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| Section | Objectives |
|---|---|
| Audit Reporting and Follow-up | - Corrective Actions
|
| Audit Planning and Preparation | - Audit Preparation
|
| Conducting Audit Activities | - On-site Audit Execution
|
| Audit Principles and Fundamentals | - Auditor Competence
|
| Quality Management System (QMS) Fundamentals | - Quality Principles
|
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質問 # 171
An organisation decides to purchase products and services only from ISO 9001 certified suppliers.
Match the four organisational functions to a potential benefit.
正解：
解説：
Explanation:
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.
References:
ISO 9001:2015 Clause 8.4.1 - General
ISO 9001:2015 Clause 8.4.2 - Type and extent of control
ISO 9001:2015 Clause 8.4.3 - Information for external providers
ISO 9001:2015 Clause 8.5 - Production and service provision
質問 # 172
(When raising a non-conformity during an audit, which two of the following items should you include in the non-conformity statement?)
正解：D、F
解説：
ISO 9001:2015 requires that nonconformities be objective, evidence-based, and referenced against defined requirements, not personal, prescriptive, or solution-driven.
When a nonconformity is raised, it must clearly show what requirement was not met and what objective evidence demonstrates this failure.
# Why D (Audit criteria) is required
* A nonconformity must reference the requirement that was not fulfilled (e.g., ISO 9001 clause, procedure, contract, or legal requirement).
* ISO 9001 defines nonconformity as "non-fulfilment of a requirement".
* Without audit criteria, there is no basis for declaring a nonconformity.
# Supported by:
* Clause 9.2.2 - Internal audits must determine whether the QMS conforms to requirements
* Clause 10.2.2 - Documented information shall describe the nature of the nonconformity
# Why E (Relevant audit evidence) is required
* ISO 9001 requires decisions and conclusions (including audit findings) to be based on evidence.
* Audit evidence ensures objectivity and prevents subjective or opinion-based findings.
# Supported by:
* Clause 9.1.3 - Analysis and evaluation shall be based on data and information
* Clause 9.2.2 - Audit results must demonstrate conformity or nonconformity based on evidence
# Why the other options are NOT correct
* A (Name of person responsible)ISO 9001 focuses on system and process failures, not blaming individuals.
* B (Target time for corrective action)This is part of corrective action planning, not the nonconformity statement itself (Clause 10.2).
* C (Name of technical expert)ISO 9001 does not require identifying auditors or experts in the nonconformity statement.
* F (Action to eliminate the nonconformity)Auditors must not prescribe solutions. The auditee determines corrective actions (Clause 10.2).
質問 # 173
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
正解：
解説：
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8 extract
Four of the 10 pallets of stock sampled in the warehouse were not labelled.
"8.5.2 ... shall use suitable means to identify outputs ..."
A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.
"8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..." One of the fork-lift truck drivers had no fork-lift truck driving licence.
"8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..." There was no pest control provision in the warehouse.
"8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.
"8.1 ... shall plan, implement and control the processes ..."
質問 # 174
An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract.
During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO
9001.
Which one of the evidence statements would support this finding?
正解：D
解説：
According to clause 10.2.1.b of ISO 9001:2015, the organization should evaluate the need for action to eliminate the causes of nonconformities, in order to prevent their recurrence. This means that the organization should identify and address the root causes and contributing factors of the nonconformities, and implement appropriate corrective actions that are effective and proportional to the impact of the nonconformities. In this case, the evidence statement that supports the finding of nonconformance is C, because it shows that the organization did not take effective actions to prevent the recurrence of the spelling errors in the print run, which resulted in repeated customer rejections and dissatisfaction. The other options are not directly related to clause 10.2.1.b, although they may indicate other nonconformities or weaknesses in the organization's QMS.
For example, option A may relate to clause 7.2 on competence, option B may relate to clause 8.6 on release of products and services, and option D may relate to clause 7.1 on resources. References: ISO 9001:2015, [ISO
9001 Auditing Practices Group Guidance on Nonconformity and Corrective Action], ISO 9001 Clause 10.
Improvement - ISO-templates.com
質問 # 175
You are carrying out an annual audit at an organisation that offers home security services. You are interviewing the Quality Manager (QM) You: "Would you tell me about your management review process?" QM: "The senior management team plans to review the management system every six months. The review follows a set agenda and records are maintained." You: "May I see the records from the last two management reviews?" Narrative: The Quality Manager gives you the latest record, which shows the last management review took place nine months ago.
The Quality Manager then gives you the previous management review record, which took place one year before the latest review.
You: "Are there any other review reports in the last two years?
QM: "No, these are the only ones."
正解：
解説：
Explanation:
Nonconformity report
ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "Top management shall review the organization's quality management system at planned intervals." Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.
質問 # 176
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ちなみに、Xhs1991 ISO-9001-Lead-Auditorの一部をクラウドストレージからダウンロードできます：https://drive.google.com/open?id=1FZluFnnQb57e08TrL7qZpJ5nFPRJREYW