UPDATED [May 21, 2024] Pass QMS ISO 9001:2015 Lead Auditor Exam Exam with Latest Questions
ISO-9001-Lead-Auditor Exam Practice Questions prepared by PECB Professionals
NEW QUESTION # 17
During a second-party audit, the auditor examines the records that are available for the external provider, ABC Forgings, to whom manufacturing has recently been outsourced.
There are standard external provider checklists for three competitors for the contract and there are inspection records from the trial manufacturing batches produced by ABC Forgings. There is no documented evidence of the criteria used to confirm the appointment of ABC Forgings, and no contract or terms and conditions.
Ongoing monitoring indicates that external provider performance is satisfactory, but no documented information has been retained.
Select two options for the evidence which demonstrates a nonconformity with clause 8.4 of ISO 9001.
- A. The auditee trusted the external provider because of a long-standing relationship with them.
- B. There was no documentation which provided evidence of any monitoring of the external provider.
- C. The auditee required the outsourced products on an urgent basis before the completion of the paperwork.
- D. There were no receipt inspection records of the incoming materials.
- E. The external provider asked for the contract details to be verbal only.
- F. The auditee did not retain documentation on the selection and evaluation of the external provider.
Answer: B,F
Explanation:
According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
*Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently.
*Evaluate the potential external providers before selecting them, using the established criteria. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed.
*Select the external providers that have demonstrated their competence and conformity to the requirements.
The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved.
*Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely.
*Monitor the performance and conformity of the external provider, using the established criteria and methods.
The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed.
In this case, the evidence statements that demonstrate a nonconformity with clause 8.4 are A and C, because they show that the organization did not retain documented information of the selection and evaluation of the external provider, and the monitoring of the external provider's performance. These are requirements of the standard and essential for ensuring the quality of the externally provided processes, products, and services.
The other options are not directly related to clause 8.4, although they may indicate other nonconformities or weaknesses in the organization's QMS. For example, option B may relate to clause 7.1.3 on contingency planning, option D may relate to clause 8.2.3 on review of requirements, option E may relate to clause 8.6 on release of products and services, and option F may relate to clause 5.1.1 on leadership and commitment.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems
NEW QUESTION # 18
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 warranty claims
- B. Decreased number of management system nonconformities
- C. Increased profits
- D. Enhanced customer satisfaction
- E. Consistently provide products that meet customers' requirements
- F. Decreased number of nonconforming products in all stages of the manufacturing cycle
Answer: D,E
Explanation:
The key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are stated in clause 0.1 of the standard, which says: "The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements." Therefore, the two options that best match these benefits are A and E, as they directly relate to providing products and services that meet customer requirements and enhancing customer satisfaction. The other options are not explicitly mentioned as key expected results, although they may be possible outcomes of implementing a quality management system. References: ISO 9001:2015 - Quality management systems - Requirements, Key Elements of an ISO 9001:2015 Quality Management System, What is ISO 9001 2015 as a Quality Management Systems?
NEW QUESTION # 19
You work as an external quality consultant for an organisation, 'A', which provides packaged food to the public. You are asked to lead a team (you as the leader and two other auditors) to audit a supplier, 'B', to ISO
9001 which provides packaging materials to your organisation. It is 4 pm and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the Closing meeting. The Closing meeting was scheduled at 5 pm.
You, as Audit Team Leader, audited top management. You explain to the audit team that you identified two nonconformities:
a. There is no documented information on Top Management Reviews, as required in clause 9.3 of ISO
9001:2015.
b. There is no evidence of Top Management Commitment as required in clause 5.1 of ISO 9001:2015. (e.g., not ensuring the availability of resources to operate the QMS, not ensuring the establishment of objectives, no promotion of improvement, no promotion of the process approach).
All agreed to present these two nonconformities. They went to meet the Top Management of 'B' and noticed that the General Manager and three other managers (Production, Human Resources, and Sales) were present in the meeting room.
Considering the seriousness of the two nonconformities to Top Management, as audit team leader, from the following select the best option:
- A. Present the nonconformities to the managers, inform them that the report will be sent within 10 days, close the meeting and leave the site.
- B. Present the nonconformities to the whole group and analyse with them how to overcome this situation.
- C. Ask the General Manager to have a private conversation in which you present the nonconformities only to him because of their sensitive nature.
- D. Present the nonconformities to the whole group and inform that you will recommend your company to remove them from the approved suppliers list.
Answer: B
Explanation:
According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee's context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.
