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CQI IRCA QMS LA study materials
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CQI IRCA QMS LA practice questions

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Question 1Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 requires an organization to determine the external and internal issues that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended results of the quality management system. Which clause contains this requirement?

  1. 5.1 Leadership and commitment
  2. 4.2 Understanding the needs and expectations of interested parties
  3. 6.2 Quality objectives and planning
  4. 4.1 Understanding the organization and its context Correct answer.

Explanation

Clause 4.1 requires the organization to determine external and internal issues relevant to its purpose and strategic direction. Clause 4.2 deals with interested parties, clause 5 with leadership and clause 6.2 with quality objectives.

Question 2Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 does not prescribe a formal risk management process, but it does require the organization to do which of the following?

  1. Appoint a risk manager who reports directly to the certification body on a monthly basis
  2. Quantify all risks using a recognized scoring method and record the scores in the quality manual
  3. Plan actions to address risks and opportunities and evaluate their effectiveness Correct answer.
  4. Maintain a documented risk register that covers every process and is reviewed by top management each quarter

Explanation

Clause 6.1 requires the organization to determine risks and opportunities, plan actions to address them, integrate the actions into QMS processes and evaluate their effectiveness. The standard deliberately leaves the method and any documentation to the organization.

Question 3Quality management fundamentals and ISO 9001 requirements

In ISO 9001:2015, the term 'documented information' refers to which of the following?

  1. Electronic files exclusively, since paper documents are no longer recognized by the standard
  2. Information to be controlled and maintained, and the medium holding it Correct answer.
  3. Only the records that are generated during product realization and after delivery
  4. Only documents that bear a revision number, an approval signature and a controlled distribution list

Explanation

Documented information is information required to be controlled and maintained by the organization and the medium on which it is contained. It covers both documents and records, in any format or medium, so neither paper nor electronic media are excluded.

Question 4Quality management fundamentals and ISO 9001 requirements

Which statement correctly distinguishes design and development verification from validation in ISO 9001:2015?

  1. Verification is carried out by the customer, whereas validation is carried out by the organization before delivery
  2. Verification is a laboratory activity, whereas validation is a documented management review of the design
  3. Verification and validation are two names for the same activity, and either one satisfies the clause
  4. Verification confirms outputs meet inputs; validation confirms fitness for intended use Correct answer.

Explanation

Verification confirms that design and development outputs meet the input requirements, while validation confirms that the resulting product or service meets the requirements for its intended use or application. They are separate activities and both must be planned and their results retained.

Question 5Quality management fundamentals and ISO 9001 requirements

Which of the following is one of the seven quality management principles on which ISO 9001:2015 is based?

  1. Statistical process control
  2. Supplier price reduction
  3. Engagement of people Correct answer.
  4. Zero defect production

Explanation

The seven principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management. Zero defect targets, statistical techniques and price reduction are not principles of the standard.

Question 6Quality management fundamentals and ISO 9001 requirements

Which statement best describes the process approach required by ISO 9001:2015?

  1. It requires every process to be documented in a written procedure before the process is first performed
  2. It means managing activities as interrelated processes to achieve planned results Correct answer.
  3. It requires the organization to outsource any process whose output cannot be measured
  4. It applies only to manufacturing processes that have clearly measurable outputs and defined tolerances

Explanation

The process approach means understanding and managing interrelated processes as a system in order to achieve consistent and predictable results. ISO 9001:2015 does not require documented procedures for every process, and it applies to all types and sizes of organization, including service providers.

Question 7Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 requires the organization to monitor customers' perceptions of the degree to which their needs and expectations have been fulfilled. What does the standard say about how this should be done?

  1. It prescribes a written customer survey as the only acceptable method of collecting the data
  2. It requires a target of 100 % customer satisfaction to be set and reported annually
  3. It leaves the methods for obtaining and using this information to the organization Correct answer.
  4. It requires satisfaction data to be reported only to the certification body at each audit

Explanation

Clause 9.1.2 requires the monitoring of customer perceptions but deliberately leaves the methods to the organization, which may use surveys, feedback, complaints analysis or market data. No method, target or external reporting channel is prescribed.

