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ISO 13485 LI study materials
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ISO 13485 LI practice questions

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Question 1Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Under ISO 13485, which document states the manufacturer's commitment to meeting applicable regulatory requirements and to maintaining the effectiveness of the quality management system?

  1. The internal audit schedule
  2. The quality objectives
  3. The management review minutes
  4. The quality policy Correct answer.

Explanation

The quality policy is the top-level statement of commitment issued under management responsibility; it provides the framework against which quality objectives are established and reviewed. It is distinct from measurable objectives, which translate the policy into targets.

Question 2Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which process does ISO 13485 require the organization to apply to determine the competence needed for personnel performing work affecting product quality?

  1. A supplier evaluation of external trainers
  2. An annual performance appraisal for all staff
  3. A customer satisfaction survey of training quality
  4. A documented procedure for competence, training and awareness Correct answer.

Explanation

The standard requires a documented procedure for establishing competence, providing training, and ensuring awareness of how each person's work contributes to quality objectives. Effectiveness of actions taken must be evaluated.

Question 3Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

In ISO 13485 terminology, what does "product realization" cover?

  1. Only the final inspection and release of finished devices
  2. Only the installation and servicing activities after delivery
  3. Only the design and development stage of a new device
  4. The processes needed to produce the medical device, from planning through design, purchasing, production and release Correct answer.

Explanation

Product realization is the broad set of processes by which the device is conceived, sourced, built, verified and released. Design, purchasing, production and monitoring of measuring equipment all fall within it.

Question 4Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which of the following best describes the role of the "medical device file" in an ISO 13485 system?

  1. It is the contract between the manufacturer and its authorized representative
  2. It is the design history file maintained only for Class III devices
  3. It is the certificate issued by a notified body after a successful audit
  4. It consolidates the documents and records demonstrating conformity to the standard and applicable regulatory requirements for a device or device family Correct answer.

Explanation

The medical device file is a defined collection of documents and records that shows conformity for a device or family. It may reference other files rather than duplicate them, and its content scales with the device and regulatory context.

Question 5Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

ISO 13485 requires the organization to identify the processes needed for the quality management system and to determine their sequence and interaction. Which element is the primary output of this activity?

  1. A register of customer complaints only
  2. A list of all employees and their job titles
  3. A description of the processes and their interaction within the system Correct answer.
  4. A copy of the national device legislation

Explanation

Process approach requires the organization to determine processes, their sequence and interaction, and the criteria needed to operate and control them. This description is typically captured in a process map or process interaction matrix.

Question 6Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which statement correctly reflects ISO 13485's position on outsourced processes?

  1. The organization must retain responsibility for conformity of outsourced processes and control them through the purchasing and monitoring arrangements it defines Correct answer.
  2. Outsourced processes are controlled only by the supplier's own certification
  3. Outsourced processes may be omitted from the quality manual if they are low risk
  4. Outsourced processes are excluded from the scope of the quality management system

Explanation

Outsourcing transfers activity but not accountability: the organization remains responsible for conformity and must apply proportionate controls. The nature and extent of control are defined in the purchasing and supplier-monitoring arrangements.

Question 7Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which of these is a required element of the management review input under ISO 13485?

  1. The personal tax records of senior managers
  2. Information on feedback from customers and other interested parties Correct answer.
  3. The list of competitors' product launches
  4. The sales forecast for the next fiscal year

Explanation

Management review inputs include feedback, complaint handling, reporting to regulatory authorities, audits, process performance, product conformity, corrective and preventive actions, follow-up actions and changes affecting the system.

Question 8Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

In ISO 13485, what is the purpose of a validation of processes for production and service provision?

  1. To certify that staff have attended the required training sessions
  2. To demonstrate that processes whose output cannot be verified by subsequent monitoring or measurement consistently achieve planned results Correct answer.
  3. To confirm that the annual internal audit plan was completed on time
  4. To verify that suppliers have delivered on schedule

Explanation

Process validation is required where the resulting output cannot be verified by later monitoring or measurement. It demonstrates the process consistently produces conforming output, with arrangements for revalidation defined.

