5739884
Descripción
Test por Ana Edwards, actualizado hace más de 1 año
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Creado por Ana Edwards
hace más de 8 años
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Pregunta 1
Pregunta
1. What does the Quality System (QS) do?
Respuesta
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a. The QS addresses good financial practices.
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b. The QS applies SEC regulations to define company operations within a regulated environment.
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c. The QS defines how company operates within a regulated environment.
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d. The QS defines a company's PTO (Paid-Time-Off) policy.
Pregunta 2
Pregunta
What is the process for managing changes to a product?
Respuesta
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a. Seapine version control software
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b. QCBD/Quality Control by Design electronic data management system
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c. Change control
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d. Risk Management
Pregunta 3
Pregunta
Which of the following requires a CA/corrective action?
Respuesta
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a. 20 out of 100 customers report missing materials in a shipment.
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b. A suggested modification to reduce likelihood of product failure.
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c. An incorrect bill is sent to a customer.
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d. A vendor files for bankruptcy.
Pregunta 4
Pregunta
Which choice is NOT part of a quality system?
Respuesta
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a. Defining how a company operates within a regulated environment
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b. Good financial and accounting practices
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c. Addressing processes that may impact quality, safety, and efficacy
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d. Good manufacturing practices
Pregunta 5
Pregunta
_______________ defines how product and process documents and records are controlled and managed. (please select a choice to complete the sentence)
Respuesta
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a. Design and Development
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b. Quality Manual
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c. Document Record Control
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d. Purchasing
Pregunta 6
Pregunta
What is VQ’s quality policy?
Respuesta
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a. Meeting customer requirements and increasing customer satisfaction
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b. Providing quality technology products and services that comply with regulations and meet customer needs
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c. Continuous creation and innovation of products and services
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d. A and b
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e. B and c
Pregunta 7
Pregunta
Which regulation is our software development aligned to?
Respuesta
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a. QSR 21 CFR 820- FDA
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b. ISO 13485-Medical Device
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c. IEC 62304-Software lifecycle
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d. ISO 14971- Risk Management
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e. IEC 62366- Usability Engineering
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f. ISO 15004 - Ophthalmic Instruments: fundamental requirements and test methods
Pregunta 8
Pregunta
Which is NOT a VisionQuest Quality objective?
Respuesta
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a. To implement and execute a Quality Management System (QMS) that is based on HIPAA regulations
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b. To provide product quality and improvements that ensure safe and effective products
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c. To implement and execute QMS that meets regulation requirements
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d. To establish supplier criteria selection and oversight for product development activities
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