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PECB ISO 13485 Foundation study materials
PECB ISO 13485 Foundation study resources

PECB ISO 13485 Foundation practice questions

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

Under ISO 13485, which document type states the organization's overall intentions and direction with respect to quality, and is formally issued by top management?

  1. The management review record
  2. The quality policy Correct answer.
  3. The quality manual
  4. The medical device file

Explanation

The quality policy expresses top management's overall intentions and direction related to quality and is the reference point against which quality objectives are established. The quality manual describes the scope and structure of the QMS but is a different document. The medical device file and management review records are operational records, not statements of intent.

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

What is the primary purpose of a Medical Device Quality Management System as described in ISO 13485?

  1. To guarantee that every device sold will never fail in clinical use
  2. To demonstrate the organization's ability to consistently provide medical devices that meet customer and applicable regulatory requirements Correct answer.
  3. To define the pricing strategy for medical device markets
  4. To replace the need for product-specific regulatory approvals

Explanation

ISO 13485 is built around demonstrating the ability to consistently meet customer requirements and applicable regulatory requirements, and to maintain the effectiveness of the QMS. It does not promise zero device failures, substitute for regulatory clearance, or address commercial pricing.

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

Which concept requires an organization to identify hazards, estimate and evaluate the associated risks, control those risks, and monitor the effectiveness of the controls throughout the product lifecycle?

  1. Risk management Correct answer.
  2. Supplier monitoring
  3. Process validation
  4. Design transfer

Explanation

Risk management is the systematic process of identifying hazards, assessing and evaluating risk, implementing controls and evaluating residual risk across the product lifecycle. Design transfer, process validation and supplier monitoring are separate activities that may support risk management but do not define it.

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

In ISO 13485 terminology, what does the term 'validation' primarily confirm?

  1. That a product has been priced correctly
  2. That a supplier has been formally audited
  3. That requirements for a specific intended use or application have been fulfilled Correct answer.
  4. That a document has been approved by the quality manager

Explanation

Validation confirms that the requirements for a specified intended use or application have been fulfilled, which is why it is applied to processes, software and product where output cannot be fully verified by later inspection. Document approval, supplier audit and pricing are unrelated to this definition.

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

Which term describes the ability of a device to perform its intended function without unacceptable risk to patients, users or others?

  1. Traceability
  2. Safety Correct answer.
  3. Efficacy
  4. Sterility

Explanation

Safety refers to freedom from unacceptable risk, meaning the device performs its intended function without causing unacceptable harm. Efficacy concerns achieving the intended clinical effect, traceability concerns identifying product history, and sterility is one specific attribute of certain devices.

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

What does the 'process approach' in a medical device QMS emphasize?

  1. Managing activities as interrelated processes and controlling the interactions between them to achieve planned results Correct answer.
  2. Documenting every employee's individual daily tasks in separate procedures
  3. Applying statistical sampling only at final inspection
  4. Outsourcing all production steps to reduce internal controls

Explanation

The process approach means understanding and managing interrelated activities as a system of processes, including the inputs, outputs and interactions between them. It is not about documenting individual tasks, outsourcing, or limiting controls to final inspection.

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

Which of the following best describes a 'medical device' in the context of ISO 13485?

  1. Any consumable used in a hospital canteen
  2. Any product sold in a pharmacy regardless of its intended use
  3. Only implantable surgical devices
  4. An instrument, apparatus or software intended by its manufacturer to be used for a medical purpose such as diagnosis, prevention or treatment of disease Correct answer.

Explanation

A medical device is defined by the manufacturer's intended medical purpose, which can include diagnosis, prevention, monitoring, treatment or alleviation of disease, and may be an instrument, apparatus, implement, software or other article. It is not defined by retail location, by being implantable, or by hospital use alone.

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

Why does ISO 13485 place emphasis on meeting applicable regulatory requirements in addition to customer requirements?

