QUESTION: 29

DRAG DROP (Drag and Drop is not supported)

In the context of a management system audit, identify the sequence of a typical process for collecting and verifying information. The first one has been done for you.

To complete the sequence click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.

See Explanation section for answer.

Answer(s): A

Explanation:

Identifying the source of information
Sampling available data
Gathering audit evidence
Verifying objective evidence
Evaluating evidence against the audit criteria
Making audit conclusions
Evaluating against the audit criteria

According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:
Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteri a. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc. Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.
Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.
Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.
Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.
Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc. Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence. The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.

Reference:

ISO 19011:2018(en), Guidelines for auditing management systems

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QUESTION: 30

DRAG DROP (Drag and Drop is not supported)
In the context of a third-party certification audit, match the roles with the following responsibilities:

See Explanation section for answer.

Answer(s): A

Explanation:

In the context of a third-party certification audit, match the roles with the following responsibilities:
Responsibilities:
Conduct the audit to the assigned area.= Auditors
Assist the auditors in identifying personnel to participate in the audit.= Guide Assign each team member's responsibility for the audit.= Audit team leader Respond to questions and provide evidence to the auditor.= Auditee

According to ISO 19011:2018, clause 3, the definitions of the roles are as follows1:
Auditors: persons with the competence to conduct an audit
Guide: person appointed by the auditee to assist the audit team

Auditee: organization being audited
Audit team leader: member of an audit team appointed to manage the audit or an audit team Therefore, the roles can be matched to the responsibilities based on these definitions and the description of the audit process in clause 6 of the standard1.

Reference:

ISO 19011:2018(en), Guidelines for auditing management systems

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QUESTION: 31

In the context of a third-party audit, select the issue which is not expected to be included in the audit plan.

Number of sites to be audited
Risk to achieving audit objectives
Expectations of the organisation's management
Scope of the audit

Answer(s): C

Explanation:

According to ISO 19011:2018, clause 6.3.2, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the following information1:
· the audit objectives, scope and criteria
· the audit team members and their roles and responsibilities
· the audit schedule, including the date, time and location of each audit activity · the expected time and duration of meetings and interviews
· the allocation of appropriate resources to critical areas of the audit · the identification of the audit client and the auditee
· the identification of the guides and observers, if any
· the documents and records to be reviewed before and during the audit · the audit methods and tools to be used
· the audit language and terminology
· the audit report content, format, distribution and expected completion date
· the risk to achieving audit objectives and the contingency plan, if any Therefore, the issue which is not expected to be included in the audit plan is C, expectations of the organisation's management. This issue is not relevant to the conduct of the audit, as the audit is based on the audit criteria, not on the management's expectations. The management's expectations may be considered during the audit initiation or the audit programme management, but they are not part of the audit plan.

Reference:

ISO 19011:2018(en), Guidelines for auditing management systems, How to create an ISO 9001 internal audit plan - Advisera

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QUESTION: 32

In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.

A recommendation is given in the report.
A finding of good practice is reported.
An opportunity for improvement is raised.
A major non-conformity is raised.
A finding of conformity is reported.
A minor non-conformity is raised.

Answer(s): D,F

Explanation:

According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization's management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization's management system to achieve the intended results, but is a deviation from the audit criteria1.
According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken. The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2. Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring. The other options are not correct, as they do not require the organization to act in response to reported findings:

· A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.
· B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization's management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.
· C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization's management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.
· E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization's management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.

Reference:

ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021- 1:2015(en), Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 1: Requirements

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