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Online ISO 13485 version 2016 Quality Management System readiness course

4.8
3 Meinungen
  • An excellent course
    |
  • It was a great reminder of the basic processes and definitions
    |
  • I learned a lot from the case studies and being able to appy what we had learned was so useful.
    |

Kurs

Online

200 € zzgl. MwSt.

Beschreibung

  • Tipologie

    Kurs

  • Methodologie

    Online

  • Unterrichtsstunden

    20h

  • Dauer

    60 Days

  • Beginn

    nach Wahl

  • Persönlicher Tutor

    Ja

Beschreibung

Emagister adds to its catalog the Online ISO 13485 v 2016 Quality Management System readiness Course.

The course focuses on readiness for implementation, certification and maintenance of your medical devices quality management system (ISO 13485 version 2016).

The goal is to be able to meet applicable regulatory requirements and improve public heath through safe medical devices.

If you want to enjoy all the benefits of the course, contact us through our website Emagister.co.uk so we can provide you with the most relevant information.

Wichtige informationen

Dokumente

  • PQBD22v16Sf30p.pdf

Welche Ziele verfolgt der Kurs?: This course will help you learn how to implement and maintain your ISO 13485 medical devices quality management system version 2016!

Ist dieser Kurs für mich?: Any person involved in the preparation, implementation, certification and maintenance of your ISO 13485 version 2016 medical devices quality management system

Wie geht es nach der Info-Anfrage weiter?: You receive an email with links to the course, to the free demo, to the help how to order and details of the contact person

Voraussetzungen: none

Einrichtungen

Lage

Beginn

Online

Beginn

nach Wahl Anmeldung möglich

Meinungen

4.8
ausgezeichnet
100%
4.7
ausgezeichnet

Kursbewertung

Empfehlung der User

Anbieterbewertung

Claudia

21.05.2019
Über den Kurs: An excellent course
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja

Massimiliano

18.05.2019
Über den Kurs: It was a great reminder of the basic processes and definitions
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja

Kristen

21.05.2019
Über den Kurs: I learned a lot from the case studies and being able to appy what we had learned was so useful.
Kurs abgeschlossen: Mai 2019
Würden Sie diesen Bildungsanbieter weiterempfehlen?: Ja
*Erhaltene Meinungen durch Emagister & iAgora

Themen

  • Quality Policy
  • Quality
  • ISO
  • Medical
  • Medical training
  • Process Control
  • Process mapping
  • Quality management
  • Quality Training
  • Quality manual

Inhalte

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)

Zusätzliche Informationen

Comments: Interactive and independant training
Students per class: 1
Contact person: André Milev

Online ISO 13485 version 2016 Quality Management System readiness course

200 € zzgl. MwSt.