PECB ISO-9001-Lead-Auditor 問題集

質問 1：
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures
cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: "I would like to begin by looking at the cleaning controls."
MM: "We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside." Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.


正解：



質問 2：
What does the application of the process approach in a QMS enable?
A. The achievement of effective process performance
B. The consideration of processes in terms of financial value
C. The improvement of processes based on the needs and expectations of interested parties
D. The reduction of resource consumption
正解：A
解説: (Topexam メンバーにのみ表示されます)

質問 3：
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.

正解：

Explanation:

The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."

質問 4：
What is a horizontal audit?
A. In-depth investigation of all the processes in major functional areas of the organization
B. In-depth investigation of one process across various departments in the organization
C. In-depth investigation of all the processes in a specific department or organizational unit
正解：B
解説: (Topexam メンバーにのみ表示されます)

質問 5：
How can an organization ensure the objectivity and impartiality of the internal audit function?
A. By having a representative of top management involved during the internal audit process
B. By assigning internal auditors that do not have operational roles related to the QMS
C. By always outsourcing the internal audit function to a third party
正解：B
解説: (Topexam メンバーにのみ表示されます)

質問 6：
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."

正解：



質問 7：
You are conducting a third-party Stage 1 audit at ABC Ltd, a single-site organisation that manufactures wooden furniture. You interview the Technical Director to learn more about the organisation. The Technical Director explains that they have had a successful year and that obtaining ISO 9001 certification will support the further growth of the business. You ask for an overview of the organisation's structure and its interrelationships with external interested parties.
The Technical Director shows you a document detailing all business processes and interrelationships. You notice in this document that another organisation called Teak Ltd manufactures wooden furniture on behalf of ABC Ltd. The Technical Director confirms this capability has been accounted for in the scope of the quality management system. You learn that the furniture manufactured by Teak Ltd has accounted for 40% of the sales revenue over the previous 12 months.
Which two of the following options best describe how you would plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd?
A. Verify the quality management system at Teak Ltd by conducting an audit at their site
B. Verify Teak Ltd supply arrangements as described in the ABC Ltd quality management system
C. Verify the controls concerning customer property implemented by Teak Ltd
D. Verify if Teak Ltd are certified to ISO 9001
E. Verify how ABC Ltd evaluates the performance of Teak Ltd
F. Verify whether the design processes of Teak Ltd comply with ISO 9001
正解：B,E
解説: (Topexam メンバーにのみ表示されます)