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163. Frage
Audit criteria are a set of requirements used as a reference against which objective evidence is compared.
Which two of the following are not potential audit criteria?
Antwort: D,E
Begründung:
According to ISO 19011:2018, clause 3.2, audit criteria are a set of policies, procedures or requirements used as a reference against which objective evidence is compared. Audit criteria are usually selected by the audit client or by agreement between the audit client and the auditee, and they should be appropriate for the audit scope and objectives1. Audit criteria may include, but are not limited to, the following sources2:
*ISO management system standards, such as ISO 9001, ISO 14001, ISO 45001, etc.
*Verbal statements by the general manager or other top management, as long as they are consistent with the documented policies and objectives of the organisation
*Verbal agreements with interested parties, such as customers, suppliers, regulators, etc., as long as they are documented and approved by the relevant authorities
*Health and safety notices, such as posters, signs, labels, etc., that communicate the organisation's legal obligations, policies, or procedures
*Written agreements with interested parties, such as contracts, orders, specifications, etc., that define the requirements and expectations of the parties involved
*Organisation's documented information, such as policies, procedures, manuals, records, etc., that describe the organisation's management system and its processes
*Commitment to follow principles issued by an NGO, such as the United Nations Global Compact, the International Labour Organization, etc., as long as they are relevant to the organisation's context and objectives
*Environmental aspects register, such as a list of the environmental impacts and risks associated with the organisation's activities, products, and services Therefore, the two options that are not potential audit criteria are F and H, as they are not reliable or verifiable sources of information, and they may not reflect the actual performance or conformity of the organisation's management system. Commercial advertisements and claims made on the organisation's website are forms of marketing communication that may be exaggerated, misleading, or inaccurate, and they are not subject to the same level of scrutiny or approval as the other sources of audit criteria.
References: ISO 19011:2018(en), Guidelines for auditing management systems, What are audit criteria? - ISO Update
164. Frage
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The
organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:
You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: "Good afternoon."
OD: "Good afternoon."
You: "What responsibility do you have concerning the SWIFT database?"
OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users." You: "Would you explain how the software amendments are controlled?" OD: "Of course. I personally update every computer myself." You: "Do you inform the database users of the changes?" OD: "No I don't. They find out for themselves by using the software, or they come to see me if they have any questions." You: "How do you ensure that the database users use the latest version?" OD: "That's easy, I update every computer myself." You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes)." OD: "I know. That's because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them." Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...
Antwort: A,C
Begründung:
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C: Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E: Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
165. Frage
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?
Antwort: A
Begründung:
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.
Reference:
ISO 19011:2018, Clause 4 - Principles of Auditing (Fair Presentation)
166. Frage
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?
Antwort: A
Begründung:
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.
167. Frage
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?" Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in-house." You: "That sounds like quite a significant change. What has been the impact of that?" Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced the manufacture of our own brand products to one of our suppliers." You: "What were the reasons for making the change?" Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods, we had staff with little to do. This was having an impact on customer satisfaction, and meant we had to charge premium prices that made our product uncompetitive." You: "How did you go about the change?" In relation to the auditor's question about how the change was managed, the auditee mentions the steps listed below. The steps represent different elements of the Plan/Do/Check/Act cycle.
Select three steps which apply to the 'check' element of the cycle.
Antwort: C,D,F
Begründung:
The "Check" stage of the PDCA cycle is about monitoring, measuring, analysing and evaluating performance against objectives, requirements and planned activities.
B is correct because reviewing data at management review is part of evaluating QMS performance.
C is correct because monitoring customer feedback is checking whether customer needs and expectations are being met.
D is correct because monitoring supplier performance checks whether the outsourced manufacturing process is effective.
A, E, F and H are mainly "Plan/Do" activities. G may be a monitoring result, but the strongest three "Check" activities are B, C and D because they directly involve review, monitoring and evaluation of QMS performance.
168. Frage
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