  1. Because customer requirements are considered irrelevant in healthcare
  2. Because regulators purchase most medical devices directly
  3. Because medical devices are subject to legally mandated safety and performance obligations that the QMS must help the organization fulfil Correct answer.
  4. Because regulatory requirements only apply to exported devices

Explanation

Medical devices are regulated products, so the QMS must support fulfilment of statutory and regulatory requirements alongside customer requirements. Customers in healthcare do not replace regulators, customer needs remain relevant, and regulatory obligations are not limited to exports.

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

A manufacturer designs a sterile syringe, defines the sterilization process, and cannot fully verify sterility by inspecting the finished batch. What should the organization do to provide confidence that the process consistently yields sterile product?

  1. Verify each syringe visually at final inspection
  2. Increase the marketing budget for the product
  3. Reduce the number of process parameters recorded
  4. Validate the sterilization process Correct answer.

Explanation

Where the output of a process cannot be verified by subsequent monitoring or measurement, the process must be validated to demonstrate it consistently achieves planned results. Visual inspection cannot confirm sterility, and commercial or documentation reductions do not provide assurance.

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

During internal audit, an auditor finds that a design change was implemented without evaluating its effect on product risk. Which principle of the MDQMS is most directly compromised?

  1. Calibration of monitoring equipment
  2. Control of nonconforming product
  3. Risk-based approach to design and change control Correct answer.
  4. Document control of external origin

Explanation

Design changes must be reviewed, verified, validated and evaluated for their effect on risk before implementation, reflecting the risk-based approach embedded in the QMS. Document control, calibration and nonconforming product control are separate requirements not directly implicated by this finding.

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

What distinguishes 'verification' from 'validation' in medical device development?

  1. Verification is performed only by regulators, while validation is performed only by suppliers
  2. Verification and validation are interchangeable terms with identical meaning
  3. Verification applies only to software, while validation applies only to hardware
  4. Verification confirms that specified requirements have been met, while validation confirms that requirements for a specific intended use have been fulfilled Correct answer.

Explanation

Verification checks conformance to specified design or product requirements, whereas validation confirms fulfilment of requirements for the intended use. They are distinct activities with different objectives and are not interchangeable or limited to particular device types or parties.

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

An organization outsources the manufacture of a critical component. According to ISO 13485 principles, how should this be treated?

  1. Outsourced processes need no monitoring because they are outside the QMS scope
  2. The component should be exempted from risk management
  3. The organization remains responsible for ensuring the outsourced process conforms to requirements and must control it through documented agreements and monitoring Correct answer.
  4. Responsibility for conformity transfers entirely to the supplier

Explanation

Outsourcing does not remove the organization's responsibility; outsourced processes must be controlled through documented agreements, supplier evaluation and monitoring. Responsibility does not transfer, the process remains within QMS scope, and risk management still applies.

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

What is the role of the 'medical device file' in the QMS?

  1. It contains or references documents and records that demonstrate conformity to ISO 13485 and applicable regulatory requirements for a device or device family Correct answer.
  2. It replaces the quality manual for the whole organization
  3. It lists only the names of certified auditors
  4. It is a financial record of device sales

Explanation

The medical device file is a compilation of documents and records, or references to them, that demonstrates conformity for a specific device or device family. It does not replace the quality manual, is not a financial document, and is not an auditor register.

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

Which activity best demonstrates the principle of 'customer focus' in a medical device QMS?

  1. Setting internal production targets without reference to user needs
  2. Deferring all customer complaints to the next financial year
  3. Reducing staff training to lower costs
  4. Determining and reviewing customer requirements, including those related to regulatory and user needs, before accepting an order Correct answer.

Explanation

Customer focus means determining customer requirements, reviewing them before commitment, and ensuring the organization can meet them, including regulatory aspects relevant to users. Internal targets, reduced training and deferred complaints all undermine rather than demonstrate this principle.

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

How does ISO 13485 treat the concept of 'documented procedure'?

