Wednesday, April 08 2020

T 43v16 - E-Learning - ISO 13485 internal audit version 2016 (test)

E-Learning (online course) - Conduct an internal audit of your ISO 13485 medical devices quality management system and your processes

$108.94
Ex. VAT
T 43v16 - E-Learning - ISO 13485 internal audit version 2016 (test)
  • Number of hours: 2 Hours
  • Added the: 11/11/2012
  • Last update: 21/11/2019
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Description of the online course internal audit of your medical devices quality management system ISO 13485: 2016

Discover the internal audit in an ISO 13485 certified company and

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  • locate the audit in the quality approach
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  • identify the stakes
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  • understand the requirements
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  • control the tools
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Get used to

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  • best practices
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  • good behavior
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  • the terminology
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  • the questionnaire
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  • the report
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The important and fundamental elements of an internal audit

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  • scope
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  • normative references
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  • principles
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  • audit program (responsibilities, records)
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  • audit conducting (objectives, evidence, conclusions)
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  • auditor competence (knowledge, training)
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The menu of the course

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  • Presentation
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  • MCT (multiple-choice test) Beginning (10 questions)
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  • 1 Scope
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  • 2 Normative references
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  • 3 Definitions
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  • 4 Principlesrn
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    • 4.1 Management principles
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    • 4.2 Audit principles
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    • 4.3 QMS performance
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  • MCT Internal audit (7 questions)
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  • 5 Audit programrn
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    • 5.1 General
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    • 5.2 Objectives
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    • 5.3 Risks
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    • 5.4 Establishing
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    • 5.5 Implementing
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    • 5.6 Monitoring
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    • 5.7 Reviewing and improving
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  • Case Audit program
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  • MCT Audit program (11 questions)
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  • 6a Audit preparationrn
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    • 6.1 General
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    • 6.2 Initiatingrn
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      • 6.2.1 First contact
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      • 6.2.2 Situations and feasibility
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    • 6.3 Preparing the auditrn
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      • 6.3.1 Document review
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      • 6.3.2 Audit plan
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  • Case Audit readiness
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  • MCT Audit preparation (8 questions)
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  • 6b Coduct an auditrn
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    • 6.4 Audit activitiesrn
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      • 6.4.1 Opening meeting
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      • 6.4.2 Audit evidence
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      • 6.4.3 Audit conclusions
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    • 6.5 Audit report
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    • 6.6 Completing the audit
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    • 6.7 Audit follow-up
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  • Case Audit report
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  • Case Management review
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  • MCT Conduct an audit (8 questions)
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  • 7 Competence and evaluation of auditorsrn
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    • 7.1 General
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    • 7.2 Auditor competence
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    • 7.3 Evaluation criteria
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    • 7.4 Evaluation methods
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    • 7.5 Auditor evaluation
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    • 7.6 Improving competence
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  • Case Auditor question
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  • MCT Auditor competence (7 questions)
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  • MCT End (20 questions)
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Read more about the online course ISO 13485 internal audit

To conduct an audit according to ISO 19011 in order to:

  • identify improvement opportunities
  • increase the satisfaction of interested parties
  • evaluate the performance of the ISO 13485 quality management system medical devices

Basic knowledge of ISO 13485, rudiments of ISO 19 011

Any person involved in the implementation and maintenance of an ISO 13485 quality management system:

  • quality director
  • quality manager
  • metrology manager
  • safety manager
  • maintenance manager
  • QSE manager
  • internal auditor (present or future)
  • quality correspondent
  • quality technician 
  • quality assistant 
  • quality operator 
  • person in charge of specific system, process or product audit 
  • future auditee 
  • student 

20 hours online on average (according to knowledge and aptitudes this duration can vary individually). One hour of online training is equivalent to at least 2 hours of training on the spot

The methods how to organize and conduct the audit:

  • build the audit plan
  • control the questionnaire
  • know how to avoid the conflicts
  • analyse the documents
  • show the strong points
  • detect the improvement opportunities
  • make so that conclusions are accepted
  • write the audit report
  • initiate the actions
  • follow-up the actions

Methods and tools:
  • dedicated Internet site
  • specific online training module
  • Open and Distance Learning (ODL) teaching
  • your training history:
    • the time you have passed on each clause and subclause of the module
    • the record of the score of all your trials of the multiple-choice tests (MCTs)
  • level test at beginning of the training
  • 6 tests (MCTs) with comments, notes on a 20 point scale and recommendations
  • true stories
  • good practices
  • bad practices
  • case studies
  • jokes
  • games
  • online tutorial :
    • a follow up of acquired material and the progress of each trainee
    • online or by e-mail within 24 hours
    • personalized answers to questions
    • advice and recommendations about documents, books and useful links 
  • delivered certificate of attendance and mastery at the end of the training 

Access to the course is 60 days from the date of validation of your order. This period will be renewed for free upon a simple request within 6 months

 The requirements of ISO 13485 version 2016 are:

On this page

Here is a MCT (Multiple-choice test) to evaluate, before beginning, the level of your knowledge for this course. (One or more correct answers are possible). You can start again as many times you wish.

1. The results of the process internal audit:

2. The objectives of an audit program are influenced by:

3. The extent of the audit program, among other things, depends on:

4. The audit procedure contains, at minimum, instructions on how to:

5. The implementation of the audit program requires:

6. The records related to the audits, among other things, contain the:

7. Improving the audit program takes into account the:

8. An internal audit is initiated, for example:

9. The audit report often contains:

10. Traps to be avoided by an auditor: