I85PREP
⌘ K
ISO 9001 LA study materials
ISO 9001 LA study resources

ISO 9001 LA practice questions

One question at a time. Build your ISO 9001 LA understanding.

First 50 of 199 questions. Each one lists the choices, the correct answer, and an explanation. The checker at the top of this page saves progress in this browser when it is available.

Continue in the practice tool above to load more questions, 50 at a time.

Question 1Fundamental principles and concepts of a quality management system

A quality management system is best described as which of the following?

  1. Part of a management system relating to quality, comprising elements used to establish objectives and achieve them Correct answer.
  2. A documented manual that lists every procedure the organization carries out and the departments responsible for each one
  3. A schedule of internal audits and finished-product inspections
  4. A software tool used for recording customer complaints and their closure dates

Explanation

A quality management system is the part of an organization's management system that is concerned with quality; it comprises interrelated elements used to establish quality objectives and the processes needed to achieve them. It is not limited to documentation, inspection or software. The system covers the whole set of interacting processes that deliver conforming products and services.

Question 2Fundamental principles and concepts of a quality management system

ISO 9001:2015 is built on a defined set of quality management principles. How many principles make up that set?

  1. Twelve
  2. Five
  3. Eight
  4. Seven Correct answer.

Explanation

The standard rests on seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management. These principles are the foundation on which the requirements of the standard are built.

Question 3Fundamental principles and concepts of a quality management system

In the plan-do-check-act cycle, which activity belongs to the 'plan' phase?

  1. Implementing the planned arrangements
  2. Establishing the objectives and the processes needed to deliver results Correct answer.
  3. Taking action to improve performance
  4. Monitoring processes against the quality policy

Explanation

Planning means establishing the objectives of the system and its processes and the resources needed to deliver results in line with customer requirements and the organization's policies. Implementation belongs to 'do', monitoring and measurement to 'check', and improvement actions to 'act'.

Question 4Fundamental principles and concepts of a quality management system

Which quality management principle states that the primary aim of quality management is to meet customer requirements and to strive to exceed customer expectations?

  1. Improvement
  2. Customer focus Correct answer.
  3. Evidence-based decision making
  4. Process approach

Explanation

Customer focus is the principle that identifies the customer, understood as the recipient of value, as the central reference point for the whole system. Sustained success comes from understanding and consistently meeting customer requirements and from striving to exceed their expectations.

Question 5Fundamental principles and concepts of a quality management system

Which principle recognizes that competent, empowered and engaged people at all levels are essential to enhance the organization's capability to create and deliver value?

  1. Relationship management
  2. Process approach
  3. Engagement of people Correct answer.
  4. Customer focus

Explanation

Engagement of people is the principle stating that competent, empowered and engaged people throughout the organization are essential to enhance its capacity to create and deliver value. It recognizes that people at all levels are the essence of the organization.

Question 6Fundamental principles and concepts of a quality management system

Which quality management principle holds that decisions based on the analysis and evaluation of data and information are more likely to produce desired results?

  1. Improvement
  2. Leadership
  3. Evidence-based decision making Correct answer.
  4. Engagement of people

Explanation

Evidence-based decision making is the principle that decisions and actions should rest on the analysis and evaluation of data and information. It increases the likelihood of achieving desired results by reducing the influence of assumption and intuition.

Question 7Fundamental principles and concepts of a quality management system

In the context of ISO 9001, a process is best described as which of the following?

  1. A sequence of audits performed over the certification cycle
  2. A set of interrelated or interacting activities that uses inputs to deliver an intended result Correct answer.
  3. A written instruction telling an operator how a task is to be performed
  4. A department with defined responsibilities within the organization

Explanation

A process is a set of interrelated or interacting activities that uses inputs to deliver an intended result. Processes are the building blocks of the management system and are managed as part of a coherent system.

Question 8Fundamental principles and concepts of a quality management system

Continual improvement is best defined as which of the following?

  1. A recurring activity to enhance performance Correct answer.
  2. A one-off project to eliminate all existing nonconformities
  3. A documented plan to purchase new equipment
  4. A periodic external audit of the quality management system

Explanation

Continual improvement is a recurring activity undertaken to enhance performance. It is not a single project or event but an ongoing element of the management system, supported by the improvement requirements of the standard.

