Pass PECB ISO-9001-Lead-Auditor Exam With Practice Test Questions Dumps Bundle
2024 Valid ISO-9001-Lead-Auditor test answers & PECB Exam PDF
NEW QUESTION # 22
Put the following steps of a third-party audit into the correct sequence in which they happen.
Answer:
Explanation:
Explanation:
Sequence:
Stage 1 Audit
Stage 2 Opening Meeting
Interviews
Stage 2 Closing Meeting
Close-out of Stage 2 Audit Findings
Issue Certificate
Surveillance Audit
Follow-up Audit
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each step:
Stage 1 Audit: This is the initial audit that aims to assess the readiness of the organization for the stage 2 audit. It involves reviewing the documentation of the quality management system, evaluating the scope and objectives of the audit, and identifying any major gaps or nonconformities34.
Stage 2 Opening Meeting: This is the meeting that marks the start of the stage 2 audit. It involves confirming the audit plan, the audit criteria, the audit scope, and the audit team. It also provides an opportunity for the auditee to ask any questions or raise any concerns34.
Interviews: This is the main activity of the stage 2 audit, where the audit team collects evidence by interviewing the personnel involved in the quality management system, observing the processes and activities, and examining the records and documents. The audit team uses various techniques, such as sampling, measurement, analysis, and evaluation, to verify the conformity and effectiveness of the quality management system345.
Stage 2 Closing Meeting: This is the meeting that marks the end of the stage 2 audit. It involves presenting the audit findings, the audit conclusions, and the audit report to the auditee. It also provides an opportunity for the auditee to provide feedback, ask questions, or dispute any findings34.
Close-out of Stage 2 Audit Findings: This is the process of verifying that the auditee has taken appropriate corrective actions to address any nonconformities or opportunities for improvement identified during the stage 2 audit. The audit team may request evidence or conduct a follow-up visit to confirm the effectiveness of the corrective actions34.
Issue Certificate: This is the process of issuing a certificate of conformity to the auditee, if the audit team is satisfied that the quality management system meets the requirements of the standard and that there are no major nonconformities or unresolved issues. The certificate is valid for a specified period, usually three years, and is subject to periodic surveillance audits34.
Surveillance Audit: This is the process of conducting periodic audits, usually once a year, to monitor the continued conformity and effectiveness of the quality management system. It involves reviewing the changes, improvements, and performance of the quality management system, and identifying any new nonconformities or opportunities for improvement34.
Follow-up Audit: This is the process of conducting an additional audit, usually in response to a significant change, a complaint, or a major nonconformity, to verify the impact and the corrective actions taken by the auditee. It may result in the suspension, withdrawal, or renewal of the certificate, depending on the outcome of the audit34.
NEW QUESTION # 23
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.
- A. Corrective action
- B. Preventive action
- C. Correction
- D. Concession
Answer: C
Explanation:
According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, correction is defined as "action to eliminate a detected nonconformity". A nonconformity is defined as "non-fulfilment of a requirement". Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:
*Concession: permission to release or use a nonconforming product, service or process
*Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence
*Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation References: ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera
NEW QUESTION # 24
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
"The reject rate of the finished product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%." As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.
From the following nonconformities, select three that the auditor could raise to ISO 9001.
- A. 8.6 - Dirty products were released to the customer.
- B. 7.1.4 - The factory environment is not suitably maintained to prevent dirty products.
- C. 10.3 - The organisation did not continuously improve. Reject rates were unchanged.
- D. 7.3 - Staff were not aware that products were falling onto the factory floor.
- E. 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).
- F. 8.5.1 - Production operations were not properly controlled to avoid reject products.
- G. 7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.
- H. 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.
Answer: B,C,G
Explanation:
The auditor could raise the following nonconformities to ISO 9001 based on the scenario:
*Option A: 10.3 - The organisation did not continuously improve. Reject rates were unchanged. This option is correct because ISO 9001:2015 clause 10.3 requires the organization to improve the suitability, adequacy and effectiveness of the quality management system. The organization did not demonstrate any improvement in reducing the reject rate of the finished product, which was a stated objective of top management. The corrective action taken by the organization was not effective in addressing the root cause of the problem and preventing its recurrence.