Question 9Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer changes the sterilization dose-setting method for an existing device. Which ISO 13485 requirement most directly governs how this change should be handled before implementation?

  1. The change requires no action because sterilization is an outsourced process
  2. The change may be implemented immediately provided the next management review notes it
  3. The change only needs to be communicated to the distributor
  4. The change must be reviewed, verified or validated, and approved before it is implemented, with records retained Correct answer.

Explanation

Design and development changes, and changes affecting product conformity, must be reviewed, verified or validated as appropriate and approved before implementation. Records of the review and resulting actions must be maintained.

Question 10Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

During an internal audit a manufacturer finds that a work instruction references an obsolete specification. What is the most appropriate ISO 13485 response?

  1. Take action to eliminate the cause of the nonconformity and verify the effectiveness of the action taken Correct answer.
  2. Revise the audit checklist so the finding is not repeated
  3. Wait until the next scheduled management review to decide
  4. Reassign the auditor who raised the finding

Explanation

A finding of this kind is a nonconformity requiring corrective action: the cause is investigated and actions are taken and reviewed for effectiveness. Document control also requires that obsolete documents be prevented from unintended use.

Question 11Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer receives a complaint suggesting a possible failure of a device still on the market. Which sequence best reflects ISO 13485 expectations?

  1. Record and evaluate the complaint, investigate as appropriate, determine whether reporting to a regulatory authority is required, and take action Correct answer.
  2. Forward the complaint to the distributor and close it once acknowledged
  3. Store the complaint and review all complaints only at the annual management review
  4. Log the complaint and issue a credit note to the customer

Explanation

Complaints must be recorded and evaluated to determine whether an investigation is needed, and if the device failed to meet specifications the investigation is performed. Where the issue is reportable to regulatory authorities, notification must occur per applicable requirements.

Question 12Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A supplier of a critical component has no certified quality system. How should the manufacturer apply ISO 13485 purchasing controls?

  1. Accept the supplier's self-declaration without further verification
  2. Define criteria for evaluation and selection, and apply controls proportionate to the risk of the purchased product, including monitoring supplier performance Correct answer.
  3. Require ISO 13485 certification as the only acceptable control for every supplier
  4. Exclude the component from incoming inspection because it is purchased

Explanation

Suppliers are evaluated and selected against defined criteria, and the type and extent of control depend on the purchased product's effect on device conformity. Monitoring of supplier performance and records of evaluation are required.

Question 13Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which activity best demonstrates that a manufacturer has applied risk management throughout product realization as ISO 13485 expects?

  1. Maintaining risk management records that are updated as design, process and post-production information changes Correct answer.
  2. Assigning risk management to the marketing department
  3. Recording risks only when a complaint is received
  4. Performing a single risk assessment at the start of the project and filing it

Explanation

ISO 13485 requires risk management throughout product realization, with records maintained and kept current as information evolves. Risk management is a living activity linked to design, process and post-market inputs.

Question 14Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer wants to claim conformity to ISO 13485 for a scope covering design, production and distribution. Which action is consistent with the standard's requirements on scope?

  1. Exclude design activities without documenting a rationale
  2. State the scope only on the certificate, not in the quality manual
  3. Document the justification for any process excluded from the scope and ensure the exclusion does not compromise conformity of the device Correct answer.
  4. Silently omit distribution activities from the quality manual

Explanation

Where a requirement is not applicable due to the activities undertaken or the nature of the device, the organization records the justification; exclusions must not affect the ability to meet conformity. The scope and justification belong in the quality manual.

Question 15Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which record-keeping practice satisfies ISO 13485 requirements for control of records?

  1. Records remain legible, identifiable and retrievable for the defined retention period, with protection against loss or alteration Correct answer.
  2. Records are stored on personal devices without backup
  3. Records are destroyed once the device leaves the factory
  4. Records are kept only while the device is in production

Explanation

Records must be legible, identifiable and retrievable for a defined retention period at least equivalent to the device lifetime as defined by the organization, and protected from loss, damage or alteration.

Question 16Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer identifies that a batch of devices may not meet a specification. What does ISO 13485 require before the batch can be released?

