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

According to the ISO 9001:2015 standard, clause 8.7 requires that an organization identify and control any nonconforming outputs that do not conform to the requirements of the customer or other relevant requirements. Nonconforming outputs are any outputs from the process, product or service that do not meet the specified quality criteria. Nonconforming outputs must be dealt with in one or more of the following ways:

Correction of the nonconformity

Segregation, containment, return or suspension of provision of products and services

Informing the customer

Authorisation for acceptance under concession

The organization must also retain documented information on the description of the nonconformity, the actions taken, any concessions obtained, and the identification of the authority deciding the action to resolve the nonconformity.

In this scenario, you have interviewed a line supervisor who is responsible for managing a manual picking line where operators are removing contaminant materials from incoming products. The supervisor has explained that these plastic items are rejected at this stage because they do not meet their processing standards and they can damage their machinery and compromise their quality standards. The supervisor has also mentioned that some of these rejected items are melted down in another process later on and some are disposed of as waste products that cannot be recycled.

Based on this information, you can investigate further by taking two actions:

A. Check the process for handling nonconforming items: You can verify whether there is a documented procedure for identifying, segregating, containing, returning or suspending provision of nonconforming items at this stage. You can also check whether there is a system for informing customers about any nonconforming items that may affect their satisfaction or expectations.

D. Determine what happens to the waste products: You can verify whether there is a documented procedure for disposing of waste products that cannot be recycled as per environmental regulations and customer requirements.

These two actions would help you to determine whether there are any nonconforming outputs at this stage and how they are controlled by the organization.

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.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015, Clause 5.1.2 (Customer Focus) states that top management must ensure customer satisfaction by monitoring customer perceptions.

In scenario 2, top management initiated customer surveys, demonstrating their commitment to customer focus as required by Clause 5.1.2.

Comprehensive and Detailed In-Depth Explanation:

Auditors must have competence in risk-based auditing to effectively assess an organization’s QMS performance and compliance.

Clause References:

ISO 19011:2018, Clause 7.2.3 – Determining Auditor Competence:

Auditors must have knowledge of risk-based thinking to assess risk impact on processes.

ISO 9001:2015, Clause 0.3.3 – Risk-Based Thinking:

The standard emphasizes proactive risk management, which auditors must understand.

Why is the Correct Answer B?

Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.

Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.

Why are the Other Options Incorrect?

A (Industry knowledge) → While helpful, it is not mandatory for all auditors.

C (Expertise in all domains) → Auditors are not required to be experts in all areas, just in audit methodology.

D (Formal degree in quality management) → ISO does not require a formal degree, just competence in audit principles and methods.

Comprehensive and Detailed In-Depth Explanation:

During communication with top management, the auditor should discuss:

The quality policy (ISO 9001:2015, Clause 5.2.1), ensuring that it is established, communicated, and understood.

Internal audits (ISO 9001:2015, Clause 9.2), verifying that they are planned and effectively implemented.

These discussions help assess leadership commitment and the effectiveness of the QMS.