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| Section | Objectives |
|---|---|
| Audit Reporting and Follow-up | - Audit Reporting
|
| Audit Principles and Fundamentals | - Auditor Competence
|
| Audit Planning and Preparation | - Audit Preparation
|
| Quality Management System (QMS) Fundamentals | - Quality Principles
|
| Conducting Audit Activities | - Audit Evidence Collection
|
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질문 # 215
During a third-party audit of a pharmaceutical company (CD9000) having seven COVID-19 vaccination stations in various terminals at a major international airport, you, as audit team leader, interview the CD9000' s Supervisor in Terminal 2.
You: "I see that the temperature of the freezer where you keep the vaccines reads -17.2 °C. I understood that the upper limit for storing vaccines was < -18.0 °C." Supervisor: "Yes, I know this. But do not worry, the people who calibrated the temperature sensors said that they have an uncertainty of +/- 1 °C. So, we ensure that the reading remains between -17 °C and -19 °C." From the following, select two options that would form your next step.
정답：A,C
설명：
ISO 9001:2015 requires auditors to base conclusions on objective evidence and to investigate potential issues before determining whether a nonconformity exists.
In this scenario, the auditor has observed:
* A freezer temperature of -17.2 °C .
* An understood storage requirement of less than -18.0 °C .
* A statement from the supervisor regarding measurement uncertainty of ±1 °C .
Before raising a nonconformity, the auditor must verify:
* The exact storage requirements and any permitted tolerances.
* The validity and calibration status of the measuring equipment.
Why A is Correct
Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
The auditor must confirm:
* The exact specification.
* Whether tolerances or measurement uncertainty have been considered in the requirement.
* Whether the storage criterion is truly a hard limit or includes allowable variation.
This follows the audit principle of obtaining sufficient objective evidence before reaching a conclusion.
Why B is Correct
Ask to see the calibration report for the measuring equipment.
ISO 9001 Clause 7.1.5 requires monitoring and measuring resources to be suitable and maintained to ensure valid results.
The supervisor has based his justification on measurement uncertainty. Therefore, the auditor should verify:
* Calibration status,
* Calibration validity,
* Measurement uncertainty,
* Traceability of calibration results.
Why the Other Options Are Incorrect
C). Raise a non-conformance immediately
At this point there is insufficient evidence. The auditor has not yet verified the specification or calibration records.
D). Ask to see competence records of supervisors of all terminals
This is not the immediate audit trail arising from the observation.
E). Immediately halt the vaccination process
Auditors do not normally have authority to stop operations except in exceptional circumstances defined by legal or contractual arrangements. The auditor must first gather evidence.
F). Accept the comment and proceed
Auditors must verify statements with objective evidence rather than accepting explanations without verification.
ISO-Aligned Conclusion
The next appropriate audit actions are to:
* Verify the storage temperature requirements, and
* Verify the calibration and uncertainty information of the measuring equipment.
Therefore, the correct answers are:
A). Ask to see the documented test method to determine if there is additional information on the limits for storage temperature.
B). Ask to see the calibration report for the measuring equipment.
질문 # 216
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
Which stages of the audit were performed?
정답：C
설명：
Comprehensive and Detailed In-Depth Explanation:
Understanding Audit Stages Based on ISO/IEC 17021-1:2015
ISO certification audits consist of two main stages:
* Stage 1 Audit (Readiness Review)
* The organization's documented information is reviewed to assess readiness for Stage 2.
* This ensures that the QMS is developed, implemented, and prepared for full assessment.
* Stage 2 Audit (On-Site Evaluation)
* Auditors assess process implementation and effectiveness through interviews, observations, and evidence collection.
* The audit team verifies if the organization meets ISO 9001 requirements in practice.
Why is the Correct Answer B?
* The audit team reviewed ME's documents, which is a Stage 1 activity.
* The audit team performed interviews, sampling, and on-site verification, which is a Stage 2 activity.
* There was no mention of an audit follow-up or a surveillance audit, which occur post-certification.
Why are the Other Options Incorrect?
* A (Audit follow-up and Stage 1 Audit) # Follow-up audits occur after certification, which was not the case here.
* C (Stage 2 Audit and Surveillance Audit) # Surveillance audits are post-certification audits and were not conducted yet.
Reference:
ISO/IEC 17021-1:2015, Clause 9.3.1 - Initial Certification Audit (Stage 1 & 2)
질문 # 217
Match the process descriptions below to the process names:
정답：
설명：
Explanation:
A white background with black text Description automatically generated
질문 # 218
Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.
The auditor samples the design records for a recently completed course for the 247 Insurance organisation.
Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor decides to review the training course design process in more depth.
Select three options that provide a meaningful audit trail for this process.
정답：A,D,F
설명：
According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:
*Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties' needs and expectations, and the potential risks and opportunities.
*Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.
*Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.
*Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.
*Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.
In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO
9001 Clause 8.3 Design and development of products and services
질문 # 219
ISO 9001 addresses changes through several requirements, two examples of which are Clause 6.3 (Planning of Changes) and Clause 8.5.6 (Control of Changes). How do the requirements of Clause 8.5.6 differ from those of Clause 6.3?
정답：A
설명：
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 recognizes change management as essential for maintaining process integrity and preventing nonconformities.
Clause References:
* Clause 6.3 (Planning of Changes) # Focuses on long-term changes that may impact QMS integrity.
* Clause 8.5.6 (Control of Changes) # Focuses on changes occurring during production and service provision to ensure conformity.
Why is the Correct Answer A?
* Clause 8.5.6 applies specifically to operational changes, ensuring that modifications in production or service processes do not compromise quality.
* Organizations must document who approves changes, how they are controlled, and how they affect product/service conformity.
Why are the Other Options Incorrect?
* B (Changes during design and development) # Covered under Clause 8.3 (Design and Development), not 8.5.6.
* C (Changes to legal and regulatory requirements) # Addressed under Clause 4.2 (Interested Parties
' Requirements).
* D (Leadership responsibilities) # Covered under Clause 5.1 (Leadership and Commitment), not
8.5.6.
질문 # 220
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