PECB ISO-9001-Lead-Auditor - QMS ISO 9001:2015 Lead Auditor Exam

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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:

Scenario 7 states that Sean planned audit activities on his own. Is this acceptable?

No, audit activities should be planned by top management

Yes, it is the responsibility of the audit team leader to plan audit activities

No, the audit team leader should always cooperate with the other members of the team to plan audit activities

Question # 52

Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were told to dismiss most of the complaints because of the poor quality of the laundered materials.

On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.

You raised a nonconformity against clause 8.5.1 of ISO 9001.

Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.

The management failed in planning to replace obsolete equipment.

The operators did not check the laundry before release to the customer.

The operators did not check the condition of the customerâ€™s product upon receipt.

Shop managers were told to make excuses to customers with complaints.

The organisation failed to control the laundry operations in 5 shops adequately.

Customer complaints are not taken seriously by the organisation.

The organisation failed to maintain all of its equipment to an adequate standard.

Explanation:

The nonconformity was raised against ISO 9001:2015 Clause 8.5.1 â€“ Control of production and service provision. This clause requires organisations to carry out production and service provision under controlled conditions, including:

the use of suitable infrastructure and equipment,

the availability and use of appropriate monitoring and control, and

the prevention of nonconforming outputs being delivered to customers.

In this scenario, the evidence shows a systemic failure in operational control, not isolated human error.

Explanation of the selected evidence:

E. The organisation failed to control the laundry operations in 5 shops adequately.

Clause 8.5.1 requires consistent control of service provision. The fact that 80% of complaints come from five specific shops demonstrates a lack of effective operational control in those locations.

G. The organisation failed to maintain all of its equipment to an adequate standard.

Clause 8.5.1 requires suitable infrastructure for service provision. Management acknowledged that equipment in these shops is old and cannot currently be replaced, meaning it is not being maintained at a level necessary to ensure conformity of service.

H. Some equipment used was not suitable for the laundry process.

The poor cleaning outcomes and high complaint levels directly indicate that the equipment is not fit for purpose, which is a clear breach of the requirement to provide suitable resources for controlled service provision under Clause 8.5.1.

Explanation of why the other options are not appropriate evidence for Clause 8.5.1:

A relates to strategic planning and investment decisions, not directly to operational control.

B and C relate to inspection activities, which were not evidenced in the scenario.

D and F relate to complaint handling behaviour, which would align more closely with Clause 9.1.2 (customer satisfaction) or Clause 10.2 (nonconformity and corrective action), not Clause 8.5.1.

ISO-aligned conclusion:

The nonconformity is justified because the organisation is continuing to provide services using unsuitable and inadequately maintained equipment, resulting in repeated service failures in multiple locations. This demonstrates a clear failure to control service provision as required by ISO 9001:2015 Clause 8.5.1, supported by evidence E, G and H.

Question # 53

What is a list of actions that should be performed during the audit with their respective timeline?

The audit objectives.

The audit criteria.

The audit schedule.

The audit offer.

Question # 54

Scenario 3:

Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.

To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.

The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.

The audit team began by gathering information about Fin-Proâ€™s understanding of ISO 9001 requirements. While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.

The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the companyâ€™s working environment (social, psychological, and physical conditions).

The audit team analyzed the evidence and prepared an audit report with findings and conclusions.

Based on the last paragraph of scenario 3, which audit principle did the audit team follow?

Fair presentation.

Integrity.

Confidentiality.

Objectivity.

Question # 55

For each of the following scenarios, select four that are corrective actions.

The government enforces a lockdown against a virulent virus

The government increases payments to dentists for dental checks for children

A complaint about cold food was resolved by reheating food in the restaurant kitchen

After the loss of an important football match 4-0, the manager is sacked

Call out roadside assistance to a broken-down car

The government develops a vaccine against a virulent virus

The organization improves product identification to prevent customer complaints

Question # 56

Which two of the following should be included in an audit plan?

List of findings from the last audit

Name of the auditee general manager

Signature of Certification Body Technical Reviewer

Sequence and timings of audit activities

Date of next audit

Name of auditees and auditors

Question # 57

Even though past audits have highlighted a consistently large number of nonconformities within an organisation's design team, the organisation has not varied the frequency or duration of audits on its audit plan.

The decision for whether this situation is acceptable or not should be governed by which of the following?

A risk-based approach to the audit programme

The authority of the audit team leader

The availability of competent internal auditors

The organization's reasoning behind the lack of change to the audit plan

Question # 58

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.

Establish how many interested parties need to be consulted

Establish how the organisation reviews information about external and internal issues

Establish how the organisation shares information with external interested parties

Establish what actions were taken to improve the QMS

Establish whether the SWOT analysis has been reviewed by the procurement manager

Establish whether the SWOT analysis is focussed solely on the QMS

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 â€” Requirements

2: Advisera, â€œContext of the organization in ISO 9001:2015 explainedâ€, https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

3: ISO Templates, â€œISO 9001 - Clause 4: Context of the organisation explainedâ€, https://resources.iso-templates.com/blog/iso-9001-clause-4-context-of-the-organisation-explained

4: Advisera, â€œHow to implement continual improvement in ISO 9001â€, https://advisera.com/9001academy/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/

Question # 59

In the context of a third-party management system certification audit, which two of the following statements are correct?

The purpose of a Stage 2 audit is to certify an organisation to ISO 9001.

The Stage 2 audit must be conducted by auditors who have never worked for the auditee

The purpose of a Stage 2 audit is to evaluate the implementation of the auditee's management system.

A Stage 2 audit evaluates how efficiently the organisation is implementing its management system

The Stage 2 audit cannot include remote access to electronic site(s) that contain information relevant to the audit of the management system.

The Stage 2 audit should include an opening meeting at the start of the audit and a closing meeting at the conclusion of the audit.

Question # 60

Based on the scenario above, answer the following question:

Based on Scenario 7, the team worked together to draft the final audit report. Is this acceptable?

Yes, audit team members should contribute to drafting one general report for the findings and conclusions

No, audit team members should draft separate reports for their findings and conclusions

No, it is the responsibility of the audit team leader to draft the audit report

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PECB ISO-9001-Lead-Auditor - QMS ISO 9001:2015 Lead Auditor Exam

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