Question 9Fundamental principles and concepts of a quality management system

Clause 4.1 of ISO 9001 requires an organization to determine external and internal issues relevant to its purpose and strategic direction. What is the main purpose of doing this?

  1. To produce a list of competitors that must be published alongside the quality policy and reviewed by top management every year
  2. To provide input so that the quality management system can achieve its intended results and to inform actions addressing risks and opportunities Correct answer.
  3. To record the names of the regulators that are entitled to impose fines on the organization
  4. To establish the selling price of the organization's products and services

Explanation

The issues identified under clause 4.1 form the foundation for designing the quality management system and feed directly into the determination of risks and opportunities under clause 6.1. They help the organization ensure the system achieves its intended results and prevents or reduces undesired effects.

Question 10Fundamental principles and concepts of a quality management system

Clause 4.2 requires the organization to determine the interested parties relevant to the quality management system and their relevant requirements. Which statement is correct?

  1. Interested parties must be limited to customers and external providers
  2. Interested parties must be reviewed only when a nonconformity is found
  3. Every interested party identified must have all of its requirements fully met by the organization at all times
  4. Only the requirements of interested parties that are relevant to the quality management system must be taken into account Correct answer.

Explanation

The organization decides which interested parties are relevant to its management system and then determines which of their requirements are relevant to it. The standard does not require every conceivable requirement of every party to be satisfied.

Question 11Fundamental principles and concepts of a quality management system

When determining the scope of its quality management system, which of the following must the organization consider?

  1. The percentage of products and services sold to export markets and the number of competitors in those markets
  2. The external and internal issues, the requirements of relevant interested parties, and the products and services of the organization Correct answer.
  3. The number of employees, the annual turnover and the number of sites operated by the organization
  4. The audit fees charged by the certification body and the length of the certification cycle

Explanation

Clause 4.3 requires the organization to consider the issues of clause 4.1, the requirements of relevant interested parties from clause 4.2, and the products and services of the organization. The resulting scope must be maintained as documented information.

Question 12Fundamental principles and concepts of a quality management system

Which statement best describes risk-based thinking as used in ISO 9001:2015?

  1. It is embedded in the planning and operation requirements and does not require a separate formal risk management process Correct answer.
  2. It requires a documented risk register and a formal risk assessment methodology
  3. It applies only to the design and development of new products and services
  4. It requires the organization to identify every conceivable risk and score it in a matrix approved by top management

Explanation

Risk-based thinking is woven throughout the standard rather than isolated in a dedicated clause or a prescribed methodology. The organization must plan actions to address risks and opportunities but is free to choose how, and no documented risk management process is mandated.

Question 13Fundamental principles and concepts of a quality management system

Clause 6.1 requires the organization to determine the risks and opportunities that need to be addressed. What is the stated purpose of this requirement?

  1. To give assurance that the quality management system can achieve its intended results and to prevent or reduce undesired effects Correct answer.
  2. To calculate the financial cost of each identified risk to the nearest currency unit
  3. To transfer all identified risks to an insurance provider before certification takes place
  4. To publish the full risk list on the organization's website so that any customer can request a copy of it at any time

Explanation

Clause 6.1 requires the organization to address risks and opportunities in order to give assurance that the management system can achieve its intended results, to prevent or reduce undesired effects, and to achieve improvement. The method of doing so is left to the organization.

Question 14Fundamental principles and concepts of a quality management system

Which of the following is a characteristic that quality objectives must have according to ISO 9001:2015?

  1. They must be approved by the certification body before they are used
  2. They must be measurable and consistent with the quality policy Correct answer.
  3. They must be identical to the quality policy statement
  4. They must cover every indicator used in every process of the organization

Explanation

Clause 6.2 requires quality objectives to be measurable, consistent with the quality policy, relevant to conformity of products and services and to enhancement of customer satisfaction, monitored, communicated and updated as appropriate. They must also take into account applicable requirements.

Question 15Fundamental principles and concepts of a quality management system

Which statement about the quality policy is correct?

