Ana Edwards
Quiz by , created more than 1 year ago

This is the test to assess employee comprehension after initial training on the VisionQuest Biomedical Quality Manual and Quality Policy

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Ana Edwards
Created by Ana Edwards over 8 years ago
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Quality Management System: Initial Training Assessment for Employees

Question 1 of 8

12

1. What does the Quality System (QS) do?

Select one of the following:

  • a. The QS addresses good financial practices.

  • b. The QS applies SEC regulations to define company operations within a regulated environment.

  • c. The QS defines how company operates within a regulated environment.

  • d. The QS defines a company's PTO (Paid-Time-Off) policy.

Explanation

Question 2 of 8

13

What is the process for managing changes to a product?

Select one of the following:

  • a. Seapine version control software

  • b. QCBD/Quality Control by Design electronic data management system

  • c. Change control

  • d. Risk Management

Explanation

Question 3 of 8

13

Which of the following requires a CA/corrective action?

Select one of the following:

  • a. 20 out of 100 customers report missing materials in a shipment.

  • b. A suggested modification to reduce likelihood of product failure.

  • c. An incorrect bill is sent to a customer.

  • d. A vendor files for bankruptcy.

Explanation

Question 4 of 8

12

Which choice is NOT part of a quality system?

Select one of the following:

  • a. Defining how a company operates within a regulated environment

  • b. Good financial and accounting practices

  • c. Addressing processes that may impact quality, safety, and efficacy

  • d. Good manufacturing practices

Explanation

Question 5 of 8

13

_______________ defines how product and process documents and records are controlled and managed. (please select a choice to complete the sentence)

Select one of the following:

  • a. Design and Development

  • b. Quality Manual

  • c. Document Record Control

  • d. Purchasing

Explanation

Question 6 of 8

12

What is VQ’s quality policy?

Select one of the following:

  • a. Meeting customer requirements and increasing customer satisfaction

  • b. Providing quality technology products and services that comply with regulations and meet customer needs

  • c. Continuous creation and innovation of products and services

  • d. A and b

  • e. B and c

Explanation

Question 7 of 8

12

Which regulation is our software development aligned to?

Select one of the following:

  • a. QSR 21 CFR 820- FDA

  • b. ISO 13485-Medical Device

  • c. IEC 62304-Software lifecycle

  • d. ISO 14971- Risk Management

  • e. IEC 62366- Usability Engineering

  • f. ISO 15004 - Ophthalmic Instruments: fundamental requirements and test methods

Explanation

Question 8 of 8

13

Which is NOT a VisionQuest Quality objective?

Select one of the following:

  • a. To implement and execute a Quality Management System (QMS) that is based on HIPAA regulations

  • b. To provide product quality and improvements that ensure safe and effective products

  • c. To implement and execute QMS that meets regulation requirements

  • d. To establish supplier criteria selection and oversight for product development activities

Explanation

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