NEW QUESTION # 20
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.
- A. Correction
- B. Preventive action
- C. Concession
- D. Corrective action
Answer: A
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 # 21
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 # 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
Who would be defined as a witness during a witness audit?
Choose two of the following options:
- A. An assessor for the accreditation body
- B. An auditor
- C. Someone with a qualification from the certification body
- D. An existing member of the audit team
Answer: A,B
Explanation:
Comprehensive and Detailed Explanation: = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3. During a witness audit, the following roles can be defined:
*An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.
*An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor's performance and competence, and for providing feedback and recommendations to the accreditation body123.
The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool. They are:
*Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.
*An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.
Therefore, the correct answer is B and D.
References: 1: DQS Inc. | Witness Audits | Auditor Training 2: Have you ever been involved with a witness audit? - IFSQN 3: Certac - Witness Audit of Certification Bodies 4: ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 24
You work for organisation A. You are asked to lead an internal audit of A's quality management system. It has a head office in Plant A1 and a second Plant A2 nearby. Due to the COVID-19 pandemic, production in A2 was discontinued and it was rented to a logistics organisation B, not related to A. There are no A employees working in A2. Organisation A expects to reassume production in A2 as soon as possible.
Which of the following actions would you consider appropriate when planning the internal audit of A's quality management system?
- A. Visit Plant A2 to interview B's quality manager
- B. Interview the A2 plant manager, now working in Plant A1
- C. Visit Plant A2 to interview personnel of company B
- D. Visit Plant A2 to interview A's security personnel and B's maintenance department
Answer: B
Explanation:
In this scenario, the organisation A has two plants, A1 and A2, but the production in A2 was discontinued due to the COVID-19 pandemic and the plant was rented to another organisation B. There are no A employees working in A2, and the organisation A expects to reassume production in A2 as soon as possible. Therefore, the appropriate action to plan the internal audit of A's quality management system is:
*Interview the A2 plant manager, now working in Plant A1: This action involves interviewing the person who is responsible for the management and operation of the plant A2, and who is currently working in the plant A1. The interview should aim to gather information about the status and condition of the plant A2, the impact of the COVID-19 pandemic on the quality management system, the arrangements and agreements with the organisation B, and the plans and actions to resume production in the plant A25 . This action is relevant and necessary for the internal audit, as it can help to assess the readiness and effectiveness of the quality management system, and to identify any gaps or nonconformities that need to be addressed.
The other options are not appropriate actions to plan the internal audit of A's quality management system, according to the web search results from my internal tool. They are:
*Visit Plant A2 to interview personnel of company B: This action involves visiting the plant A2 and interviewing the personnel of the organisation B, who are not related to the organisation A and who are not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview B's quality manager: This action involves visiting the plant A2 and interviewing the quality manager of the organisation B, who is not related to the organisation A and who is not part of the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
*Visit Plant A2 to interview A's security personnel and B's maintenance department: This action involves visiting the plant A2 and interviewing the security personnel of the organisation A and the maintenance department of the organisation B, who are not directly involved in the quality management system. This action is irrelevant and unnecessary for the internal audit, as it can not provide any evidence or information about the conformity and improvement of the quality management system of the organisation A5 .
Therefore, the correct answer is D.
References: 1: Quality audit - Wikipedia 2: A step-by-step guide to internal quality audits 3: ISO 9001:2015 - Quality management systems - Requirements 4: ISO 19011:2018 - Guidelines for auditing management systems 5: Audit Process | Flowchart | Summary - Accountinguide : What are the Stages of the Auditing Process & Why it is Important ...
NEW QUESTION # 25
Select one option that must be considered when determining the scope of a QMS to ISO 9001.
- A. External issues of the organisation's context
- B. Competence of top management
- C. Business improvement
- D. Performance of business processes
Answer: A
Explanation:
According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.
Therefore, the correct answer is C, as external issues of the organization's context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 4.1 and 4.3 ISO 9001:2015 - How to determine the scope of your QMS - Advisera, section "Considerations for determining the scope of the QMS in ISO 9001" ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 4
NEW QUESTION # 26
In the context of a third-party certification audit, match the roles with the following responsibilities:
Answer:
Explanation:
Explanation:
In the context of a third-party certification audit, match the roles with the following responsibilities:
Responsibilities:
Conduct the audit to the assigned area.= Auditors
Assist the auditors in identifying personnel to participate in the audit.= Guide Assign each team member's responsibility for the audit.= Audit team leader Respond to questions and provide evidence to the auditor.= Auditee According to ISO 19011:2018, clause 3, the definitions of the roles are as follows1:
Auditors: persons with the competence to conduct an audit
Guide: person appointed by the auditee to assist the audit team
Auditee: organization being audited
Audit team leader: member of an audit team appointed to manage the audit or an audit team Therefore, the roles can be matched to the responsibilities based on these definitions and the description of the audit process in clause 6 of the standard1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 27
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 # 28
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 provide confidence in the effectiveness of the quality management system.
