Explanation:
Non-Conformity Report:
ISO 9001 Clause Number
Nature of Problem
ISO 9001 Requirement That Has Not Been Fulfilled
6.1.1
Several risks and opportunities have not been determined.
" The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed. "
6.1.2 (a)
Actions to address risks and opportunities not planned.
" The organization shall plan actions to address risks and opportunities. " Step-by-Step Reasoning:
Clause 6.1.1 - Determining Risks and Opportunities:
Requirement: The organization must determine risks and opportunities that are relevant to its Quality Management System (QMS). This ensures that the QMS achieves intended results and prevents undesired effects.
Problem Identified: While some risks and opportunities were discussed, the organization did not perform a systematic evaluation of all risks (e.g., health and safety legislation changes, retiring trainers).
Clause 6.1.2 (a) - Planning Actions for Risks and Opportunities:
Requirement: The organization must plan actions to address identified risks and opportunities. These actions should be integrated into the QMS processes to ensure continuous improvement.
Problem Identified: The Quality Systems Manager confirmed that no plans were made to address the risks and opportunities because the Managing Director deemed it unnecessary. This violates the requirement to plan actions.
Correct Options Selected:
Clause 6.1.1 with the nature of the problem as: " Several risks and opportunities have not been determined. " Clause 6.1.2 (a) with the nature of the problem as: " Actions to address risks and opportunities not planned. " ISO 9001 Requirements Not Fulfilled:
For 6.1.1: " The organization shall consider the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed. " For 6.1.2 (a): " The organization shall plan actions to address risks and opportunities. "

Comprehensive and Detailed In-Depth Explanation:
According to ISO 9001:2015, Clause 9.2 (Internal Audit):
* Internal audits can be conducted on an ongoing basis as part of continual improvement.
* Audits consider both conformity and effectiveness (A is incorrect).
Thus, C is the correct answer.
Reference:
ISO 9001:2015, Clause 9.2 (Internal Audit)

Comprehensive and Detailed Explanation From Exact Extract:
Correct Option B - "Communicate a policy commitment to continual improvement" This aligns directly with Clause 5.2.1(d) of ISO 9001:2015, which states that the quality policy shall include a commitment to continual improvement of the QMS:
"Top management shall establish, implement and maintain a quality policy that... includes a commitment to continual improvement of the quality management system." A clearly communicated policy sets expectations and a strategic direction that cascades throughout the organization, promoting a culture that values ongoing enhancement.
Correct Option F - "Use the management review process to identify improvements" This is based on Clause 9.3.3 of ISO 9001:2015, which specifies that outputs of management reviews must include decisions and actions related to:
"a) opportunities for improvement;
b) any need for changes to the quality management system;
c) resource needs."
The management review process is a structured mechanism to analyze data, monitor performance, assess risks and opportunities, and drive continual improvement initiatives.
Why the Other Options Are Incorrect:
A (Appoint external consultants to train staff): While training may help improve competence, ISO 9001 emphasizes internal process evaluation and strategic improvement. This option is not directly aligned with the systematic improvement of the QMS.
C (Require higher standards): Higher standards alone don't ensure continual improvement unless supported by a structured QMS approach involving evaluation, planning, and measurement.
D (Require fewer mistakes): Unrealistic or unqualified demands like "make fewer mistakes" don't support structured process-based improvement and may conflict with ISO's emphasis on risk-based thinking and root cause analysis.
E (Send Chief Executive on a course): While leadership involvement is vital (Clause 5), this action by itself does not constitute a continual improvement mechanism for the QMS.
References:
ISO 9001:2015 Clause 5.2.1(d) - Establishing the Quality Policy
ISO 9001:2015 Clause 9.3.3 - Management Review Outputs
ISO 9001:2015 Clause 10.3 - Continual Improvement

According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:
The products and services are intended for incorporation into the organization's own products and services.
They are provided directly to customers by the external provider on behalf of the organization.
A process, or part of a process, is provided by an external provider as a result of a decision by the organization.
In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.

Relevant ISO 9001 Requirement
Clause 7.3 - Awareness states that persons doing work under the organisation's control shall be aware of:
* The quality policy;
* Relevant quality objectives;
* Their contribution to the effectiveness of the QMS;
* The implications of not conforming with QMS requirements.
A critical point is that ISO 9001 uses the phrase:
"persons doing work under the organisation ' s control"
This includes:
* Employees,
* Temporary personnel,
* Agency personnel,
* Subcontractors performing work on behalf of the organisation.
Why Option B is Correct
In the scenario:
* The refrigeration engineers performing the actual maintenance and repair services are all subcontractors.
* The Managing Director states that these subcontractors have not been informed of:
* the Quality Policy,
* quality objectives,
* plans to address risks and opportunities.
The justification given is that the subcontractors themselves have ISO 9001-certified management systems.
However, ISO 9001 certification of a subcontractor does not remove the organisation ' s responsibility to ensure persons working under its control are aware of the organisation ' s own QMS requirements.
Therefore, the organisation has failed to demonstrate compliance with Clause 7.3 Awareness .
Why the Other Options Are Incorrect
A). Clause 7.4 - Communication
The scenario does not primarily indicate a failure of communication processes.
The issue is not whether communication methods exist, but whether the subcontractors have the required awareness.
C). Clause 7.2 - Competence
The Managing Director explicitly states that competence requirements are applied to both full-time staff and subcontractors.
No evidence is presented that competence has not been determined or evaluated.
Therefore, a competence failure is not the strongest conclusion.
D). Clause 7.5 - Documented Information
The scenario indicates documented information exists and was reviewed by the auditor.
No evidence suggests documented information is missing, uncontrolled, or unavailable.
Therefore, Clause 7.5 is not the most likely issue.
ISO-Aligned Conclusion
The organisation relies entirely on subcontracted refrigeration engineers to deliver its certified services.
Because these personnel perform work under the organisation ' s control, ISO 9001 requires them to be aware of the organisation ' s quality policy, objectives, and relevant QMS requirements.
The evidence shows this awareness has not been established.