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| Section | Objectives |
|---|---|
| Audit Reporting and Follow-up | - Audit Reporting
|
| Audit Planning and Preparation | - Audit Program Management
|
| Audit Principles and Fundamentals | - Audit Concepts
|
| Quality Management System (QMS) Fundamentals | - ISO 9001:2015 Structure and Clauses
|
| Conducting Audit Activities | - Audit Evidence Collection
|
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NEW QUESTION # 118
You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture.
You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?" Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in-house." You: "That sounds like quite a significant change. What has been the impact of that?" Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced the manufacture of our own brand products to one of our suppliers." You: "What were the reasons for making the change?" Auditee: "Our manufacturing section was a small operation, and we struggled to cope with fluctuations in demand. During busy periods, we found it hard to meet lead times, and in quiet periods, we had staff with little to do. This was having an impact on customer satisfaction, and meant we had to charge premium prices that made our product uncompetitive." You: "How did you go about the change?" In relation to the auditor's question about how the change was managed, the auditee mentions the steps listed below. The steps represent different elements of the Plan/Do/Check/Act cycle.
Select three steps which apply to the 'check' element of the cycle.
Answer: A,B,E
Explanation:
The "Check" stage of the PDCA cycle is about monitoring, measuring, analysing and evaluating performance against objectives, requirements and planned activities.
B is correct because reviewing data at management review is part of evaluating QMS performance.
C is correct because monitoring customer feedback is checking whether customer needs and expectations are being met.
D is correct because monitoring supplier performance checks whether the outsourced manufacturing process is effective.
A, E, F and H are mainly "Plan/Do" activities. G may be a monitoring result, but the strongest three "Check" activities are B, C and D because they directly involve review, monitoring and evaluation of QMS performance.
NEW QUESTION # 119
Who is responsible for the development of surveillance activities?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.6.2 (Surveillance Activities):
* The certification body is responsible for planning and conducting surveillance audits to ensure continued compliance.
* The auditee's top management (A) does not develop surveillance activities, but they must participate.
* The audit team leader (C) conducts the surveillance audit, but they do not develop the program.
Thus, B is the correct answer.
NEW QUESTION # 120
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were told to dismiss most of the complaints because of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
You raised a nonconformity against clause 8.5.1 of ISO 9001.
Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.
Answer: C,G,H
NEW QUESTION # 121
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.
Answer:
Explanation:
NEW QUESTION # 122
You are auditing a manufacturer of specialty tea products during a Stage 2 certification audit. In the quality laboratory, you interview one of three operatives conducting sensory testing of a batch from the production line.
Select three options of evidence which could demonstrate conformance with clause 9.1.1 of ISO 9001:2015.
Answer: D,G,H
Explanation:
Comprehensive and Detailed Explanation From Exact Extract:
Clause 9.1.1 - Monitoring, measurement, analysis and evaluation (General) requires the organization to:
"Determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results, and when results shall be analyzed and evaluated." The goal is to ensure valid, reliable, and consistent measurement of process and product performance. Here's how each correct option supports compliance:
# B. Analysis of the results of sensory tests
This directly aligns with the requirement for analysis and evaluation of monitoring results. Clause 9.1.3 also supports the use of such data for evaluating product conformity and process effectiveness.
# G. Sensory testing results are recorded
This supports documented evidence of monitoring results, as required under 9.1.1(e), to verify that quality checks (such as flavor and aroma assessments) are being done consistently.
# H. The Hedonic Method is used to monitor the quality of the product
Use of a standardized measurement method like the Hedonic Scale aligns with 9.1.1(b), which requires defined methods to ensure valid and reproducible results.
Why the Other Options Are Incorrect or Less Relevant:
A). University degrees # Related to competence (Clause 7.2), not monitoring and measurement (Clause 9.1.1).
C). Independent expert review # Not part of regular monitoring unless it's built into the process.
D). Respiratory testing # Irrelevant to product quality monitoring.
E). Outsourcing # Would shift responsibility but doesn't demonstrate internal conformance.
F). Safe disposal # Pertains to Clause 8.5.4 (Preservation), not Clause 9.1.1.
References:
ISO 9001:2015 Clause 9.1.1 - Monitoring, measurement, analysis and evaluation ISO 9001:2015 Clause 9.1.3 - Analysis and evaluation ISO 9001:2015 Clause 7.2 - Competence (for contrast)
NEW QUESTION # 123
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