  1. Release the batch after informing the sales team
  2. Investigate the nonconformity and, where the product is accepted under concession, document the justification and approval by authorized personnel Correct answer.
  3. Release the batch if the deviation is small in percentage terms
  4. Release the batch and monitor field performance

Explanation

Nonconforming product must be identified and controlled to prevent unintended use; acceptance under concession requires documented justification and approval by authorized persons, and applicable regulatory requirements must still be met.

Question 17Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Why does ISO 13485 require the organization to plan and document the monitoring and measurement of product at appropriate stages?

  1. To verify that product requirements have been met, with records identifying the person authorizing release Correct answer.
  2. To satisfy the marketing department's launch schedule
  3. To replace the need for design verification
  4. To reduce the number of internal audits required

Explanation

Product monitoring and measurement confirm that requirements have been met at planned stages, and release proceeds only when planned arrangements are satisfactorily completed. Records identify the person authorizing release.

Question 18Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

An organization wants to use a software tool to manage device master records and training records. Which ISO 13485 consideration applies?

  1. The software must be validated for its intended use, with the approach proportionate to the associated risk Correct answer.
  2. Software used for records is exempt from validation if it is commercially available
  3. Validation is unnecessary because records are reviewed at audits
  4. Validation is needed only if the software was developed in-house

Explanation

Computer software used in the quality system must be validated for its intended application, with the validation approach and activities proportionate to the risk involved, including the risk to product conformity and record integrity.

Question 19Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which pair of activities best illustrates the distinction between verification and validation in design and development?

  1. Verification concerns purchasing; validation concerns training
  2. Verification happens after launch; validation happens before design input
  3. Verification confirms that design outputs meet design inputs; validation confirms that the resulting device meets user needs and intended use Correct answer.
  4. Verification is performed by the regulator; validation is performed by the manufacturer

Explanation

Verification checks outputs against inputs, while validation confirms the device meets the needs of the intended user and intended use under specified conditions. Both are required at planned stages of design and development.

Question 20Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manager argues that because the company holds an ISO 13485 certificate, it need not maintain a separate procedure for advisory notices. How should this be assessed?

  1. The argument is valid: certification replaces the need for any documented procedure
  2. The argument fails: the standard requires documented procedures for advisory notices and for notification to regulatory authorities Correct answer.
  3. The argument is valid if the device is low risk
  4. The argument is valid if the distributor handles field actions

Explanation

ISO 13485 requires documented procedures for the issue and implementation of advisory notices, and for notification to regulatory authorities where required. Certification demonstrates system conformity but does not replace required documented procedures.

Question 21Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer's quality manual omits any description of the interaction between its sterilization, packaging and release processes. Which conclusion is most defensible?

  1. The manual is acceptable because process interaction may be described orally during audits
  2. The manual is acceptable because sterilization is outsourced
  3. The manual does not meet the requirement to describe the interaction of processes included in the quality management system Correct answer.
  4. The manual is acceptable if the processes are listed in the training matrix

Explanation

The quality manual must include a description of the interaction between the processes of the quality management system. Listing processes elsewhere, such as a training matrix, does not satisfy that requirement.

Question 22Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Two corrective actions address the same recurring nonconformity: one retrains the operator, the other changes the fixture design. Which analysis is most consistent with ISO 13485?

  1. Both actions are equivalent because both are documented
  2. Retraining is always sufficient because operator error is the root cause
  3. Neither action is valid without a customer complaint on file
  4. The design change addresses a systemic cause and is more likely to prevent recurrence, while retraining alone may not eliminate the underlying cause Correct answer.

Explanation

Corrective action must address the cause of nonconformity to prevent recurrence; action proportionate to the effects of the nonconformity is expected. Where the cause is inherent in the process or design, a technical change is more likely to be effective than retraining alone.

Question 23Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A notified body auditor notes that the manufacturer's internal audit program covers all clauses but always audits the same two departments. What is the most accurate assessment?

  1. The program is deficient only if a nonconformity was missed
  2. The program is adequate because all clauses are covered by the checklist
  3. The program is adequate because internal auditors are independent
  4. The program is deficient because audits must cover the quality system's processes and activities, with scheduling based on status and importance Correct answer.

