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NEW QUESTION # 89
You are carrying out an audit to ISO 9001 at an organisation which offers consultancy services on the implementation of ISO 9001 quality management systems to manufacturers of cosmetics.
You are interviewing the Technical and Quality Director (TQD), who manages a team of biochemists responsible for providing ISO 9001 consultancy services to customers.
You: "How do you ensure your team's competence concerning regulatory and ISO 9001 requirements?" TQD: "We subcontract a part-time lead consultant who has years of experience working as a biochemist in the cosmetics industry. She is responsible for ensuring the team's competency." You: "Do they retain any documented information on the individual competency of each consultant?" TQD: "No. The lead consultant is a dedicated individual with lots of contacts in the sector. We rely on her decision on the consultants' competency. She says that she thought that it was not necessary to keep documented information; however, after the event two weeks ago, which could not be solved due to the lack of documentation, she may consider in the future to plan which information we may need to keep." You: "How does the organisation enable the consultants you employ to maintain updated their competence on ISO 9001 and regulatory requirements?" TQD: "As I said before, we leave that up to the lead consultant. She tells us when we need to employ more young consultants and when changes are introduced in the applicable regulations. Our regular survey shows that customers are quite satisfied with our consultants; last year's objective of customer satisfaction was achieved. We gave a salary increase to consultants when they knew that the objectives had been achieved." You decide to raise a non-conformity.
To complete the non-conformity report, 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:
Non-conformity Report
ISO 9001 Clause Number:
7.2
Nature of problem:
Documented information is not retained on the necessary competence of consultants with respect to relevant regulatory and ISO 9001 requirements.
ISO 9001 requirement that has not been fulfilled:
ISO 9001 - "The organization shall retain appropriate documented information as evidence of competence." ISO 9001:2015 places a clear requirement on organisations to ensure that persons doing work under its control that affects performance and conformity are competent, and that this competence is demonstrated and evidenced.
Relevant ISO 9001 requirements
* Clause 7.2 - Competence requires the organisation to:
* determine the necessary competence of persons doing work under its control,
* ensure that these persons are competent on the basis of appropriate education, training, or experience, and
* retain appropriate documented information as evidence of competence.
In the scenario:
* Competence decisions are entirely delegated to a subcontracted lead consultant.
* No documented information is retained to demonstrate individual consultant competence.
* A recent event could not be resolved specifically due to the absence of documented competence records, which directly confirms non-fulfilment of Clause 7.2.
* Reliance on customer satisfaction results or the personal judgement of a consultant does not replace the ISO 9001 requirement for objective evidence.
Why other clauses are not applicable:
* Clause 7.1 relates to provision of resources, not evidence of competence.
* Clause 7.3 relates to awareness of quality objectives, not competence records.
* Statements such as "consultants are not aware of customer satisfaction objectives" or "persons necessary are not determined" are not supported by the scenario evidence.
ISO-aligned conclusion:
The organisation has failed to retain documented information as evidence of competence for consultants providing ISO 9001 and regulatory consultancy services. This is a clear and justified nonconformity against ISO 9001:2015 Clause 7.2.
NEW QUESTION # 90
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.
Based on the last paragraph of scenario 3, which audit principle did the audit team follow?
Answer: A
Explanation:
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.
NEW QUESTION # 91
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME ' s revenue dropped significantly. In addition, customers ' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME ' s documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME ' s representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME ' s top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME ' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of 45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to general principles of sampling procedure, did the audit team select a valid sample for electrical services?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
The audit team selected 4 out of 45 customer complaints for electrical services, which is too low based on standard statistical sampling methods. According to ISO 19011:2018 (Guidelines for Auditing Management Systems), for a population size between 13 and 52, a minimum sample size should be 5 to achieve a reasonable level of confidence.
This means the selected sample (4 complaints) was insufficient and did not align with standard sampling procedures. Therefore, the correct answer is A.
Reference:
ISO 19011:2018, Clause 6.4.5 (Sampling Methods in Auditing)
NEW QUESTION # 92
Which type of audit risk is the risk that a significant defect may occur in the QMS, although the organization has internal control mechanisms in place?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Audit risks are categorized into different types based on where failures may occur in the QMS audit process.
Clause References:
* ISO 19011:2018, Clause 6.3 - Managing Audit Risk: Defines different audit risks, including control risk.
Why is the Correct Answer A?
* Control risk occurs when internal controls fail to prevent or detect nonconformities.
* Even if controls exist, the risk remains if the QMS fails to identify or correct defects.
Why are the Other Options Incorrect?
* B (Inherent risk) # This refers to risks naturally present in processes, even before controls are applied.
* C (Detection risk) # This is the risk that an auditor fails to detect nonconformities.
* D (Operational risk) # This refers to risks related to day-to-day business operations, not QMS audits.
Reference:
ISO 19011:2018, Clause 6.3 - Managing Audit Risk
NEW QUESTION # 93
What type of audit evidence are policies and guidelines?
Answer: A
Explanation:
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.
Reference:
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
NEW QUESTION # 94
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