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deGRANDSON Learner Alex

ISO 13485 Lead Auditor Training

SKU: Course 036.

€1,265

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EASY PAYMENT PLAN:  Pay in four equal monthly installments.

Standard: ISO 13485
Latest Version: 2016
Revision of: ISO 13485:2003
Duration: 36 hours approx. (including auditor certification exam) Delivery: Online (on-demand and self-paced)

CPD/CEU Units: 6.0

Description: This ISO 13485 lead auditing course is an ISO 21001 certified lead auditor training course designed to provide lead auditors with the skills and knowledge needed to audit medical device management systems (MDMS). It is based on the requirements of ISO 13485:2016, known in full as Medical devices management system requirements for regulatory purposes.
Course Content

  • Module 0: Introduction and background to the ISO 13485 standard and to auditing
  • Module 1: Auditing Skills based on the auditing standard ISO 19011:2018
  • Module 2: Knowledge of the Standard, ISO 13485:2016. Includes EU, UK, USA (QSR & QMSR), Health Canada MDSAP Regulations & EN Annexes (Amendment 11)
  • Module 3: Practice with Scenarios, based n actual audits, and inludes advice on dealing with awkward situations and individuals.
 Related Courses:

  • ISO 13485 Lead Auditor Extension – if you are already a Lead Auditor for another standard
  • ISO 13485 Lead Auditor Refresher – if you need to update your knowledge and skills
  • ISO 13485 Lead Implementer – if your focus is on implementing and maintaining an MDMS
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Category: ISO 13485. Tag: Lead Auditor Certification Online Course.
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  • Description

ISO 13485 Lead Auditor Training Course Content

Be an internationally-certified Lead Auditor

This ISO 13485 Lead Auditor Training course provides you with the Auditing Skills, the Knowledge of the Standard and the practical application of that knowledge with Audit Scenarios to enable you, as Audit Team Leader, to undertake and manage Certification Audits.

 

Who should enroll in this ISO 13485 Lead Auditor Course?

 

This ISO 13485 Lead Auditor Training course is intended for:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Project managers
  • Design engineers
  • Software engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Medical affairs
  • Legal Professionals

 

What will I learn from this ISO 13485 Lead Auditor Course?

 

This comprehensive ISO 13485 Lead Auditor Training course covers all aspects of Internal Auditing and is divided into five Courses:

  • Module 0: Introduction and background to the Standard and auditing. Includes EU, UK, USA Regulations & MDSAP
  • Module 1: Auditing Skills to Lead Auditor Level and based on the auditing standard ISO 19011:2018
    • Auditing Skills
    • Terms and definitions
    • Principles of auditing
    • Auditor skills
    • Managing an audit program
    • Audit Team Leadership
    • Overview of Audit Activities
    • Audit activities – Step 1
    • Audit activities – Step 2
    • Audit activities – Step 3 (2 modules)
    • Audit activities – Step 4
    • Audit activities – Step 5
    • Audit Activities – Step 6
    • FAQs about Auditing
    • Online Course Examination
  • Module 2: Knowledge of the Standard, ISO 13485:2016, Medical Devices – Quality management systems – Requirements for regulatory purposes
    • Introduction to ISO 13485:2016
    • Developing & Implementing a QMS
    • Terms & Definitions – ISO 13485:2016
    • Some Key aspects of QMS Auditing
    • Fundamentals of Medical Device Management Systems
    • Structure & content of ISO 13485:2016
    • Parts 1, 2 & 3
    • Part 4: Quality Management System Requirements
    • Part 5: Management Responsibility
    • Part 6: Resources
    • Part 7: Product Realisation (3 lessons)
    • Part 8: Measurement, Analysis & Improvement (2 lessons)
    • Annexes ZA & ZB (from Amendment 11)
    • Advanced aspects of QMS Auditing (3 lessons)
    • FAQs about the Standard
    • Online Course Examination
  • Module 3: Practice with Scenarios, based on actual audits and includes advice on dealing with awkward situations and individuals.
    • Audit Scenarios – Internal Auditor
    • More Audit Scenarios – Lead Implementers
    • FAQs about the Auditing Experience
    • Online Final Examination

 

What materials are included in this ISO 13485 Lead Auditor Course?

