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Online ISO 13485 version 2016 Quality Management System readiness course

4.8
3 opiniões
  • 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.
    |

Online

R$ 1.324

* Preço indicativo

Montante original emEUR:

200 €

Descrição

  • Tipologia

    Curso

  • Metodologia

    Online

  • Horário de aulas

    20h

  • Duração

    60

  • Início

    Datas a escolher

  • Tutor pessoal

    Sim

Descrição

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.

Informação importante

Documentos

  • PQBD22v16Sf30p.pdf

Quais são os objetivos da formação?: This course will help you learn how to implement and maintain your ISO 13485 medical devices quality management system version 2016!

Esta formação é para mim?: Any person involved in the preparation, implementation, certification and maintenance of your ISO 13485 version 2016 medical devices quality management system

Qual é o processo de inscrição?: 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

Requisitos: none

Instalações

Localização

Início

Online

Início

Datas a escolher Inscrições abertas

Opiniões

4.8
excelente
100%
4.7
excelente

Avaliação do curso

O recomendam

Avaliação do Centro

Claudia

21/05/2019
Sobre o curso: An excellent course
Curso realizado: Maio 2019
Você recomendaria esse centro?: sim

Massimiliano

18/05/2019
Sobre o curso: It was a great reminder of the basic processes and definitions
Curso realizado: Maio 2019
Você recomendaria esse centro?: sim

Kristen

21/05/2019
Sobre o curso: I learned a lot from the case studies and being able to appy what we had learned was so useful.
Curso realizado: Maio 2019
Você recomendaria esse centro?: sim
* Opiniões recebidas pela Emagister e iAgora

Matérias

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

Programa

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)

Informação adicional

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

Online ISO 13485 version 2016 Quality Management System readiness course

R$ 1.324

* Preço indicativo

Montante original emEUR:

200 €