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Quiz

Quality Management System: Initial Training Assessment for Employees

Ana Edwards 8 perguntas 5,0 (1 avaliação)

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Perguntas do quiz (8)

  1. 11. What does the Quality System (QS) do?
    1. Aa. The QS addresses good financial practices.
    2. Bb. The QS applies SEC regulations to define company operations within a regulated environment.
    3. Cc. The QS defines how company operates within a regulated environment.
    4. Dd. The QS defines a company's PTO (Paid-Time-Off) policy.
  2. 2What is the process for managing changes to a product?
    1. Aa. Seapine version control software
    2. Bb. QCBD/Quality Control by Design electronic data management system
    3. Cc. Change control
    4. Dd. Risk Management
  3. 3Which of the following requires a CA/corrective action?
    1. Aa. 20 out of 100 customers report missing materials in a shipment.
    2. Bb. A suggested modification to reduce likelihood of product failure.
    3. Cc. An incorrect bill is sent to a customer.
    4. Dd. A vendor files for bankruptcy.
  4. 4Which choice is NOT part of a quality system?
    1. Aa. Defining how a company operates within a regulated environment
    2. Bb. Good financial and accounting practices
    3. Cc. Addressing processes that may impact quality, safety, and efficacy
    4. Dd. Good manufacturing practices
  5. 5_______________ defines how product and process documents and records are controlled and managed. (please select a choice to complete the sentence)
    1. Aa. Design and Development
    2. Bb. Quality Manual
    3. Cc. Document Record Control
    4. Dd. Purchasing
  6. 6What is VQ’s quality policy?
    1. Aa. Meeting customer requirements and increasing customer satisfaction
    2. Bb. Providing quality technology products and services that comply with regulations and meet customer needs
    3. Cc. Continuous creation and innovation of products and services
    4. Dd. A and b
    5. Ee. B and c
  7. 7Which regulation is our software development aligned to?
    1. Aa. QSR 21 CFR 820- FDA
    2. Bb. ISO 13485-Medical Device
    3. Cc. IEC 62304-Software lifecycle
    4. Dd. ISO 14971- Risk Management
    5. Ee. IEC 62366- Usability Engineering
    6. Ff. ISO 15004 - Ophthalmic Instruments: fundamental requirements and test methods
  8. 8Which is NOT a VisionQuest Quality objective?
    1. Aa. To implement and execute a Quality Management System (QMS) that is based on HIPAA regulations
    2. Bb. To provide product quality and improvements that ensure safe and effective products
    3. Cc. To implement and execute QMS that meets regulation requirements
    4. Dd. To establish supplier criteria selection and oversight for product development activities

Informações

Descrição
This is the test to assess employee comprehension after initial training on the VisionQuest Biomedical Quality Manual and Quality Policy
Idioma
English
Visualizações
135
Avaliação
5,0 de 5 · 1 avaliação
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