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Select the two statements that are true.
Answer : C, E
Analyzing Each Statement:
A . Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.
B . Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.
C . Correct. If audit objectives are unattainable based on available evidence, the individual(s) managing the audit programme (e.g., the certification body) must be informed immediately. This ensures that appropriate action can be taken. Reference: ISO 19011:2018, Clause 6.6.2.
D . Incorrect. Changes to the audit scope require the approval of the audit client (e.g., the certification body), not just the auditee. The scope is agreed upon in advance, and significant changes must be communicated with all stakeholders.
E . Correct. The audit team leader is responsible for periodically assessing the audit progress to ensure it aligns with the audit objectives and planned scope. Reference: ISO 19011:2018, Clause 6.4.5.
F . Incorrect. While immediate and significant risks should be communicated to the auditee, notifying the certification body is not an immediate responsibility of the audit team leader. The communication process depends on the procedures defined by the audit programme manager.
Why Options C and E Are Correct:
C: Communicating unattainable audit objectives ensures the audit remains effective and prevents unnecessary effort or misalignment with goals.
E: Periodic assessments by the team leader help in maintaining alignment with the scope, objectives, and time constraints, ensuring the audit's success.
Relevant Reference from ISO Standards:
ISO 19011:2018, Clause 6.6.2: Describes procedures for when audit objectives are unattainable.
ISO 19011:2018, Clause 6.4.5: Emphasizes the audit team leader's responsibility for ongoing assessment of audit progress.
XYZ Corporation employs 100 people, and during a Stage 1 certification audit, certain issues are identified with the Quality Management System (QMS). Which two options describe the circumstances in which you could raise a nonconformity against Clause 6.2 of ISO 9001:2015?
Answer : D, F
Understanding Clause 6.2 of ISO 9001:2015: Clause 6.2 (Quality Objectives and Planning to Achieve Them) specifies that organizations must:
Establish measurable and relevant quality objectives consistent with the quality policy (Clause 6.2.1).
Include objectives applicable to product/service conformity and customer satisfaction.
Document these objectives and their planning as documented information (Clause 6.2.1 & 6.2.2).
Plan how to achieve the objectives, including defining actions, resources, responsibilities, timelines, and methods for evaluation.
Analysis of Options:
A. Quality objectives are not being implemented by the organisation's personnel: Incorrect. While implementation is critical, this relates more to operational aspects rather than the direct requirements of Clause 6.2. Implementation issues would typically raise concerns under Clause 9.1 (Performance Evaluation).
B. The consultant has not interpreted ISO 9001 correctly: Incorrect. The consultant's interpretation of ISO 9001 is irrelevant in terms of Clause 6.2 compliance. The focus is on whether the organization aligns with the requirements, not the consultant's role.
C. Establishing quality objectives did not include top management: Incorrect. While top management involvement is vital for QMS effectiveness (Clause 5.1), this is not a direct requirement of Clause 6.2. Top management alignment is implied but not explicitly mandated for establishing quality objectives.
D. Quality objectives were not established in alignment with the organisation's quality policy: Correct. Clause 6.2.1 requires that quality objectives be consistent with the organization's quality policy, ensuring they reflect its purpose, strategic direction, and commitment to continual improvement. Misalignment would constitute a nonconformity.
E. The organisation cannot afford to undertake quality objectives all at once: Incorrect. Financial constraints are not directly addressed in Clause 6.2. The clause focuses on planning to achieve objectives, which includes defining the necessary resources but does not demand achieving all objectives simultaneously.
F. Quality objectives are not maintained as documented information: Correct. Clause 6.2.1 specifically requires that quality objectives be maintained as documented information. Failure to document the objectives is a direct violation of this clause.
Why Options D and F Are Correct:
D: Misalignment between the quality objectives and the quality policy directly violates Clause 6.2.1, which mandates that objectives support the strategic direction of the organization.
