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NEW QUESTION # 13
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 # 14
Whistiekleen is a national dry cleaning and laundry organisation with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry.
The Quality Manager tells you that these are the oldest shops in the organisation. The deaning equipment needs replacing but the organisation cannot afford it now. You learn that the shop managers were told to dismiss most of the claims based on 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.
Match the ISO 9001 Clauses to the statements.
Answer:
Explanation:
Explanation:
A screenshot of a computer AI-generated content may be incorrect.
* Clause 8.5.3 - Property Belonging to Customers or External Providers:This clause requires the organization to care for customer property while it is under their control. If there is damage, they must inform the customer and retain documented information. Thus, informing customers of the reason for laundry damage relates directly to this clause.# Reference: ISO 9001:2015 Clause 8.5.3
* Clause 7.1.3 b - Infrastructure:It refers to the provision and maintenance of infrastructure necessary for the operation of processes. This includes equipment. If resources are not allocated for outdated equipment, it directly breaches this clause.# Reference: ISO 9001:2015 Clause 7.1.3 b
* Clause 10.2.1 b - Corrective Action:This clause covers actions to eliminate the causes of nonconformities to prevent recurrence, including evaluating and correcting customer complaints.# Reference: ISO 9001:2015 Clause 10.2.1 b
* Clause 5.1.2 b - Customer Focus (Top Management):Top management must ensure risks to customer satisfaction, including property damage, are addressed. This aligns with addressing the risk of damaging customer laundry.# Reference: ISO 9001:2015 Clause 5.1.2 b
* Clause 6.2 - Quality Objectives and Planning to Achieve Them:Setting objectives for reducing customer complaints (like those about laundry damage) falls under this clause.# Reference: ISO 9001:
2015 Clause 6.2
NEW QUESTION # 15
What competence, among others, should each audit team member have?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must have competence in risk-based auditing to effectively assess an organization's QMS performance and compliance.
Clause References:
* ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence:
* Auditors must have knowledge of risk-based thinking to assess risk impact on processes.
* ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking:
* The standard emphasizes proactive risk management, which auditors must understand.
Why is the Correct Answer B?
* Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.
* Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.
Why are the Other Options Incorrect?
* A (Industry knowledge) # While helpful, it is not mandatory for all auditors.
* C (Expertise in all domains) # Auditors are not required to be experts in all areas, just in audit methodology.
* D (Formal degree in quality management) # ISO does not require a formal degree, just competence in audit principles and methods.
NEW QUESTION # 16
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?
Answer: C,E
Explanation:
According to ISO 9001:2015, clause 8.4, an organization is required to control the processes, products and services provided by external providers, including those that affect the quality of the organization's own products and services. This includes determining the controls to be applied to the external provision of processes, products and services, as well as the information to be communicated to the external providers. The organization is also required to monitor, measure, and evaluate the performance of the external providers and retain documented information of these activities.
Therefore, in the scenario given, ABC Ltd is responsible for controlling the processes, products and services provided by Teak Ltd, as they affect the quality of ABC Ltd's own products and services. This means that ABC Ltd should have established criteria and methods for evaluating the performance of Teak Ltd, as well as documented information of the results of such evaluation. ABC Ltd should also have defined the supply arrangements with Teak Ltd, including the specifications, requirements, and verification activities related to the products and services provided by Teak Ltd.
Hence, the best options to describe how to plan the audit of the interrelationship with Teak Ltd during the Stage 2 audit at ABC Ltd are A and D, as they are aligned with the requirements of ISO 9001:2015, clause
8.4. The other options are either irrelevant or beyond the scope of the audit, as they do not pertain to the control of external provision by ABC Ltd.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 8.4 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.1 and 6.4.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
NEW QUESTION # 17
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?
Answer: C
Explanation:
Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.
References: ISO 9001:2015, Clause 5.2
NEW QUESTION # 18
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