  1. It permits procedures to exist only verbally
  2. It applies only to design activities
  3. It requires a procedure to be established, documented, implemented and maintained for specified activities Correct answer.
  4. It requires every procedure to be notarized by an external body

Explanation

A documented procedure means the activity must be established, documented, implemented and maintained as required by the standard. It does not require external notarization, is not limited to design, and cannot be purely verbal.

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

A notified body auditor asks how the organization ensures that personnel performing work affecting product quality are competent. Which principle is being examined?

  1. Purchasing information
  2. Control of monitoring and measuring equipment
  3. Competence, awareness and training Correct answer.
  4. Design and development planning

Explanation

Competence, awareness and training addresses determining necessary competence, providing training, evaluating effectiveness and ensuring awareness of relevance of activities. The other options concern design planning, purchasing documentation and measurement equipment control respectively.

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

Which statement best reflects the principle of 'continual improvement' in a medical device QMS?

  1. The organization should continually improve the effectiveness of the QMS through use of the quality policy, objectives, audit results, data analysis, corrective and preventive actions and management review Correct answer.
  2. Continual improvement requires changing the device's intended use annually
  3. Continual improvement is optional for small manufacturers
  4. Continual improvement means replacing the QMS every year

Explanation

Continual improvement means ongoing enhancement of QMS effectiveness using defined inputs such as policy, objectives, audit results, data analysis, corrective and preventive action and management review. It does not mean replacing the system, is not optional, and does not require changing intended use.

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

What is the purpose of a corrective action in the MDQMS?

  1. To eliminate the cause of a potential nonconformity before it occurs
  2. To eliminate the cause of a detected nonconformity so it does not recur Correct answer.
  3. To document customer complaints for archival purposes
  4. To rework a nonconforming product to make it conform

Explanation

Corrective action addresses the cause of an existing nonconformity to prevent recurrence. Eliminating the cause of a potential nonconformity is preventive action, reworking product is correction, and archiving complaints is recordkeeping.

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

An organization identifies that a supplier's component has caused two field failures. Which combination of QMS principles is most relevant to address this?

  1. Only document control and calibration
  2. Only management review and internal audit scheduling
  3. Only design transfer and purchasing information
  4. Supplier evaluation and control together with corrective action and risk management Correct answer.

Explanation

Addressing supplier-caused field failures requires controlling and re-evaluating the supplier, taking corrective action to eliminate the cause, and evaluating the resulting risk to the device. Document control, calibration, design transfer and audit scheduling may be relevant elsewhere but do not directly form this combination.

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

Which statement correctly describes the relationship between ISO 13485 and ISO 9001?

  1. ISO 13485 can only be applied by organizations already certified to ISO 9001
  2. ISO 13485 and ISO 9001 are identical documents
  3. ISO 13485 is a standalone standard for medical device QMS that includes requirements specific to the medical device sector and can be used independently of ISO 9001 Correct answer.
  4. ISO 13485 excludes all process-based requirements found in ISO 9001

Explanation

ISO 13485 is a standalone standard written for the medical device sector, adding regulatory and device-specific requirements while retaining a process-based structure. It does not require prior ISO 9001 certification, does not exclude process requirements, and is not identical to ISO 9001.

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

A manufacturer receives a complaint suggesting a possible safety issue with a marketed device. What is the most appropriate immediate QMS response?

  1. Evaluate the complaint, assess the associated risk, and determine whether investigation, corrective action or regulatory notification is required Correct answer.
  2. Immediately recall all devices without any evaluation
  3. Ignore the complaint until several similar reports accumulate
  4. Forward the complaint to marketing for promotional use

Explanation

Complaints must be evaluated, investigated where appropriate, and assessed for risk and any regulatory reporting obligations before deciding on action. Ignoring complaints, recalling without evaluation, or using complaints for promotion are inappropriate responses.

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

Which of the following best explains why traceability is a fundamental principle in a medical device QMS?

