Online training Package ISO 13485 version 2016
Course
Online
*Indicative price
Original amount in EUR:
272 €
Take this course and improve public health through safe medical devices!
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Type
Course
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Methodology
Online
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Class hours
30h
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Duration
60 Days
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Start date
Different dates available
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Personal tutor
Yes
Emagister adds to its catalog the Online training Package ISO 13485 v 2016. Readiness for implementation, certification, maintenance, internal audit and improvement of your medical devices quality management system (ISO 13485 v 2016) in order to meet applicable regulatory requirements, improve public health through safe medical devices and increase the satisfaction of interested parties.
If you want to enjoy all the benefits of the course, contact with us through our website so we can provide you with the most relevant information.
Important information
Documents
- PQBD22v16Sf30p.pdf
- PQBD42v16Sf10p.pdf
Facilities
Location
Start date
Start date
About this course
This pack of courses will help you learn how to implement, audit and improve your ISO 13485 v 2016 medical devices quality management system
Any person involved in the implementation, improvement and internal audit of your ISO 13485 v 2016 medical devices quality management system
Notions of a quality management system
Certificate of mastery and attendance
Low price, you can train when you want, where you want, at your own rhythm of progress, games, jokes, case studies, true stories, good practices, bad practices
You receive an email with links to the courses, to the free demos, to the help how to order, details of the contact person
Reviews
This centre's achievements
All courses are up to date
The average rating is higher than 3.7
More than 50 reviews in the last 12 months
This centre has featured on Emagister for 16 years
Subjects
- Audit
- Quality
- ISO
- Medical
- Medical training
- Quality Training
- Management
- Management of Risk
- Process Control
- Process mapping
Teachers and trainers (1)
Milev André
Manager
Course programme
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)
The menu of the course
- Presentation
- MCT (multiple-choice test) Beginning (10 questions)
- 1 Scope
- 2 Normative references
- 3 Definitions
- 4 Principles
- 4.1 Management principles
- 4.2 Audit principles
- 4.3 QMS performance
- MCT Internal audit (6 questions)
- 5 Audit programme
- 5.1 General
- 5.2 Objectives
- 5.3 Establishing
- 5.4 Implementing
- 5.5 Monitoring
- 5.6 Reviewing and improving
- Case Audit programme
- MCT Audit programme (11 questions)
- 6a Audit preparation
- 6.1 General
- 6.2 Initiating
- 6.2.1 First contact
- 6.2.2 Situations and feasibility
- 6.3 Preparing the audit
- 6.3.1 Document review
- 6.3.2 Audit plan
- Case Audit readiness
- MCT Audit preparation (9 questions)
- 6b Performing an audit
- 6.4 Audit activities
- 6.4.1 Opening meeting
- 6.4.2 Audit evidence
- 6.4.3 Audit conclusions
- 6.5 Audit report
- 6.6 Completing the audit
- 6.7 Audit follow-up
- 6.4 Audit activities
- Case Audit report
- Case Management review
- MCT Performing an audit (8 questions)
- 7 Competence and evaluation of auditors
- 7.1 General
- 7.2 Auditor competence
- 7.3 Evaluation criteria
- 7.4 Evaluation methods
- 7.5 Auditor evaluation
- 7.6 Improving the competence
- Case Auditor question
- MCT Auditor competences (8 questions)
- MCT End (20 questions)
Additional information
Students per class: 1
Contact person: André Milev
Online training Package ISO 13485 version 2016
*Indicative price
Original amount in EUR:
272 €