Question 8Quality management fundamentals and ISO 9001 requirements

Under ISO 9001:2015, internal audits must be conducted at which frequency?

  1. At planned intervals Correct answer.
  2. Only when a nonconformity is found by a customer
  3. At least once every twelve months
  4. Whenever the certification body requests it

Explanation

Clause 9.2 requires internal audits at planned intervals, with the frequency set by the organization taking into account the importance of processes, changes affecting the organization and the results of previous audits. A fixed annual cycle is not mandated.

Question 9Quality management fundamentals and ISO 9001 requirements

Which of the following is an input that ISO 9001:2015 specifically requires to be considered in management review?

  1. The status of actions from previous management reviews Correct answer.
  2. The number of employees holding engineering degrees
  3. The results of competitor benchmarking studies
  4. The organization's sales forecast for the next period

Explanation

Clause 9.3.2 lists the status of actions from previous management reviews as a required input, together with audit results, customer feedback, process performance, nonconformities, monitoring results, external provider performance and resource adequacy.

Question 10Quality management fundamentals and ISO 9001 requirements

Clause 8.5.6 on control of changes requires the organization to review and control changes to production and service provision to the extent necessary to ensure continuing conformity with requirements. What else does it require?

  1. That all changes are approved in writing by the customer before they are implemented
  2. That every change is recorded in the quality manual and approved by top management
  3. That the review results, authorizing persons and required actions are recorded Correct answer.
  4. That every change is validated by an external laboratory before implementation

Explanation

Clause 8.5.6 requires retention of documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions. Customer approval or external validation is needed only where separately required by contract or regulation.

Question 11Quality management fundamentals and ISO 9001 requirements

When a nonconformity occurs, what is the first thing ISO 9001:2015 requires the organization to do?

  1. Issue a new revision of the quality manual and inform all process owners
  2. React to it, control and correct it, and deal with the consequences Correct answer.
  3. Retrain every employee in the affected department before work resumes
  4. Notify the certification body in writing within 24 hours of its detection

Explanation

Clause 10.2.1 requires the organization to react to the nonconformity and, as applicable, take action to control and correct it and deal with the consequences, before evaluating the need to eliminate the cause. Informing the certification body is not a general requirement.

Question 12Quality management fundamentals and ISO 9001 requirements

Which of the following does ISO 9001:2015 require in relation to competence?

  1. A documented training plan must exist for each individual employee
  2. Every person doing work under the organization's control must hold a formal qualification recognized by a national body
  3. Necessary competence must be determined and evidence of it retained Correct answer.
  4. Competence must be verified each year by an external training provider

Explanation

Clause 7.2 requires the organization to determine the necessary competence of persons doing work under its control, ensure they are competent and retain appropriate documented information as evidence of competence. It does not prescribe how competence is obtained or verified.

Question 13Quality management fundamentals and ISO 9001 requirements

When determining the scope of its quality management system, what must an organization take into account under ISO 9001:2015?

  1. The external and internal issues and the relevant interested parties' requirements Correct answer.
  2. Only the requirements of its largest customer and the contracts it has signed with them
  3. Only the processes it chooses to outsource to external providers and their locations
  4. Only the statutory and regulatory requirements of the country in which it manufactures

Explanation

Clause 4.3 requires the scope to take into account the issues identified under 4.1 and the requirements of relevant interested parties identified under 4.2, together with the organization's products and services. The scope must be maintained as documented information.

Question 14Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 requires the organization to determine the knowledge necessary for the operation of its processes and to do what with it?

  1. Patent it before it can be used in any production or service process
  2. Restrict access to it to members of top management and their assistants
  3. Publish it in a publicly accessible database maintained by the organization
  4. Maintain it and make it available as needed Correct answer.

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, then maintain it and make it available to the extent necessary.

Question 15Quality management fundamentals and ISO 9001 requirements

A company buys a machined component from an external provider, incorporates it into an assembly and sells the assembly to its customer. Under ISO 9001:2015, who is responsible for ensuring the component conforms to requirements?