- C. To safeguard the integrity 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 # 29
Which of the following two documents does an auditor need to prepare and complete prior to the on-site audit?
- A. Audit Plan
- B. Risk Matrices
- C. Findings
- D. Audit Report
- E. Procedures
- F. Checklist / Prompts
Answer: A,F
Explanation:
According to ISO 19011:2018, clause 6.3, the audit plan is a document that provides the basis for agreement regarding the conduct of the audit. The audit plan should include the information listed in my previous response, such as the audit objectives, scope, criteria, schedule, team, methods, report, etc. The audit plan should be prepared and completed prior to the on-site audit, and should be communicated to the audit team and the auditee1.
According to ISO 19011:2018, clause 6.4.3, the checklist / prompts are documents that list the questions or topics that need to be covered during an audit. The checklist / prompts can help the auditor to collect and verify information relevant to the audit criteria, and to ensure the consistency and completeness of the audit.
The checklist / prompts should be prepared and completed prior to the on-site audit, and should be based on the audit plan and the audit scope and objectives1.
Therefore, the two documents that an auditor needs to prepare and complete prior to the on-site audit are B and D, as they are essential for planning and conducting the audit. The other options are not correct, as they are either prepared or completed after the on-site audit, or not required by the standard:
*A. Audit Report: The audit report is a document that provides a complete, accurate, concise, and clear record of the audit. The audit report should include the information listed in my previous response, such as the audit objectives, scope, criteria, findings, conclusions, etc. The audit report should be prepared and completed after the on-site audit, and should be distributed to the audit client and the auditee1.
*C. Procedures: Procedures are documents that specify the way activities are to be performed. Procedures may be part of the audit criteria, if they are part of the organization's management system, or part of the audit programme, if they are part of the certification body's or registrar's requirements. Procedures are not prepared or completed by the auditor prior to the on-site audit, but rather reviewed or followed by the auditor during the audit1.
*E. Risk Matrices: Risk matrices are tools that help to assess and prioritize the risks and opportunities associated with the audit programme or the audit. Risk matrices may be part of the audit programme management, if they are used to determine and evaluate the audit programme risks and opportunities, or part of the audit preparation, if they are used to determine and evaluate the audit risks and opportunities. Risk matrices are not prepared or completed by the auditor prior to the on-site audit, but rather used or updated by the auditor during the audit programme management or the audit preparation1.
*F. Findings: Findings are the results of the evaluation of the collected audit evidence against the audit criteria.
Findings can indicate either conformity or nonconformity, as well as positive aspects or opportunities for improvement. Findings are not prepared or completed by the auditor prior to the on-site audit, but rather generated and recorded by the auditor during the audit activities1.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 30
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 # 31
A Health Trust has contracted with Servitup, a catering services organisation which has been certified to ISO
9001 for 1 year. It provides services to ten, small rural
hospitals in remote locations involving purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. An auditor is conducting the first sole surveillance audit at one site with the Deputy Catering Manager (DCM).
At the closing meeting attended solely by the DCM, the auditor informs him that he has found numerous gaps in the QMS processes which lead him to consider recommending suspension of the organisation's certification. He is particularly concerned with the evidence that patient health is being adversely affected by produce stored beyond its safe consumption date, poor kitchen hygiene and undercooked meals. The DCM says that he cannot make any decisions about these issues in the absence of the Catering Manager due to illness but will write everything down and report to the Catering Manager.
Which two actions should you take in the context of the audit?
- A. Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit.
- B. Recommend that all personnel should be given urgent in-depth training in the QMS.
- C. Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work.
- D. Thank the DCM for his time and express an expectation that improvements will be made in the QMS.
- E. Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body.
- F. Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course.