*Option B: 7.1.4 - The factory environment is not suitably maintained to prevent dirty products. This option is correct because ISO 9001:2015 clause 7.1.4 requires the organization to determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
The organization did not ensure that the factory floor was clean and dry, which affected the quality of the products and increased the risk of nonconformity.
*Option C: 7.1.1 - The organization failed to provide the required resources to prevent nonconforming products. This option is correct because ISO 9001:2015 clause 7.1.1 requires the organization to determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. The organization did not provide adequate collection baskets for the products ejecting from the moulding machines, which resulted in products falling onto the factory floor and becoming nonconforming.
The following options are not correct:
*Option D: 9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3). This option is not correct because ISO 9001:2015 clause 9.2.2 does not specify the requirements for the wording of nonconformities in internal audit reports. The nonconformity (NC 3) stated by the internal auditor was clear and relevant to the audit criteria and audit evidence. The issue is not with the report, but with the corrective action taken by the organization.
*Option E: 8.6 - Dirty products were released to the customer. This option is not correct because ISO
9001:2015 clause 8.6 requires the organization to implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. The scenario does not indicate that the dirty products were released to the customer, but that they were recalled and repaired then returned to the customers. The issue is not with the release, but with the production process and the environment.
*Option F: 7.3 - Staff were not aware that products were falling onto the factory floor. This option is not correct because ISO 9001:2015 clause 7.3 requires the organization to ensure that the persons doing work under its control are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the quality management system, and the implications of not conforming with the quality management system requirements. The scenario does not indicate that the staff were not aware of these aspects, but that the management did not provide adequate resources and environment for the staff to perform their work. The issue is not with the awareness, but with the management responsibility and resource provision.
*Option G: 10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity. This option is not correct because ISO 9001:2015 clause 10.2.1 requires the organization to react to the nonconformity and, as applicable, take action to control and correct it and deal with the consequences. The scenario indicates that the Quality Manager conducted an investigation into the reject rates and identified the cause of the nonconformity. The issue is not with the investigation, but with the corrective action taken by the management.
*Option H: 8.5.1 - Production operations were not properly controlled to avoid reject products. This option is not correct because ISO 9001:2015 clause 8.5.1 requires the organization to implement production and service provision under controlled conditions. The scenario indicates that the production operations were controlled by the moulding machines, which ejected the products into the collection baskets. The issue is not with the production operations, but with the size of the collection baskets and the condition of the factory floor.
References:
*ISO 9001:2015 Quality management systems - Requirements
*ISO 9001 Lead Auditor Course Material, Module 6: Reporting Audit Findings, Slide 14: Writing Nonconformity Statements
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 6.2: Reporting Audit Findings
*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 # 25
You will lead a third-party audit next Monday on ABC, an organisation that provides services for cleaning windows from the outside of tall buildings. They work on demand, and usually have 4-5 orders per week. All documented information on these activities is kept at the central office.
On Friday evening, before the audit, you are informed by mail that customers cancelled all orders for the next week; therefore, the auditors will not have the chance to see them working at the customer's premises, but the field supervisors will be available at the ABC offices.
You have prepared the audit plan and the checklist. Choose the best action you would take:
- A. Ask the Certification Body you work for how to proceed with the audit.
- B. Complete the audit but ask the quality manager to clean some windows at the ABC's office, simulating the process they carry out at customers' premises.
- C. Start the audit on Monday as planned, interviewing the functions that regularly work at the central office, and visit another customer's premises they cleaned the week before.
- D. Start the audit on Monday at ABC's as planned, interviewing the functions that regularly work at the central office, and plan visits to ABC customers wherever they may be working during the following week.
Answer: A
Explanation:
According to ISO 19011:2018, clause 6.3.3, the audit plan should be reviewed and revised as necessary to address changes that occur during the audit planning. The audit plan should be agreed upon, preferably in writing, by the audit team leader, the audit client and the auditee1. Therefore, if there is a significant change in the auditee's situation, such as the cancellation of all orders for the next week, the audit plan should be reviewed and revised accordingly, with the agreement of all parties involved.
According to ISO/IEC 17021-1:2015, clause 9.1.4, the certification body should have a process to ensure that the audit team has the competence to achieve the audit objectives, and that the audit methods are appropriate for the scope and complexity of the audit. The certification body should also have a process to ensure that the audit is conducted under reasonable conditions and within a reasonable time frame2. Therefore, if there is a risk that the audit objectives cannot be achieved, or that the audit methods are not suitable, due to the change in the auditee's situation, the certification body should be consulted and informed on how to proceed with the audit.
