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| Section | Objectives |
|---|---|
| Audit Planning and Preparation | - Audit Program Management
|
| Audit Principles and Fundamentals | - Auditor Competence
|
| Conducting Audit Activities | - On-site Audit Execution
|
| Audit Reporting and Follow-up | - Audit Reporting
|
| Quality Management System (QMS) Fundamentals | - Quality Principles
|
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NEW QUESTION # 39
You are carrying out an annual audit at an organisation that has been certificated to ISO 9001 for two years.
The organisation offers home security
services. The scope of the quality management system covers alarm installation, alarm servicing, alarm monitoring and response. The business operates from a single office and employs subcontract installers and service technicians across the country.
You have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: "I would like to gain an understanding of how the quality management system has been supporting your business and its strategic direction." MD: "We are continuing to face difficult times. The market is extremely competitive, and customers typically look for the least expensive option when choosing home security services. We have not yet seen any business benefit from our quality management system." You: "Tell me how you determine external and internal issues." MD: "We use SWOT analysis (Strengths Weaknesses, Opportunities, Threats)." You: "How have the outputs from your SWOT been used?" Select two of the following audit trails would you take to explore the extent to which the SWOT analysis and the outputs from this have been used to enable the business to achieve the intended results(s) of its quality management system according to ISO 9001.
Answer: B,C
Explanation:
According to ISO 9001:2015, clause 4.1, the organisation must determine the external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended results of its quality management system. The organisation must also monitor and review the information about these issues. SWOT analysis is a tool that can help the organisation to identify its strengths, weaknesses, opportunities, and threats. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to review the information periodically and update it as necessary. Therefore, one audit trail would be to establish how the organisation reviews information about external and internal issues, such as how often, by whom, using what criteria, and with what results. 123 According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 References:
1: ISO 9001:2015 - Quality management systems - Requirements
2: Advisera, "Context of the organization in ISO 9001:2015 explained", https://advisera.com/9001academy
/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
3: ISO Templates, "ISO 9001 - Clause 4: Context of the organisation explained", https://resources.iso- templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained
4: Advisera, "How to implement continual improvement in ISO 9001", https://advisera.com/9001academy
/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/
NEW QUESTION # 40
Select one option that must be considered when determining the scope of a QMS to ISO 9001.
Answer: B
Explanation:
According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause
4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.
Therefore, the correct answer is C, as external issues of the organization's context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 4.1 and 4.3 ISO 9001:2015 - How to determine the scope of your QMS - Advisera, section "Considerations for determining the scope of the QMS in ISO 9001" ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 4
NEW QUESTION # 41
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization 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:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.
NEW QUESTION # 42
You work for an organisation, ' ABC ' , which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit an external provider, ' XYZ ' , which provides packaging materials to your organisation. It is
4 pm, and the audit is dlose to an end;
you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled for 5 pm.
' XYZ ' has two manufacturing lines: M1 is a clean room for primary packaging materials (i.e. will be in direct contact with the food), and M2 is for secondary materials (i.e. will not be in direct contact with food).
Auditor 1 audited the two manufacturing lines.
You: " What findings would you report? "
Auditor 1: " I have one issue. Earlier today in the morning I saw some secondary material stocked in the clean room. I would propose raising a nonconformity. " You: " How would you write the nonconformity? " Auditor 1: " In the clean room, there was a pallet with secondary materials. " What additional information would you add to this text to complete the nonconformity report? Select six.
Answer: B,C,E,F,G,J
NEW QUESTION # 43
Which of the following three options could be considered potential threats to impartiality in an audit context?
Answer: A,D,E
Explanation:
Potential threats to impartiality in an audit context include familiarity (having a close relationship with the auditee), intimidation (being coerced or feeling pressured), and self-audit (auditing one's own work). These factors can compromise the auditor's objectivity and the audit's integrity. References: = The information is based on the ISO 9001 Auditing Practices Group documents which discuss threats to auditor impartiality and how they may compromise an auditor's objectivity123.
NEW QUESTION # 44
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