  1. It must be maintained as documented information and be available to relevant interested parties as appropriate Correct answer.
  2. It must be revised at every management review meeting regardless of whether anything has changed
  3. It must be signed by every employee of the organization and displayed in all customer-facing areas
  4. It must include the names of the organization's key customers and external providers

Explanation

Clause 5.2 requires the quality policy to be available and maintained as documented information, to be communicated within the organization, and to be available to relevant interested parties as appropriate. The content requirements are that it is appropriate to the purpose and context of the organization and supports its strategic direction.

Question 16Fundamental principles and concepts of a quality management system

ISO 9001:2015 uses the term 'documented information'. What does this term cover?

  1. Only paper documents held in a controlled filing system
  2. Information that the organization is required to control and maintain, and the medium that contains it Correct answer.
  3. Only electronic records generated by the organization's software
  4. Only records that the certification body requires the organization to keep for a defined retention period

Explanation

Documented information covers information the organization must control and maintain, together with the medium on which it is held. The standard deliberately avoids prescribing paper or electronic form. The term merges the earlier concepts of documents and records.

Question 17Fundamental principles and concepts of a quality management system

An organization has determined the required inputs and expected outputs of its processes, defined their sequence and interaction, and assigned responsibilities and authorities. It has not, however, defined the criteria and methods needed to operate and control those processes effectively. Which requirement of clause 4.4 remains unmet?

  1. Assigning the responsibilities and authorities for these processes
  2. Determining the sequence and interaction of these processes
  3. Determining the inputs required and the outputs expected from these processes
  4. Determining the criteria and methods needed for the effective operation and control of its processes Correct answer.

Explanation

Clause 4.4 requires the organization to determine the criteria and methods needed for the effective operation and control of its processes, in addition to inputs, outputs, sequence, interaction, resources and responsibilities. Without defined criteria and methods, process performance cannot be consistently controlled or evaluated.

Question 18Fundamental principles and concepts of a quality management system

Clause 9.1.2 requires the organization to monitor customer satisfaction. Which statement reflects this requirement?

  1. The organization must monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled Correct answer.
  2. Customer satisfaction surveys must be sent to every customer once a month
  3. Customer satisfaction results must be reported to the certification body every quarter
  4. Customer satisfaction must be measured solely by counting the number of formal complaints received each quarter

Explanation

The requirement is to monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled. The organization determines the methods for obtaining, monitoring and reviewing this information.

Question 19Fundamental principles and concepts of a quality management system

When a nonconformity occurs, what does ISO 9001 require the organization to do as its first response?

  1. Revise the quality policy and the quality objectives so that they reflect the nature of the nonconformity found
  2. React to it and, as applicable, take action to control and correct it and deal with the consequences Correct answer.
  3. Suspend the certification of the affected process until the cause has been eliminated
  4. Retrain every employee whose process was involved in the nonconformity

Explanation

Clause 10.2 requires the organization to react to the nonconformity and, as applicable, to take action to control and correct it and to deal with the consequences. Evaluating the need for action to eliminate the cause follows after this initial reaction.

Question 20Fundamental principles and concepts of a quality management system

Which statement reflects the ISO 9001:2015 requirements for externally provided processes, products and services?

  1. External providers must hold ISO 9001 certification before they can be used by the organization
  2. The organization must ensure that externally provided processes, products and services conform to requirements Correct answer.
  3. All externally provided processes, products and services must be covered by a written contract reviewed by top management
  4. External providers must be audited on site by the organization at least once every year

Explanation

Clause 8.4 requires the organization to ensure that externally provided processes, products and services conform to requirements. It must apply criteria for the selection, evaluation, monitoring of performance and re-evaluation of external providers.

Question 21Fundamental principles and concepts of a quality management system

Clause 7.1.6 addresses organizational knowledge. Which statement reflects its requirements?

  1. The organization must determine the knowledge necessary for its processes, maintain it and make it available to the extent necessary Correct answer.
  2. The organization must purchase an external knowledge database before it can be certified
  3. The organization must delete knowledge that is not relevant to its current customer contracts
  4. The organization must record all knowledge held by its employees in a single controlled manual updated every year

Explanation

The organization must determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services, maintain it and make it available to the extent necessary. It must also consider how to acquire or access any additional knowledge and required updates when needs change.

