ISO 13485:2016 Awareness Assessment 2023

Which of the following is the main emphasis in the ISO 13485?

• Product identification

• Product traceability

• Product safety and performance

• Product Recall

The definition “combination of the probability of occurrence of harm and the severity of that harm” is called ........

• Hazard

• Risk

• Traceability

• Criticality

Tags

NGSS.HS-ETS1-3

The organization shall document procedures to ensure that purchased product conforms to specified purchasing information. This statement in clause 7.4.1 of this standard refers to which of the following process?

• Finished product QC testing

• Incoming material QC testing

• In-process QC testing

• Internal audit

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This statement is referring to which of the following process in your QMS?

• Finished product QC testing

• Material QC testing

• Internal audit

• Calibration

Tags

NGSS.MS-PS1-2

The below information is true on type of document and record that needs to be checked during an internal audit exercise for compliance with clause number 6.2.

• Training SOP

• Training Attendance Record

• Training Effectiveness Evaluation record such as test paper

• All of the above

Below are main criteria that must be used by

the organization Risk Review Board to prioritize risks for risk control measures to comply with the new ISO 13485:2016 requirements.

• Customer expectation

• Product consumer safety

• Product performance as per its intended use

• All of the above

Tags

NGSS.HS-ETS1-3

The below statement is the definition for ________."The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Action must be taken without undue delay".

• Corrective Action

• Preventive Action

• Correction

• Remedial action

Which of the statement below to demonstrate evidence of conformity to ISO 13485:2016 is FALSE?

• Appointment of QMR done via internal memo or an email

• Management responsibilities documented in JD

• Quality Policy approved by Managers.

• Quality manual approved by MD

Which of the below statement based on evidence of conformity to ISO 13485:2016 is FALSE?

• Changes made to QMS documents does not need to be tracked

• External documents such as ISO standard need to be controlled.

• Retention period for QMS documents must be defined.

• Changes made to a record must be traceable

Which of the below statement to demonstrate evidence of conformity to ISO 13485:2016 is TRUE?

• Quality Manual documentation is optional

• Medical device file includes Purchase order

• Changes in process parameter does not need to be tracked

• Risk assessment activity must be based on the safety and performance of device.