  1. It guarantees that devices will never be defective
  2. It enables the organization to trace the history, location and distribution of devices so that necessary actions such as recalls can be executed effectively Correct answer.
  3. It is only relevant for implantable devices
  4. It allows the organization to avoid documenting production records

Explanation

Traceability supports identification of device history and distribution so that actions such as recalls or corrections can be targeted and effective. It does not remove documentation obligations, cannot guarantee defect-free devices, and is relevant beyond implantables, although the extent may vary with device risk.

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

An organization wants to reduce documentation but still comply with ISO 13485. Which approach is most consistent with the standard's principles?

  1. Retain only documents that customers request in writing
  2. Eliminate all documented procedures because the standard favours minimal documentation
  3. Keep documentation only in paper form to avoid electronic control
  4. Establish documented procedures and records only where the standard requires them or where they are necessary for effective operation and control of processes Correct answer.

Explanation

ISO 13485 requires documented procedures and records for specified activities and where needed for effective operation and control, allowing the organization to determine the extent necessary. It does not permit eliminating required procedures, limit documentation to customer requests, or dictate paper format.

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

How should an organization apply a risk-based approach when determining controls for its QMS processes?

  1. By applying identical controls to every process regardless of risk
  2. By focusing controls only on financial risk
  3. By delegating all risk decisions to the purchasing department
  4. By considering the risk associated with the process and the device, and applying controls proportionate to that risk while meeting applicable requirements Correct answer.

Explanation

A risk-based approach means evaluating the risk associated with processes and devices and applying controls proportionate to that risk while still meeting all applicable requirements. Uniform controls ignore proportionality, financial risk is not the focus, and risk decisions are not delegated solely to purchasing.

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

Which of the following scenarios best illustrates the principle of 'control of nonconforming product'?

  1. A supplier is added to the approved supplier list after an audit
  2. A device failing final inspection is identified, segregated and evaluated to determine whether it can be reworked, accepted under concession or must be rejected Correct answer.
  3. A new employee completes induction training
  4. A management review meeting is scheduled for next quarter

Explanation

Control of nonconforming product involves identifying, segregating and evaluating nonconforming output and deciding on its disposition, such as rework, concession or rejection. Supplier approval, training and meeting scheduling relate to other QMS processes.

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

In ISO 13485, what is the primary purpose of the quality management system (QMS) for a medical device organization?

  1. To replace the need for regulatory approvals
  2. To maximize profits by minimizing documentation
  3. To ensure that medical devices consistently meet customer and applicable regulatory requirements Correct answer.
  4. To guarantee that medical devices are free from all defects

Explanation

ISO 13485 defines the QMS as a system to direct and control an organization with regard to quality, specifically to meet customer and applicable regulatory requirements for medical devices. It does not guarantee zero defects, replace regulatory approvals, or focus on profit maximization.

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

Which of the following is a key principle of a medical device QMS according to ISO 13485?

  1. Maximizing shareholder value
  2. Risk-based approach Correct answer.
  3. Zero-defect manufacturing
  4. Minimizing customer involvement

Explanation

ISO 13485 incorporates a risk-based approach throughout the QMS, requiring organizations to identify and manage risks associated with medical devices. Zero-defect manufacturing, shareholder value, and minimizing customer involvement are not principles of the standard.

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

What does the term 'medical device' refer to in the context of ISO 13485?

  1. Any product used in a hospital setting
  2. Only implantable devices
  3. Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article intended by the manufacturer to be used for medical purposes Correct answer.
  4. Only devices that require a prescription

Explanation

ISO 13485:2016 defines a medical device broadly to include instruments, apparatus, implements, machines, appliances, implants, reagents for in vitro use, software, materials, or other similar articles intended for medical purposes. It is not limited to implants, prescription devices, or hospital-only products.

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

Which document typically contains the general description of the medical device, intended use, and key specifications, and is part of the medical device file?

  1. Design history file
  2. Quality manual
  3. Medical device file Correct answer.
  4. Risk management report

Explanation

The medical device file is a compilation of documents that provides a comprehensive description of the device, including intended use, specifications, and manufacturing details. The quality manual describes the QMS, the design history file records design activities, and the risk management report summarizes risk management.

