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.

Clause 8.3.4.d of ISO 9001:2015 requires that design and development validation be performed to ensure that the resulting products or services meet the requirements for their specified application or intended use. Validation is critical to confirm that the product works as intended in real-world conditions.

In this case, Noitol omitted the design validation step approximately 50% of the time, which is a direct violation of Clause 8.3.4.d. Although they collect feedback after the fact, this is not a substitute for formal validation before the product is released. The nonconformity arises because the process of validation was neglected, not the recording of improvements or feedback.

Other options, such as documenting improvements (A) or issues with planning verification (B), are important but do not directly address the primary concern: the lack of consistent design validation before product release. Option D (8.6) concerns product release, but this nonconformity focuses on the validation stage, not just approval for release​.

According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.

Therefore, the correct answer is C, as external issues of the organization’s context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.

Comprehensive and Detailed In-Depth Explanation:

A horizontal audit examines one process across multiple departments to assess consistency.

Thus, A is the correct answer.

Comprehensive and Detailed In-Depth Explanation:

The audit team selected 4 out of 45 customer complaints for electrical services, which is too low based on standard statistical sampling methods. According to ISO 19011:2018 (Guidelines for Auditing Management Systems), for a population size between 13 and 52, a minimum sample size should be 5 to achieve a reasonable level of confidence.

This means the selected sample (4 complaints) was insufficient and did not align with standard sampling procedures. Therefore, the correct answer is A.

Reduced incoming inspection → A. Quality

Improved communication with suppliers → B. Procurement

Purchased materials received on time → C. Logistics

Reduced variability within processes → D. Production

According to ISO 9001:2015, Clause 8.4 - Control of externally provided processes, products and services, organisations are required to ensure that externally provided products and services conform to specified requirements. When an organisation sources from ISO 9001 certified suppliers, there is greater assurance of consistency in quality, delivery, and communication. This enhances internal operations across various functions:

Reduced incoming inspection (Quality): ISO 9001 certified suppliers have robust quality controls (Clause 8.4.2), reducing the need for repeated inspections upon receipt. This aligns with Quality’s responsibility for incoming inspection and verification.

Improved communication with suppliers (Procurement): Clause 8.4.3 emphasizes the communication of detailed requirements to external providers. Procurement plays a key role in ensuring these requirements are understood and met.

Purchased materials received on time (Logistics): Timely deliveries are often a result of structured supplier evaluation and selection (Clause 8.4.1). Logistics benefits through fewer delays and better scheduling of internal processes.

Reduced variability within processes (Production): Consistency of supplied materials supports stable and predictable production processes, which is a key aspect of Clause 8.5 – Production and service provision.

Comprehensive and Detailed In-Depth Explanation:

Clause 5.1.1 of ISO 9001:2015 – Leadership and Commitment – specifically mandates that top management must take accountability for the effectiveness of the QMS. They are also responsible for ensuring:

Integration of the QMS into business processes (5.1.1 c)

Promotion of customer focus and continual improvement (5.1.1 d, i)

Availability of necessary resources (5.1.1 e)

That the QMS achieves its intended results (5.1.1 g)

Let’s analyze the selected options:

✅ A. Top management is not accountable for the effectiveness of the QMS.

This directly violates clause 5.1.1 a, which explicitly requires top management to take accountability for the effectiveness of the QMS. Delegating this to a middle-level Quality Manager, as described in the scenario, constitutes a nonconformity.

✅ F. The Quality Manager does not have access to the resources needed for the QMS.

According to clause 5.1.1 e, top management must ensure the availability of required resources for maintaining and improving the QMS. If the Quality Manager is resource-constrained, it indicates top management has failed to meet this requirement.

Now, why the other options are incorrect in terms of direct clause 5.1.1 nonconformity:

❌ B. Avoiding giving improvement actions to the Chief Executive – While this may reflect poor communication, it is not, by itself, a clear breach of 5.1.1 unless linked directly to top management’s lack of accountability or commitment.

❌ C. Chief Executive never attending meetings – ISO 9001 does not require physical attendance of the Chief Executive at management reviews. What matters is whether top management is fulfilling their roles, not how.

❌ D. Completing only half of improvement actions – This indicates performance issues but does not necessarily indicate top management’s lack of accountability, unless they failed to monitor progress entirely.

❌ E. Reporting to one designated senior manager – This is not inherently nonconforming unless that senior manager does not fulfill top management’s responsibilities under 5.1.1.

Relevant ISO 9001:2015 Reference:

Clause 5.1.1 a, e, g, h:

" Top management shall demonstrate leadership and commitment with respect to the quality management system by:

a) taking accountability for the effectiveness of the quality management system;

e) ensuring that the resources needed for the quality management system are available... "

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to assess both internal and external issues that could impact the effectiveness of their Quality Management System (QMS).

Clause Reference:

Clause 4.1 – Understanding the Organization and Its Context states that organizations must determine external and internal issues that affect their ability to achieve intended results.

Internal issues include:

Knowledge within the organization (documented or undocumented)

Organizational culture

Resource availability

Technological advancements

Infrastructure and capabilities

Why is the Correct Answer C?

Knowledge (Clause 7.1.6) is a critical internal factor that directly affects the implementation and maintenance of a QMS.

Organizations must identify, maintain, and make available the necessary knowledge to achieve quality objectives and meet customer requirements.

Why are the Other Options Incorrect?

A (Social and economic environments) → These are considered external issues rather than internal.

B (Competitive environment) → Competition is external, not an internal issue affecting the QMS.

D (Expectations of suppliers) → Supplier expectations relate to external interested parties, covered under Clause 4.2 (Understanding the Needs and Expectations of Interested Parties).