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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Managing an ISO 9001 audit program | 12.5% | - Audit program management - Audit program monitoring and improvement |
| Topic 2: Fundamental audit concepts and principles | 12.5% | - Audit concepts and principles - Management of combined audits - Personal attributes and behaviors of a professional auditor |
| Topic 3: Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Risks and opportunities - 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) |
| Topic 4: Conducting an ISO 9001 audit | 22.5% | - Audit findings and conclusions - Audit techniques and evidence collection - Audit conducting process |
| Topic 5: 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 6: Closing an ISO 9001 audit | 13.75% | - Audit report preparation - Management of audit records - Audit completion and follow-up |
| Topic 7: Preparing an ISO 9001 audit | 12.5% | - Roles and responsibilities of the audit team leader and members - Audit feasibility - Evidence types and their characteristics - Steps and activities to prepare a QMS audit |
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NEW QUESTION # 233
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 # 234
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: A
Explanation:
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 References 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.
NEW QUESTION # 235
In the context of a second-party audit, match the activity with the party responsible for conducting it.
Answer:
Explanation:
Explanation:
Here is the correct matching of the activities with the responsible parties in the context of a second-party audit:
Define the audit scope: Customer
Develop the audit plan: Audit team leader
Respond to the audit findings: External provider
Conduct the audit: Audit team
This reflects the typical division of responsibilities in a second-party audit, where the customer (the party commissioning the audit) sets the scope, the audit team leader manages the planning, the external provider responds to findings, and the audit team carries out the audit.
NEW QUESTION # 236
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM) You: "Would you tell me about your management review process?" QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?" Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
Answer:
Explanation:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.
NEW QUESTION # 237
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence.
They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
What type of evidence has been collected by the ACB's audit team, as presented in scenario 3?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Audit evidence includes information collected through different methods to assess compliance with ISO
9001:2015 requirements.
Clause References:
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence: Audit evidence must be objective, verifiable, and based on facts.
* ISO 9001:2015, Clause 9.1.1 - Monitoring, Measurement, Analysis, and Evaluation: Requires organizations to collect and analyze data from multiple sources to verify effectiveness.
Types of Audit Evidence Collected in Scenario 3:
* Verbal Evidence - Employee interviews regarding training and awareness sessions.
* Documentary Evidence - Organizational charts, job descriptions, training records.
* Physical Evidence - Workplace observations to assess working conditions.
Why is the Correct Answer B?
* The audit team used a combination of verbal (interviews), documentary (records), and physical (site observations) evidence.
* This triangulation approach enhances audit reliability and ensures compliance verification.
Why are the Other Options Incorrect?
* A (Confirmative evidence) # Not a formal audit term in ISO 9001 or ISO 19011.
* C (Analytical evidence) # Incorrect, as analysis was not a primary method used.
* D (Qualitative evidence only) # Incorrect because the audit involved both qualitative (interviews) and quantitative (documents, physical) evidence.
Reference:
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
ISO 9001:2015, Clause 9.1.1 - Monitoring, Measurement, Analysis, and Evaluation
NEW QUESTION # 238
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