  1. The organization Correct answer.
  2. The external provider alone
  3. The certification body
  4. The customer

Explanation

Clause 8.4.1 makes the organization responsible for ensuring that externally provided processes, products and services conform to requirements. Outsourcing transfers activity to a provider but not the organization's responsibility for conformity.

Question 16Quality management fundamentals and ISO 9001 requirements

Which of the following is required by ISO 9001:2015 in relation to external providers?

  1. Selection and re-evaluation criteria must be applied and the results retained Correct answer.
  2. External providers must be audited on site by the organization at least once every twelve months
  3. A documented supplier scorecard containing at least five performance indicators must be maintained for each provider
  4. Every external provider must hold a third-party certified quality management system before the first order is placed

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, and to retain documented information of these activities and of any necessary actions. The specific controls chosen are left to the organization.

Question 17Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 requires the organization to analyse and evaluate appropriate data and information arising from monitoring and measurement. What is this analysis used for?

  1. Evaluating product conformity, customer satisfaction and supplier performance Correct answer.
  2. Setting the selling price of each product and service offered to customers
  3. Ranking employees for the annual bonus scheme and for promotion decisions
  4. Determining the market share of each product line and of each sales region

Explanation

Clause 9.1.3 requires analysis and evaluation of data to assess conformity of products and services, customer satisfaction, the performance and effectiveness of the QMS, the effectiveness of planning, risks and opportunities, and the performance of external providers.

Question 18Quality management fundamentals and ISO 9001 requirements

Quality objectives established under ISO 9001:2015 must be which of the following?

  1. Confidential and restricted to the management review meeting
  2. Identical for every process and reviewed once each year
  3. Approved in advance by the customer or the certification body
  4. Measurable and consistent with the quality policy Correct answer.

Explanation

Clause 6.2.1 requires quality objectives to be consistent with the quality policy, measurable, monitored, communicated, updated as appropriate, and relevant to conformity of products and services and to the enhancement of customer satisfaction.

Question 19Quality management fundamentals and ISO 9001 requirements

When an output does not conform to requirements, what does ISO 9001:2015 require the organization to do?

  1. Scrap the output regardless of whether the nonconformity can be corrected
  2. Deliver it whenever the measured deviation is below a 5 % threshold
  3. Obtain a written concession from the certification body before releasing it
  4. Take action to correct it and keep documented information describing it Correct answer.

Explanation

Clause 8.7 requires appropriate action based on the nature of the nonconformity and its effect on conformity, and retention of documented information describing the nonconformity, the actions taken, any concessions obtained and the authority deciding the action.

Question 20Quality management fundamentals and ISO 9001 requirements

Under ISO 9001:2015, when measurement traceability is a requirement or is considered by the organization to be essential, measuring equipment must be which of the following?

  1. Calibrated only by the original equipment manufacturer or its agent
  2. Calibrated against standards traceable to national or international standards Correct answer.
  3. Replaced at fixed intervals regardless of its condition and its record of use
  4. Verified by the user before each use with no reference standard

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 standards. Where no such standards exist, the basis used for calibration must be retained as documented information.

Question 21Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 requires the organization to review its ability to meet the requirements for products and services before committing to supply. What must be retained as a result of this review?

  1. Signed minutes of every meeting held with the customer during contract negotiation
  2. A detailed cost breakdown for each order that is accepted
  3. The customer's internal quality manual and its process maps
  4. Documented information of the review results and any new requirements Correct answer.

Explanation

Clause 8.2.3 requires the review to be conducted before commitment to supply and documented information to be retained on the results of the review and on any new or changed requirements for the products and services.

Question 22Quality management fundamentals and ISO 9001 requirements

Continual improvement under ISO 9001:2015 requires the organization to do which of the following?

  1. Hold a monthly improvement meeting with all process owners
  2. Improve the characteristics of its products and services only
  3. Improve the suitability, adequacy and effectiveness of the QMS Correct answer.
  4. Apply corrective action whenever a nonconformity is identified by an auditor

Explanation

Clause 10.3 requires the organization to continually improve the suitability, adequacy and effectiveness of the quality management system, taking into account the results of analysis and evaluation and the outputs of management review.

