ISO-9001-Lead-Auditor Questions and Answers

The action that the auditor would have accepted is:

•Option B: Apply the existing process of addressing the risks and opportunities of milk production. This option is correct because ISO 9001:2015 clause 8.1 requires the organization to plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement actions determined in clause 6.1, which refers to the actions to address risks and opportunities. The organization should apply the existing process of addressing the risks and opportunities of milk production, which may include identifying the sources of variability, assessing the potential impacts and consequences, determining and implementing appropriate actions to reduce or eliminate the variability, monitoring and measuring the effectiveness of the actions, and reviewing and updating the actions as necessary.

The following options are not correct:

•Option A: Modify the contract with the current customer to provide them with only 1,500 litres of milk per day and make an agreement with a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option C: Retain the current contract and try to sell the occasional surplus milk to a second customer. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to meet the customer and applicable statutory and regulatory requirements, as required by ISO 9001:2015 clause 8.2.2.

•Option D: Analyse the daily dispatch of milk for 7 days to determine its variability. This option is not correct because it does not address the root cause of the variability in the daily production of the milking yard, which may affect the quality and consistency of the products and services provided by the organization. It also does not demonstrate the organization’s commitment to implement actions to address risks and opportunities, as required by ISO 9001:2015 clause 8.1.

References:

•ISO 9001:2015 Quality management systems - Requirements, Clause 8: Operation, Subclause 8.1: Operational planning and control, Subclause 8.2: Requirements for products and services

•ISO 9001 Lead Auditor Course Material, Module 4: ISO 9001:2015 Requirements, Slide 23: Clause 8 - Operation

•ISO 9001 Lead Auditor Training Course - IRCA Certified, Section 4.2: ISO 9001:2015 Requirements, Subsection 4.2.8: Clause 8 - Operation

•Lead Auditor Exam Preparation Guide (EPG) Template - PECB, Section 3.2: Exam Content Outline, Subsection 3.2.1: Section 1 - Audit Fundamentals, Subsection 3.2.2: Section 2 - Audit Principles, Subsection 3.2.3: Section 3 - Audit Process, Subsection 3.2.4: Section 4 - Audit Competencies

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 …

Here is the correct matching of actions to the statements in the context of leading the internal audit:

If practicablecarry out a formal opening meeting

You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)

You need notchange the audit team (unless there is a specific reason, such as conflict of interest)

You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)

You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)

You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals)

This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.

 Responsibilities of the Audit Team Leader:ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:2015, specifies the responsibilities of an audit team leader. These responsibilities include:

Planning the audit and establishing effective communication between the audit team and auditee.

Ensuring that formal communication channels are agreed upon and followed.

Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.

Managing the audit team and ensuring adherence to the defined objectives and scope.

 Analysis of Options:

A. Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.

B. Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process.

C. Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.

D. Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.

 Why Option A is Correct:The audit team leader does not have any obligation to report unattainable objectives to the accreditation body. Instead, they are responsible for communicating issues to the audit client (typically the certification body). The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.

 Relevant References:

ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client.

ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.

In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee’s request. The two best responses allow for flexibility without compromising the audit's rigor:

A. I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.

C. I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.

The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns​.

According to ISO 19011:2018, clause 3.2, audit criteria are a set of policies, procedures or requirements used as a reference against which objective evidence is compared. Audit criteria are usually selected by the audit client or by agreement between the audit client and the auditee, and they should be appropriate for the audit scope and objectives1. Audit criteria may include, but are not limited to, the following sources2:

•ISO management system standards, such as ISO 9001, ISO 14001, ISO 45001, etc.

