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NEW QUESTION # 191
According to ISO 19011, what two activities take place during the conduct of a audit follow-up?
Answer: D,F
Explanation:
According to ISO 19011:2018, clause 6.7, the audit follow-up is the process of verifying the completion and effectiveness of corrective actions taken by the auditee as a result of an audit. The audit follow-up can include two main activities:
Verifying the effectiveness of the implemented corrective actions: this means checking whether the actions taken by the auditee have addressed the root causes of the nonconformities and prevented their recurrence or occurrence in other areas. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.
Verifying corrections taken to fix the reported non-conformities: this means checking whether the auditee has corrected the nonconformities identified during the audit and eliminated their immediate effects. The verification can be done by reviewing documents, records, data, or other evidence provided by the auditee, or by conducting a follow-up audit on site or remotely.
The audit follow-up can be conducted as a separate audit or as part of a subsequent audit, depending on the audit programme, the audit objectives, the audit criteria, the audit scope, the audit risks, and the audit findings.
The audit follow-up should be planned and conducted in accordance with the same principles and processes as the initial audit, and the results should be documented and reported accordingly. References:
ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.7 ISO 19011 Management Systems Audit Checklist | Process Street, task 6.7.1 and 6.7.2 Conducting the Audit Follow-Up: When to Verify - The Auditor, section "Conducting the audit follow-up"
NEW QUESTION # 192
During an ISO 9001 audit of an electric cable manufacturer, you are reviewing the customer file for XYZ Construction in the Sales Department. This contract specifies that the installation configuration of the cable runs should meet national fire safety standards for Category A.
You discover that the customer later agreed to the approval of a less stringent Category B configuration instead.
The organization has the following quality policy document displayed in the reception area.
"This organization is committed to providing electric cables to customers' requirements, in accordance with statutory regulations for their use. Continual improvement is a permanent objective of the organization. This policy shall be communicated to all employees and, where required, to all interested parties." Referring to the scenario, select the two options for which the organization is meeting its policy commitments.
Answer: B,F
NEW QUESTION # 193
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 # 194
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.
Answer: A,E
Explanation:
According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization's management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization's management system to achieve the intended results, but is a deviation from the audit criteria1.
According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken. The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.
Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring. The other options are not correct, as they do not require the organization to act in response to reported findings:
*A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.
*B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization's management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.
*C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization's management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.
*E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization's management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.
References: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment - Requirements for bodies providing audit and certification of management systems
- Part 1: Requirements
NEW QUESTION # 195
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.
After reviewing the documented information, Li Na claimed that it was not necessary to report the minor nonconformities that were identified; instead, they would be discussed in the next audit phase. Is this acceptable?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
As per ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action), all identified nonconformities, including minor ones, must be documented and communicated to the auditee.
Minor nonconformities can lead to major issues if left unaddressed. The auditor must inform the organization before moving to the next audit phase so that corrective actions can be taken. Clause 9.2.2 (Internal Audit) states that audit findings should be reported without undue delay.
Since Li Na did not report the minor nonconformities immediately, her decision was incorrect. Minor nonconformities should always be documented and communicated before proceeding to the next phase.
Reference:
ISO 9001:2015, Clause 9.2.2 (Internal Audit Reporting)
ISO 9001:2015, Clause 10.2 (Nonconformity and Corrective Action)
NEW QUESTION # 196
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