Question 23Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 requires persons doing work under the organization's control to be aware of which of the following?

  1. The names and audit histories of all external providers currently in use
  2. The organization's financial results and its annual sales targets
  3. The quality policy and their own contribution to the effectiveness of the QMS Correct answer.
  4. The personal objectives of the chief executive officer and the board

Explanation

Clause 7.3 requires awareness of the quality policy, relevant quality objectives, each person's contribution to the effectiveness of the QMS including the benefits of improved performance, and the implications of not conforming with QMS requirements.

Question 24Quality management fundamentals and ISO 9001 requirements

A process output cannot be verified by subsequent monitoring or measurement. What does ISO 9001:2015 require the organization to do in this situation?

  1. Validate and periodically revalidate the process to achieve planned results Correct answer.
  2. Obtain written customer approval for every batch that is produced
  3. Increase the frequency of final inspection to compensate for the risk
  4. Outsource the process to an external provider that holds a certified QMS

Explanation

Clause 8.5.1 f) requires validation and periodic revalidation of the ability to achieve planned results for processes where the resulting output cannot be verified by subsequent monitoring or measurement. Additional inspection cannot compensate, because the characteristic cannot be measured later.

Question 25Quality management fundamentals and ISO 9001 requirements

The outputs of management review under ISO 9001:2015 must include decisions and actions related to which of the following?

  1. Feedback from customers and other relevant interested parties
  2. The results of internal audits and the status of corrective actions
  3. The extent to which quality objectives have been met
  4. Opportunities for improvement and any need for QMS changes Correct answer.

Explanation

Clause 9.3.3 requires the outputs of management review to include decisions and actions related to opportunities for improvement and any need for changes to the quality management system. The other items listed are required inputs under clause 9.3.2.

Question 26Quality management fundamentals and ISO 9001 requirements

ISO 9001:2015 is built on a set of quality management principles. Which of the following is one of those principles?

  1. Supplier dominance
  2. Regulatory compliance
  3. Cost optimisation
  4. Engagement of people Correct answer.

Explanation

The standard's requirements are founded on quality management principles including customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management. Engagement of people is one of these principles; the other listed items are management goals or obligations rather than principles.

Question 27Quality management fundamentals and ISO 9001 requirements

What does ISO 9001:2015 require in relation to the quality policy?

  1. It must be kept confidential to top management only
  2. It must be reviewed and approved by an external certification body before it is released
  3. It must be available to relevant interested parties, as appropriate Correct answer.
  4. It must be displayed at every workstation in the organization

Explanation

The quality policy must be maintained as documented information, communicated within the organization and made available to relevant interested parties as appropriate. Internal communication and external availability are both specified; external approval is not.

Question 28Quality management fundamentals and ISO 9001 requirements

Clause 7.1.3 requires the organization to determine, provide and maintain the infrastructure necessary for the operation of its processes. Which of the following is an example of infrastructure?

  1. The measurement traceability of test equipment
  2. The competence of machine operators
  3. Transport and communication resources Correct answer.
  4. The temperature of the storage area

Explanation

Infrastructure covers buildings, associated utilities, equipment including hardware and software, transportation resources, and information and communication technology. Competence, ambient conditions and measurement traceability are addressed by other clauses.

Question 29Quality management fundamentals and ISO 9001 requirements

Clause 7.4 requires the organization to determine the internal and external communications relevant to the quality management system. Which of the following must be determined?

  1. Only the communication channels used by top management
  2. The languages in which documents must be written
  3. Only the content of communications with customers
  4. What, when, with whom, how and who communicates Correct answer.

Explanation

Clause 7.4 specifies that the organization determines what it will communicate, when, with whom, how and who communicates. The scope is all relevant internal and external communications, not only customer or top-management communications.

Question 30Quality management fundamentals and ISO 9001 requirements

An organization is deciding which interested parties to monitor and review for its quality management system. According to ISO 9001:2015, what makes an interested party relevant?