•Verbal statements by the general manager or other top management, as long as they are consistent with the documented policies and objectives of the organisation

•Verbal agreements with interested parties, such as customers, suppliers, regulators, etc., as long as they are documented and approved by the relevant authorities

•Health and safety notices, such as posters, signs, labels, etc., that communicate the organisation’s legal obligations, policies, or procedures

•Written agreements with interested parties, such as contracts, orders, specifications, etc., that define the requirements and expectations of the parties involved

•Organisation’s documented information, such as policies, procedures, manuals, records, etc., that describe the organisation’s management system and its processes

•Commitment to follow principles issued by an NGO, such as the United Nations Global Compact, the International Labour Organization, etc., as long as they are relevant to the organisation’s context and objectives

•Environmental aspects register, such as a list of the environmental impacts and risks associated with the organisation’s activities, products, and services

Therefore, the two options that are not potential audit criteria are F and H, as they are not reliable or verifiable sources of information, and they may not reflect the actual performance or conformity of the organisation’s management system. Commercial advertisements and claims made on the organisation’s website are forms of marketing communication that may be exaggerated, misleading, or inaccurate, and they are not subject to the same level of scrutiny or approval as the other sources of audit criteria.

References: ISO 19011:2018(en), Guidelines for auditing management systems, What are audit criteria? - ISO Update

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

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

A white background with black text Description automatically generated

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

In the context of ISO 9001:2015 audits, it is the audit team leader who holds the responsibility for assigning work to the audit team. According to ISO 19011:2018 (Guidelines for auditing management systems, which complements ISO 9001:2015), the audit team leader is responsible for the organization and direction of the audit, including assigning specific roles and responsibilities to audit team members. This includes preparation of the audit plan, leading the audit, and ensuring that each team member understands their tasks.

According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:

Understand the requirements of ISO 9001 and how they relate to the audit

Understand the organization’s quality management system and its processes

Understand the applicable legal, regulatory, contractual and other requirements that affect the audit

Understand the needs and expectations of interested parties other than customers

Plan and conduct audits in accordance with ISO 19011

Evaluate audit evidence and draw appropriate conclusions

Communicate audit findings effectively1

Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.

References:

ISO 9001:2015 - Quality management systems — Requirements

ISO 19011:2018 - Guidelines for auditing management systems

Identifying the source of information

Sampling available data

Gathering audit evidence

Verifying objective evidence

Evaluating evidence against the audit criteria

Making audit conclusions

Evaluating against the audit criteria

According to ISO 19011:2018, clause 6.4, the process of collecting and verifying information during an audit involves the following steps1:

Identifying the source of information: The audit team should identify the sources of information that are relevant to the audit objectives, scope and criteria. These sources may include documents, records, personnel, processes, activities, facilities, equipment, etc. The audit team should also determine the methods and tools for accessing and collecting the information, such as interviews, observations, document review, sampling, etc.

Sampling available data: The audit team should select a representative sample of the available data to verify the conformity and effectiveness of the management system. The sample size and selection method should be based on the audit objectives, scope and criteria, as well as the level of confidence and risk. The audit team should also consider the validity, reliability, relevance and sufficiency of the data.

Gathering audit evidence: The audit team should use the methods and tools identified in the previous step to collect audit evidence, which is the records, statements of fact or other information that are relevant to the audit criteria and verifiable. The audit team should record the audit evidence in a clear, concise and objective manner, using notes, checklists, photographs, audio or video recordings, etc.

Verifying objective evidence: The audit team should verify the accuracy, completeness and authenticity of the audit evidence collected. This may involve cross-checking different sources of information, confirming the identity and authority of the persons providing the information, examining the original documents or records, etc. The audit team should also identify any discrepancies, inconsistencies or gaps in the audit evidence.

Evaluating evidence against the audit criteria: The audit team should compare the audit evidence with the audit criteria to determine the extent of conformity and nonconformity. The audit team should also identify any opportunities for improvement, best practices, positive aspects or potential risks. The audit team should use professional judgement and apply the principles of auditing when evaluating the audit evidence.

Making audit conclusions: The audit team should consolidate the audit findings and evaluate the overall performance and effectiveness of the management system. The audit team should also consider the audit objectives, scope and criteria, as well as the context and expectations of the auditee and other interested parties. The audit team should provide a clear, concise and objective statement of the audit conclusions, which may include the degree of conformity, the achievement of the intended outcomes, the need for corrective actions, the suitability for certification, etc.