Question 30Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

In the context of ISO 13485, what is a 'documented procedure'?

  1. A procedure that is established, documented, implemented and maintained Correct answer.
  2. A procedure that is only written down but not necessarily followed
  3. A procedure that is only required for design activities
  4. A procedure that is optional for the organization

Explanation

ISO 13485 defines a documented procedure as one that is established, documented, implemented, and maintained. It is not merely written but must be put into practice and kept up to date. It is not optional when the standard requires it, and it applies to many processes, not just design.

Question 31Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which of the following best describes the role of 'top management' in a medical device QMS?

  1. To focus solely on financial performance
  2. To conduct all internal audits personally
  3. To provide evidence of commitment to the development and implementation of the QMS and to maintain its effectiveness Correct answer.
  4. To delegate all quality responsibilities to the quality manager

Explanation

ISO 13485 requires top management to demonstrate commitment to the QMS by ensuring resources, communicating the importance of meeting requirements, and maintaining effectiveness. Delegating all responsibilities, focusing only on finances, or personally conducting audits does not fulfill this requirement.

Question 32Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

What is the purpose of the 'quality policy' in a medical device QMS?

  1. To serve as a replacement for the quality manual
  2. To describe the detailed steps of each manufacturing process
  3. To list all applicable regulatory requirements
  4. To provide a framework for establishing and reviewing quality objectives Correct answer.

Explanation

The quality policy is a top-level document that commits the organization to quality and provides a framework for setting quality objectives. It does not list all regulations, describe detailed processes, or replace the quality manual.

Question 33Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which of the following is a required element of the management review input according to ISO 13485?

  1. Marketing strategies
  2. Results of audits Correct answer.
  3. Employee satisfaction surveys
  4. Competitor analysis

Explanation

ISO 13485 specifies that management review inputs must include results of audits, among other items such as customer feedback, process performance, and product conformity. Employee satisfaction, competitor analysis, and marketing strategies are not specifically required inputs.

Question 34Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer is updating its quality manual to align with ISO 13485:2016. Which of the following is an acceptable approach regarding the documentation of procedures?

  1. The organization must create a separate procedure for every clause of the standard.
  2. The organization must follow the exact clause structure of ISO 13485 for all procedures.
  3. The organization may use any document structure that suits its needs, as long as the required documented procedures are established and maintained. Correct answer.
  4. The organization must use the term 'quality manual' for the top-level document.

Explanation

ISO 13485 allows flexibility in the structure and format of documentation, provided that the required documented procedures are established and maintained. It does not mandate a specific clause structure, one procedure per clause, or the term 'quality manual' (though a quality manual is often used).

Question 35Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

During a management review, the team is discussing how to ensure that quality objectives are measurable and consistent with the quality policy. Which of the following best illustrates a measurable quality objective?

  1. Increase employee awareness
  2. Enhance product quality
  3. Improve customer satisfaction
  4. Reduce customer complaints by 10% within the next 12 months Correct answer.

Explanation

A measurable objective includes a specific target and timeframe, such as reducing complaints by 10% within 12 months. The other options are broad goals without measurable criteria.

Question 36Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

An organization is implementing ISO 13485 and wants to ensure that its QMS processes are effectively controlled. Which approach is most consistent with the standard's process approach?

  1. Document every single activity in detail to ensure control.
  2. Define the inputs, outputs, and interrelationships of processes, and apply risk-based controls to achieve planned results. Correct answer.
  3. Outsource all processes to reduce complexity.
  4. Focus only on production processes and ignore support processes.

Explanation

The process approach in ISO 13485 emphasizes understanding processes as a system, defining inputs and outputs, and managing risks to achieve planned results. Over-documentation, ignoring support processes, or indiscriminate outsourcing do not align with the standard's principles.

Question 37Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A medical device company is identifying the processes needed for its QMS. Which of the following should be included as a QMS process according to ISO 13485?