  1. Whether they are named in the organization's quality manual or in the scope statement of the QMS
  2. Whether they have a signed contract with the organization
  3. Whether they can affect the organization's ability to provide conforming outputs Correct answer.
  4. Whether they are regulators with statutory authority over the organization's activities

Explanation

Clause 4.2 requires the organization to determine the interested parties that are relevant to the quality management system and the requirements of those parties that are relevant. Relevance is judged by the party's potential effect on the organization's ability to consistently provide conforming products and services and on customer satisfaction.

Question 31Quality management fundamentals and ISO 9001 requirements

When planning its quality management system, the organization must address risks and opportunities. What is the purpose of doing so?

  1. To give assurance that the QMS can achieve its intended results Correct answer.
  2. To satisfy only the specific risk requirements imposed by the organization's customers
  3. To replace the need for corrective action whenever a nonconformity is detected in a process
  4. To eliminate the need to maintain a documented risk register and a risk owner for each process

Explanation

Clause 6.1 requires the organization to address risks and opportunities in order to give assurance that the QMS can achieve its intended results, enhance desirable effects, prevent or reduce undesired effects, and achieve improvement. It is a planning obligation, and the standard prescribes neither a risk register nor a prescribed method.

Question 32Quality management fundamentals and ISO 9001 requirements

Clause 6.3 addresses the planning of changes to the quality management system. What must the organization consider when carrying out such changes?

  1. Whether the proposed change has been reviewed and endorsed by the organization's certification body before implementation
  2. The purpose of the change, its consequences and the integrity of the QMS Correct answer.
  3. Whether the change reduces the number of documented procedures and work instructions in the QMS
  4. Only the cost of implementing the change and whether the budget for it has been approved by top management

Explanation

Changes must be carried out in a planned manner, considering the purpose of the change and its potential consequences, the integrity of the quality management system, the availability of resources, and the allocation or reallocation of responsibilities and authorities. Cost and auditor endorsement are not the criteria in the clause.

Question 33Quality management fundamentals and ISO 9001 requirements

Clause 7.5.3 requires the organization to control documented information. Which activity does that control include?

  1. Translating all documented information into every language used by the workforce
  2. Approving every document at each level of the organization before use
  3. Retaining all obsolete documents indefinitely so that past decisions can be traced
  4. Preventing the unintended use of obsolete documented information Correct answer.

Explanation

Control of documented information includes ensuring it is available and suitable for use where and when needed, and protecting it from loss of integrity, improper access and unintended alteration. Obsolete information retained for any purpose must be prevented from unintended use.

Question 34Quality management fundamentals and ISO 9001 requirements

Clause 8.5.2 requires the organization to use suitable means to identify outputs. When is documented information enabling traceability required?

  1. Whenever the product is intended for export
  2. Whenever the organization employs more than ten people
  3. Where traceability is a requirement Correct answer.
  4. Whenever a nonconformity has been identified in a previous audit

Explanation

Under clause 8.5.2 the organization must retain documented information necessary to enable traceability when traceability is a requirement. That requirement may arise from customers, statutory or regulatory obligations, or the organization's own decision.

Question 35Quality management fundamentals and ISO 9001 requirements

A food manufacturer holds ingredients in store before production. Which of the following is the best example of preservation under clause 8.5.4?

  1. Training operators in the correct mixing time and recording their competence
  2. Using temperature-controlled storage and protective packaging until delivery Correct answer.
  3. Calibrating the weighing scale used in the mixing process at defined intervals
  4. Recording the batch number of each ingredient on the process sheet and in the product record

Explanation

Preservation requires the organization to preserve the outputs during production and service provision to the extent necessary to maintain conformity, and includes identification, handling, contamination control, packaging, storage, transmission or transportation and protection. Temperature-controlled storage and protective packaging are preservation activities.

Question 36Quality management fundamentals and ISO 9001 requirements

Clause 8.6 requires documented information on the release of products and services. What must that documented information include?

  1. The names of all external providers involved and the dates on which they were approved
  2. The cost of the verification activities performed and the time taken to complete them at each stage
  3. A copy of the customer's purchase order together with the signed delivery note
  4. Evidence of conformity with acceptance criteria and traceability to the authorising person Correct answer.

