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deGRANDSON Learner Ivana

ISO 14971 Risk Management – Advanced

SKU: Course 724.

€420 Original price was: €420.€336Current price is: €336.

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EASY PAYMENT PLAN:  Pay in four equal monthly instalments.

Standard: ISO 14971
Latest Version: 2019
Revision of: 
ISO 14971:2007
Duration: 16 hours approx. (including auditor certification exam) Delivery: Online (on-demand and self-paced)

CPD/CEU Units: 2.7

Description:
This ISO 14971 risk management training course is for those wishing to manage medical device risk for their companies. It is based on ISO 14971:2019 and ISO/TR 24971:2020.
Course Content

This advanced risk management course covers the selection, application, and recording of Risk Management methods and is divided into four Modules:

  • Module 0: Introduction and background to the Course.
  • Module 1: Application of Risk Management to Medical Devices based on the auditing standard ISO 14971:2019 and includes …
    • Risk Management Process
    • Management Responsibilities
    • Qualification of Personnel
    • Risk Management Plan
    • Risk Management File
  • Module 2: Selecting and applying the methods and tools used, including …
    • SWIFT – What-If Analysis
    • Checklists – various types
    • PHA – Preliminary Hazard Analysis
    • FTA – Fault Tree Analysis
    • ETA – Event Tree Analysis
    • FMEA– Failure Mode and Effects Analysis (general)
    • dFMEA – Design FMEA
    • pFMEA – Process FMEA
    • uFMEA – User FMEA
    • HAZOP – Hazard and Operability Study
    • HACCP – Hazard Analysis & Critical Control Points
  • Module 3: Advanced Risk Management including …
    • Risk Acceptance
    • Risk Control
    • Risk Evaluation
    • Special Risk Situations including IVDs
Related Courses:

  • ISO 14971 Risk Management Course (Foundation) – if you are already an internal auditor

Customer Feedback

Gnana Sakaran Rajagopal (Principal, GSR Consulting Services)

On-line study at my own pace is most suitable learning media to me. The course is timely with the latest 2019 edition of the Standard coupled with value for money package.

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Category: Risk Management. Tag: Risk Assessment and Risk Management Courses.
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  • Description

ISO 14971:2019 Risk Management – Advanced Course Contentiso 21001 Certified

Be an internationally-certified Medical Device Risk Management Professional

deGRANDSON’S Risk Management courses — both foundation and advanced versions — provide you with the Tools, Skills and Knowledge necessary to plan, implement and maintain a Risk Management Programme for your medical device (or component) manufacturing organization.

 

Who should enroll in this ISO 14971 Risk Management – Advanced Course?

 

This 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 14971 Risk Management – Advanced Course?

 

This comprehensive Course covering all aspects of medical device risk management is divided into four Modules …

    • Module 0: Introduction and background to the Course
    • Module 1: Application of Risk Management to Medical Devices based on the auditing standard ISO 14971:2019 and includes …
      • Risk Management Process
      • Management Responsibilities
      • Qualification of Personnel
      • Risk Management Plan
      • Risk Management File
      • Risk Analysis process
      • Intended use and reasonably foreseeable misuse
      • Identification of characteristics related to safety
      • Identification of hazards and hazardous situations
      • Risk Estimation
      • Implementation of risk controls
      • Residual risk evaluation
      • Benefit-risk analysis
      • Completeness of risk control
      • Online Module 1 Examination
    • Module 2: Selecting and applying the methods and tools used, including …
      • SWIFT – What-If Analysis
      • Checklists – various types
      • PHA – Preliminary Hazard Analysis
      • FTA – Fault Tree Analysis
      • ETA – Event Tree Analysis
      • FMEA– Failure Mode and Effects Analysis (general)
      • dFMEA – Design FMEA
      • pFMEA – Process FMEA
      • uFMEA – User FMEA
      • HAZOP – Hazard and Operability Study
      • HACCP – Hazard Analysis & Critical Control Points
      • Online Module 2 Examination
    • Module 3: Advanced Risk Management including …
      • Risk Acceptance
      • Risk Control
      • Risk Evaluation
      • Information for Safety and on Residual Risk
      • Role of ISO and IEC Standards in Risk Management
      • Risks related to Information Security
      • Components and Devices designed without using ISO 14971
      • Using ISO 14971 in in-vitro Diagnostic Medical Devices (with examples)
      • Online Module 3 Examination

 

What materials are included in this ISO 14971 Risk Management – Advanced Course?

 

These include examples. illustrative figures and a set of Hazard Analysis Templates, namely:

  • Risk Management Process
  • Terms and Definitions for ISO 14971
  • Example Design FMEA
  • Example Process FMEA
  • Example User FMEA
  • Example FMECA Rating Table
  • Note: Choice of Tools used for Riak Assessment
  • Note: HACCP Principles and Hazard Analysis
  • Note: Supply Chain Integrity Best Practice
  • Fig 1: Hazards – Sequence of Events – Hazardous Situations
  • Fig 2: Example of Risk Chart
  • Fig 3: Example of Qualitative 3 x 3 Risk Matrix
  • Fig 4: Example of Semi-quantitative 5 x 5 Risk Matrix
  • Fig 5: Sequence of events and risk – Safety
  • Fig 6: Sequence of events and risk – Information Security
  • Fig 7: Production and Post-production Information Sources
  • Fig 8: Example of the application of the P1 x P2 Approach
  • Form 724-001 SWIFT What-If Analysis
  • Form 724-002 Hazard Identification Checklist
  • Form 724-003 Preliminary Hazard Analysis
  • Form 724-004-A Event Tree Analysis
  • Form 724-004-B Event Tree Analysis with probabilities
  • Form 724-005-A FMEA Team Start
  • Form 724-005-B Design FMEA Scope Worksheet
  • Form 724-005-C Process FMEA Scope Worksheet
  • Form 724-005-D FMEA Worksheet (Word file)
  • Form 724-005-E FMEA Worksheet (Excel file)
  • Example HACCP Plan

 

How is this ISO 14971 Risk Management – Advanced Course delivered?

 

deGRANDSON’s risk management courses are 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 11 and,
  • Complete the Module at home on your Notebook PC running on Windows 8.1

 

Are there any prequalifications to enroll in this ISO 14971 Risk Management – Advanced Course?

 

For this advanced course, 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.

A working knowledge of ISO 13485 and relevant regulations is needed to get the maximum benefit from this Course.

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 14971 Course for you?deGRANDSON Global Monthly News Subscribe button

Check out our ISO 14971 Medical Device Risk Management – Foundation course for comparison or see our answers to frequently asked questions about ISO 14971.

 

Related Courses

ISO 13485 Training Courses

ISO 45001 Training Courses

 

Related Articles

Risk Management in ISO Management System Standards

ISO 13485 Requires Risk Management & Risk-based Thinking

ISO 45001 requires Risk Management & not just Risk-based Thinking

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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