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質問 # 84
You are carrying out an audit to ISO 9001 at an organisation which offers consultancy services on the implementation of ISO 9001 quality management systems to manufacturers of cosmetics.
You are interviewing the Technical and Quality Director (TQD), who manages a team of biochemists responsible for providing ISO 9001 consultancy services to customers.
You: "How do you ensure your team's competence concerning regulatory and ISO 9001 requirements?" TQD: "We subcontract a part-time lead consultant who has years of experience working as a biochemist in the cosmetics industry. She is responsible for ensuring the team's competency." You: "Do they retain any documented information on the individual competency of each consultant?" TQD: "No. The lead consultant is a dedicated individual with lots of contacts in the sector. We rely on her decision on the consultants' competency. She says that she thought that it was not necessary to keep documented information; however, after the event two weeks ago, which could not be solved due to the lack of documentation, she may consider in the future to plan which information we may need to keep." You: "How does the organisation enable the consultants you employ to maintain updated their competence on ISO 9001 and regulatory requirements?" TQD: "As I said before, we leave that up to the lead consultant. She tells us when we need to employ more young consultants and when changes are introduced in the applicable regulations. Our regular survey shows that customers are quite satisfied with our consultants; last year's objective of customer satisfaction was achieved. We gave a salary increase to consultants when they knew that the objectives had been achieved." You decide to raise a non-conformity.
To complete the non-conformity report, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.
正解：
解説：
Explanation:
Non-conformity Report
ISO 9001 Clause Number:
7.2
Nature of problem:
Documented information is not retained on the necessary competence of consultants with respect to relevant regulatory and ISO 9001 requirements.
ISO 9001 requirement that has not been fulfilled:
ISO 9001 - "The organization shall retain appropriate documented information as evidence of competence." ISO 9001:2015 places a clear requirement on organisations to ensure that persons doing work under its control that affects performance and conformity are competent, and that this competence is demonstrated and evidenced.
Relevant ISO 9001 requirements
* Clause 7.2 - Competence requires the organisation to:
* determine the necessary competence of persons doing work under its control,
* ensure that these persons are competent on the basis of appropriate education, training, or experience, and
* retain appropriate documented information as evidence of competence.
In the scenario:
* Competence decisions are entirely delegated to a subcontracted lead consultant.
* No documented information is retained to demonstrate individual consultant competence.
* A recent event could not be resolved specifically due to the absence of documented competence records, which directly confirms non-fulfilment of Clause 7.2.
* Reliance on customer satisfaction results or the personal judgement of a consultant does not replace the ISO 9001 requirement for objective evidence.
Why other clauses are not applicable:
* Clause 7.1 relates to provision of resources, not evidence of competence.
* Clause 7.3 relates to awareness of quality objectives, not competence records.
* Statements such as "consultants are not aware of customer satisfaction objectives" or "persons necessary are not determined" are not supported by the scenario evidence.
ISO-aligned conclusion:
The organisation has failed to retain documented information as evidence of competence for consultants providing ISO 9001 and regulatory consultancy services. This is a clear and justified nonconformity against ISO 9001:2015 Clause 7.2.
質問 # 85
The following are stages of an audit, put them in the order they would be conducted.
正解：
解説：
Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each stage:
Establishing the audit programme objectives: This is the first stage of the audit process, where the purpose, scope, and criteria of the audit programme are defined. The audit programme objectives should be aligned with the strategic direction and policies of the organization, and should address the needs and expectations of the interested parties12.
Determining and evaluating the audit programme risks and opportunities: This is the second stage of the audit process, where the factors that can affect the achievement of the audit programme objectives are identified and assessed. The audit programme risks and opportunities should consider the internal and external issues, the requirements and changes of the interested parties, and the results and feedback from previous audits12.
Establishing the audit programme: This is the third stage of the audit process, where the audit programme is designed and implemented. The audit programme should include the audit programme procedures, the audit programme resources, the audit methods and techniques, the audit frequency and schedule, and the audit programme performance indicators12.
Initiating the audit: This is the fourth stage of the audit process, where the audit is prepared and planned. The audit initiation involves selecting the audit team, establishing the contact with the auditee, defining the audit objectives, scope, and criteria, developing the audit plan, and conducting the document review123.
Preparing all audit activity: This is the fifth stage of the audit process, where the audit activities are organized and coordinated. The audit preparation involves assigning the audit tasks, communicating with the auditee and the audit team, arranging the logistics, preparing the working documents, and conducting the opening meeting123.
Conducting the audit activities: This is the sixth and final stage of the audit process, where the audit evidence is collected and evaluated. The audit conduct involves performing the audit activities, such as interviews, observations, document reviews, and tests, documenting the audit findings, preparing the audit conclusions, and conducting the closing meeting123.
I hope this helps you with your ISO 9001 Lead Auditor objectives and content. If you have any further questions, please feel free to ask. # References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Process | Flowchart | Summary - Accountinguide 3: What are the Stages of the Auditing Process & Why it is Important ...