Question 22Fundamental principles and concepts of a quality management system

ISO 9001:2015 contains no separate clause titled 'preventive action'. How is preventive action addressed in the standard?

  1. It has been removed because certified organizations are no longer expected to prevent problems
  2. It is addressed through risk-based thinking built into the planning and operation requirements Correct answer.
  3. It is addressed only for organizations that design and develop their own products and services
  4. It is addressed only in clause 10.2, where corrective action and preventive action are dealt with together

Explanation

The concept of preventive action is expressed through risk-based thinking, which underpins the planning and operation requirements of the standard, particularly clause 6.1. Organizations determine risks and opportunities and plan actions to address them before problems arise.

Question 23Fundamental principles and concepts of a quality management system

If a requirement of ISO 9001 cannot be applied by an organization, what does the standard require?

  1. The requirement must be excluded from the audit scope with the verbal agreement of the audit team
  2. The non-applicability must be stated and justified, and must not affect the ability to ensure conforming products and services Correct answer.
  3. The organization must still apply the requirement but may record it as a minor nonconformity
  4. The organization must apply to the accreditation body for a formal written waiver before the certification audit can take place

Explanation

Clause 4.3 allows a requirement to be determined as not applicable only where it does not affect the organization's ability or responsibility to ensure conformity of its products and services and the enhancement of customer satisfaction. The non-applicability must be stated and justified within the scope, which is maintained as documented information.

Question 24Fundamental principles and concepts of a quality management system

Which statement about ISO 9001 certification is correct?

  1. Certification removes the need for regulatory approval of the organization's products and services
  2. Certification specifies the technical requirements that the organization's products and services must meet
  3. Certification guarantees that no defective products or services will ever be delivered to any customer of the organization
  4. Certification confirms conformity of the quality management system, not of the products and services Correct answer.

Explanation

ISO 9001 specifies requirements for a quality management system and does not set technical requirements for products and services. Certification therefore provides confidence that the management system conforms, not that every output will conform or that regulatory approval is unnecessary.

Question 25Fundamental principles and concepts of a quality management system

Which observation provides the strongest evidence that an organization has genuinely adopted the process approach?

  1. The organization runs an annual quality awareness day supported by a poster campaign across all of its sites
  2. Managers focus on the interfaces between processes and on overall system performance rather than on departmental compliance Correct answer.
  3. Each department maintains its own procedures and reports its own results separately to top management at the monthly review meeting
  4. Every clause of the standard is assigned to a named clause owner who reports on compliance with that clause

Explanation

The process approach means understanding and managing interrelated processes as a system, with attention to the interfaces between them and to the contribution of each process to overall performance. Focusing only on departmental results or on clause-by-clause compliance indicates a functional or checklist-driven approach instead.

Question 26Fundamental principles and concepts of a quality management system

Which quality management principle holds that the primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations?

  1. Leadership
  2. Improvement
  3. Customer focus Correct answer.
  4. Engagement of people

Explanation

Customer focus is the principle stating that the primary focus of quality management is to meet customer requirements and to strive to exceed them; ISO 9001 operationalises it through requirements on determining customer requirements and monitoring customer satisfaction. Leadership concerns establishing unity of purpose and direction, engagement of people concerns competent and empowered personnel, and improvement concerns sustained efforts to enhance performance.

Question 27Fundamental principles and concepts of a quality management system

In the Plan-Do-Check-Act cycle as applied to a quality management system, which activity belongs to the 'Check' stage?

  1. Establishing the objectives of the system and the processes needed to deliver them
  2. Taking action to improve performance where results fall below expectations
  3. Monitoring and measuring processes against planned results Correct answer.
  4. Implementing the arrangements and processes as planned across the organization

Explanation

In the PDCA cycle, 'Check' covers monitoring and measurement of processes, products and services against policies, objectives, requirements and planned activities, and reporting the results. Setting objectives is part of Plan, implementing the arrangements is part of Do, and improving performance is part of Act.

