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NEW QUESTION # 22
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 manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time." You: "I'm sure. 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?" The auditor asks to speak to the purchasing manager about the selection of the subcontractor to manufacture the company's own brand products.
You: "How did you choose a supplier to manufacture your products?"
Auditee: "We have had a long-term relationship with a supplier ABC Ltd - we gave them our design drawings, got them to complete a supplier questionnaire and run a couple of trial batches for us. We were happy with the result and we have used them ever since." ISO 9001:2015, clause 8.4.1 outlines situations when controls need to be applied to externally provided processes, products and services. Which one of the following situations is applicable to this scenario?
Answer: D
Explanation:
According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:
The products and services are intended for incorporation into the organization's own products and services.
They are provided directly to customers by the external provider on behalf of the organization.
A process, or part of a process, is provided by an external provider as a result of a decision by the organization.
In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.
NEW QUESTION # 23
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
How do you assess the situation presented in the last paragraph of scenario 4?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires collaboration between the auditee (TD Advertising), the certification body, and the audit leader when making changes to audit scope.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.2.3 - Conducting the Audit: Any change in audit scope must be agreed upon by all parties before proceeding.
Why is the Correct Answer C?
* TD cannot unilaterally change the scope without agreement from the certification body and audit leader.
* The certification body must ensure the scope remains relevant and that resources are allocated properly.
Why are the Other Options Incorrect?
* A (Anne cannot withdraw) # Incorrect, Anne CAN withdraw if the changes make the audit unfeasible, but she must consult with the certification body first.
* B (TD cannot change the scope) # Incorrect, scope changes are allowed but must be formally approved.
* D (Anne has full authority to reject scope changes) # Incorrect, scope changes require mutual agreement among all parties.
Reference:
ISO/IEC 17021-1:2015, Clause 9.2.3 - Conducting the Audit
NEW QUESTION # 24
In the context of a third-party audit, match the event with the responsibility for conducting it.
Answer:
Explanation:
Explanation:
The correct answer is:
Event
Selecting audit team = Individual(s) managing the audit programme
Conducting the audit = Audit team
Preparing the audit plan = Audit team leader
Requesting the audit = Audit client
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme Audit team Audit team leader Audit client According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1 According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1 According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1 According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1 References:
1: ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 25
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: E,F,G,H,I,J
NEW QUESTION # 26
Read the following role descriptions. Select two roles that are not directly involved in the audit process.
Answer: C,E
NEW QUESTION # 27
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