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Viewing questions 31-40 out of questions

Questions # 31:

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:

Options:

The audit team leader will refer to the quality manager to determine which clause they agree with.

Advise that he will think about the clause and announce his decision during the Closing meeting.

Immediately agree with the second auditor that clause 9.1.1 would be better.

Immediately overule the objection of the second auditor with no discussion of the clause.

Invite you and the second auditor to fully explain your point of view and then decide which clause to select.

Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply.

Suggest that neither clause is accurate and instead propose clause 9.1.3 as the best one for the nonconformity.

Questions # 32:

What is the responsibility of the audit committee during an internal audit?

Options:

To define the audit schedule

To supervise all audit functions and activities

To establish an internal audit program

Questions # 33:

You are conducting an ISO 9001 audit of a Materials Recycling Facility. The organisation processes

waste plastics into raw materials 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. Match the following

statements to the correct ISO 9001 standard clause shown.

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.

Question # 33

Options:

Answer

Answer:

Explanation

A → 8.4.3.a

B → 7.2.b

C → 10.2.2

D → 10.2.1

E → 6.2

F → 5.2.2.c

8.4.3.a – No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:

“The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider.”

7.2.b – The picking operators have been trained:This falls under Competence requirements. Clause 7.2(b) requires that persons are competent on the basis of education, training, or experience:

“Ensure that these persons are competent on the basis of appropriate education, training, or experience.”

10.2.2 – No documentation is retained for rejected materials:This relates to corrective action documentation. Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:

“The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken…”

10.2.1 – The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause 10.2.1 discusses actions such as containment or segregation for nonconforming outputs:

“Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment…”

6.2 – Management has set an objective for the level of recycling:This refers to quality objectives. Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:

“The organization shall establish quality objectives at relevant functions… The quality objectives shall be measurable…”

5.2.2.c – The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:

“The quality policy shall be… available to relevant interested parties, as appropriate.”

[References:, ISO 9001:2015, Clause 8.4.3 – Information for external providers, Clause 7.2 – Competence, Clause 10.2.2 – Corrective action documentation, Clause 10.2.1 – Nonconforming outputs, Clause 6.2 – Quality objectives, Clause 5.2.2 – Communicating the quality policy, ]

Questions # 34:

Which two of the following may be changed once a Stage 2 certification audit has commenced?

Options:

Agreed language of the audit

Audit scope

Audit plan

Agreed standard for the audit criteria

Audit checklist

Increase of audit duration

Answer

C, F

Explanation

Comprehensive and Detailed In-Depth Explanation:

Once a Stage 2 certification audit has commenced, certain logistical or planning-related elements may still be adjusted, while others are fixed by prior agreement and cannot be changed.

✅ C. Audit Plan:

The audit plan is a document that outlines the scope, objectives, criteria, and logistics of the audit. According to ISO/IEC 17021-1:2015 (the standard for bodies providing audit and certification of management systems), clause 9.2.3.3 allows for modification of the audit plan based on real-time conditions during the audit — such as availability of auditees or changes in process access.

✅ F. Increase of Audit Duration:

Audit duration is generally determined during audit planning based on factors like employee count, risk, complexity, etc. However, if during Stage 2 it is found that more time is needed (e.g., due to additional processes, scope not fully covered, or significant findings), auditors are permitted to extend the audit. This ensures full coverage of all required areas as per ISO/IEC 17021-1 clause 9.1.4 and IAF MD 5.

❌ A. Agreed Language of the Audit:

This is determined and agreed upon in the contract and audit planning stages. Changing it during Stage 2 would create communication and documentation issues, especially in multi-site or multi-national audits.

❌ B. Audit Scope:

The audit scope is defined in the contract and certification agreement based on clause 4.3 of ISO 9001:2015. Changing it mid-audit would invalidate planning, required competencies, and potentially even the certification basis.

❌ D. Agreed Standard for the Audit Criteria:

Changing the standard (e.g., from ISO 9001 to ISO 13485) is fundamentally altering the purpose and contractual basis of the audit and is not permissible once Stage 2 has started.

❌ E. Audit Checklist:

The checklist is a tool prepared by the auditor as part of audit preparation and is based on the audit plan and standard requirements. While it may be adapted during the audit (e.g., if new risks arise), it does not constitute a formal change like duration or scope.

Relevant References:

ISO/IEC 17021-1:2015 Clause 9.2.3.3 (Audit Plan Modification)

IAF MD 5:2019 (Duration of QMS Audits)

ISO 9001:2015 Clause 4.3 (Scope of the QMS)

ISO/IEC 17021-1:2015 Clause 9.1.4 (Audit Duration)

Questions # 35:

Who is responsible for the development of surveillance activities?

Options:

A representative of the auditee's top management

The certification body

The audit team leader

Questions # 36:

In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.

Options:

A recommendation is given in the report.

A finding of good practice is reported.

An opportunity for improvement is raised.

A major non-conformity is raised.

A finding of conformity is reported.

A minor non-conformity is raised.

Answer

D, F

Explanation

According to ISO 19011:2018, clause 6.6.2, a nonconformity is the non-fulfilment of a requirement. A nonconformity can be classified as either major or minor, depending on the nature and extent of the deviation from the audit criteria. A major nonconformity is a nonconformity that affects the ability or the integrity of the organization’s management system to achieve the intended results. A minor nonconformity is a nonconformity that does not affect the ability or the integrity of the organization’s management system to achieve the intended results, but is a deviation from the audit criteria1.