Evaluating against the audit criteria: The audit team should review the audit conclusions and ensure that they are consistent with the audit criteria and supported by sufficient and appropriate audit evidence. The audit team should also ensure that the audit conclusions are communicated to the auditee and other relevant parties in a timely and effective manner, using the agreed audit report format and distribution method.

References: ISO 19011:2018(en), Guidelines for auditing management systems

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 …”

According to the ISO 9001:2015 standard, clause 4.1 requires organizations to determine the external and internal issues that are relevant to their purpose and that affect their ability to achieve the intended outcomes of their quality management system. Clause 6.1 requires organizations to plan actions to address the risks and opportunities associated with these issues. These actions must be integrated into the quality management system processes and evaluated for effectiveness.

In this scenario, the General Manager of the pharmaceutical organization has shown a lack of understanding and involvement in the process of identifying and addressing the external and internal issues that affect their quality management system. The General Manager has relied on the legal compliance expert, who is not an employee of the organization, to guide them on this process. The General Manager has also admitted that they did not document these issues, which is contrary to the requirement of retaining documented information on the context of the organization. The General Manager has also delegated the responsibility of determining and planning the actions to address the risks and opportunities to the Technical Manager, who is absent due to COVID-19.

Based on this information, you can respond to the General Manager’s suggestion by taking two options:

B. I would ask for a different guide instead of the legal compliance expert: You can request to have a different guide who is an employee of the organization and who is familiar with the quality management system processes and the external and internal issues that affect them. The legal compliance expert may not have the necessary knowledge and authority to answer your questions or provide you with the relevant evidence.

C. I would look for evidence that the actions resulting from the risk assessment had been taken: You can verify whether the organization has implemented and evaluated the actions to address the risks and opportunities associated with the external and internal issues. You can look for evidence such as records of risk analysis, action plans, monitoring and review results, and improvement measures.

These two options would help you to assess the conformity and effectiveness of the organization’s quality management system with respect to the requirements of clauses 4.1 and 6.1.

The appropriate response in this situation would be:

C. I will raise it as a minor nonconformity; you have the option to appeal to our Certification Body.

This response acknowledges the restaurant manager’s point that the shortage of some hamburgers may not constitute a management system failure. However, the fact remains that the menu was not updated to reflect the current availability of products, which led to customer dissatisfaction. This is a deviation from the ISO 9001 standard, which requires that the organization ensures the availability of resources needed to provide products and services as promised1. Raising it as a minor nonconformity allows the organization to address the issue within a specified timeframe and provides an opportunity for appeal if the organization disagrees with the auditor’s decision2.

Quality management principles:

Customer focus = Increased revenue and market share

Engagement of people = Enhanced trust and collaboration throughout the organisation

Improvement = Enhanced drive for innovation

Evidence-based decision-making = Increased ability to demonstrate effectiveness of past actions

According to the Quality management principles document published by ISO, each quality management principle has a statement, a rationale, key benefits, and actions you can take to apply it. Based on these descriptions, the potential benefits can be matched to the corresponding principles as follows:

Customer focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. The key benefits of this principle include increased customer value, customer satisfaction, customer loyalty, repeat business, reputation, customer base, revenue and market share.

Engagement of people: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value. The key benefits of this principle include improved understanding of the organization’s objectives and values, increased involvement in improvement activities, enhanced personal development, increased motivation and empowerment, enhanced trust and collaboration, and increased recognition and rewards.

Improvement: Successful organizations have an ongoing focus on improvement. The key benefits of this principle include improved organizational capabilities, alignment of improvement activities at all levels, increased ability to anticipate and react to opportunities and threats, enhanced drive for innovation, and increased levels of satisfaction.

Evidence-based decision-making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results. The key benefits of this principle include improved decision-making processes, increased ability to demonstrate the effectiveness of past decisions, increased ability to review, challenge and change opinions and decisions, and increased ability to improve performance.