Question 28Fundamental principles and concepts of a quality management system

An organization shares performance data with a key supplier and works jointly with it to solve recurring delivery problems instead of merely enforcing contractual penalties. Which quality management principle does this best reflect?

  1. Improvement
  2. Evidence-based decision making
  3. Process approach
  4. Relationship management Correct answer.

Explanation

Relationship management with interested parties, including external providers, is directed at mutual value creation and sustained performance rather than purely transactional enforcement. ISO 9001 reflects this by requiring control of externally provided processes while encouraging cooperative relationships with providers.

Question 29Fundamental principles and concepts of a quality management system

Senior managers of a firm have set a quality policy and objectives, but production staff report that they are never consulted about how to improve their work and that their suggestions are ignored. Which quality management principle is most directly underused?

  1. Engagement of people Correct answer.
  2. Customer focus
  3. Relationship management
  4. Evidence-based decision making

Explanation

Engagement of people reflects the principle that competent, empowered and engaged people at all levels are essential to enhance the organization's capacity to create and deliver value. Staff who are not consulted or recognised indicate that this principle is weak, even where policy and objectives exist.

Question 30Quality management system (QMS) requirements

Which clause of ISO 9001:2015 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction?

  1. Clause 5.2 Quality policy
  2. Clause 4.1 Context of the organization Correct answer.
  3. Clause 6.1 Actions to address risks
  4. Clause 9.1 Monitoring and measurement

Explanation

Clause 4.1 requires the organization to determine the external and internal issues relevant to its purpose and strategic direction that affect its ability to achieve the intended results of the QMS. Clause 6.1 then draws on those issues when planning actions to address risks and opportunities.

Question 31Quality management system (QMS) requirements

In addition to determining which interested parties are relevant to the quality management system, clause 4.2 requires the organization to determine:

  1. Their relevant requirements Correct answer.
  2. The size of each party's workforce
  3. Each party's own quality policy
  4. Each party's financial stability

Explanation

Clause 4.2 requires the organization to determine the interested parties relevant to the QMS and the requirements of those parties that are relevant to the QMS. The organization must then monitor and review information about these parties and their relevant requirements.

Question 32Quality management system (QMS) requirements

When determining the processes needed for the quality management system, clause 4.4.1 requires the organization to determine:

  1. The name of every process owner
  2. A documented procedure for every process
  3. The inputs required and the outputs expected Correct answer.
  4. The budget allocated to each process

Explanation

Clause 4.4.1 lists what must be determined for the QMS processes, including the inputs required and outputs expected, the sequence and interaction of the processes, criteria and methods, resources, responsibilities and authorities, risks and opportunities, and how processes are evaluated and improved. It does not require a documented procedure for every process.

Question 33Quality management system (QMS) requirements

Which of the following is an explicit responsibility of top management under clause 5.1.1?

  1. Personally authoring all documented procedures
  2. Taking accountability for QMS effectiveness Correct answer.
  3. Personally conducting all internal audits of the QMS
  4. Personally approving all nonconforming outputs

Explanation

Clause 5.1.1 requires top management to demonstrate leadership and commitment by taking accountability for the effectiveness of the QMS, among other actions such as ensuring the policy and objectives are established and promoting improvement.

Question 34Quality management system (QMS) requirements

Clause 5.2.1 requires the quality policy to be appropriate to the purpose and context of the organization and to:

  1. Be signed by every employee
  2. Be reviewed by an external auditor
  3. Support its strategic direction Correct answer.
  4. Be limited in length

Explanation

Clause 5.2.1 requires the quality policy to be appropriate to the purpose and context of the organization and to support its strategic direction. It must also provide a framework for setting quality objectives, include commitments to satisfy applicable requirements and to continual improvement, and be maintained as documented information.

Question 35Quality management system (QMS) requirements

Clause 5.3 requires top management to assign and communicate responsibilities and authorities, including responsibility for:

  1. Approving the organization's strategic plan
  2. Selecting and approving all external providers
  3. Setting the salary levels of all process owners
  4. Ensuring the QMS conforms to the standard Correct answer.