Explanation

Internal audits must determine whether the quality management system conforms and is effectively implemented and maintained, which requires coverage of processes and activities, with frequency based on the status and importance of the area. Clause coverage alone does not demonstrate that.

Question 24Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A company markets the same device under two brand names with identical design and manufacturing. How should it approach the medical device file?

  1. No file is needed because the design is unchanged
  2. The file may be replaced by the distributor's product brochure
  3. A single file may cover the device family where the devices are sufficiently similar and the file demonstrates conformity for each variant Correct answer.
  4. A separate complete file must be created for every brand name regardless of similarity

Explanation

The medical device file may cover a family or group of similar devices, provided it demonstrates conformity for each variant covered. Duplication is not required where design and manufacturing are common.

Question 25Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer claims a process exclusion because the device is supplied non-sterile and requires no installation. How should this be treated?

  1. The exclusion is valid only for Class I devices
  2. The exclusion is valid only if approved by the distributor
  3. Any exclusion is prohibited under ISO 13485
  4. The exclusion may be justified for installation, but sterilization-related requirements would also need justification if not performed, and both must be recorded Correct answer.

Explanation

Non-applicability of a requirement must be justified in the quality manual and must not affect the organization's ability to ensure device conformity. Each excluded requirement needs its own rationale tied to the activities performed and device nature.

Question 26Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

ISO 13485 is built on a process-based quality management model. Which statement best describes what this means for a medical device manufacturer?

  1. Only production processes fall within the scope of the quality management system, because support activities do not affect device conformity.
  2. Processes needed for the quality management system must be identified, their sequence and interaction determined, and their effectiveness monitored and measured. Correct answer.
  3. Each department must document its own procedures independently, and the quality manager combines them into a quality manual without reviewing interactions.
  4. Processes must be certified individually by a notified body before the manufacturer may apply the standard to them.

Explanation

ISO 13485 adopts a process approach: the organization determines the processes needed for the quality management system, their sequence and interaction, criteria and methods for effective operation and control, and the resources and information needed to support them. It then monitors, measures and analyzes these processes and implements actions to achieve planned results and maintain their effectiveness. This applies across the whole system, not only to production.

Question 27Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer defines the scope of its ISO 13485 quality management system. Which statement correctly reflects how the standard treats requirements that the organization does not apply?

  1. Any requirement may be left out if the manufacturer explains the reason in a marketing brochure rather than in the quality management system documentation.
  2. No requirement of ISO 13485 may ever be excluded, so every organization must apply design and development controls regardless of its activities.
  3. Exclusions are limited to requirements in clause 7 that are not applicable due to the nature of the device or the activities undertaken, and the justification must be documented. Correct answer.
  4. Requirements may be excluded freely provided the excluded activities are performed by a subcontractor rather than in-house.

Explanation

Under ISO 13485, non-applicability of requirements is restricted to clause 7 (product realization) and is permitted only where it is justified by the nature of the medical device and the activities the organization undertakes. The justification for any such exclusion must be maintained in the quality management system documentation, and roles that are regulated differently may be handled accordingly. Requirements elsewhere in the standard, such as document control or management responsibility, cannot be excluded.

Question 28Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer is deciding which documents and records must exist to demonstrate conformity to ISO 13485. Which principle best guides this decision?

  1. A single combined document is mandatory, and separate procedures for different processes are not acceptable under the standard.
  2. Only documents explicitly named in the standard are permitted, and additional documents must be removed during certification audits.
  3. The organization must maintain the documented procedures and records required by the standard, plus any additional documents it determines are necessary for effective operation of its quality management system. Correct answer.
  4. Documents are required only for processes that are fully automated, because manual processes are controlled through operator competence alone.

Explanation

ISO 13485 sets a baseline of documented procedures and records that must exist, but it also requires the organization to determine and maintain any additional documentation needed to ensure effective planning, operation and control of its processes. The extent of documentation therefore depends on the organization's size, activities, the complexity of its processes and the competence of personnel. It is not limited to the documents named in the standard.