Therefore, the best action to take is B, ask the certification body you work for how to proceed with the audit.
This action will ensure that the audit plan is revised and agreed upon by all parties, and that the audit team has the competence and the methods to conduct the audit effectively and efficiently. The other options are not correct, as they may compromise the quality and validity of the audit:
*A. Start the audit on Monday at ABC's as planned, interviewing the functions that regularly work at the central office, and plan visits to ABC customers wherever they may be working during the following week:
This action may not be feasible or acceptable, as it may extend the audit duration and cost beyond the agreed terms, and it may not provide sufficient and appropriate audit evidence to verify the conformity and effectiveness of the auditee's processes. Moreover, this action may not be agreed upon by the audit client and the auditee, and it may not be approved by the certification body.
*C. Start the audit on Monday as planned, interviewing the functions that regularly work at the central office, and visit another customer's premises they cleaned the week before: This action may not be relevant or reliable, as it may not reflect the current performance and condition of the auditee's processes. The audit evidence collected from the previous customer may not be valid or representative of the audit criteria, and it may not address the risks and opportunities associated with the auditee's context and objectives. Moreover, this action may not be agreed upon by the audit client and the auditee, and it may not be approved by the certification body.
*D. Complete the audit but ask the quality manager to clean some windows at the ABC's office, simulating the process they carry out at customers' premises: This action may not be objective or impartial, as it may introduce bias and influence in the audit process. The audit evidence collected from the simulated process may not be accurate or authentic, and it may not demonstrate the actual capability and effectiveness of the auditee's processes. Moreover, this action may not be ethical or professional, as it may compromise the integrity and credibility of the audit and the certification.
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 # 26
Which two of the following are included in the objectives of the 'Stage 1 initial certification audit'?
- A. To evaluate the preparedness of the organisation for a Stage 2 audit.
- B. To evaluate the performance of monitoring and reviewing activities.
- C. To evaluate the internal audit and management review processes.
- D. To make a decision on certification to ISO 9001:2015.
- E. To review the quality manual.
- F. To evaluate the operational processes of the organisation.
Answer: A,E
Explanation:
*To evaluate the preparedness of the organisation for a Stage 2 audit: This objective involves assessing the readiness of the organisation to undergo the Stage 2 audit, where the conformity and effectiveness of the quality management system will be verified123. The audit team will check the level of implementation and understanding of the quality management system, identify any major gaps or nonconformities, and confirm the audit scope, criteria, and plan123.
*To review the quality manual: This objective involves reviewing the documented information of the quality management system, such as the quality policy, the quality objectives, the scope, the processes, and the procedures, to ensure that they meet the requirements of ISO 9001:2015123. The audit team will also evaluate the organisation's understanding and application of the standard, and identify any areas of improvement or concern123.
The other options are not included in the objectives of the Stage 1 initial certification audit, according to the web search results from my internal tool. They may be related to other stages or types of audits, but they are not the focus of the Stage 1 audit.
Therefore, the correct answer is B and D.
References: 1: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified 2: Stage 1 of your Audit
| NQA Blog 3: Getting Certified to ISO 9001 - the Stage 1 Audit
NEW QUESTION # 27
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 # 28
Match the process descriptions below to the process names:
Answer:
Explanation:
Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
NEW QUESTION # 29
Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?
- A. Decreased number of nonconforming products in all stages of the manufacturing cycle
- B. Increased profits
- C. Decreased number of management system nonconformities
- D. Enhanced customer satisfaction
- E. Decreased number of warranty claims
- F. Consistently provide products that meet customers' requirements
Answer: D,F
Explanation:
According to the ISO 9001:2015 document, the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are:
*the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
*the enhancement of customer satisfaction.
These results are derived from the quality management principles of customer focus and process approach, which are the basis of the ISO 9000 family of standards1. Customer focus means understanding and meeting customer needs and expectations, as well as exceeding them when possible1. Process approach means managing activities as interrelated processes that function as a coherent system, which leads to consistent and predictable results1.
Therefore, the correct answer is C and F.
