
Planning of Product Realization (clause 7.1)
Example of planning Product Realization
Overview of Customer-Related processes (clause 7.2.1)
Review of a contract or customer purchase order (clause 7.2.2)
Communication methods for the Customer-Related processes (clause 7.2.3)
Design and development overview (clause 7.3.1)
Planning for design and development (clause 7.3.2)
Design and development inputs (clause 7.3.3)
Design and development outputs (clause 7.3.4 and 7.3.5)
Design and development verification and validation (clause 7.3.6 and 7.3.7)
Design and development transfer to production (clause 7.3.8)
Control of design and development changes (clauses 7.3.9, 7.3.10)
Related documentation
Recap quiz
Module 4 - Purchasing, Production, and Service Provision
Introduction & suggested reading
Purchasing overview (clause 7.4)
Vendor Evaluation and performance (clause 7.4.1)
Purchasing information and verification of product (clauses 7.4.2 and 7.4.3)
Production and service provision overview (clause 7.5.1)
Qualification of your infrastructure (clauses 7.5.3 and 7.5.6)
Validation of processes (clauses 7.5.6 and 7.5.7)
Labeling and packaging (clause 7.5.11)
Cleanliness of product (clauses 7.5.2 and 7.5.5)
Identification and traceability (clauses 7.5.8 and 7.5.9)
Customer property and preservation (clauses 7.5.10 and 7.5.11)
Post-delivery processes (clauses 7.5.3 and 7.5.4)
Related documentation
Recap quiz
Module 5 - Measurement, Analysis, and Improvement
Introduction & suggested reading
Monitoring and measuring overview (clause 8.1)
Monitoring and measurement of products (clause 8.2.6)
Monitoring and measurement of processes (clause 8.2.5)
Feedback (clause 8.2.1)
Complaint handling (clause 8.2.2)
Reporting to regulatory authorities (clause 8.2.3)
Internal audits (clause 8.2.4)
Control of non-conforming product (clause 8.3)
Analysis of data (clause 8.4)
Improvement (clause 8.5.1)
Corrective actions (clause 8.5.2)
Preventive actions (clause 8.5.3)
Related documentation
Recap quiz
Module 6 - Auditing Basics
Introduction & suggested reading
Auditor assumptions
Techniques for finding evidence
Sampling the records
Interviewing techniques
The audit findings
Nonconformities
Observations
Internal vs. external audit
Annual audit program
Audit plan for an individual audit
Creation of the checklist
Internal audit report
Corrective action requests and corrective action follow-up
Recording the evidence
Recap quiz
Module 7 - Understanding Auditing Standards
Introduction & suggested reading
What is certification?
Certification process
Certification of integrated management systems
Introduction to accreditation and ISO 17021
Competences of lead auditors required by ISO 17021-1
Introduction to International Accreditation Forum (IAF) documents
Introduction to ISO 19011
Principles of auditing
Recap quiz
Module 8 - Understanding Audit Roles and Responsibilities
Introduction & suggested reading
Audit Team Leader / Lead Auditor
Auditor
Technical Specialist
Certification Reviewer
Audit Client
Management Team
Auditee
Hosts / Guides
Recap quiz
Module 9 - Planning the Audits
Introduction & suggested reading
Audit criteria and objectives
Audit scope
Selecting audit methods
Sampling evidence in audits
Types of remote auditing techniques
Deciding when to use remote auditing techniques
Planning the use of remote auditing techniques
Selecting the audit team
Managing audit risks
Preparing the audit plan
Allocating audit activities to auditors
Making contact with the audit client
Preparation of audit resources
Recap quiz
Module 10 - Managing the Audit Process
Introduction & suggested reading
Opening meeting
Managing site visits
Interviews
Audit evidence requests
Debriefing sessions
Dealing with conflicts
Related documentation
Recap quiz
Module 11 - Managing Your Audit Team
Introduction & suggested reading
The importance of managing your audit team
Communication with the team before the audit
Managing audit progress
Team meetings
Managing audit findings
Managing audit records
What to do when you hit problems
Evaluating your audit management
Recap quiz
Module 12 - Completing a Successful Audit
Introduction & suggested reading
Audit findings
How to reach audit conclusions
Planning the closing meeting
Holding an effective closing meeting
Dealing with feedback at closing meetings
Effective audit report writing
Post-audit activities, corrections, and correction actions
Certification review process
Related documentation
Recap quiz
Instructions for taking the exam and obtaining the certificate
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Advisera’s courses are accredited by ASIC
ASIC is one of the world's largest international accreditation agencies for schools, colleges, universities, and online learning providers. Based in the UK, this government-approved quality assurance body is recognized globally, with more than 400 providers accredited in over 65 countries.
