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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Conducting an ISO 9001 audit | 22.5% | - Audit conducting process - Audit techniques and evidence collection - Audit findings and conclusions |
| Topic 2: Fundamental principles and concepts of a quality management system (QMS) | 12.5% | - Advantages of implementing a QMS based on ISO 9001 - Applicability and scope of ISO 9001 - Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004) |
| Topic 3: Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Structure of the standard - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Context of the organization, interested parties, and QMS scope (clause 4) - Risks and opportunities |
| Topic 4: Fundamental audit concepts and principles | 12.5% | - Audit concepts and principles - Personal attributes and behaviors of a professional auditor - Management of combined audits |
| Topic 5: Preparing an ISO 9001 audit | 12.5% | - Steps and activities to prepare a QMS audit - Evidence types and their characteristics - Audit feasibility - Roles and responsibilities of the audit team leader and members |
| Topic 6: Closing an ISO 9001 audit | 13.75% | - Management of audit records - Audit completion and follow-up - Audit report preparation |
| Topic 7: Managing an ISO 9001 audit program | 12.5% | - Audit program monitoring and improvement - Audit program management |
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NEW QUESTION # 70
Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to 'knowledge'?
Answer: C,E
Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
According to ISO 19011:2018 - Guidelines for Auditing Management Systems, which is referenced in ISO
9001 Lead Auditor training and practice, auditor competence is defined by a combination of knowledge, skills
, and personal attributes. Here's how each selected option aligns:
* D. Determining what evidence to gather: This activity is rooted in knowledge of audit principles, criteria, and risk-based thinking. It requires an understanding of which types of evidence (documents, records, interviews, observations) are necessary to evaluate conformity to the audit criteria (Clause
7.2.3 of ISO 19011:2018).
* E. Evaluate proposals of corrective actions: This task involves applying knowledge of ISO 9001 requirements, root cause analysis methods, and risk controls to assess whether proposed actions are suitable to prevent recurrence. It demands comprehension of quality management principles and corrective action methodologies, linking it firmly to knowledge.
Other options such as A (Communicate with auditee) and B (Conduct audit meetings) are predominantly skills-based, requiring interpersonal and communication abilities, not theoretical or regulatory knowledge.
C (Determine how to seek evidence) and F (Identify findings) involve both knowledge and skill but are more action-oriented and tied to situational judgment and auditor behavior.
References:
ISO 19011:2018, Clause 7.2.3 - Establishing Auditor Competence
ISO 9001:2015, Clause 9.2 - Internal Audit
ISO 19011:2018, Annex A.1 - Knowledge and skills of auditors
NEW QUESTION # 71
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.
Answer:
Explanation:
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 criteria. 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.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 72
During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.
Which corrective action is the best one?
Answer: B
Explanation:
Understanding Clause 7.1.5.2 - Measurement Traceability:ISO 9001:2015 requires organizations to ensure that measuring equipment (e.g., spectrometers) is calibrated and traceable to recognized standards. The failure to maintain calibration within valid dates directly violates this clause and raises concerns about the reliability of the measurement results.
Root Cause of the Nonconformity:The organization failed to plan for the possibility that the calibration service provider (X-TECH) might become unavailable, leading to expired calibration. This indicates inadequate risk-based thinking, which is required under Clause 6.1 of ISO 9001:2015.
Option Analysis:
A). Select one sample for external lab analysis to use as an internal standard:Incorrect. While using an internal standard could provide short-term verification of results, this action does not address the root cause (failure to consider risks associated with external providers).
B). Look for a local company to provide this service:Incorrect. While finding a new local service provider resolves the immediate calibration issue, it does not address the risk of future provider unavailability.
C). Double-check one out of ten samples externally:Incorrect. This corrective action ensures some quality assurance for batch release but does not resolve the nonconformance related to expired calibration.
D). Add this issue to the external issue register, assess its associated risk, and plan action to address that risk:
Correct. This approach directly addresses the root cause (failure to anticipate the calibration provider leaving) and ensures proper risk management. ISO 9001:2015 emphasizes risk-based thinking under Clause 6.1, requiring organizations to identify risks and opportunities and implement plans to mitigate them.
Why D is the Best Option:
By adding the issue to the external issue register, the organization ensures it is monitored and tracked.
Assessing the risk ensures proactive measures are in place for similar issues in the future.
Planning actions to address the risk ensures a sustainable solution is implemented, such as identifying multiple service providers or ensuring backup plans for calibration services.
ISO 9001 References:
Clause 6.1 (Actions to Address Risks and Opportunities): Requires organizations to consider risks and opportunities that could affect the intended results of the QMS.
Clause 7.1.5.2 (Measurement Traceability): Mandates that measuring equipment must be calibrated and traceable to ensure valid results.
Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to determine the root cause of nonconformities and take actions to ensure they do not recur.
NEW QUESTION # 73
(When raising a non-conformity during an audit, which two of the following items should you include in the non-conformity statement?)
Answer: D,E
Explanation:
ISO 9001:2015 requires that nonconformities be objective, evidence-based, and referenced against defined requirements, not personal, prescriptive, or solution-driven.
When a nonconformity is raised, it must clearly show what requirement was not met and what objective evidence demonstrates this failure.
# Why D (Audit criteria) is required
* A nonconformity must reference the requirement that was not fulfilled (e.g., ISO 9001 clause, procedure, contract, or legal requirement).
* ISO 9001 defines nonconformity as "non-fulfilment of a requirement".
* Without audit criteria, there is no basis for declaring a nonconformity.
# Supported by:
* Clause 9.2.2 - Internal audits must determine whether the QMS conforms to requirements
* Clause 10.2.2 - Documented information shall describe the nature of the nonconformity
# Why E (Relevant audit evidence) is required
* ISO 9001 requires decisions and conclusions (including audit findings) to be based on evidence.
* Audit evidence ensures objectivity and prevents subjective or opinion-based findings.
# Supported by:
* Clause 9.1.3 - Analysis and evaluation shall be based on data and information
* Clause 9.2.2 - Audit results must demonstrate conformity or nonconformity based on evidence
# Why the other options are NOT correct
* A (Name of person responsible)ISO 9001 focuses on system and process failures, not blaming individuals.
* B (Target time for corrective action)This is part of corrective action planning, not the nonconformity statement itself (Clause 10.2).
* C (Name of technical expert)ISO 9001 does not require identifying auditors or experts in the nonconformity statement.
* F (Action to eliminate the nonconformity)Auditors must not prescribe solutions. The auditee determines corrective actions (Clause 10.2).
NEW QUESTION # 74
Which of the following three options could be considered potential threats to impartiality in an audit context?
Answer: B,C,E
Explanation:
Potential threats to impartiality in an audit context include familiarity (having a close relationship with the auditee), intimidation (being coerced or feeling pressured), and self-audit (auditing one's own work). These factors can compromise the auditor's objectivity and the audit's integrity. References: = The information is based on the ISO 9001 Auditing Practices Group documents which discuss threats to auditor impartiality and how they may compromise an auditor's objectivity123.
NEW QUESTION # 75
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