ISO-9001-LEAD-AUDITOR TEST PDF - EXAM ISO-9001-LEAD-AUDITOR FORMAT

ISO-9001-Lead-Auditor Test Pdf - Exam ISO-9001-Lead-Auditor Format

ISO-9001-Lead-Auditor Test Pdf - Exam ISO-9001-Lead-Auditor Format

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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q50-Q55):

NEW QUESTION # 50
ABC is a service organisation that cleans and irons bed and table linen for four large hospitals in the city centre. It claims to meet ISO 9001:2015 requirements. During an internal audit, an auditor observes that machine No. 4 is being operated with the three variables outside the limits established in the applicable documented procedure SP-701. The auditor has decided to raise a nonconformity.
Which six elements should be included in the nonconformity report?

  • A. Competence record of the machine operator
  • B. Name of the Quality Manager
  • C. Number of the production order
  • D. Applicable procedure: SP-701
  • E. Condition of the table linens upon receipt from the hospital
  • F. Weight of linen being washed vs the maximum weight required in SP-701
  • G. Identification number of the washing machine
  • H. Manufacturer of the washing machine
  • I. The planned duration of the process vs the minimum time required in SP-701
  • J. The concentration of the cleaning liquid used vs the concentration fixed in SP-701

Answer: A,D,F,G,I,J

Explanation:
B: Applicable procedure: SP-701
D: Identification number of the washing machine
H: The concentration of the cleaning liquid used vs the concentration fixed in SP-701 I: The planned duration of the process vs the minimum time required in SP-701 J: Weight of linen being washed vs the maximum weight required in SP-701 C: Competence record of the machine operator


NEW QUESTION # 51
Select the words that best complete the sentence:

Answer:

Explanation:

Explanation:
According to the ISO 19011:2018 document, the audit plan should provide the basis for agreement regarding the conduct and scheduling of the audit activities. The amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives1. The scope of the audit refers to the extent and boundaries of the audit, such as the audit criteria, the audit objectives, the organizational and functional units, and the processes to be audited1. The complexity of the audit refers to the degree of difficulty or intricacy of the audit, such as the number and diversity of the auditees, the audit criteria, the audit methods, and the audit team composition2. The risk of not achieving the audit objectives refers to the possibility that the audit may fail to provide reliable and sufficient audit evidence to support the audit conclusions and report1.
Therefore, the complete sentence is:
In the context of a third-party audit, the amount of detail provided in the audit plan should reflect the scope and complexity of the audit, as well as the risk of not achieving the audit objectives.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Complexity - an overview | ScienceDirect Topics


NEW QUESTION # 52
During a second-party audit of a dairy farm (by a potential customer) complying with ISO 9001:2015, the auditor verifies that there is large variability in the daily production of the milking yard. The current agreement with their only customer is to provide 2,000 litres per day. However, in the last two years, they have noticed an increasing variability in daily production.
If they produce less than 2,000 litres, they are penalised with a fine of 1.5 pesos for every litre that they do not provide. If they produce more than 2,000 litres, they use the extra milk to feed the pigs.
This process has been in operation for decades. The dairy farm was founded by the grandfather of the current owners, who did not want to alter the established practices.
The auditor raises a nonconformity on the basis that the process is not under control (Clause 8.1).
If you had been the auditor, which one of the following actions would you have accepted?

  • A. Apply the existing process of addressing the risks and opportunities of milk production.
  • B. Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer.
  • C. Retain the current contract and try to sell the occasional surplus milk to a second customer.
  • D. Analyse the daily dispatch of milk for 7 days to determine its variability.

Answer: A

Explanation:
The action that the auditor would have accepted is:
*Option B: Apply the existing process of addressing the risks and opportunities of milk production. This option is correct because ISO 9001:2015 clause 8.1 requires the organization to plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement actions determined in clause 6.1, which refers to the actions to address risks and opportunities. The organization should apply the existing process of addressing the risks and opportunities of milk production, which may include identifying the sources of variability, assessing the potential impacts and consequences, determining and implementing appropriate actions to reduce or eliminate the variability, monitoring and measuring the effectiveness of the actions, and reviewing and updating the actions as necessary.
The following options are not correct:
*Option A: Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization's commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.
*Option C: Retain the current contract and try to sell the occasional surplus milk to a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization's commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.
*Option D: Analyse the daily dispatch of milk for 7 days to determine its variability. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization's commitment to implement actions to address risks and opportunities, as required by ISO 9001:2015 clause 8.1.
References:
*ISO 9001:2015 Quality management systems - Requirements, Clause 8: Operation, Subclause 8.1:
Operational planning and control, Subclause 8.2: Requirements for products and services
*ISO 9001 Lead Auditor Course Material, Module 4: ISO 9001:2015 Requirements, Slide 23: Clause 8 - Operation
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 4.2: ISO 9001:2015 Requirements, Subsection 4.2.8: Clause 8 - Operation
*Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection
3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies


NEW QUESTION # 53
You have been nominated audit team leader of a third-party audit. Which of the following could be the two most relevant objectives of this audit?

  • A. Evaluate the satisfaction interested parties
  • B. Identify the need of resources
  • C. Evaluate the effectiveness of the management system
  • D. Evaluate the benefits obtained since the implementation of the management system
  • E. Identify opportunities for improvement
  • F. Evaluate the capability of the management system to establish and achieve objectives

Answer: C,F


NEW QUESTION # 54
In a third-party audit to ISO 9001, select two options of when the organisation is required to act in response to reported findings.

  • A. A finding of good practice is reported.
  • B. A finding of conformity is reported.
  • C. A major non-conformity is raised.
  • D. A recommendation is given in the report.
  • E. A minor non-conformity is raised.
  • F. An opportunity for improvement is raised.

Answer: C,E

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


NEW QUESTION # 55
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