Explanation

Clause 5.3 requires responsibilities and authorities to be assigned and communicated for ensuring the QMS conforms to ISO 9001, ensuring processes deliver intended outputs, promoting customer focus, maintaining QMS integrity during changes, and reporting on QMS performance and opportunities for improvement.

Question 36Quality management system (QMS) requirements

Clause 6.1 requires the organization to plan actions to address risks and opportunities, and for these actions to be:

  1. Approved by a certified risk management professional
  2. Based on a rigorous quantitative risk analysis
  3. Proportionate to potential impact on conformity Correct answer.
  4. Recorded in a formal risk register

Explanation

Clause 6.1.2 requires actions to address risks and opportunities to be proportionate to the potential impact on the conformity of products and services. The organization may choose to avoid the risk, take it to pursue an opportunity, remove the source, change likelihood or consequence, share the risk, or accept it.

Question 37Quality management system (QMS) requirements

Which of the following is a requirement for quality objectives under clause 6.2.1?

  1. They must be re-approved by an external body
  2. They must be agreed with each customer
  3. They must be measurable Correct answer.
  4. They must be expressed in financial terms

Explanation

Clause 6.2.1 requires quality objectives to be consistent with the quality policy, measurable, take into account applicable requirements, be relevant to conformity of products and services and to enhancement of customer satisfaction, be monitored, communicated and updated as appropriate, and be maintained as documented information.

Question 38Quality management system (QMS) requirements

Clause 6.3 requires changes to the quality management system to be carried out in a planned manner, considering:

  1. The number of employees who will be affected
  2. Its purpose and its potential consequences Correct answer.
  3. The availability of external consultants to support it
  4. Only the cost that the change will incur

Explanation

Clause 6.3 requires the organization to consider the purpose of the changes and their potential consequences, the integrity of the QMS, the availability of resources, and the allocation or reallocation of responsibilities and authorities.

Question 39Quality management system (QMS) requirements

Where measurement traceability is a requirement, clause 7.1.5.2 requires measuring equipment to be:

  1. Calibrated against traceable standards at specified intervals Correct answer.
  2. Replaced at intervals defined by the equipment supplier
  3. Kept in a locked cabinet that only designated quality staff may access
  4. Verified by the machine operator only when a customer files a complaint

Explanation

Clause 7.1.5.2 requires measuring equipment to be calibrated or verified, or both, at specified intervals or prior to use, against measurement standards traceable to international or national measurement standards. Where no such standards exist, the basis used for calibration or verification must be retained as documented information.

Question 40Quality management system (QMS) requirements

What does clause 7.1.6 require the organization to do in relation to organizational knowledge?

  1. Back up all IT systems at least once per day
  2. Keep a documented list of every employee's qualifications
  3. Determine the knowledge needed to operate its processes Correct answer.
  4. Publish internal knowledge on the public website

Explanation

Clause 7.1.6 requires the organization to determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. That knowledge must be maintained and made available to the extent necessary, and the organization must consider how to acquire or access additional knowledge when needs change.

Question 41Quality management system (QMS) requirements

Which of the following is required by clause 7.2 for persons doing work under the organization's control that affects QMS performance?

  1. Require each employee to hold an ISO 9001 certificate
  2. Test all employees annually with a written examination
  3. Determine the necessary competence of these persons Correct answer.
  4. Require every employee to hold a university degree

Explanation

Clause 7.2 requires the organization to determine the necessary competence of persons doing work under its control that affects QMS performance, ensure they are competent on the basis of education, training or experience, take actions to acquire necessary competence, and retain appropriate documented information as evidence of competence.

Question 42Quality management system (QMS) requirements

Clause 7.4 requires the organization to determine the internal and external communications relevant to the QMS, including:

  1. The annual budget for communications
  2. The language skills of each employee
  3. The name of the courier used for deliveries
  4. What, when, with whom and how Correct answer.

Explanation

Clause 7.4 requires the organization to determine what it will communicate, when, with whom and how. These communications are planned as part of the QMS and take account of relevant interested parties.