 

The ISO 13485 Lead Auditor Certification course comes with:

  • Diagram: ISO Auditor Certification Process
  • Diagram: 6-Stage Audit Process
  • Sample Code of Ethics
  • Management of an Audit Programme
  • Sample Audit Plan
  • Sample Audit Work Order
  • Sample Nonconformity Report
  • Sample Working Document & Checklist
  • Risk Assessment Tools and Methodologies
  • Documented Information Requirements of ISO 13485:2016
  • Determining the Context of the Organization
  • ISO 13485:2016 and Risk Management
  • Risk Assessment Tools and Methodologies (with examples)
  • Terms & Definitions
  • Typical Process Map

 

How is this ISO 13485 Lead Auditor Course delivered?

 

The ISO 13485 Lead Auditor Training course is delivered online from our Learning Management System (LMS) at www.degrandsonLMS.com (provided by Inquisiq). 

All Modules have a full resume and scaling capabilities. This means, for example, you can…

  • Start a Module at work on your Work Station running on Windows 10,
  • Continue the Module on the train home on your iPad running on iOS 9 and,
  • Complete the Module at home on your Notebook PC running on Windows 8.1

 

Are there any prequalifications to enroll in this ISO 13485 Lead Auditor Course?

 

For this ISO lead auditor training online the minimum of a Secondary School Certificate (such as a High School Diploma, Baccalaureate or similar National Vocational Qualification) combined with 5 years’ work experience, with at least 2 at managerial/supervisory level, is recommended.

You do not have to provide us with any evidence of your qualifications and experience. However, if you do not meet these requirements, you can expect to struggle with the Program.

Not sure this is the best ISO 13485 Course for you?

See our ISO 13485 course overview page for the full list of our ISO 13485 courses or our answers to frequently asked questions about ISO 13485 certification.

 

Related Courses

ISO 13485 Internal Auditor Course – to conduct effective internal audits

ISO 13485 Lead Auditor Extension Course – to add to your existing certification

ISO 13485 Lead Auditor Refresher Course – to refresh your knowledge and skills

Related Articles

  • How to Implement ISO 13485: A 33 Step Guide
  • ISO 13485 and Supplying to the Medical Device Sector: 9 FAQs
ISO 21001 Educational Organization certified

Learn more about our ISO 21001 Certification

Path to ISO 13485 MDMS Certification infographic

Download Copy of ISO 13485 Certification Chart

ISO 13485 FAQs eBook cover

Download free ISO 13485 Certification FAQs eBook

Frequently Asked Questions


Is the Program Certified?

Yes, deGRANDSON is an ISO 21001 certified educational organization certified by BQAI, an internationally accredited certification body.

ISO 21001 is a university grade standard used globally by schools, colleges, and universities. We are also certified to ISO 29993: 2017 (Learning services outside formal education and Service requirements) and ISO 29994:2021 (Education and learning services; Requirements for distance learning).

Are there corporate discounts?
Yes, details of discounts, based on numbers enrolled, can be found on the Corporate Discounts page.

How can I pay?
You can pay by Debit Card, Credit Card or PayPal during the Program Enrolment procedure. Click on this link to view the Payment Process.

Is there an Examination?
Yes. In addition to the Quizzes at the end of each Module, there is at the end of each Course (set of Modules/Lessons) a formal Examination. The decision to award a Certificate is based on the combined scores achieved. The Examinations are open-book (you can have the Standard and other notes open beside you), time-limited and taken online. There are no extra costs involved.

What do I get when I’ve completed the Program?
Once you have completed the Examination, your Certificate is immediately available to you. Your Certificate will be forwarded to you as an email attachment that you may print as often as you like. There is no time limit on the validity of your Certificate.

What else will I need to become a competent auditor?
Provided you have the required personal attributes, all you need to add is auditing experience.

Who can I contact for more information?
Just send an e-mail to [email protected] or, for other options, see Contact Us.

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