F: Lack of documentation for quality objectives breaches the requirement to maintain them as documented information under Clause 6.2.1.
Relevant Reference:
Clause 6.2.1: Establishing quality objectives aligned with the quality policy.
Clause 6.2.2: Maintaining documented information for quality objectives and planning to achieve them.
Clause 5.1.1: Top management's responsibility to ensure alignment between the QMS and strategic direction.
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 : D
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 Reference:
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.
A small deaning services organisation is about to start work on a hospital dleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced. You: "How was the cleaning plan for the contract developed?" Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001. You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow- up audit, the corrective action proposed was to "obtain a concession from the Health Trust for use of the new chemical." Which one of the following options is the reason why you did not accept this action taken?
Answer : D
Clause 8.2.4 of ISO 9001:2015 -- Changes to Requirements for Products and Services:
ISO 9001:2015 Clause 8.2.4 states that when changes to requirements for products or services are made, they must be communicated and agreed upon with relevant interested parties (in this case, the Health Trust). The lack of communication and agreement for substituting the cleaning chemical represents a clear violation of this clause.
Analysis of the Corrective Action Proposed:
The organization proposed 'obtaining a concession from the Health Trust for the use of the new chemical.' This action is reactive and assumes approval from the Health Trust without addressing the systemic issue: the lack of a defined change control process for managing contract changes.
Option Analysis:
A . The substitute chemical has not been used before in the Health Trust:
Incorrect. While this may be a concern, it is not directly relevant to the root cause of the nonconformity, which is the absence of a process to handle contract changes.
B . The action assumes that the Health Trust will agree to the change:
Incorrect. Although this is true, it is not the primary issue. The nonconformity lies in the lack of a structured approach to obtain agreement, not whether the Health Trust agrees.
C . Staff have not been trained in the use of the new chemical:
Incorrect. This is a separate issue related to staff competence (Clause 7.2), but it is not the main reason why the corrective action is unacceptable under Clause 8.2.4.
D . The process for making changes to the contract has not been addressed:
Correct. The fundamental issue is the organization's failure to follow or establish a change control process for amending contracts, including gaining formal agreement from the Health Trust. The proposed corrective action does not ensure that such issues will be systematically prevented in the future.
E . The substitute chemical may not be as effective as the original:
Incorrect. The effectiveness of the substitute chemical is secondary to the primary issue, which is the lack of a change management process.
ISO 9001 Reference Supporting the Correct Answer:
Clause 8.2.4: Requires that changes to product/service requirements be reviewed, communicated, and agreed upon with the customer.
Clause 10.2 (Nonconformity and Corrective Action): Requires the organization to address the root cause of the nonconformity and take actions to ensure it does not recur. In this case, the root cause is the absence of a change control process.
Why D is the Best Answer:
The core issue is that the organization did not have a formalized process for managing and agreeing upon changes to contract requirements. Addressing this process gap is essential to prevent recurrence of similar nonconformities. Merely seeking a concession from the Health Trust is a one-off solution that does not address the systemic issue.
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oll and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged
steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality
Manager explains that the Managing Director authorised release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
Which of the following options for the best description of the nonconformity?
Answer : C
Clause Reference -- ISO 9001:2015 Clause 8.6 (Release of Products and Services): ISO 9001 requires that products and services are not released to the customer until:
All planned verification activities have been completed.
Acceptance criteria have been met.
Any necessary approvals have been obtained.
In this scenario:
The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.
This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.
Option Analysis:
A. A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager: Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.
B. Release of the product without acceptable test results has been accepted by the customer for Project DK: Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.
C. Products for Project DK have been released before product approval through the quality control process: Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.
D. The untested product was not recalled until the galvanic efficiency of the anodes was verified: Incorrect. The issue is not about recalling the product but about releasing it without completing the required tests. Recalling the product is not mentioned in the scenario.
Why C is Correct:
The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.
This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO 9001 compliance.
Key ISO 9001 Reference:
Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.