Answer: E,F
Explanation:
The actions that should be taken in the context of the audit are:
*Option B: Call the individual(s) managing the audit programme to explain the situation and recommend immediate suspension of certification to protect the integrity of the Certification Body. This option is correct because the auditor has found serious and significant gaps in the QMS processes that affect the health and safety of the patients, which is a major nonconformity that may warrant suspension of certification. The auditor should inform the individual(s) managing the audit programme of the situation and the audit findings, and recommend immediate suspension of certification to protect the integrity of the Certification Body and the credibility of the certification scheme. The auditor should also follow the Certification Body's procedures and rules for suspension of certification and communicate the decision and the consequences to the auditee.
*Option C: Continue with the meeting, present the audit conclusions and inform the DCM that the organisation will receive the audit report in due course. This option is correct because the auditor should not terminate or postpone the closing meeting due to the absence of the Catering Manager, as the DCM is the auditee's nominated representative for the audit. The auditor should continue with the meeting, present the audit conclusions and the audit findings, and inform the DCM that the organisation will receive the audit report in due course. The auditor should also explain the audit outcome recommendation and the suspension of certification, and request the DCM to acknowledge the receipt and understanding of the audit results.
The following options are not correct:
*Option A: Close the meeting immediately after the DCM's response and advise that the issues will be addressed at the next surveillance visit. This option is not correct because the auditor should not close the meeting without presenting the audit conclusions and the audit findings, as this would violate the audit principles of fairness and transparency. The auditor should also not advise that the issues will be addressed at the next surveillance visit, as this would imply that the auditor is accepting the auditee's delay and inaction, and that the auditor is not taking the major nonconformity seriously.
*Option D: Conclude the meeting early and advise that it will be rescheduled once the Catering Manager has returned to work. This option is not correct because the auditor should not conclude the meeting early or reschedule it due to the absence of the Catering Manager, as this would disrupt the audit process and the audit schedule. The auditor should also not wait for the Catering Manager to return to work, as this would delay the communication and resolution of the major nonconformity, and potentially compromise the health and safety of the patients.
*Option E: Recommend that all personnel should be given urgent in-depth training in the QMS. This option is not correct because the auditor should not recommend or prescribe specific corrective actions to the auditee, as this would violate the audit principles of independence and objectivity. The auditor should only report the audit findings and the audit outcome recommendation, and leave the responsibility and authority for determining and implementing the corrective actions to the auditee.
*Option F: Thank the DCM for his time and express an expectation that improvements will be made in the QMS. This option is not correct because the auditor should not thank the DCM for his time and express an expectation that improvements will be made in the QMS, as this would imply that the auditor is satisfied and optimistic with the auditee's performance and response, and that the auditor is not taking the major nonconformity seriously. The auditor should instead express the concern and dissatisfaction with the auditee's QMS processes and the impact on the health and safety of the patients, and communicate the suspension of certification and the need for urgent and effective corrective actions.
References:
*ISO 19011:2018 Guidelines for auditing management systems, Clause 6.4.2: Conducting audit activities, Subclause k) and l)
*ISO 9001 Lead Auditor Course Material, Module 5: Conducting an Audit, Slide 20: Closing Meeting
*ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 5.5: Closing Meeting
*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 # 32
Which two of the following auditors would not participate in a first-party audit?
- A. An auditor employed by an external consultancy organisation
- B. An auditor certified by IRCA
- C. An auditor from an interested party
- D. An auditor from a customer
- E. An auditor trained in-house
- F. An auditor trained in the IRCA scheme
Answer: A,D
Explanation:
A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited1. The purpose of a first-party audit is to assess the conformity of the organization's quality management system to the requirements of ISO 9001 and to identify opportunities for improvement2. Therefore, the two auditors who would not participate in a first-party audit are:
*A. An auditor employed by an external consultancy organization: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit (if the external consultancy organization is a customer or supplier of the organization being audited) or a third-party audit (if the external consultancy organization is a certification body or registrar).
*F. An auditor from a customer: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit, as a customer is an interested party that has specific requirements for the organization being audited.
The other options are not correct, as they could participate in a first-party audit, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited:
*B. An auditor from an interested party: This auditor could be a first-party auditor, as long as the interested party is within the organization being audited. For example, an auditor from the finance department could audit the production department, as long as they are not involved in the production process or affected by its outcomes.
*C. An auditor trained in-house: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The source of the auditor's training is not relevant for determining the type of audit, as long as the auditor is competent and qualified to perform the audit.
