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NEW QUESTION # 254
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?
Answer: A,J
Explanation:
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
NEW QUESTION # 255
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 # 256
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
An audit's feasibility must be assessed using multiple factors, not just resource availability.
Clause References:
* ISO 19011:2018, Clause 5.3 - Establishing the Audit Program: Requires consideration of logistical, technical, and cooperation factors when assessing audit feasibility.
* ISO/IEC 17021-1:2015, Clause 9.1.3 - Determining Feasibility of the Audit: Requires evaluating more than just resources to ensure a successful audit.
Why is the Correct Answer B?
* Audit feasibility should consider:
* Availability of information (documents, records).
* Cooperation from the auditee.
* Operational conditions that might affect the audit.
* Scope and complexity of the QMS being audited.
* Resource availability alone is not enough to determine feasibility.
Why are the Other Options Incorrect?
* A (Top management determines feasibility) # Incorrect because feasibility is determined by the certification body, not the auditee.
* C (Resources alone are sufficient) # Incorrect because other key factors must be evaluated.
* D (Final authority lies with the audit leader) # Incorrect because ISO requires multiple factors to be considered, not just an auditor's decision.
Reference:
ISO 19011:2018, Clause 5.3 - Establishing the Audit Program
ISO/IEC 17021-1:2015, Clause 9.1.3 - Determining Feasibility of the Audit
NEW QUESTION # 257
Match each of the following statements into the table below to show whether they apply to first-party audits, second-party audits or third-party audits:
Answer:
Explanation:
Explanation:
Table
Statement
First-party audits
Second-party audits
Third-party audits
The audit scope is typically determined by the organisation being audited.
Yes
No
No
The outcome of the audit is typically certification to a recognised standard.
No
No
Yes
The audit scope is typically confined to service/product provision capability.
No
Yes
No
Here is a brief explanation of each statement:
The audit scope is typically determined by the organisation being audited: This statement applies to first-party audits, also known as internal audits, where the organisation audits its own processes and activities to ensure conformity and improvement1. The organisation can decide the scope of the audit based on its own needs and objectives2. This statement does not apply to second-party audits, where the customer audits the supplier, or third-party audits, where an independent body audits the organisation. In these cases, the audit scope is determined by the customer or the certification body, respectively34.
The outcome of the audit is typically certification to a recognised standard: This statement applies to third- party audits, where an independent body audits the organisation to verify that it meets the requirements of a specific standard, such as ISO 9001, and issues a certificate of conformity if the audit is successful34. This statement does not apply to first-party audits or second-party audits, where the outcome of the audit is not certification, but rather self-improvement or supplier qualification13.
The audit scope is typically confined to service/product provision capability: This statement applies to second- party audits, where the customer audits the supplier to ensure that they are meeting the requirements specified in the contract, such as service or product quality, delivery, or performance34. The audit scope is usually focused on the specific aspects of the service or product that are of interest to the customer3. This statement does not apply to first-party audits or third-party audits, where the audit scope is broader and covers the entire quality management system or the relevant clauses of the standard14.
NEW QUESTION # 258
Which statement regarding the drafting of the audit conclusions is correct?
Answer: C
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 # 259
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