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T 22v16D - Free demo course - E-Learning ISO 13485: 2016 readiness

Free demo E-Learning (online course) - Implementation, maintenance and improvement of your medical devices management system ISO 13485 version 2016 - You save 31 euros on the documents provided!

 
For free !
T 22v16D - Free demo course - E-Learning ISO 13485: 2016 readiness
  • Number of hours: 3 Hours
  • Added the: 07/03/2017
  • Last update: 05/12/2018
See other trainings
 

Opinions

It was great. Claudia. 26/05/2018

Very useful to recover basic informations concerning the processes and the definitions. Massimiliano. 09/07/2018

I learned the most from the cases - being able apply the information was very helpful. Kristen. 23/08/2018

Description of the online course for your medical devices quality management system ISO 13485 version 2016

Discover the ISO 13485 standard and

  • its contents
  • its principles
  • its requirements
  • its stakes

Get used to

  • process approach
  • medical device terminology
  • risk-based thinking
  • improvement
  • feedback

The important and fundamental elements of a medical device quality management system

  • quality approach (quality management principles, PDCA cycle)
  • standards and specifications
  • process approach (definitions, process types, mapping)
  • applicable regulatory requirements
  • management review
  • risks and opportunities
  • resources, communication, documents
  • production and service provision
  • performance evaluation
  • improvement

The menu of the course

  • Presentation
  • MCT (multiple-choice test) Beginning (10 questions)
  • 1 Quality approach
    • 1.1 Background and references
    • 1.2 Scope
  • 2 Principles and steps
  • MCT Quality approach (8 questions)
  • 3 Process approach
    • 3.1 Definitions
    • 3.2 Processes
      • 3.2.1 Management process
      • 3.2.2 Realization process
      • 3.2.3 Support process
    • 3.3 Process mapping
    • 3.4 Process approach
  • MCT Process approach (6 questions)
  • 4 QMS
    • 4.1 General
    • 4.2 Documentation
  • Case Interested parties
  • MCT QMS (9 questions)
  • 5 Management responsibility
    • 5.1 Management commitment
    • 5.2 Customer focus
    • 5.3 Quality policy
    • 5.4Planning
    • 5.5 Responsibility
    • 5.6 Management review
  • 6 Resource management
    • 6.1 Provision of resources
    • 6.2 Personnel
    • 6.3 Infrastructure
    • 6.4 Work environment
  • Case Customer & need
  • Case Clean room
  • Case Management review
  • MCT Management responsibility (8 questions)
  • 7 a Product realization
    • 7.1 Planning
    • 7.2 Customers
    • 7.3 Design and development
  • MCT Planning (8 questions)
  • 7 b Product realization
    • 7.4 Purchasing
    • 7.5 roduction
    • 7.6 Monitoring and measuring equipment
  • Case Process stability
  • Case Selecting suppliers
  • Case New line
  • MCT Purchasing and production (8 questions)
  • 8 Improvement
    • 8.1 General
    • 8.2 Monitoring and measurement
    • 8.3 Nonconforming product
    • 8.4 Analysis of data
    • 8.5 Improvement
  • Case Nonconformities
  • Case Audit programme
  • Case Kaizen & problem
  • MCT Improvement (9 questions)
  • MCT End (20 questions)

 

Read more about the online course ISO 13485 version 2016

Readiness for implementation, certification, maintenance and improvement of your quality management system ISO 13485 in order to:

  • meet applicable regulatory requirements
  • improve public health through safe medical devices
  • increase the satisfaction of interested parties
  • improved image of the company
  • one step ahead of the competition
  • increased safety of staff
  • reduction of production costs
  • reducing or eliminating incidents
  • increased confidence of interested parties
  • the prevention of risks becoming routine
  • better economic results
  • increased daily effectiveness
  • staff is aware, consulted, motivated and proud
  • high level of risk control
  • commitment profitable for all
  • good practices valorized
  • standardization of know-how
  • control of processes
  • regulatory requirements up-to-date

Good knowledge of quality management systems

Any person involved in the preparation and implementation of a medical device quality management system:

  • director
  • quality director
  • quality manager
  • metrology manager
  • safety manager
  • maintenance manager
  • project leader
  • quality correspondent
  • quality technician
  • quality assistant
  • quality operator
  • internal auditor
  • 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.

At the end of the module, you will be able to:

  • interpret the requirements of the ISO 13485 standard
  • take part in the development of the quality policy and objectives
  • take part in the implementation of the document system
  • understand and implement the 7 quality management principles
  • evaluate the ISO 13485 certification project
  • be familair with the steps and tools for implementation of your QMS

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 MCTs (multiple-choice tests)
  • level test at beginning of the training
  • 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 the ISO 13485 standard v 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 standard ISO 13485 defines for a medical devices quality management system:

2. A process is, among other things, determined by its:

3. The general requirements request that the QMS be:

4. The mandatory procedures of ISO 13485 v 2016 are:

5. Top management commitment, among other things, is:

6. Resource management requires that:

7. The review of product requirements includes:

8. The design and development outputs:

9. The internal audit:

10. The documented procedure for preventive action includes: