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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q198-Q203):
NEW QUESTION # 198
An audit team leader arrives at a printing company to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. The Quality Manager wants the ISO
9001 certificate to cover the new contract.
During the audit, a team member found that some print jobs had been rejected by several clients over some months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract.
The auditor finds that the responsibility for checking spelling errors is placed on the printer that sets up the print run.
In line with the policy of the certification body, the audit team raise improvement opportunities in the audit report. Which three of the following options would represent acceptable opportunities for improvement in the report?
- A. A plan to determine why the errors occur and to prevent them.
- B. An intensive training plan that involves all production personnel.
- C. The recruitment process to include spelling tests to filter out unsuitable candidates.
- D. Operational planning activities may benefit from a clearer risk-based approach.
- E. More process time needs to be allocated to the new employees.
- F. The organisation needs to delay its certification to gain more experience of the QMS.
- G. The responsibility for checking printing needs to be independent of the operators.
- H. A business consultant can be recommended for advice on improving operations.
Answer: A,D,G
Explanation:
According to the ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities1, an improvement opportunity is a suggestion made by the auditor for the auditee to consider that, if implemented, may enhance the performance of the QMS. Improvement opportunities are not mandatory, but they should be based on objective evidence and aligned with the audit criteria and objectives. Improvement opportunities should also be realistic, feasible, and beneficial for the auditee. In this case, the evidence statements that represent acceptable improvement opportunities in the report are A, C, and E, because they address the potential causes and effects of the spelling errors in the print run, and propose possible actions that may improve the quality of the products and services, and the effectiveness of the QMS. These options are consistent with the requirements and principles of ISO 9001, such as clause 6.1 on actions to address risks and opportunities, clause 8.1 on operational planning and control, clause 8.5.1 on control of production and service provision, and clause 10.2 on nonconformity and corrective action. The other options are not appropriate improvement opportunities, because they are either irrelevant, unrealistic, or unhelpful for the auditee. For example, option B may contradict the audit objective and scope, option D may imply a lack of auditor competence or impartiality, option F may not address the root cause of the problem, option G may not be applicable or effective, and option H may not be feasible or justified. References: ISO 9001 Auditing Practices Group Guidance on Improvement Opportunities, ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Audit Evidence
NEW QUESTION # 199
What is a list of actions that should be performed during the audit with their respective timeline?
- A. The audit offer.
- B. The audit criteria.
- C. The audit schedule.
- D. The audit objectives.
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
The audit schedule provides a structured timeline of activities to be conducted during the audit.
Clause References:
* ISO 19011:2018, Clause 6.4.2 - Preparing the Audit Plan:
* Requires the development of an audit schedule, including the sequence and timing of activities
.
* ISO/IEC 17021-1:2015, Clause 9.1.3 - Audit Program:
* Certification bodies must establish a schedule for conducting audits.
Why is the Correct Answer C?
* The audit schedule ensures systematic execution of the audit by defining activities, responsible auditors, and timeframes.
* A well-planned schedule improves efficiency and helps auditors cover all necessary areas within the given time.
Why are the Other Options Incorrect?
* A (Audit objectives) # Define why the audit is conducted, not the schedule.
* B (Audit criteria) # Define the standards and requirements to be evaluated, not the timeline.
* D (Audit offer) # Refers to the initial proposal sent to the auditee, not the activity timeline.
NEW QUESTION # 200
What are the criteria for reviewing documented information?
- A. Archive, volume, and confidentiality of documented information
- B. Content, format, and the procedure for managing documented information
- C. Language of documented information, internal audit reports, client feedback
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information), the criteria for reviewing documented information include:
* Content - The accuracy and relevance of the information.
* Format - Ensuring readability and proper structuring (e.g., language, versioning).
* Procedure for managing documented information - Ensuring control, access, and updates.
Other options, such as internal audit reports and client feedback, are important for overall QMS evaluation but are not the main criteria for reviewing documented information.
NEW QUESTION # 201
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. Analyse the daily dispatch of milk for 7 days to determine its variability.
- C. 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.
- D. Retain the current contract and try to sell the occasional surplus milk to a second customer.
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 # 202
Which two of the following aspects of a quality management system must the organisation continually improve?
- A. Efficiency
- B. Effectiveness
- C. Adaptability
- D. Suitability
- E. Responsiveness
- F. Applicability
Answer: A,B
Explanation:
Effectiveness and efficiency are two of the seven quality management principles that form the basis of ISO
9001. According to ISO 9000:2015, clause 3.2.14, effectiveness is the "extent to which planned activities are realized and planned results achieved". According to clause 3.2.15, efficiency is the "relationship between the result achieved and the resources used". In other words, effectiveness is about doing the right things, and efficiency is about doing things right. ISO 9001:2015, clause 10.3, requires the organisation to continually improve the suitability, adequacy, and effectiveness of the quality management system. This implies that the organisation should also improve the efficiency of its processes, products, and services, as efficiency is a key factor in achieving customer satisfaction, reducing costs, and increasing profitability. Some of the ways that the organisation can improve its effectiveness and efficiency are: - Establishing SMART (specific, measurable, achievable, relevant, and time-bound) objectives and monitoring their progress - Implementing the Plan-Do-Check-Act (PDCA) cycle to plan, execute, evaluate, and improve its activities - Applying the process approach to manage its interrelated processes as a coherent system - Using evidence-based decision making to analyse data and information and take appropriate actions - Seeking feedback from customers and other interested parties and addressing their needs and expectations - Identifying and addressing risks and opportunities that can affect its performance and conformity - Encouraging innovation and creativity to find new and better ways of doing things - Benchmarking its performance against best practices and industry standards - Providing training and development opportunities for its personnel to enhance their competence and motivation 12345 References:
1: ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
2: ISO 9001:2015 - Quality management systems - Requirements
3: ISO 9001 Explained: A Comprehensive Guide to Quality Management Systems - ISMS.online
4: The 7 Principles of ISO 9001 | ISO Standards Explained
5: Key Elements of an ISO 9001:2015 Quality Management System
NEW QUESTION # 203
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