References: 2: ISO 9001:2015 - Quality management systems - Requirements 1: ISO - Quality management principles
NEW QUESTION # 30
The following are stages of an audit, put them in the order they would be conducted.
Answer:
Explanation:
Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each stage:
Establishing the audit programme objectives: This is the first stage of the audit process, where the purpose, scope, and criteria of the audit programme are defined. The audit programme objectives should be aligned with the strategic direction and policies of the organization, and should address the needs and expectations of the interested parties12.
Determining and evaluating the audit programme risks and opportunities: This is the second stage of the audit process, where the factors that can affect the achievement of the audit programme objectives are identified and assessed. The audit programme risks and opportunities should consider the internal and external issues, the requirements and changes of the interested parties, and the results and feedback from previous audits12.
Establishing the audit programme: This is the third stage of the audit process, where the audit programme is designed and implemented. The audit programme should include the audit programme procedures, the audit programme resources, the audit methods and techniques, the audit frequency and schedule, and the audit programme performance indicators12.
Initiating the audit: This is the fourth stage of the audit process, where the audit is prepared and planned. The audit initiation involves selecting the audit team, establishing the contact with the auditee, defining the audit objectives, scope, and criteria, developing the audit plan, and conducting the document review123.
Preparing all audit activity: This is the fifth stage of the audit process, where the audit activities are organized and coordinated. The audit preparation involves assigning the audit tasks, communicating with the auditee and the audit team, arranging the logistics, preparing the working documents, and conducting the opening meeting123.
Conducting the audit activities: This is the sixth and final stage of the audit process, where the audit evidence is collected and evaluated. The audit conduct involves performing the audit activities, such as interviews, observations, document reviews, and tests, documenting the audit findings, preparing the audit conclusions, and conducting the closing meeting123.
I hope this helps you with your ISO 9001 Lead Auditor objectives and content. If you have any further questions, please feel free to ask.
References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Process | Flowchart | Summary - Accountinguide 3: What are the Stages of the Auditing Process & Why it is Important ...
NEW QUESTION # 31
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8 extract
Four of the 10 pallets of stock sampled in the warehouse were not labelled.
"8.5.2 ... shall use suitable means to identify outputs ..."
A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.
"8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..." One of the fork-lift truck drivers had no fork-lift truck driving licence.
"8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..." There was no pest control provision in the warehouse.
"8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.
"8.1 ... shall plan, implement and control the processes ..."
NEW QUESTION # 32
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 minor non-conformity is raised.
- B. A recommendation is given in the report.
- C. An opportunity for improvement is raised.
- D. A finding of conformity is reported.
- E. A finding of good practice is reported.
- F. A major non-conformity is raised.
Answer: A,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
NEW QUESTION # 33
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.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."
NEW QUESTION # 34
An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
"The reject rate of 'finished' product of 9.7% needs improvement as it doesn't meet the stated objective of top management of 5%." Just before the Closing meeting of a third-party audit, the audit team leader is invited to a meeting with the Quality Manager. He tells the audit team leader that a member of the audit team was seen taking photographs of the factory on his phone during the day and wants him suspended from the Closing meeting with any nonconformities raised by him rescinded. The issue of photographs was not discussed during the opening meeting.
Select the three options for how the audit team leader might deal with this situation.
- A. Delay the Closing meeting until the audit team leader has consulted his audit programme manager at Head Office
- B. State that the auditor will take no further part in the audit and all his photographs will be deleted
- C. Advise the Quality Manager that the auditor will be reported to Head Office
- D. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done
- E. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered
- F. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting
Answer: B,D,E
Explanation:
The audit team leader should deal with this situation in a professional and ethical manner, while maintaining the integrity and credibility of the audit process and the audit findings. The audit team leader should also try to resolve the conflict with the Quality Manager in a constructive and respectful way, without compromising the audit objectives or the audit team's independence and impartiality. According to the ISO 9001 Lead Auditor Reference Materials guides and documents, the possible actions that the audit team leader might take are:
*A. Insist that the nonconformities must stand since they have been agreed by the team from other evidence gathered. This action is consistent with the principle of evidence-based approach, which states that the audit team should collect and verify information that is appropriate, sufficient, and reliable to support the audit findings and conclusions. The audit team leader should explain to the Quality Manager that the nonconformities are not based solely on the photographs, but on other audit evidence that corroborates them.