Nonconformity report

ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - “Top management shall review the organization’s quality management system at planned intervals.” Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.

According to the ISO 9001:2015 standard, clause 10.2.1 defines nonconformity as the non-fulfilment of a requirement. A requirement can be related to the quality management system, the products and services, the customer expectations, or the applicable statutory and regulatory requirements. Nonconformities can be detected through various sources, such as audits, inspections, tests, customer complaints, or internal reviews. Nonconformities must be addressed by taking appropriate actions to correct them and prevent their recurrence.

In this scenario, the auditee has shown several issues that indicate nonconformities in their quality management system. Two statements that apply to the term nonconformity are:

A. No quality objectives planned for the top management team: According to ISO 9001, clause 6.2.1, the organization must establish quality objectives at relevant functions, levels, and processes. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The top management team is responsible for providing leadership and direction for the quality management system and ensuring its alignment with the organization’s purpose and context. Therefore, the absence of quality objectives for the top management team is a nonconformity as it violates the requirement of clause 6.2.1.

E. Quality improvements not aligning with the quality policy: According to ISO 9001, clause 5.2.1, the quality policy is a statement of the organization’s intentions and direction regarding quality, as formally expressed by top management. The quality policy must provide a framework for setting quality objectives and be compatible with the context and strategic direction of the organization. The quality policy must also be communicated, understood, and applied within the organization. Therefore, if the quality improvements are not aligned with the quality policy, it is a nonconformity as it violates the requirement of clause 5.2.1.

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

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

According to the ISO 9001:2015 standard, clause 8.4.1 requires organizations to ensure that externally provided processes, products and services conform to requirements. Controls must be applied to externally provided processes, products and services when:

The products and services are intended for incorporation into the organization’s own products and services.

They are provided directly to customers by the external provider on behalf of the organization.

A process, or part of a process, is provided by an external provider as a result of a decision by the organization.

In this scenario, the auditee has chosen a supplier to manufacture their own brand products based on their design drawings, supplier questionnaire and trial batches. This means that the supplier is providing a process (manufacturing) as a result of a decision by the organization (the auditee). Therefore, clause 8.4.1 applies to this situation.

According to ISO 9001:2015, clause 4.1, the organisation must determine the external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended results of its quality management system. The organisation must also monitor and review the information about these issues. SWOT analysis is a tool that can help the organisation to identify its strengths, weaknesses, opportunities, and threats. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to review the information periodically and update it as necessary. Therefore, one audit trail would be to establish how the organisation reviews information about external and internal issues, such as how often, by whom, using what criteria, and with what results. 123

According to ISO 9001:2015, clause 10.3, the organisation must continually improve the suitability, adequacy, and effectiveness of the quality management system. The organisation must also consider the results of analysis and evaluation, and the outputs from management review, to determine if there are any needs or opportunities for improvement. SWOT analysis can help the organisation to identify the areas where improvement is needed or possible, such as addressing the weaknesses and threats, or exploiting the strengths and opportunities. However, the SWOT analysis alone is not sufficient to comply with the requirement, as the organisation also needs to take actions to implement the improvement, such as setting objectives, allocating resources, assigning responsibilities, and evaluating the effectiveness. Therefore, another audit trail would be to establish what actions were taken to improve the QMS, such as what, when, by whom, how, and with what results. 124 References:

1: ISO 9001:2015 - Quality management systems — Requirements

2: Advisera, “Context of the organization in ISO 9001:2015 explained”, https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

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

4: Advisera, “How to implement continual improvement in ISO 9001”, https://advisera.com/9001academy/knowledgebase/how-to-implement-continual-improvement-in-iso-9001/

•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

Evaluate the effectiveness of the management system: This objective involves verifying that the quality management system meets the requirements of a specific standard, such as ISO 9001:2015, and that it achieves the intended results and outcomes. The audit team will collect and analyse audit evidence to determine the degree of conformity and performance of the quality management system23.

