The document is an exam on the requirements of ISO 13485:2016 for quality management systems for medical devices. It contains 20 multiple choice questions testing knowledge of key requirements such as: [1] Management review being performed by top management; [2] Processes being managed in accordance with regulatory and ISO 13485 requirements; [3] Document control procedures.
The document is an exam on the requirements of ISO 13485:2016 for quality management systems for medical devices. It contains 20 multiple choice questions testing knowledge of key requirements such as: [1] Management review being performed by top management; [2] Processes being managed in accordance with regulatory and ISO 13485 requirements; [3] Document control procedures.
The document is an exam on the requirements of ISO 13485:2016 for quality management systems for medical devices. It contains 20 multiple choice questions testing knowledge of key requirements such as: [1] Management review being performed by top management; [2] Processes being managed in accordance with regulatory and ISO 13485 requirements; [3] Document control procedures.
The document is an exam on the requirements of ISO 13485:2016 for quality management systems for medical devices. It contains 20 multiple choice questions testing knowledge of key requirements such as: [1] Management review being performed by top management; [2] Processes being managed in accordance with regulatory and ISO 13485 requirements; [3] Document control procedures.
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Zenith Quality Assessors Pvt. Ltd.
Exam on the Medical Devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
First name / Surname Date
Neha Ukale 06/02/2022
THIS SPACE IS RESERVED FOR THE EXAMINER
Number of questions Maximum points: Minimum points:
20 20 15
Examiner: Received points: Approved:
☐Yes 󠅮󠅮☐No
Page 1 of 6 Zenith Quality Assessors Pvt. Ltd. 1) Management review is:
A performed by the management representative at planned intervals
B performed by organization’s top management C is conducted within internal audits D none of the above options
2) The quality management system processes for medical devices shall be managed in accordance with:
A regulatory requirement B the requirements of ISO 13485:2016 C the requirements of ISO 13485:2016 and regulatory requirements
3) A documented procedure shall define the controls needed to:
A ensure that the current revision status of and changes to documents are identified B ensure that documents remain legible and readily identifiable C prevent deterioration or loss of documents D all of the above options apply E none of the above options
4) TOP management shall provide evidence of its commitment to the development and implementation of the QMS and maintenance of its effectiveness by:
A conducting management reviews
B establishing the quality policy C ensuring the availability of resources D all of the above options apply E none of the above options
5) TOP management shall ensure the customer requirements and applicable regulatory requirements are determined and met.
A True B False
Page 2 of 6 Zenith Quality Assessors Pvt. Ltd. 6) The INPUT to management review shall include information arising from:
A feedback B monitoring and measurement of processes C corrective and preventive action D all of the above options apply E none of the above options
7) The OUTPUT from management review shall be recorded and include the input reviewed and any decisions and actions related to:
A improvement of product related to customer requirements
B employee’s needs C applicable regulatory requirements
8) The OUTPUTS of design and development shall be in a form suitable for verification against the design and development inputs and shall be approved prior to release.
A True B False
9) If the conditions for the work environment can have an adverse effect on product quality, the organization shall document the requirements for the work environment and the procedures to monitor and control the work environment.
A True B False
10) The organization shall plan and document arrangements for communicating with customers in relation to:
A product information B information about contracts or order handling C customer feedback, including complaints D all of the above options apply
Page 3 of 6 Zenith Quality Assessors Pvt. Ltd. 11) The organization shall document verification plans that include methods, acceptance criteria, but shall not document statistical techniques with rationale for sample size.
A True B False
12) Results and conclusions of the transfer shall not be recorded.
A True B False
13) As appropriate, production controls shall include:
A qualification of infrastructure B availability and use of monitoring and measuring equipment C implementation of product release, delivery and post-delivery activities D all of the above options apply E none of the above options
14) The organization shall document procedures for validation of processes, including
A defined criterion for review and approval of the process
B equipment qualification and qualification of personnel C use of specific methods, procedures and acceptance criteria D all of the above options apply E none of the above options
15) The organization shall not document procedures to ensure that medical devices returned to the organization are defined and distinguished from conforming product.
A True B False
16) The organization shall protect product from alternation, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling and distribution by
Page 4 of 6 Zenith Quality Assessors Pvt. Ltd.
A designing and constructing suitable packaging and shipping containers
B reporting to top management on the performance of QMS for review C increasing the promotion of awareness of customer requirements and legislation throughout the organization D none of the above options
17) The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to
A demonstrate conformity of product
B ensure conformity of QMS C maintain the effectiveness of QMS D all of the above options apply
18) The organization shall conduct internal audits at planned intervals to determine whether the QMS
A conforms to planned and documented arrangements, requirements of the standard,
QMS requirements established by the organization and applicable regulatory requirements B is effectively implemented and maintained C all of the above options apply D none of the above options
19) Audit criteria, scope, interval and methods shall be defined and recorded. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.
A True B False
20) The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the QMS as well as medical device
Page 5 of 6 Zenith Quality Assessors Pvt. Ltd. safety and performance through the use of
A quality policy and objectives
B audit results and post market surveillance C analysis of data and management review D corrective and preventive actions E all of the above options apply
