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NEW QUESTION # 59
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:
Answer: A,C
Explanation:
According to clause 4.1 of ISO 9001:2015, the organization should determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended results of its quality management system. The organization should monitor and review these issues and update them as necessary. Although the standard does not explicitly require documented information of these issues, it does require documented information as evidence of the implementation of the actions taken to address risks and opportunities, as per clause 6.1. The organization should also retain documented information as evidence of the results of the monitoring, measurement, analysis and evaluation of its QMS, as per clause 9.1. Therefore, the auditor should not accept the legal compliance expert answering the question, as he is not the person responsible for the process and may not have the necessary competence or knowledge of the QMS. The auditor should also look for evidence that the actions resulting from the risk assessment had been taken, as this is a requirement of the standard and a way to verify the effectiveness of the QMS. The other options are not appropriate courses of action for the auditor, because they do not address the audit objective or criteria, or they may compromise the audit integrity or impartiality. For example, option B may not be feasible or reliable, as the Technical Manager may not be available or able to provide the necessary evidence by phone. Option C may cause unnecessary delay and inconvenience for the audit process and the auditee. Option E may not solve the problem, as the guide is not the main source of evidence or information for the audit. Option F may be disrespectful or unprofessional, as the consultant may have a legitimate role or interest in the audit.
References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Context of the Organization, ISO 9001 Auditing Practices Group Guidance on Audit Evidence
NEW QUESTION # 60
A person who provides specific knowledge or expertise to the audit team during the audit is known as a/an:
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
A technical expert is someone with specialized knowledge that helps the audit team understand specific technical aspects of the auditee's processes.
Clause References:
ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts:
Technical experts support the audit team with specialized knowledge but do not perform the audit themselves.
Why is the Correct Answer B?
A technical expert is needed when auditors lack deep expertise in specific areas, such as engineering, software, or medical devices.
They assist in interpreting complex technical requirements but do not act as auditors.
Why are the Other Options Incorrect?
A (Observer) # Observers do not contribute expertise; they only watch the audit (e.g., trainees).
C (Guide) # Guides help with logistics but do not provide technical expertise.
Reference:
ISO 19011:2018, Clause 7.3.4 - Use of Technical Experts
NEW QUESTION # 61
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 and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years. The organisation uses a software programme called SWIFT, which is used to record sales, plan production, purchase supplies, print despatch notes, track new product development, perform traceability exercises, carry out mass balance checks, raise invoices, create budgets, and support financial control.
You are nearing the end of the audit and you are reviewing your audit notes. You notice a recurring trend concerning the SWIFT database as shown below:
You ask the Quality Manager to explain how the SWIFT database is controlled. You learn that the Operations Director is responsible for determining and progressing SWIFT software updates. You decide to meet the Operations Director (OD).
You: "Good afternoon."
OD: "Good afternoon."
You: "What responsibility do you have concerning the SWIFT database?"
OD: "I maintain it. If anyone wishes to propose an update to the database, they send me an email with details of their proposal. I then either process the database update myself, or I send the request to the consultant who designed the database 20 years ago. The necessary software changes are made, and the amended software is immediately released to users." You: "Would you explain how the software amendments are controlled?" OD: "Of course. I personally update every computer myself." You: "Do you inform the database users of the changes?" OD: "No I don't. They find out for themselves by using the software, or they come to see me if they have any questions." You: "How do you ensure that the database users use the latest version?" OD: "That's easy, I update every computer myself." You: "During the audit, I noted there were several versions of SWIFT in use (you refer to your audit notes)." OD: "I know. That's because some versions work better than others, and depending on user needs and experiences, we allow users to revert to using an earlier version if they find it works better for them." Based on the scenario, which two of the following statements are true? There is evidence of nonconformity with a requirement defined in ...
Answer: A,C
Explanation:
Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:
C). Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.
E). Clause 7.5.3 Control of documented information: The Operations Director's approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.
These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system.
The scenario described shows a casual approach to managing critical software updates, which could affect the organization's ability to consistently meet customer and regulatory requirements.
NEW QUESTION # 62
You are conducting a Stage 1 audit at an organisation that services refrigeration equipment for a large customer base. The scope of certification is "Provision of refrigeration equipment maintenance and repair services". You are interviewing the Managing Director to learn more about the organisation and to explore how the requirements for policy, objectives, and risks and opportunities in ISO 9001 are addressed.
The Managing Director explains that they only use sub-contract refrigeration engineers and do not have any full-time refrigeration engineers, which helps to optimise overhead costs. The full-time staff employed are essentially a small team of office staff who process customer enquiries, schedule jobs and process invoices.
The Managing Director adds that the ISO 9001 requirements for competence of personnel extends to both sub- contract and full-time staff. He also states that the full-time staff are aware of the Quality Policy, objectives and plans to address risk and opportunities.
You ask if the sub-contract engineers have been informed of the Quality Policy, objectives and plans to address risks and opportunities, to which the Managing Director replies that this is not applicable as they only use sub-contractors who operate ISO 9001 certificated quality management systems. The documented information provided to the auditor confirms this.
Which clause in ISO 9001 is most likely not to have been fulfilled in this instance?
Answer: B
Explanation:
Relevant ISO 9001 Requirement
Clause 7.3 - Awareness states that persons doing work under the organisation's control shall be aware of:
* The quality policy;
* Relevant quality objectives;
* Their contribution to the effectiveness of the QMS;
* The implications of not conforming with QMS requirements.
A critical point is that ISO 9001 uses the phrase:
"persons doing work under the organisation ' s control"
This includes:
* Employees,
* Temporary personnel,
* Agency personnel,
* Subcontractors performing work on behalf of the organisation.
Why Option B is Correct
In the scenario:
* The refrigeration engineers performing the actual maintenance and repair services are all subcontractors.
* The Managing Director states that these subcontractors have not been informed of:
* the Quality Policy,
* quality objectives,
* plans to address risks and opportunities.
The justification given is that the subcontractors themselves have ISO 9001-certified management systems.
However, ISO 9001 certification of a subcontractor does not remove the organisation ' s responsibility to ensure persons working under its control are aware of the organisation ' s own QMS requirements.
Therefore, the organisation has failed to demonstrate compliance with Clause 7.3 Awareness .
Why the Other Options Are Incorrect
A). Clause 7.4 - Communication
The scenario does not primarily indicate a failure of communication processes.
The issue is not whether communication methods exist, but whether the subcontractors have the required awareness.
C). Clause 7.2 - Competence
The Managing Director explicitly states that competence requirements are applied to both full-time staff and subcontractors.
No evidence is presented that competence has not been determined or evaluated.
Therefore, a competence failure is not the strongest conclusion.
D). Clause 7.5 - Documented Information
The scenario indicates documented information exists and was reviewed by the auditor.
No evidence suggests documented information is missing, uncontrolled, or unavailable.
Therefore, Clause 7.5 is not the most likely issue.
ISO-Aligned Conclusion
The organisation relies entirely on subcontracted refrigeration engineers to deliver its certified services.
Because these personnel perform work under the organisation ' s control, ISO 9001 requires them to be aware of the organisation ' s quality policy, objectives, and relevant QMS requirements.
The evidence shows this awareness has not been established.
NEW QUESTION # 63
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 # 64
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