Question 29Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer's top management delegates quality management system activities to a designated member of management. Which description of that role is most consistent with ISO 13485?

  1. The designated person replaces top management entirely, so management review may be conducted without any involvement of the organization's executive level.
  2. The designated person must be an external consultant so that objectivity about the quality management system is preserved.
  3. The designated person is responsible only for internal audits, because all other quality management system duties remain with top management and cannot be delegated.
  4. The designated person has defined authority to ensure processes needed for the quality management system are established and maintained, and to report on the effectiveness of the system and the need for improvement. Correct answer.

Explanation

ISO 13485 allows top management to appoint a member of management who, irrespective of other responsibilities, has defined authority to ensure that processes needed for the quality management system are established, implemented and maintained, and to report to top management on the effectiveness of the quality management system and any need for improvement. The role also typically covers promoting awareness of regulatory and customer requirements. Top management remains accountable, including for reviewing the system.

Question 30Medical Devices Quality Management System (MDQMS)

Under ISO 13485:2016, which document is required to describe the interaction between the processes of the quality management system?

  1. A quality manual Correct answer.
  2. A design history file
  3. A supplier scorecard
  4. A validation protocol

Explanation

Clause 4.2.2 requires the organization to document a quality manual that includes the scope of the QMS, documented procedures or references, and a description of the interaction between processes. It is an explicit documented requirement, not an optional summary.

Question 31Medical Devices Quality Management System (MDQMS)

An organization outsources sterilization of its sterile devices. Under ISO 13485:2016, how must this activity be treated?

  1. As a regulatory submission issue outside the QMS scope
  2. As an internal process needing no agreement because it is not on site
  3. As a purchased product subject to supplier controls, with a written agreement Correct answer.
  4. As a design output requiring no further control

Explanation

Clause 4.1.5 requires outsourced processes to be controlled, and the controls must be proportionate to the risk involved and to the supplier's ability to meet requirements. A written quality agreement defining responsibilities is expected for critical outsourced processes such as sterilization.

Question 32Medical Devices Quality Management System (MDQMS)

Which item is a record rather than a document under the ISO 13485:2016 documentation structure?

  1. Device master record index
  2. Sterilization work instruction
  3. Completed batch production record Correct answer.
  4. Quality policy statement

Explanation

Records are evidence of results achieved or activities performed and cannot be revised; they are retained per clause 4.2.5. Documents such as policies, instructions, and indexes state requirements and can be changed through document control.

Question 33Medical Devices Quality Management System (MDQMS)

A company wants to exclude clause 7.3 design and development from its QMS. What does ISO 13485:2016 require?

  1. Exclude it silently because design is never mandatory
  2. Justify the exclusion and show it does not affect the ability to meet applicable requirements Correct answer.
  3. Record the exclusion only in the design history file
  4. Obtain customer approval for the exclusion before the audit

Explanation

Clause 1 requires that any exclusion be justified and documented, and that it not affect the organization's ability to meet customer and applicable regulatory requirements. Regulatory requirements may still impose design controls even where the standard clause is excluded.

Question 34Medical Devices Quality Management System (MDQMS)

What is the primary purpose of a management review under ISO 13485:2016?

  1. To assess QMS suitability, adequacy, and effectiveness and decide on improvement Correct answer.
  2. To close individual customer complaints
  3. To sign off supplier audit reports
  4. To approve individual device release decisions

Explanation

Clause 5.6 requires top management to review the QMS at planned intervals to ensure continuing suitability, adequacy, and effectiveness, with defined inputs and outputs including improvement actions. It is a strategic review, not operational record approval.

Question 35Medical Devices Quality Management System (MDQMS)

Which input is explicitly required for management review by ISO 13485:2016?

  1. Individual employee performance ratings
  2. Marketing campaign budgets
  3. Competitor pricing analysis
  4. Status of corrective and preventive actions Correct answer.

Explanation

Clause 5.6.2 lists required inputs including feedback, complaints, reporting to regulatory authorities, audits, process performance, product conformity, corrective and preventive actions, follow-up actions, changes, and new or revised regulatory requirements. CAPA status is one of these mandated inputs.

