ISO-9001-Lead-Auditor Dumps with Practice Exam Questions Answers

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Comprehensive and Detailed In-Depth Explanation:

Clause 8.3.2 e) – Internal Resource Needs:Delays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.

Clause 8.3.6 – Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.

Clause 8.3.5 – Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.

Clause 8.3.4 d) – Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.

Clause 8.3.2 e) – External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.

Comprehensive and Detailed In-Depth Explanation:

Auditors must report findings truthfully and accurately to ensure an unbiased assessment of the QMS.

Clause References:

ISO 19011:2018, Clause 4 – Principles of Auditing:

Fair Presentation → Requires auditors to report truthfully and accurately, without bias or omission.

Integrity → Ensures auditors adhere to ethical conduct.

Why is the Correct Answer A?

The audit team reported findings truthfully, based on collected evidence.

Fair presentation ensures that both positive and negative findings are included in the audit report.

Objective evidence was gathered through interviews, document reviews, and observations.

Why are the Other Options Incorrect?

B (Integrity) → Related to ethics and professional conduct, but not specifically about presenting findings.

C (Confidentiality) → Important, but does not apply to the principle of reporting findings accurately.

D (Objectivity) → Ensures impartiality, but "fair presentation" directly addresses accurate reporting of findings.

Comprehensive and Detailed In-Depth Explanation:

ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.

Thus, C is the correct answer.

The auditor could raise the following nonconformities to ISO 9001 based on the scenario:

•Option A: 10.3 - The organisation did not continuously improve. Reject rates were unchanged. This option is correct because ISO 9001:2015 clause 10.3 requires the organization to improve the suitability, adequacy and effectiveness of the quality management system. The organization did not demonstrate any improvement in reducing the reject rate of the finished product, which was a stated objective of top management. The corrective action taken by the organization was not effective in addressing the root cause of the problem and preventing its recurrence.

•Option B: 7.1.4 - The factory environment is not suitably maintained to prevent dirty products. This option is correct because ISO 9001:2015 clause 7.1.4 requires the organization to determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. The organization did not ensure that the factory floor was clean and dry, which affected the quality of the products and increased the risk of nonconformity.

•Option C: 7.1.1 - The organization failed to provide the required resources to prevent nonconforming products. This option is correct because ISO 9001:2015 clause 7.1.1 requires the organization to determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization did not provide adequate collection baskets for the products ejecting from the moulding machines, which resulted in products falling onto the factory floor and becoming nonconforming.

The following options are not correct:

•Option D: 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3). This option is not correct because ISO 9001:2015 clause 9.2.2 does not specify the requirements for the wording of nonconformities in internal audit reports. The nonconformity (NC 3) stated by the internal auditor was clear and relevant to the audit criteria and audit evidence. The issue is not with the report, but with the corrective action taken by the organization.

•Option E: 8.6 - Dirty products were released to the customer. This option is not correct because ISO 9001:2015 clause 8.6 requires the organization to implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The scenario does not indicate that the dirty products were released to the customer, but that they were recalled and repaired then returned to the customers. The issue is not with the release, but with the production process and the environment.

•Option F: 7.3 - Staff were not aware that products were falling onto the factory floor. This option is not correct because ISO 9001:2015 clause 7.3 requires the organization to ensure that the persons doing work under its control are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the quality management system, and the implications of not conforming with the quality management system requirements. The scenario does not indicate that the staff were not aware of these aspects, but that the management did not provide adequate resources and environment for the staff to perform their work. The issue is not with the awareness, but with the management responsibility and resource provision.

•Option G: 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity. This option is not correct because ISO 9001:2015 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. The scenario indicates that the Quality Manager conducted an investigation into the reject rates and identified the cause of the nonconformity. The issue is not with the investigation, but with the corrective action taken by the management.

•Option H: 8.5.1 - Production operations were not properly controlled to avoid reject products. This option is not correct because ISO 9001:2015 clause 8.5.1 requires the organization to implement production and service provision under controlled conditions. The scenario indicates that the production operations were controlled by the moulding machines, which ejected the products into the collection baskets. The issue is not with the production operations, but with the size of the collection baskets and the condition of the factory floor.

Comprehensive and Detailed In-Depth Explanation:

Policies and guidelines are considered documentary evidence because they are written records that demonstrate how an organization complies with ISO 9001 requirements.

Clause References:

ISO 19011:2018, Clause 6.4.6 – Audit Evidence:

Documentary evidence includes manuals, procedures, and policies.

Why is the Correct Answer C?

Documentary evidence includes written records such as policies, procedures, and documented instructions that support QMS implementation.

Auditors review policies to verify conformance with ISO 9001.

Why are the Other Options Incorrect?

A (Confirmative evidence) → Not a recognized category in ISO auditing.

B (Technical evidence) → Technical evidence refers to measurements, test results, or product data, not policies.