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    HR-04 Training Evaluation Questionair - IsO 13485

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    Amit Pal
    The document is a training evaluation questionnaire for employees who received training on ISO 13485:2016. It contains 10 multiple choice questions to assess the employee's understanding of key aspects of ISO 13485:2016, including its purpose as a quality management system for medical devices. It also addresses topics like management responsibility, corrective actions, product realization requirements, and benefits of implementation such as improved quality and reduced liability risks. The questionnaire is out of a total assigned marks and calculates the employee's training evaluation percentage. It determines if retraining is required.

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    HR-04 Training Evaluation Questionair - IsO 13485

    Uploaded by

    Amit Pal
    42 views2 pages
    The document is a training evaluation questionnaire for employees who received training on ISO 13485:2016. It contains 10 multiple choice questions to assess the employee's understanding of key aspects of ISO 13485:2016, including its purpose as a quality management system for medical devices. It also addresses topics like management responsibility, corrective actions, product realization requirements, and benefits of implementation such as improved quality and reduced liability risks. The questionnaire is out of a total assigned marks and calculates the employee's training evaluation percentage. It determines if retraining is required.

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    The document is a training evaluation questionnaire for employees who received training on ISO 13485:2016. It contains 10 multiple choice questions to assess the employee's understanding of key aspects of ISO 13485:2016, including its purpose as a quality management system for medical devices. It also addresses topics like management responsibility, corrective actions, product realization requirements, and benefits of implementation such as improved quality and reduced liability risks. The questionnaire is out of a total assigned marks and calculates the employee's training evaluation percentage. It determines if retraining is required.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as docx, pdf, or txt
    42 views2 pages

    HR-04 Training Evaluation Questionair - IsO 13485

    Uploaded by

    Amit Pal
    The document is a training evaluation questionnaire for employees who received training on ISO 13485:2016. It contains 10 multiple choice questions to assess the employee's understanding of key aspects of ISO 13485:2016, including its purpose as a quality management system for medical devices. It also addresses topics like management responsibility, corrective actions, product realization requirements, and benefits of implementation such as improved quality and reduced liability risks. The questionnaire is out of a total assigned marks and calculates the employee's training evaluation percentage. It determines if retraining is required.

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    of 2

    ANNEXURE

    PARAS SURGICO
    DOC.NO. FRM/HR/04
    Training Evaluation Questionnaire SUPERSEDES: 00
    EFFECTIVE DATE: 15.03.2023

    Employee name: Department:


    Job title: Date of Training:
    Training Topic: ISO 13485:2016 awareness
    Name of Trainer:

    Questionnaires:
    (Note: Please Tick““the correct Answer. Each correct answer carries __Mark)
    Marks Obtained

    1.What is ISO 13485 :2016


    a. A Quality management System b.-Medical devices Quality management system
    c. Rule d. Quality management system for automobile Industry
    Ans:

    2. Quality management System which is applied to medical devices .


    a. ISO13485:2016 b. ISO 9001 :2015.
    c. IATF d. ISO 16949
    Ans.

    3. ISO 13485:2016 Clause 4 is related to


    a. Quality Management system b. Production
    c. medical Checkup d. management responsibility
    Ans:

    4.Which of the following is NOT a benefit of implementing ISO 13485:2016?


    a. Improved product quality and reliability b. Increased customer satisfaction
    c. Reduced risk of product liability d. product quality decreases
    Ans

    5-What is the purpose of a corrective action in ISO 13485:2016?


    a. To punish employees who made mistakes b. To prevent nonconformities from recurring
    c. To meet regulatory requirements d. To reduce production costs
    Ans:

    6-Which of the following is a requirement of ISO 13485:2016 for product realization?

    a. Establishing a risk management process b. Conducting design reviews

    c. Implementing a process for production and service provision d. All of the above

    Ans:

    7. What is the purpose of a QMS surveillance audit in ISO 13485:2016?

    a. To verify compliance with ISO 13485:2016 requirements b. To provide feedback for improving the QMS
    ANNEXURE
    PARAS SURGICO
    DOC.NO. FRM/HR/04
    Training Evaluation Questionnaire SUPERSEDES: 00
    EFFECTIVE DATE: 15.03.2023

    c. To determine if the organization should be certified to ISO 13485:2016 d. All of the above

    Ans :

    8. Which of the following is an example of a medical device under ISO 13485:2016?

    a. A smartphone app for tracking fitness goals b. A bicycle helmet

    c. A pacemaker d. A toy car

    Ans:

    9. What is the difference between ISO 13485:2016 and ISO 9001:2015?

    a. ISO 13485 is specific to medical devices, while ISO 9001 is generic for all industries

    b. ISO 9001 is specific to medical devices, while ISO 13485 is generic for all industries

    c. Both standards have the same requirements and scope

    d. ISO 13485 is a newer version of ISO 9001

    Ans.

    10. Which of the following is a benefit of implementing an effective CAPA process in ISO 13485:2016?

    a. Improved product quality and reliability b. Increased customer satisfaction

    c. Reduced risk of product liability d. All of the above

    Ans:

    Total Marks Obtained: ________

    Total Marks Obtained

    Training Evaluation (%) =

    Out of Total Marks assigned

    Retraining requirements (Required / required not):

    Training Evaluated By (Sign/Date):

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