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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.
Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people
are present and waiting for them: the Health and Safety supervisor and the administrative officer. Neither has participated in
the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified
during the audit (NC1 and NC2).
They said:
Health and Safety supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a
serious car accident, and the other two managers have had to leave urgently to attend to the emergency."
Administration officer: "Our quality manager, before leaving, left a written message about 'NC2'. He declares that the
correction and corrective action have been already implemented and has attached some documents to the message as
evidence of these actions. Therefore, he expects that 'NC2' will not be included in the report."
Which one of the following would be your preferred answer to the Quallty Manager's request?
How can an organization ensure the objectivity and impartiality of the internal audit function?
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 ...
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation which manufactures sacrificial anodes for the
oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. As one of
the auditors, you find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the
anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the
release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests rarely fall below the
required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed with the clause of ISO 9001 selected for the
above nonconformity. He thinks it should be clause 9.1.1.
Choose three options for how the audit team leader should best respond to the situation:
Select six of the activities that are specifically required by ISO 17021-1 as part third-party (Certification Body) surveillance audit processes.
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.
In scenario 4, the audit team determined the audit feasibility by considering only the resources available for the audit. Is this acceptable?
You are conducting 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
You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
The Closing meeting of a second-party audit was planned for 6 pm with the general manager and the quality manager.
At 6 pm, when the audit team enters the meeting room, only the Quality Manager is present and walting for them.
The dialogue among them is as follows:
Auditor team leader: "Good evening, could you please inform the general manager that we are ready to start with the closing meeting?"
Quality manager: "Good evening. I am sorry to inform you that the general manager will not be able to attend the meeting. He will try to
participate virtually to make some closing remarks."
Auditor team leader: "OK. We identified seven nonconformities - these are the reports. Could you please review them and sign them?"
Quality manager: "OK. As you know, I reviewed them after yesterday's meeting and accept of all them, where shall I sign?"
General manager (from speakers in the room and addressing the quality manager): "Hold on! Do not sign the two nonconformities related to ABC
Bank! I have just checked, and we did not provide any services to ABC Bank during September! You can sign the remaining five nonconformities."
How would you proceed with the audit? Select one.
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The company
processes waste plastics into raw material for plastic bottle manufacturers. You reach the manual
picking line where operators are removing contaminant materials from incoming products, such as
plastic bags, plastic film and badly contaminated items that would compromise the recycling process.
You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also
compromise our quality standards. We need to protect our reputation for good quality output
materials."
You: "What happens to the rejected items?"
Auditee: "Some get melted down in another process later on and some are disposed of as waste
products that cannot be recycled."
You: "What happens to the waste products?"
Auditee: "I'm not sure. I suppose they go to landfill."
After further auditing, you have gathered additional evidence.
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