Explanation

The documented information on release must include evidence of conformity with acceptance criteria and traceability to the person or persons authorising the release. Planned verification arrangements must be satisfactorily completed before release unless approved by a relevant authority and, where applicable, by the customer.

Question 37Quality management fundamentals and ISO 9001 requirements

A tooling company uses a mould supplied by its customer and accidentally damages it during production. What does ISO 9001:2015 require of the organization?

  1. Record the damage in the internal audit report and discuss it at the next management review
  2. Report the damage to the customer and retain documented information about it Correct answer.
  3. Nothing, because the mould remains the property of the customer and is not covered by the QMS
  4. Replace the mould with an equivalent item before the customer becomes aware of the damage

Explanation

Clause 8.5.3 requires the organization to exercise care with property belonging to customers or external providers while it is under the organization's control or being used. If such property is lost, damaged or otherwise found to be unsuitable for use, the organization must report this to the customer or external provider and retain documented information on what has occurred.

Question 38Quality management fundamentals and ISO 9001 requirements

Clause 8.3.3 requires the organization to determine the requirements essential for the specific type of products and services to be designed and developed. Which of the following is an input the clause explicitly lists?

  1. The marketing budget allocated to the product launch and the expected sales volume
  2. The availability of second-source suppliers for each purchased component
  3. The cost of the design and development process and the budget available for it
  4. The potential consequences of failure Correct answer.

Explanation

Design and development inputs include functional and performance requirements, information from previous similar activities, statutory and regulatory requirements, standards or codes of practice the organization has committed to, and the potential consequences of failure due to the nature of the products and services. Inputs must be adequate, complete and unambiguous.

Question 39Quality management fundamentals and ISO 9001 requirements

A prototype is tested in the laboratory against the design specifications; later the product is trialled by end users in its intended application. Which clause requirement does each activity satisfy?

  1. Both activities satisfy design and development validation, because both demonstrate the product works
  2. Both activities satisfy design and development verification, because both compare results against criteria
  3. The laboratory testing satisfies validation; the user trial satisfies verification
  4. The laboratory testing satisfies verification; the user trial satisfies validation Correct answer.

Explanation

Verification confirms that design and development outputs meet the input requirements, while validation confirms that the resulting products and services meet the requirements for the specified application or intended use. Laboratory testing against specifications is therefore verification, and use in the intended application is validation.

Question 40Quality management fundamentals and ISO 9001 requirements

Clause 8.5.5 requires the organization to meet requirements for post-delivery activities. When determining their extent, what must the organization consider?

  1. Statutory requirements, potential undesired consequences, intended lifetime and customer feedback Correct answer.
  2. Only the terms explicitly agreed in the sales contract, plus any discount offered at the time of the sale
  3. Only the organization's internal audit schedule and the findings raised in the previous certification audit
  4. Only the profitability of the after-sales service line and the cost of providing spare parts to distributors

Explanation

When determining the extent of post-delivery activities, the organization must consider statutory and regulatory requirements, the potential undesired consequences associated with the products and services, their nature, use and intended lifetime, customer requirements, and customer feedback. The list is broader than the contract alone.

Question 41Audit principles, audit types and the audit programme (ISO 19011)

Which audit principle creates the obligation to report audit findings truthfully, accurately and in a timely manner?

  1. Due professional care
  2. Integrity
  3. Fair presentation Correct answer.
  4. Evidence-based approach

Explanation

ISO 19011 defines fair presentation as the obligation to report truthfully and accurately, including reporting significant obstacles encountered and unresolved divergences of opinion. It governs how findings, conclusions and reports are communicated to the auditee and other interested parties.

Question 42Audit principles, audit types and the audit programme (ISO 19011)

An organisation audits its own quality management system using its own staff. This is best described as:

  1. A third-party audit
  2. A certification audit
  3. An internal audit Correct answer.
  4. A second-party audit

Explanation

Audits are classified by the relationship between the auditor and the auditee. When an organisation audits its own management system, the audit is a first-party, or internal, audit.

Question 43Audit principles, audit types and the audit programme (ISO 19011)

Which situation describes a second-party audit?