Why Advisera chose ASIC
Advisera chose ASIC accreditation because it is focused primarily on leading universities and online training organizations. When compared to other accreditation bodies, it has the largest portfolio of higher education organizations, as well as distance education providers.
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About the ISO 13485 Lead Auditor course
How do I purchase exams for several people?
We have prepared a discount if you purchase certificates for more than one student at once. Do not hesitate to contact us at sales@advisera.com to find out the prices.
Are the ISO 13485 Lead Auditor course and certificate accredited?
Yes, both the course and the certificate are accredited by ASIC, an internationally renowned quality standard for schools, colleges, universities, and online learning providers. This accreditation provides additional credibility for the quality of Advisera’s courses and ensures that the certificate is globally recognized.
What is the deadline for attending the video lectures?
There is no time limit, so you can take as long as you need to watch the video lectures. We do, however, recommend that you watch them all within three to four weeks so that you get the most benefit from them.
What is needed to access the ISO 13485 Lead Auditor online training?
All you need to access the course is your PC, Mac, or mobile device; any major browser (Chrome, Firefox, Internet Explorer, Safari, etc.); and a broadband Internet connection. And, of course, enough available time to devote to the course.
What do I need to know before attending the course?
You don’t need any prior knowledge or experience in auditing – this course was designed so that a beginner to these topics will understand it.
How do I participate in the workshop?
To participate in the online workshop, we will send you a special link to connect to Zoom. All you need is a computer with a microphone, speakers, and web camera. We recommend that you have the web camera on during the workshop for an enhanced learning experience.
Are there prerequisites for attending the workshop?
Completion of all of the video lessons is the only prerequisite.
How do I get certified as ISO 13485 lead auditor?
It's simple:
- Watch complete videos of all of the lessons, and answer all of the practice exams.
- Attend the workshop
- Pass the online exam.
When will I receive the certificate for the course?
After watching all of the video lessons and completing the workshop, you may take the ISO 13485 Lead Auditor certification exam. If you earn a passing score, you will be issued the certificate. Please note that during the exam, an online proctoring service will verify your identity and ensure that you take the exam without assistance. Click here to learn more about our online proctoring service.
About the ISO 13485 Lead Auditor examWhat does it take to pass the exam and earn the certificate?
The ISO 13485 Lead Auditor course materials (video lectures, quizzes, reading materials, practice exams, and other resources) are all you need to successfully pass the certification exam and receive your certificate.
How many questions are on the exam?
There are a total of 93 questions on the exam; some of them are True/False questions, while the others are multiple choice questions, and all correctly answered questions are worth 1 mark.
How much time is allowed for the exam?
The time allowed to answer all the questions on the ISO 13485 Lead Auditor exam is 150 minutes. However, please reserve an additional 15 minutes of your time for a system check up before you start the exam session.
In which language is the exam?
The exam is in English.
Where will I take the examination?
The certification exam can be taken online, from anywhere. To make this possible, we employ an online proctoring service. Click here to learn more.
Online course
Workshop and certificate
- 1-day online workshop
- Accredited course
- ISO 13485 Internal Audit Checklist
- Course script
- Access to practice exam
- Exam retake
Exam submitted
Exam failed
Exam passed
Exam failed
Please expect an email from exams@proctorexam.com titled "Please register for your exam." This email will usually arrive within one business day of purchase.
Your time slot for the exam will be open right after your complete the system check. You will be able to enter the session the moment you click on the link from the email titled "You are now ready to take your exam" as seen here.
Please contact us at support@advisera.com if you need our help.
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US $1797
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Course Instructors
Kristina Zvonar Brkic
Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and auditor and assessor for MDD.
Carlos Pereira da Cruz
Carlos Pereira da Cruz has more than 30 years of experience working as a consultant, trainer, and auditor with ISO 9001 and ISO 14001. He is a university teacher and author of several books on strategic management, ISO 9001, and ISO 14001.
Garry Cornell
Garry Cornell has more than 25 years of global experience as a senior manager, certification auditor, and consultant, helping a wide range of businesses in their implementations of ISO 14001, ISO 45001, and ISO 50001. He has developed various courses and is the author of several books on auditing techniques and ISO 14001. He is a member of the Institute of Environmental Management and Assessment.
Why Advisera ISO 13485 Lead Auditor Course?
Free unlimited access to the entire course
Globally recognized accreditation by ASIC
Expert support from Advisera's top experts
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