質問 # 86
Will the auditee be subject to an audit follow-up if a minor nonconformity has been reported by the audit team leader in the audit conclusions?
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:
According to ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions):
* Minor nonconformities do not require a follow-up audit but must be corrected before the next surveillance audit.
* Follow-up audits are required only for major nonconformities.
* The audit team should recommend corrective actions, not enforce immediate follow-ups for minor nonconformities.
Thus, A is the correct answer.
Reference:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions for Minor Nonconformities)
質問 # 87
ISO 9001 is based on quality management principles. Match each of the following quality management principles to the related activity.
正解：
解説：
Explanation:
Related Activity
Correct Quality Management Principle
Communicate client needs and expectations throughout the organisation.
Customer focus
Encourage an organisation-wide commitment to quality.
Leadership
Empower staff to determine constraints to performance and to take the initiative without fear.
Engagement of people
Establish authority, responsibility, and accountability for managing processes.
Process approach
Continuously educate and train people at all levels on how to apply basic tools and methodologies to achieve objectives.
Improvement
Determine, measure, and monitor key indicators to demonstrate the organisation's performance.
Evidence-based decision making
Determine relevant interested parties (such as providers, partners, customers, investors, employees, or society as a whole) and their connection with the organisation.
Relationship management
1. Customer focus
ISO 9001 states that organizations must understand and consistently meet customer needs and expectations.
# Communicating client needs throughout the organization ensures alignment and customer satisfaction.
Reference: Clause 0.2; Clause 5.1.2 (Customer focus)
2. Leadership
Leadership establishes unity of purpose and direction and promotes a culture of quality across the organization. # Encouraging organization-wide commitment to quality is a core leadership responsibility.
Reference: Clause 0.2; Clause 5.1 (Leadership and commitment)
3. Engagement of people
ISO emphasizes that competent, empowered, and engaged people at all levels enhance organizational capability. # Empowering staff to identify constraints and act without fear reflects true engagement.
Reference: Clause 0.2; Clause 7.3 (Awareness)
4. Process approach
The process approach requires clear definition of responsibilities, authorities, inputs, outputs, and controls. # Establishing authority, responsibility, and accountability for processes is fundamental to this principle.
Reference: Clause 0.2; Clause 4.4 (QMS and its processes)
5. Improvement
Organizations must continually improve products, services, and system effectiveness. # Ongoing education and training enable improvement through better tools and methods. Reference: Clause 0.2; Clause 10.3 (Continual improvement)
6. Evidence-based decision making
Effective decisions are based on the analysis of data and information. # Measuring and monitoring KPIs directly supports evidence-based decisions. Reference: Clause 0.2; Clause 9.1 (Monitoring, measurement, analysis, and evaluation)
7. Relationship management
Sustained success depends on managing relationships with relevant interested parties. # Identifying interested parties and understanding their connection to the organization reflects this principle. Reference: Clause 0.2; Clause 4.2 (Interested parties)
質問 # 88
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The company processes waste plastics into raw material for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process.
You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." After further auditing, you have gathered additional evidence.
正解：
解説：
Explanation:
A # 8.4.3.a
B # 7.2.b
C # 10.2.2
D # 10.2.1
E # 6.2
Comprehensive and Detailed Explanation From Exact Extract:
# A. There is no specification for incoming materials # 8.4.3.a
Clause 8.4.3(a) relates to the control of externally provided processes, products, and services, specifically the requirement to communicate appropriate specifications and requirements to suppliers:
"The organization shall ensure the adequacy of requirements prior to their communication to the external provider." Failure to specify requirements for incoming materials (e.g., what is acceptable waste plastic) risks compromising product quality.
# B. The picking operators have been trained # 7.2.b
Clause 7.2(b) relates to Competence and mandates:
"Ensure that these persons are competent on the basis of appropriate education, training, or experience." Training is a critical part of establishing and maintaining operator competence in quality-affecting tasks.
# C. The picked reject materials are not documented # 10.2.2
This clause focuses on the retention of documented information regarding nonconformities and actions taken:
"The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken..." If rejects are not recorded, traceability and root cause analysis for quality failures are weakened.
# D. The rejected materials are segregated # 10.2.1
Clause 10.2.1 relates to nonconformity and corrective action, including containment activities such as:
"Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment..." Segregation ensures nonconforming material doesn't contaminate acceptable output.
# E. Management has set an objective for the level of rejects # 6.2
Clause 6.2 is about quality objectives. It requires organizations to:
"Establish quality objectives at relevant functions... The quality objectives shall be measurable..." Setting a measurable reject-level target aligns with improving process control and reducing waste.
References:
ISO 9001:2015 Clause 8.4.3.a - Information for External Providers
ISO 9001:2015 Clause 7.2.b - Competence
ISO 9001:2015 Clause 10.2.2 - Documentation of Nonconformity
ISO 9001:2015 Clause 10.2.1 - Control of Nonconforming Outputs
ISO 9001:2015 Clause 6.2 - Quality Objectives
質問 # 89
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