Pass the PECB ISO 9001 ISO-9001-Lead-Auditor Questions and answers with ExamsMirror

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.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 emphasizes continual improvement as a fundamental requirement of an effective Quality Management System (QMS).

Clause Reference:

Clause 4.4.1 (Quality Management System and Its Processes) states that organizations must:

Determine processes needed for the QMS

Establish criteria and methods for process effectiveness

Ensure continual improvement of the system

Why is the Correct Answer C?

Continual improvement is a core principle of ISO 9001.

Organizations must regularly assess and enhance their QMS to adapt to new challenges and maintain effectiveness.

Why are the Other Options Incorrect?

A (To change the QMS quarterly) → ISO 9001 does not mandate a specific frequency for system changes.

B (To review the QMS annually) → QMS reviews must be conducted as needed, not strictly annually.

D (To conduct a QMS gap analysis every two years) → Gap analysis is useful but is not a mandatory requirement under Clause 4.4.

Comprehensive and Detailed In-Depth Explanation:

ISO 9000:2015 defines quality as "the degree to which a set of inherent characteristics of an object fulfills requirements."

Clause 3.6.2 (Quality) confirms this definition.

Quality is determined by how well an object (product, service, or process) meets defined requirements (customer, regulatory, or internal).

The other options do not align with the official ISO definition:

Option A refers to performance capability but does not define quality.

Option C describes work conditions, not quality.

Option D focuses on efficiency rather than fulfilling requirements.

The action that the auditor would have accepted is:

•Option B: Apply the existing process of addressing the risks and opportunities of milk production. This option is correct because ISO 9001:2015 clause 8.1 requires the organization to plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement actions determined in clause 6.1, which refers to the actions to address risks and opportunities. The organization should apply the existing process of addressing the risks and opportunities of milk production, which may include identifying the sources of variability, assessing the potential impacts and consequences, determining and implementing appropriate actions to reduce or eliminate the variability, monitoring and measuring the effectiveness of the actions, and reviewing and updating the actions as necessary.

The following options are not correct:

•Option A: Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option C: Retain the current contract and try to sell the occasional surplus milk to a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option D: Analyse the daily dispatch of milk for 7 days to determine its variability. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to implement actions to address risks and opportunities, as required by ISO 9001:2015 clause 8.1.

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 6.2.2 (Audit Planning):

The audit team leader is responsible for planning the audit and assigning roles.

Top management (A) does not plan the audit, but they provide resources.

While team members may provide input, the leader has the final authority.

Thus, B is the correct answer.

ISO/IEC 17021-1 is the standard that specifies requirements for bodies providing audit and certification of management systems. It includes provisions for determining audit time for third-party certification audits, ensuring that the audits are conducted in a consistent, comparable, and reliable manner, which can be applied to a variety of management systems, including ISO 9001.

In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.

Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information. References: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store

Comprehensive and Detailed In-Depth Explanation:

According to ISO 19011:2018, Clause 5.3.2 (Access to Information), internal auditors must have unrestricted access to:

Employees and executives for interviews and observations.

Documented information to verify compliance with ISO 9001.

This ensures a transparent and objective audit process. The CEO’s approval (B) is not required unless restricted information is involved.

In this scenario, the time allocated by the audit team leader for the Human Resources audit is fixed, and as an auditor, you must work within that constraint. Although the sampling criteria suggests reviewing 25 personnel files, it is acceptable to adjust the sample size based on time and resource limitations. ISO 9001:2015 emphasizes risk-based thinking and practical resource management (Clause 7.1), so it is reasonable to review a smaller sample if the time is insufficient.

Option B is a pragmatic approach, allowing you to focus on quality over quantity by reviewing as many cases as time allows without compromising the audit schedule.

Options like extending the audit (A, C, D) are impractical in a structured audit environment, especially for second-party audits where maintaining the agreed schedule is important​​.