  1. An organisation auditing one of its suppliers against contractual requirements Correct answer.
  2. An organisation auditing its own departments against its procedures
  3. An independent certification body auditing an organisation's management system
  4. A regulator inspecting an organisation within its legal jurisdiction

Explanation

A second-party audit is carried out by a party that has an interest in the auditee, typically a customer auditing a supplier or a purchaser auditing a contractor. The auditor is external to the auditee but is not an independent third party.

Question 44Audit principles, audit types and the audit programme (ISO 19011)

In ISO 19011 terminology, an audit programme is best described as:

  1. A set of one or more audits planned for a specific time frame Correct answer.
  2. The agenda of meetings held during a single audit
  3. The scope, criteria and timetable of one individual audit
  4. A checklist used by the audit team during fieldwork

Explanation

The audit programme covers the arrangements for a set of audits planned for a specific time frame and directed at a specific purpose. A single audit within that set is covered by an audit plan.

Question 45Audit principles, audit types and the audit programme (ISO 19011)

What is the purpose of an audit plan?

  1. To list the corrective actions the auditee must take after the audit
  2. To record the findings and conclusions reached by the audit team
  3. To define the objectives of the audit programme for the coming year
  4. To describe the activities and arrangements for an individual audit Correct answer.

Explanation

An audit plan provides the basis for agreement among the audit client, audit team and auditee on how a specific audit will be conducted. It covers objectives, scope, criteria, dates, team roles and methods for that single audit.

Question 46Audit principles, audit types and the audit programme (ISO 19011)

Two or more management systems of the same auditee are audited together in one audit. This is called:

  1. A combined audit Correct answer.
  2. A joint audit
  3. A surveillance audit
  4. A follow-up audit

Explanation

ISO 19011 defines a combined audit as an audit carried out together on two or more management systems of the same auditee. It should not be confused with a joint audit, where two or more auditing organisations cooperate.

Question 47Audit principles, audit types and the audit programme (ISO 19011)

Which audit principle requires that conclusions be reached only from verifiable information obtained through a rational and systematic process?

  1. Integrity
  2. Due professional care
  3. Risk-based approach
  4. Evidence-based approach Correct answer.

Explanation

The evidence-based approach requires auditors to use systematic processes to obtain and verify information, and to base findings and conclusions solely on that evidence. Sampling is used because an audit is conducted within a limited time and with limited resources.

Question 48Audit principles, audit types and the audit programme (ISO 19011)

Why does ISO 19011 require risks and opportunities to be considered when establishing an audit programme?

  1. To satisfy the documentation requirements of a certification body
  2. To guarantee that no nonconformity escapes detection
  3. To reduce the number of auditors needed for each audit
  4. To focus audit effort where it matters and improve programme effectiveness Correct answer.

Explanation

A risk-based audit programme directs attention and resources towards areas of higher risk to the auditee's objectives and to the programme's own effectiveness. Risks to the programme itself, such as resource or competence shortfalls, are also identified so that they can be addressed.

Question 49Audit principles, audit types and the audit programme (ISO 19011)

Which of the following is an example of a remote audit method?

  1. Walking through the warehouse with the auditee's staff
  2. Interviewing process owners by video conference Correct answer.
  3. Inspecting physical records in the auditee's archive
  4. Observing a production line while it is running

Explanation

ISO 19011 distinguishes on-site and remote methods, where remote means the audit activities are performed at a distance from the auditee using electronic means. Interviews conducted by video conference are remote, whereas physical observation and inspection are on-site.

Question 50Audit principles, audit types and the audit programme (ISO 19011)

According to ISO 19011, the competence of auditors comprises which two elements?

  1. Personal behaviour and the ability to apply knowledge and skills Correct answer.
  2. Technical knowledge of the standard and speed of report writing
  3. Formal qualifications and total years of work experience
  4. Number of training hours completed and number of audits performed

Explanation

Competence is defined as the ability to apply knowledge and skills to achieve intended results, and ISO 19011 treats personal behaviour as equally important. The standard therefore addresses both the behavioural attributes of auditors and their knowledge and skills.