QUESTION: 9

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Select the words that best complete the sentence:

See Explanation section for answer.

Answer(s): A

Explanation:

According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.

Reference:

1:ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics

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QUESTION: 10

DRAG DROP (Drag and Drop is not supported)
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:

See Explanation section for answer.

Answer(s): A

Explanation:

Table
First-party Second-party
Statement audits 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.

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QUESTION: 11

Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?

During the Stage 1 audit, the audit team:
Verifies the degrees of customer satisfaction
Evaluates the conditions of all sites
Reviews the client's management system documented information
Evaluates the results of the last management review
Verifies the compliance with legal requirements
Reviews the processes with high level of risk

Answer(s): D,G

Explanation:

·
Reviews the client's management system documented information: This activity involves checking the documentation of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
· Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is D and G.

Reference:

1:ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit | NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit

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QUESTION: 12

Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?

To evaluate the performance of monitoring and reviewing activities.
To evaluate the preparedness of the organisation for a Stage 2 audit.
To evaluate the internal audit and management review processes.
To review the quality manual.
To make a decision on certification to ISO 9001:2015.
To evaluate the operational processes of the organisation.

Answer(s): B,D

Explanation:

· To evaluate the preparedness of the organisation for a Stage 2 audit: This objective involves assessing the readiness of the organisation to undergo the Stage 2 audit, where the conformity and effectiveness of the quality management system will be verified123. The audit team will check the level of implementation and understanding of the quality management system, identify any major gaps or nonconformities, and confirm the audit scope, criteria, and plan123. · To review the quality manual: This objective involves reviewing the documented information of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team will also evaluate the organisation's understanding and application of the standard, and identify any areas of improvement or concern123.
The other options are not included in the objectives of the Stage 1 initial certification audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is B and D.

Reference:

1:ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit | NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit

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QUESTION: 9

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QUESTION: 10

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QUESTION: 11

Explanation:

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QUESTION: 12

Explanation:

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