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NEW QUESTION # 160
Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to 'knowledge'?
Answer: C,E
Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
According to ISO 19011:2018 - Guidelines for Auditing Management Systems, which is referenced in ISO
9001 Lead Auditor training and practice, auditor competence is defined by a combination of knowledge, skills
, and personal attributes. Here's how each selected option aligns:
* D. Determining what evidence to gather: This activity is rooted in knowledge of audit principles, criteria, and risk-based thinking. It requires an understanding of which types of evidence (documents, records, interviews, observations) are necessary to evaluate conformity to the audit criteria (Clause
7.2.3 of ISO 19011:2018).
* E. Evaluate proposals of corrective actions: This task involves applying knowledge of ISO 9001 requirements, root cause analysis methods, and risk controls to assess whether proposed actions are suitable to prevent recurrence. It demands comprehension of quality management principles and corrective action methodologies, linking it firmly to knowledge.
Other options such as A (Communicate with auditee) and B (Conduct audit meetings) are predominantly skills-based, requiring interpersonal and communication abilities, not theoretical or regulatory knowledge.
C (Determine how to seek evidence) and F (Identify findings) involve both knowledge and skill but are more action-oriented and tied to situational judgment and auditor behavior.
References:
ISO 19011:2018, Clause 7.2.3 - Establishing Auditor Competence
ISO 9001:2015, Clause 9.2 - Internal Audit
ISO 19011:2018, Annex A.1 - Knowledge and skills of auditors
NEW QUESTION # 161
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization 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.
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
Answer:
Explanation:
NEW QUESTION # 162
The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.
Answer:
Explanation:
Explanation:
The following table shows the possible matching of the records to the requirements of clause 8.4:
Table
Requirements
Records
Define product requirements
Product specification
Criteria for selection
List of requirements to be met by the external provider
Evaluation of potential external provider
External provider questionnaire
External provider selection
Approved external provider list
Communicate requirements
Purchase order
Monitoring of performance
External provider delivery times and quality issues
Comprehensive and Detailed Explanation: = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement.
Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement.
Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.
Select the external providers that have demonstrated their competence and conformity to the requirements.
The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.
Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement.
Monitor the performance and conformity of the external provider, using the established criteria and methods.
The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems
NEW QUESTION # 163
Which statement regarding the drafting of the audit conclusions is correct?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.9 (Audit Conclusions):
* Audit conclusions must be based on verified evidence.
* The evidence must be evaluated both quantitatively and qualitatively to ensure accuracy.
* Observations alone (A) are insufficient; conclusions must be supported by objective evidence.
Thus, B is the correct answer.
NEW QUESTION # 164
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
Answer:
Explanation:
Explanation:
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According to the ISO 9000:2015 document, the seven quality management principles are:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.
Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:
Table
Quality management principle
Potential benefit
Customer focus
Increased revenue and market share
Engagement of people
Enhanced trust and collaboration throughout the organization
Improvement
Enhanced drive for innovation
Evidence-based decision making
Increased ability to demonstrate effectiveness of past actions
NEW QUESTION # 165
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