Question 36Medical Devices Quality Management System (MDQMS)

A notified body auditor finds that a procedure was revised but the change was not communicated to affected staff. Which clause area is most directly implicated?

  1. Internal audit scheduling
  2. Product preservation
  3. Document control Correct answer.
  4. Purchasing information

Explanation

Clause 4.2.4 requires documents to be reviewed and approved before issue and changes to be reviewed and approved, with the current version available at points of use. Failure to communicate a revision to users is a document control failure.

Question 37Medical Devices Quality Management System (MDQMS)

What does ISO 13485:2016 require regarding a documented procedure for corrective action?

  1. It must be reviewed by the notified body before use
  2. It must define requirements for reviewing nonconformities and investigating causes Correct answer.
  3. It must apply only to supplier-related nonconformities
  4. It must guarantee that no recurrence is ever possible

Explanation

Clause 8.5.2 requires a documented procedure for corrective action covering review of nonconformity, determination of cause, evaluation of the need for action, and review of effectiveness. The standard requires proportionate action, not an impossible guarantee.

Question 38Medical Devices Quality Management System (MDQMS)

An organization receives a complaint about a device already on the market. What must be done when the investigation shows the complaint is not related to a failure to meet requirements?

  1. Retain the complaint and investigation records even though no corrective action is needed Correct answer.
  2. Transfer the complaint to the supplier and delete internal records
  3. Discard the complaint because it is not a valid nonconformity
  4. Reclassify the complaint as a suggestion and remove it from the QMS

Explanation

Clause 8.2.1 requires feedback to be used as input to risk management and to the improvement process, and complaints must be recorded and investigated. Even where no corrective action is warranted, the complaint and its investigation remain records that must be retained.

Question 39Medical Devices Quality Management System (MDQMS)

When must a manufacturer notify regulatory authorities of an adverse event, according to ISO 13485:2016 clause 8.2.3?

  1. Only after the next scheduled management review
  2. In accordance with applicable regulatory requirements for reporting Correct answer.
  3. Never, because reporting is outside the QMS
  4. Only when a customer requests notification

Explanation

Clause 8.2.3 requires the organization to have documented procedures for timely notification to regulatory authorities when an adverse event meets the criteria for reporting. The timing and criteria are set by applicable regulatory requirements, not by internal review cycles.

Question 40Medical Devices Quality Management System (MDQMS)

Which activity best demonstrates fulfilment of the clause 8.2.2 internal audit requirement?

  1. Delegating all audits to the supplier quality function
  2. Auditing processes at planned intervals using objective, independent auditors Correct answer.
  3. Auditing only when a customer complaint is received
  4. Having the process owner audit their own process annually

Explanation

Clause 8.2.2 requires audits at planned intervals to determine whether the QMS conforms and is effectively implemented, with auditors selected so they do not audit their own work. The programme is planned and considers process status and importance.

Question 41Medical Devices Quality Management System (MDQMS)

What is the required output of the design and development planning activity under ISO 13485:2016?

  1. A marketing requirements specification only
  2. A plan describing stages, review, verification, validation, and responsibility Correct answer.
  3. A finished design history file with all test results
  4. A regulatory clearance certificate

Explanation

Clause 7.3.2 requires design and development planning that identifies the stages, required reviews, verification and validation activities, and the responsibilities and authorities for each. The plan is updated as design evolves.

Question 42Medical Devices Quality Management System (MDQMS)

During design verification, a team checks that outputs meet input requirements. Which activity confirms that the device meets user needs and intended use under actual conditions?

  1. Design review
  2. Design verification
  3. Design transfer
  4. Design validation Correct answer.

Explanation

Clause 7.3.6 requires design verification to confirm outputs meet inputs, while clause 7.3.7 requires design validation to confirm the product meets requirements for the specified application or intended use. Validation typically uses production units or equivalents under defined conditions.

Question 43Medical Devices Quality Management System (MDQMS)

Which element must a design history file contain?