*D. An auditor trained in the IRCA scheme: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The IRCA scheme is a professional certification scheme for auditors of management systems, which provides recognition of the auditor's competence and credibility3. However, being trained in the IRCA scheme does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
*E. An auditor certified by IRCA: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. Being certified by IRCA means that the auditor has met the requirements of the IRCA scheme and has demonstrated their competence and credibility as an auditor of management systems3. However, being certified by IRCA does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
References: First Party Audits: The 5 Steps to Success - Sync Resource Inc, ISO 9001 Auditing Practices Group, IRCA - International Register of Certificated Auditors
NEW QUESTION # 33
Select the word that best completes the sentence:
Answer:
Explanation:
Explanation:
According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.
Therefore, the complete sentence is:
"The purpose of a management system standard is to improve the performance of an organisation."
NEW QUESTION # 34
You are carrying out an audit to ISO 9001 at an organisation which offers regulatory consultancy services to manufacturers of cosmetics.
You are interviewing the Technical Director (TD), who manages a team of regulatory experts responsible for providing regulatory services to customers.
You: "How do you ensure your regulatory team's competence concerning regulatory requirements is maintained?" TD: "The two Regulatory Experts we employ full-time have years of experience of working in the cosmetics industry." You: "How is their regulatory competence maintained?" TD: "They are dedicated individuals with lots of contacts in the sector." You: "How does the business enable them to maintain their understanding of current regulatory requirements?" TD: "We leave that up to them."
Answer:
Explanation:
Explanation:
A screenshot of a computer Description automatically generated
NEW QUESTION # 35
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?
- A. Quality objectives are not maintained as documented information.
- B. Quality objectives were not established in alignment with the organisation's quality policy.
- C. The consultant has not interpreted ISO 9001 correctly.
- D. The organisation cannot afford to undertake quality objectives all at once.
- E. Establishing quality objectives did not include top management.
- F. Quality objectives are not being implemented by the organisations' personnel.
Answer: A,B
Explanation:
According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.
The organization is also required to maintain documented information on the quality objectives, as per clause
7.5.1.
Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization's quality policy, as they are based on those of a competitor, rather than the organization's own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization's vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.
Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 6.2.1 and 7.5.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
NEW QUESTION # 36
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?
- A. Verifies the degrees of customer satisfaction
- B. Evaluates the conditions of all sites
- C. During the Stage 1 audit, the audit team:
- D. Evaluates the results of the last management review
- E. Reviews the client's management system documented information
- F. Reviews the processes with high level of risk
- G. Verifies the compliance with legal requirements
Answer: E,F
Explanation:
* Reviews the client's management system documented information: This activity involves checking the documentation 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 also evaluates the client's understanding and implementation of the standard, and identifies any gaps or nonconformities that need to be addressed before the Stage 2 audit123.
*Reviews the processes with high level of risk: This activity involves assessing the processes that have a significant impact on the quality of the products or services, or that pose a high risk of nonconformity or customer dissatisfaction123. The audit team also verifies the client's risk management approach, and evaluates the effectiveness of the controls and actions taken to mitigate the risks123.
The other options are not statements that are true for the Stage 1 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 D and G.
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 # 37
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. Operational planning activities may benefit from a clearer risk-based approach.
- B. A business consultant can be recommended for advice on improving operations.
- C. The responsibility for checking printing needs to be independent of the operators.
- D. A plan to determine why the errors occur and to prevent them.
- E. More process time needs to be allocated to the new employees.
- F. An intensive training plan that involves all production personnel.
- G. The recruitment process to include spelling tests to filter out unsuitable candidates.
- H. The organisation needs to delay its certification to gain more experience of the QMS.
Answer: A,C,D
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 # 38
Which two of the following aspects of a quality management system must the organisation continually improve?
- A. Effectiveness
- B. Adaptability
- C. Applicability
- D. Efficiency
- E. Suitability
- F. Responsiveness
Answer: A,D
Explanation:
According to the ISO 9001:2015 document, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system1. However, among the six options given, only effectiveness is directly mentioned as an aspect of the quality management system that must be continually improved. Therefore, C is one of the correct answers.
Efficiency, on the other hand, is not explicitly stated as an aspect of the quality management system that must be continually improved, but it is implied by the quality management principle of improvement, which states that successful organisations have an ongoing focus on improvement2. One of the key benefits of applying this principle is improving operational effectiveness and efficiency2. Therefore, E is another correct answer.
Suitability, adaptability, responsiveness, and applicability are not aspects of the quality management system that must be continually improved, according to the ISO 9001:2015 document. They may be related to the quality management system, but they are not the focus of continual improvement.
Therefore, the correct answer is C and E.
References: 1: ISO 9001:2015 - Quality management systems - Requirements 2: ISO - Quality management principles
NEW QUESTION # 39
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