The audit team leader should also remind the Quality Manager that the nonconformities are subject to review and approval by the certification body, and that any attempt to influence or interfere with the audit results would be considered a breach of the audit agreement and the certification rules.
*D. State that the auditor will take no further part in the audit and all his photographs will be deleted. This action is consistent with the principle of confidentiality, which states that the audit team should exercise discretion in the use and protection of information acquired during the audit. The audit team leader should acknowledge that the auditor's behavior was inappropriate and unprofessional, and that he violated the audit rules and the auditee's rights. The audit team leader should apologize for the inconvenience and the discomfort caused by the auditor, and assure the Quality Manager that the auditor will be removed from the audit team and that his photographs will be erased from his phone and any other device or media. The audit team leader should also inform the auditor of his misconduct and the consequences, and report the incident to the audit program manager and the certification body.
*F. Advise the Quality Manager that he, as audit team leader, needs to speak to the auditor about the situation and he will report back to the Quality Manager once this is done. This action is consistent with the principle of communication, which states that the audit team should exchange information with the auditee in a timely, open, honest, and respectful manner. The audit team leader should express his concern and his willingness to address the issue with the auditor, and ask for the Quality Manager's patience and cooperation. The audit team leader should also explain that the audit process is not finished yet, and that the Closing meeting is an opportunity to present and discuss the audit findings and conclusions, and to seek feedback and clarification from the auditee. The audit team leader should then speak to the auditor privately, and follow the steps described in action D.
The other options are not appropriate or effective ways to deal with this situation, because they either:
*B. Delay the Closing meeting until the audit team leader has consulted his audit program manager at Head Office. This action would disrupt the audit schedule and the audit plan, and create unnecessary delays and costs for both the audit team and the auditee. It would also show a lack of leadership and decision-making skills from the audit team leader, and undermine his authority and credibility. The audit team leader should be able to handle the situation on site, and consult his audit program manager only if the situation escalates or becomes unmanageable.
*C. Advise the Quality Manager that the auditor will be reported to Head Office. This action would escalate the conflict and create a hostile and defensive atmosphere between the audit team and the auditee. It would also imply that the audit team leader is not capable or willing to resolve the issue himself, and that he is threatening or punishing the auditee for raising a legitimate concern. The audit team leader should try to defuse the tension and restore the trust and the rapport with the Quality Manager, and report the auditor to Head Office only after the audit is completed and the audit report is submitted.
*E. Apologise for the situation and ensure the Quality Manager that all photographs will be deleted during the Closing meeting. This action would not address the root cause of the problem, and would not prevent the auditor from taking more photographs or using them for other purposes. It would also expose the audit team and the auditee to unnecessary risks and liabilities, and compromise the confidentiality and the security of the audit information. The audit team leader should delete the photographs as soon as possible, and not wait until the Closing meeting.
References: ISO 9001:2015, ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor, Common Audit Problems and How to Deal with Them, The Auditor's Guide to Conflict Resolution, Conflict Resolution in your Audit Career, How to Be a Good Auditor as a Team Leader
NEW QUESTION # 35
Below are four of the seven principles on which ISO 9000 series are based. Match a potential benefit to each of the quality management principles (QMP).
Answer:
Explanation:
Explanation:
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According to the ISO 9000:2015 document, the seven quality management principles are:
Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management
For each principle, the document provides a statement, a rationale, key benefits, and actions you can take to apply the principle in your organization.
Based on the document, here is a possible way to match a potential benefit to each of the four quality management principles you mentioned:
Table
Quality management principle
Potential benefit
Customer focus
Increased revenue and market share
Engagement of people
Enhanced trust and collaboration throughout the organization
Improvement
Enhanced drive for innovation
Evidence-based decision making
Increased ability to demonstrate effectiveness of past actions
NEW QUESTION # 36
Select the term that best describes the purpose of retaining documented information in a quality management system to ISO 9001.
- A. To support the operation of the processes of the quality management system.
- B. To safeguard the integrity of the quality management system.
- C. To provide confidence in the effectiveness of the quality management system.
- D. To facilitate auditing for proof of conformity to the standard.
Answer: A
Explanation:
Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information.
References: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store
NEW QUESTION # 37
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