  1. Only the regulatory submission correspondence
  2. Records demonstrating conformity of the design to the design and development plan Correct answer.
  3. Only the minutes of marketing meetings
  4. Only the final released drawings

Explanation

Clause 7.3.10 requires a design history file to contain records necessary to demonstrate the design was developed in accordance with the approved design and development plan and the requirements of the standard. It is a compilation of design records, not a single document type.

Question 44Medical Devices Quality Management System (MDQMS)

A production process whose output cannot be verified by subsequent monitoring or measurement must be handled how?

  1. Inspected more frequently at final release
  2. Documented only in the quality policy
  3. Excluded from the QMS scope
  4. Validated, with arrangements for equipment, personnel, methods, and revalidation Correct answer.

Explanation

Clause 7.5.6 requires validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement, including defined criteria and arrangements for equipment qualification, personnel competence, methods, and revalidation.

Question 45Medical Devices Quality Management System (MDQMS)

What does ISO 13485:2016 require for the identification of product and its status with respect to monitoring and measurement?

  1. Identification only on the shipping carton
  2. Identification only when the customer asks
  3. Identification only for sterile products
  4. Documented procedures for identification and status, maintained throughout realization Correct answer.

Explanation

Clause 7.5.8 requires documented procedures for product identification and for identifying the status of product with respect to monitoring and measurement requirements throughout product realization. Identification supports traceability and prevents mix-ups.

Question 46Medical Devices Quality Management System (MDQMS)

Which requirement applies to the traceability of implantable devices under ISO 13485:2016?

  1. Traceability is required only for the raw materials
  2. Records must allow traceability from the device to its batch or serial number and distribution records Correct answer.
  3. Traceability is limited to the sterilization load only
  4. Traceability is optional if the device is single-use

Explanation

Clause 7.5.9.1 requires documented procedures for traceability, and for implantable devices the records must enable tracing from the device to its batch, lot, or serial number and to distribution. This supports recalls and vigilance activities.

Question 47Medical Devices Quality Management System (MDQMS)

A customer returns a device for repair. Which clause governs the handling of customer property in the organization's possession?

  1. Clause 8.3 control of nonconforming product
  2. Clause 6.4 work environment
  3. Clause 7.4 purchasing
  4. Clause 7.5.10 customer property Correct answer.

Explanation

Clause 7.5.10 requires the organization to exercise care with customer property while under its control, identify, protect, and safeguard it, and report loss, damage, or unsuitability. Returned devices held for repair are customer property.

Question 48Medical Devices Quality Management System (MDQMS)

What is the purpose of product preservation requirements in ISO 13485:2016 clause 7.5.11?

  1. To define the marketing approval strategy
  2. To protect product during handling, storage, and distribution including special handling for critical components Correct answer.
  3. To set the selling price of the device
  4. To determine the internal audit frequency

Explanation

Clause 7.5.11 requires preservation of product conformity during processing, storage, handling, and distribution, including identification, handling, packaging, and protection. It also requires special arrangements for components with special requirements such as shelf life or sterile condition.

Question 49Medical Devices Quality Management System (MDQMS)

Which activity is required when planning monitoring and measurement equipment control under clause 7.6?

  1. Using equipment without identification to reduce paperwork
  2. Replacing all equipment every year regardless of condition
  3. Recording the results of calibration or verification for each instrument Correct answer.
  4. Calibrating only equipment used by final inspection

Explanation

Clause 7.6 requires measuring equipment to be calibrated or verified at specified intervals, identified to enable status determination, safeguarded, and for records of calibration or verification results to be maintained. The records support confidence in measurement validity.

Question 50Medical Devices Quality Management System (MDQMS)

How does ISO 13485:2016 treat risk management in product realization?

  1. Risk management must be applied throughout product realization and records maintained Correct answer.
  2. Risk management is performed only by the regulatory affairs department
  3. Risk management is optional for Class I devices
  4. Risk management applies only during design and is then closed

Explanation

Clause 7.1 requires risk management to be applied throughout product realization, with records maintained and proportionate to the risk. The standard also links risk-based approaches to supplier controls and process validation.