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Online training Package ISO 13485 version 2016

Kurs

Online

225 € zzgl. MwSt.

Beschreibung

  • Tipologie

    Kurs

  • Methodologie

    Online

  • Unterrichtsstunden

    30h

  • Dauer

    60 Days

  • Beginn

    nach Wahl

  • Persönlicher Tutor

    Ja

Beschreibung

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.

Wichtige informationen

Dokumente

  • PQBD22v16Sf30p.pdf
  • PQBD42v16Sf10p.pdf

Welche Ziele verfolgt der Kurs?: This pack of courses will help you learn how to implement, audit and improve your ISO 13485 v 2016 medical devices quality management system

Ist dieser Kurs für mich?: Any person involved in the implementation, improvement and internal audit of your ISO 13485 v 2016 medical devices quality management system

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

Voraussetzungen: Notions of a quality management system

Einrichtungen

Lage

Beginn

Online

Beginn

nach Wahl Anmeldung möglich

Themen

  • Management
  • Audit
  • Quality
  • ISO
  • Medical
  • Medical training
  • Management of Risk
  • Process Control
  • Process mapping
  • Quality Training

Inhalte

The T 22v16 readiness course:

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 T 42v16 internal audit course:

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
  • 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)

Zusätzliche Informationen

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

Online training Package ISO 13485 version 2016

225 € zzgl. MwSt.