  1. Management responsibility, resource management, product realization, and measurement, analysis and improvement Correct answer.
  2. Only processes that are outsourced
  3. Only product realization processes
  4. Only processes that directly create the device

Explanation

ISO 13485 is structured around key process areas: management responsibility, resource management, product realization, and measurement, analysis and improvement. The QMS encompasses all these processes, not just product realization or outsourced activities.

Question 38Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer is deciding how to apply risk management throughout the product lifecycle. Which of the following best reflects ISO 13485 requirements?

  1. Apply risk management only to production processes.
  2. Maintain a risk management file that includes risk analysis, evaluation, control measures, and residual risk evaluation for each device. Correct answer.
  3. Conduct a risk assessment only during design and never update it.
  4. Use a generic risk assessment for all devices without customization.

Explanation

ISO 13485 requires risk management throughout the product lifecycle, with a risk management file that documents the process, including analysis, evaluation, control, and residual risk evaluation. Risk management is not limited to design or production, and must be device-specific.

Question 39Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

An organization is establishing a QMS and wants to ensure that it meets the requirements for control of documents. Which of the following is a required control for documents?

  1. Ensuring that documents are reviewed and approved for adequacy prior to issue Correct answer.
  2. Keeping obsolete documents without any identification
  3. Storing all documents only in paper format
  4. Allowing unrestricted access to all documents by all employees

Explanation

ISO 13485 requires that documents be reviewed and approved for adequacy before issue, and that changes be reviewed and approved. Unrestricted access, paper-only storage, and uncontrolled obsolete documents are not compliant.

Question 40Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer is reviewing its purchasing process. Which of the following is required by ISO 13485 for suppliers?

  1. Evaluate and select suppliers based on their ability to supply product in accordance with requirements, and monitor their performance. Correct answer.
  2. Select suppliers solely based on the lowest price.
  3. Avoid supplier evaluations to save time.
  4. Use only suppliers that are ISO 13485 certified.

Explanation

ISO 13485 requires organizations to evaluate and select suppliers based on their ability to meet requirements, and to monitor supplier performance. Price alone, skipping evaluations, or requiring ISO 13485 certification as the only criterion are not compliant.

Question 41Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which of the following best describes the relationship between ISO 13485 and regulatory requirements for medical devices?

  1. ISO 13485 replaces the need to comply with national regulations.
  2. ISO 13485 requires organizations to identify applicable regulatory requirements and incorporate them into the QMS. Correct answer.
  3. ISO 13485 prohibits organizations from exceeding regulatory requirements.
  4. ISO 13485 is only applicable to devices sold in the European Union.

Explanation

ISO 13485 emphasizes that organizations must identify and meet applicable regulatory requirements as part of the QMS. It does not replace national regulations, is not limited to the EU, and does not prohibit exceeding requirements.

Question 42Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A company is implementing a corrective action process. Which of the following steps is essential to ensure effectiveness?

  1. Documenting only the problem, not the solution
  2. Closing the corrective action immediately after implementation
  3. Implementing the action without reviewing its impact
  4. Verifying that the corrective action does not adversely affect the ability to meet requirements and does not introduce new risks Correct answer.

Explanation

ISO 13485 requires that corrective actions be verified for effectiveness and that they do not adversely affect the product or QMS. Implementing without review, closing prematurely, or incomplete documentation are not compliant.

Question 43Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

Which of the following is a characteristic of a 'special process' in medical device manufacturing?

  1. The process is only used for sterile devices.
  2. The process is always performed by an external supplier.
  3. The output cannot be fully verified by subsequent inspection and testing, so validation is required. Correct answer.
  4. The process does not require any documentation.

Explanation

A special process is one where the result cannot be fully verified by later inspection, so it must be validated to ensure the output meets requirements. It is not limited to external suppliers or sterile devices, and requires documentation.

Question 44Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

An organization is conducting an internal audit. Which of the following is a requirement for the audit program according to ISO 13485?

  1. Audits must be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. Correct answer.
  2. Audits must focus only on production processes.
  3. Audits must be performed annually for all processes.
  4. Audits must be conducted only by external auditors.

