T 22v16 - E-Learning - ISO 13485 readiness medical devices management system version 2016
E-Learning (online course) - Implementation, maintenance and improvement of your medical devices management system ISO 13485 version 2016 - You save 36 euros on the documents provided!
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See the online course T 42v16 ISO 13485 Internal audit See the online training package T 72v16 ISO 13485 |
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| Result of the training satisfaction survey : | 80% | Last update on July 14, 2023 |
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
Very thorough information. Thomas. 06/06/2023
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
- MD readiness documents
- MD internal audit documents
- 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
- Case Interested parties
- MCT Process approach (6 questions)
- 4 QMS
- 4.1 General
- 4.2 Documentation
- Case New risk
- Case Risk treatment
- Case Risk register
- Case Change
- MCT QMS (9 questions)
- 5 Management responsibility
- 5.1 Management commitment
- 5.2 Customer focus
- 5.3 Quality policy
- 5.4 Planning
- 5.5 Responsibility
- 5.6 Management review
- Case 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
- MCT Management responsibility (8 questions)
- 7 a Product realization
- 7.1 Planning
- 7.2 Customers
- 7.3 Design and development
- Case Communication
- Case Priority tasks
- Case Design review
- MCT Planning (8 questions)
- 7 b Product realization
- 7.4 Purchasing
- 7.5 Production
- 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 readiness
- Case Audit program
- Case Auditor question
- Case Audit report
- 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)
- your training history:
- the time you have passed on each clause and sub-clause 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
- videos
- 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 (example)
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 version 2016 are:
Test your knowledge of the requirements of ISO 13485 version 2016 in relation to the clauses and sub-clauses of the standard by answering the questions of the:
What is ISO 13485 for medical devices? 8' 27"
Evolution of ISO 13485:2016 and ISO 9001:2015 standards 22' 12"
ISO 13485:2016 VIDEO PRESENTATION 23' 24"
How to Simplify Your Compliance with the New ISO 13485:2016 1h 45' 23"
ISO 13485: 2016 Part 1: Getting Ready for Changes 15' 39"
ISO 13485: 2016 Part 2: Getting Ready for Changes 36' 50"
ISO 13485:2016 Part 3: Getting Ready for Changes 21' 25"
A Risk-Based Approach to QMS Ahead of ISO 13485 Changes 1h 29' 10"
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 determined, among other things, by its:
3. The general requirements request that the QMS be:
4. The mandatory procedures of ISO 13485 version 2016 are:
5. Top management commitment is, among other things:
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:
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