According to ISO/IEC 17021-1:2015, clause 9.4.9, the organization is required to analyze the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time. The organization is also required to provide the certification body with records and evidence of the implementation and effectiveness of the correction and corrective actions taken. The certification body will then verify the correction and corrective actions taken by the organization and decide on the certification status2.

Therefore, the two options of when the organization is required to act in response to reported findings are D and F, as they indicate the presence of nonconformities that need to be corrected and prevented from recurring. The other options are not correct, as they do not require the organization to act in response to reported findings:

•A. A recommendation is given in the report: A recommendation is a suggestion for improvement that is not related to a nonconformity. A recommendation is not binding for the organization and does not affect the certification status. The organization may choose to accept or reject the recommendation, but it is not required to act on it.

•B. A finding of good practice is reported: A finding of good practice is a positive observation that indicates a strength or a best practice of the organization’s management system. A finding of good practice is not related to a nonconformity and does not affect the certification status. The organization may choose to acknowledge or share the finding of good practice, but it is not required to act on it.

•C. An opportunity for improvement is raised: An opportunity for improvement is a potential area where the organization’s management system can be enhanced or optimized. An opportunity for improvement is not related to a nonconformity and does not affect the certification status. The organization may choose to pursue or ignore the opportunity for improvement, but it is not required to act on it.

•E. A finding of conformity is reported: A finding of conformity is a confirmation that the organization’s management system fulfils the audit criteria. A finding of conformity is not related to a nonconformity and does not affect the certification status. The organization may choose to celebrate or communicate the finding of conformity, but it is not required to act on it.

[References: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements, , ]

Questions # 37:

You are an auditor from a construction organisation who is conducting a second party audit to ISO 9001 at a steel rolling mill producing

structural steelwork. When auditing the rolling process, you find that the operator who is unloading the furnace does not use the

adjacent infrared pyrometer to measure the appropriate product temperature in readiness for the next production stage.

You: "How do you tell when the billet is ready for the rolling stage?"

Operator: "I've done this job for 20 years. I can tell by the bright red colour."

You: "What happens if the colour is wrong?"

Operator: "The billet goes back into the furnace."

You: "Is the pyrometer ever used?"

Operator: "Only in borderline cases."

You continue to interview the operator and find that around 25% of the billets are sent back to the furnace. This includes 80% of the borderline cases.

Select three options that would provide evidence of conformance with clause 9.1.1 of ISO 9001.

Options:

Periodic analysis of the results of temperature checks.

Certification of conformance to national standards from the manufacture of the pyrometer.

An increase in the use of the pyrometer by operators.

Maintenance plan for the furnace.

A procedure that provides instruction in taking billet temperature.

Planning for monitoring and measuring the billet temperature.

A quality objective to achieve lower recycle rates for billets.

Questions # 38:

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."

The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us

to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in

which he explains why."

Which one of the following would be your preferred answer (as team leader) to the General

Manager's request?

Options:

OK. I will get in contact with my company tomorrow to ask for instructions on what to do with

this non-conformity.

OK. Please, let me review the message. I will try to see if I can change the text of the

nonconformity if necessary. Let's take a 10-minute break, as I would like to discuss this issue with

the audit team.

Please tell him that I will phone him in two days and will discuss the issue. Could you please give

me his mobile phone number?

Please tell him that this nonconformity has been previously accepted by the quality manager

during the audit and will stand. I will include it in the report, along with the concern of the

General Manager about it.

Questions # 39:

Scenario 7: POLKA is a car manufacturing company based in Stockholm, Sweden. The company has around 14,000 employees working in different sectors which help with the design, painting, assembling, and test drives of the final product. The company is widely known for its qualitative products and affordable prices. In order to retain their reputation, POLKA implemented a quality management system (QMS) based on ISO 9001.

Before applying for certification, the company decided to conduct an internal audit to check whether there are any nonconformities in their QMS and if the requirements of ISO 9001 are being fulfilled. The top management appointed Sean, the internal auditor, as the team leader of the internal audit team. Sean required from the top management to have unrestricted access to the employees and executives of POLKA and to the documented information. Furthermore, Sean required to establish a team with a large number of auditors, considering the size and the complexity of the organization. The top management of POLKA agreed with Sean's requirements.

The top management, in cooperation with Sean, assigned 10 more employees to the audit team. Following that. Sean planned the audit activities and assigned the roles and responsibilities to each auditor. They began by interviewing employees of different manufacturing departments to check whether they are aware of the process of the QMS implementation. While conducting these activities, one of the auditors asked Sean for permission to audit the department in which he worked on a daily basis, as he was very familiar with the processes of the department.

Along the way, the teams findings showed that the staff were trained, documented information was updated, and the QMS fulfilled the requirements of ISO 9001. The internal audit took three weeks to complete, and on the last week the audit team held a final meeting

The team shared their results and together drafted the audit report This report was submitted to the top management of the company. The report was maintained as documented information, and was available to the relevant interested parties.

Based on the scenario above, answer the following question:

Ten employees of POLKA were part of the audit team that conducted the internal audit. Is this acceptable?

Options:

Yes, members of the company can join the internal audit team

No, ISO 9001 requires hiring a professional team of auditors who are not part of the company to conduct the internal audit

Yes, it is a requirement of ISO 9001 to include employees of the company in the internal audit

Questions # 40:

Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top-notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.

In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.

Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS. They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.

During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS. AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.

Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.

Based on the scenario above, answer the following question:

Which of the following misconceptions about ISO 9001 was present in scenario 1?