Question 43Quality management system (QMS) requirements

Clause 9.3.2 requires management review inputs to include information on:

  1. The financial results of the sales department
  2. The status of actions from previous management reviews Correct answer.
  3. The personal development plans of all employees
  4. The organization's marketing strategy

Explanation

Clause 9.3.2 lists required inputs, which include the status of actions from previous management reviews, changes in external and internal issues, customer satisfaction and feedback, the extent to which quality objectives have been met, process performance and conformity of products and services, nonconformities and corrective actions, audit results and the performance of external providers.

Question 44Quality management system (QMS) requirements

Clause 7.5.3 requires documented information to be controlled so that it is protected from:

  1. Loss of integrity or unintended alteration Correct answer.
  2. Unplanned review of the information by internal auditors
  3. Translation errors introduced by external translation contractors
  4. Use of the information by customers during contract review

Explanation

Clause 7.5.3.1 requires documented information to be controlled to ensure it is available and suitable for use where and when it is needed, and to protect it from loss of integrity, unintended alteration, or loss of confidentiality. Control activities include distribution, access, retrieval and use, storage and preservation, control of changes, retention and disposition.

Question 45Quality management system (QMS) requirements

Before offering products and services to customers, clause 8.2.2 requires the organization to ensure that the requirements are defined, including applicable statutory and regulatory requirements, and that the organization:

  1. Can meet the claims it makes for them Correct answer.
  2. Has no outstanding customer complaints
  3. Has priced them below its competitors
  4. Holds a certified ISO 9001 certificate

Explanation

Clause 8.2.2 requires the organization to define the requirements for the products and services to be offered, including applicable statutory and regulatory requirements and any the organization considers necessary, and to ensure it can meet the claims it makes for those products and services.

Question 46Quality management system (QMS) requirements

Which of the following is an input that clause 8.3.3 requires the organization to consider for design and development?

  1. Statutory and regulatory requirements Correct answer.
  2. The annual marketing budget
  3. The results of recent internal audits
  4. The financial reports of key suppliers

Explanation

Clause 8.3.3 requires the organization to determine, consider and document the inputs essential to the specific type of design and development, including statutory and regulatory requirements, information derived from previous similar design and development activities, and other requirements essential for design and development. Inputs must be adequate, complete, unambiguous and not in conflict with one another.

Question 47Quality management system (QMS) requirements

Clause 8.4.1 requires the organization to apply criteria for the evaluation and selection of external providers, for monitoring of their performance, and for:

  1. Auditing of competitors
  2. Compensation of external providers
  3. Certification status of external providers
  4. Re-evaluation of external providers Correct answer.

Explanation

Clause 8.4.1 requires the organization to determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements.

Question 48Quality management system (QMS) requirements

Clause 8.5.4 requires preservation of outputs during production and service provision to the extent necessary to ensure conformity, and this includes:

  1. Storage conditions in the organization's warehouse only
  2. Identification and traceability of outputs only
  3. Packaging and transportation activities only
  4. Handling, packaging, storage and protection Correct answer.

Explanation

Clause 8.5.4 requires the organization to preserve outputs during production and service provision to the extent necessary to ensure conformity to requirements, covering identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. Preservation also applies to the constituent parts of a product or service.

Question 49Quality management system (QMS) requirements

Under clause 8.6, products and services are not to be released to the customer until:

  1. The invoice has been issued to the customer
  2. Planned arrangements have been completed Correct answer.
  3. The sales department has approved the release
  4. The external provider has been paid in full

Explanation

Clause 8.6 requires that planned arrangements at appropriate stages be satisfactorily completed before release of products and services to the customer. Documented information on release must be retained, including evidence of conformity with acceptance criteria and traceability to the person authorizing the release.

Question 50Quality management system (QMS) requirements

Clause 8.7.1 requires nonconforming outputs to be controlled, and permits the organization to deal with them by:

  1. Acceptance under concession by a relevant authority Correct answer.
  2. Deleting all records of them once the batch has been shipped
  3. Releasing them with a verbal warning to the customer at delivery
  4. Waiting for the next management review before deciding what to do

Explanation

Clause 8.7.1 permits correction, segregation, containment, return or suspension of provision of products and services, informing the customer, or obtaining authorization for acceptance under concession by a relevant authority and, where applicable, by the customer. When nonconforming outputs are corrected, conformity to requirements must be verified.