Explanation

ISO 13485 requires that internal audits be planned based on process status, importance, and prior results. Auditors can be internal or external, audits may be more frequent than annually if needed, and all QMS processes are subject to audit.

Question 45Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer is designing a new device and must ensure that design inputs are adequate. Which of the following is a requirement for design inputs?

  1. Design inputs must be based solely on customer requests.
  2. Design inputs must include functional, performance, usability, and safety requirements, and be reviewed for adequacy. Correct answer.
  3. Design inputs must be kept confidential from the design team.
  4. Design inputs must be finalized before any design work begins.

Explanation

ISO 13485 requires design inputs to include functional, performance, usability, and safety requirements, and to be reviewed for adequacy. They are not limited to customer requests, may evolve during design, and must be communicated to the design team.

Question 46Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

During a design review, the team identifies that a potential use error could lead to patient harm. Which action is most consistent with ISO 13485 principles?

  1. Modify the design to eliminate or reduce the risk, or implement protective measures, and verify the effectiveness. Correct answer.
  2. Rely on user training alone to mitigate the risk.
  3. Document the risk but take no action until after launch.
  4. Ignore the risk because the device has not yet been released.

Explanation

ISO 13485 emphasizes risk management throughout design. When a risk is identified, the organization should modify the design to eliminate or reduce it, or apply protective measures, and verify effectiveness. Ignoring, delaying, or relying solely on training is not acceptable.

Question 47Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

An organization is implementing a new software system for managing quality records. Which of the following must be considered to comply with ISO 13485?

  1. The software must be developed internally.
  2. The software must be validated for its intended use, and data integrity and security must be ensured. Correct answer.
  3. The software must be approved by a regulatory body before use.
  4. The software must replace all paper records immediately.

Explanation

ISO 13485 requires validation of software used in the QMS to ensure it performs as intended, and that data integrity and security are maintained. Internal development, regulatory approval, or immediate replacement of paper records are not requirements.

Question 48Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A manufacturer is notified by a supplier that a component has a potential defect that could affect device safety. Which action is most appropriate under ISO 13485?

  1. Inform only the internal quality team and take no further action.
  2. Evaluate the risk, determine if a corrective action or field safety corrective action is needed, and notify regulatory authorities as required. Correct answer.
  3. Return the component to the supplier without further assessment.
  4. Continue production and wait for complaints.

Explanation

ISO 13485 requires organizations to evaluate risks, take corrective action, and notify regulatory authorities when required, especially for safety issues. Ignoring the issue, limited notification, or simply returning the component without assessment is non-compliant.

Question 49Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

An organization is reviewing its complaint handling process. Which of the following is a requirement for complaint handling according to ISO 13485?

  1. Complaints must be handled only by the sales department.
  2. Complaints must be resolved within 24 hours.
  3. Complaints must be documented but not investigated.
  4. Complaints must be reviewed and evaluated to determine if they represent a potential nonconformity or safety issue, and investigated accordingly. Correct answer.

Explanation

ISO 13485 requires complaint handling procedures that include review, evaluation, and investigation of complaints to determine if they indicate nonconformities or safety issues. There is no 24-hour resolution requirement, complaints should be handled by trained personnel, and investigation is necessary.

Question 50Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

A company is deciding whether to outsource a critical manufacturing process. According to ISO 13485, what is the organization's responsibility?

  1. The organization must perform the process internally if it is critical.
  2. The organization must obtain ISO 13485 certification for the supplier.
  3. The organization must ensure that the outsourced process is controlled and that the supplier meets requirements, including through written agreements. Correct answer.
  4. The organization has no responsibility once the process is outsourced.

Explanation

ISO 13485 requires that organizations retain responsibility for outsourced processes, ensuring they are controlled and that suppliers meet requirements through written agreements and monitoring. The organization cannot absolve itself of responsibility, ISO 13485 certification is not mandatory for suppliers, and critical processes may be outsourced if properly controlled.