•Evaluate the capability of the management system to establish and achieve objectives: This objective involves verifying that the quality management system supports the strategic direction and policies of the organization, and that it addresses the needs and expectations of the interested parties. The audit team will assess the suitability, adequacy, and alignment of the quality management system objectives, and the effectiveness of the planning and implementation processes to achieve them23.

The other options are not the most relevant objectives of a third-party audit, according to the web search results from my internal tool. They may be related to other aspects or types of audits, but they are not the focus of a third-party audit.

Therefore, the correct answer is B and D.

References: 1: Safeguarding Your Business: The Power of Third-Party Security Audits 2: ISO 19011:2018 - Guidelines for auditing management systems 3: Third Party Audit – QMSGurus.com

According to the ISO 9001:2015 standard, clause 6.2.1 requires organizations to establish quality objectives at relevant functions, levels, and processes needed for the quality management system. The quality objectives must be consistent with the quality policy and the strategic direction of the organization. The quality objectives must also be measurable, monitored, communicated, and updated as appropriate.

In this scenario, the Quality Manager of XYZ Corporation has set quality objectives for every employee in the organization except top management. This has created a lot of resistance to the QMS, and the Chief Executive is asking questions about the cost and the method of setting objectives. The Quality Manager asks for your opinion as an auditor on whether this is the correct method of setting objectives.

As an auditor, you cannot provide advice to the organization on how it should operate its QMS. Your role is to assess the conformity and effectiveness of the QMS against the requirements of the standard and the organization’s own policies and objectives. Therefore, you should respond with the following options:

B. Advise the Quality Manager to read the ISO 9001 standard and interpret in relation to the organization’s requirements: You can suggest that the Quality Manager should familiarize himself with the requirements of clause 6.2.1 and understand how they apply to his organization. He should also consider the context and the needs and expectations of interested parties when setting quality objectives. He should ensure that the quality objectives are aligned with the quality policy and the strategic direction of the organization.

C. Advise the Quality Manager that you will raise an opportunity for improvement if the quality objectives are not addressed properly: You can inform the Quality Manager that you will evaluate the quality objectives during the audit and check whether they meet the requirements of clause 6.2.1. If you find any gaps or weaknesses in the quality objectives, you will raise an opportunity for improvement to help the organization improve its QMS. You will also verify whether the quality objectives are monitored, communicated, and updated as appropriate.

D. Inform the Quality Manager that you will comment on the subject in your audit report: You can inform the Quality Manager that you will document your findings and observations on the quality objectives in your audit report. You will also provide a summary of the audit results and any recommendations for improvement. You will also indicate the level of conformity and effectiveness of the QMS.

These three options would help you to maintain your impartiality and professionalism as an auditor and to provide constructive feedback to the organization

 Understanding "Context of the Organization":The term "context of the organization" is defined in ISO 9001:2015 Clause 4.1, which states:

"The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system."

The definition emphasizes identifying both internal and external issues that influence the organization's approach to developing and achieving its objectives.

 Option Analysis:

Option A:Correct. This option aligns with the standard definition as it explicitly mentions the combination of internal and external issues that affect the organization’s approach to achieving its objectives, which is the essence of Clause 4.1.

Option B:Incorrect. The term "comparison of internal and external issues" does not reflect the ISO 9001 requirements. The standard does not require a comparison but rather an understanding of these issues.

Option C:Incorrect. Although it mentions "complexity," the focus of ISO 9001:2015 is on identifying relevant issues rather than the complexity of those issues.

Option D:Incorrect. This option mentions "coordination" and focuses only on the positive or negative effects. ISO 9001 requires identifying issues but does not emphasize coordination.

 Clause Reference and Relevance:ISO 9001:2015 requires organizations to understand their context because internal and external factors can influence the Quality Management System's effectiveness. Understanding this context helps in:

Addressing risks and opportunities (Clause 6.1).

Aligning the QMS with the organization’s strategic direction.

 Why A is Correct:"Combination of internal and external issues" captures the essence of Clause 4.1, making it the accurate definition of the context of the organization.