iso 9001 internal audit case study examples

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ISO 9001:2015 – Internal Audit Criteria with examples

This page is dedicated to helping you learn the art & science of internal auditing. It is by no means a comprehensive list but it gives you the basis of ISO 9001:2015 – Internal Audit Criteria with examples.

In this first part, I will give some basic fundamentals of internal auditing.

T he difference between objectivity and impartiality in this context.

Objectivity: Objectivity is sticking to the facts, being guided by the evidence and considering an event will be closer to the truth the more supporting evidence it has. This is important when gathering evidences during the audit.

Impartiality: impartiality is not taking sides, giving up making value judgments and treat as equivalent different versions of an event, believing the truth is in the middle.

The difference between being argumentative and being assertive, in the context of an audit.

Argumentative: going into an argument with clients – being disagreeable. This is an emotional reaction. Often aggressive.  

Assertive: being respectful of the client who is disagreeing with you, while standing behind the point that you are making (which is backed-up by a specific clause from the standard). This is without emotion, just stating facts.  

Customer Satisfaction

When doing an internal audit, two methods in which an organisation can monitor customer satisfaction :

• Customer surveys
• Market-share analysis

Verification Activities

Clause 8.3.4 of ISO 9001:2015 requires design and development verification to be carried out. List two verification activities that may be used by the design function of an organization.

• Modelling/simulation
• Experiments/tests

Note: 8.3.4 has 3 requirements:

• Review: planning on how things happen
• Verification: internally checking that product developed meets the desired output
• Validation: customer confirms that outputs meet customer requirements

How an auditor can verify that agreed corrective actions have been effectively implemented.

After noting a corrective action as documented information an auditor can:

• Check whether changes are made to the management systems and talk with the people involved to ensure that they know/implement the change
• Update risks and opportunities during planning, and ensure that the right actions are taken and implemented to mitigate risks and seize opportunities for effective risk based management as per ISO 9001:2015
• Go on site, to confirm that the changes has been implemented.

ISO 9001:2015 – Internal Audit Criteria examples: Leadership + Auditor

7 quality management principles.

ISO 9000:2015 identifies ‘evidence-based decision-making as one of the 7 Quality Management Principles that facilitate the achievement of Quality Objectives .

‘Evidence-based decision-making means that decisions are taken based facts on objective analysis of data and information, rather than hunches. This means that data is collected, and effectively analysed to come up with factual information regarding a situation – and subsequently evidence-based decision making can be done.

ISO 9001:2015 clauses that support ‘evidence-based decision making’

The following are examples of ISO 9001:2015 – Internal Audit Criteria for evidence-based decision making.

• 4.1 – internal & external issues
• 4.4.1 – QMS and its processes
• 6.2 – quality objectives
• 7.2 – competence
• 8.5.1 – control of production and service provision
• 9.1.2 – customer satisfaction
• 9.1.3 – analysis and evaluation
• 9.2 – Internal Audit
• 9.3 – Management Review Meeting  

Evaluation of Leadership

ISO 9001:2015 requires Top Management to demonstrate leadership and commitment with respect to the QMS. Here are some methods for evaluating leadership in ISO 9001:2015 – Internal Audit Criteria with examples

To evaluate Top Management leadership and commitment, and internal auditor can:

• interview the top management, I would ensure that they are committed to the quality policy, in a way that the quality objectives are defined that support the quality policy. And that they quality objectives are compatible with the context and strategic direction of the organization. Moreover, I would confirm that the data relating to these objectives is being collected, effectively analysed, and discussed during management review meetings, and that appropriate decisions are taken by top management to reach the quality objectives.

To audit Top Management leadership and commitment, and internal auditor can look for:

• 5.2 – quality policy is available as documented information, communicated and understood throughout the organization, and available to relevant interested parties
• 5.3 – organizational roles and responsibilities are assigned, communicated and understood within the organization.
• 9.3.3 – the outputs from the management review meeting consider all items mentioned in 9.3.2 and that decisions and actions related to opportunities for improvement, changes to the QMS and any resources needed are discussed and actioned (with the allocation of the right budgets – time and money).

Demonstrating Leadership & Commitment

Top management shall demonstrate leadership and commitment with respect to the quality management system by:

• taking accountability for the effectiveness of the quality management system;
• ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization;
• ensuring the integration of the quality management system requirements into the organization’s business processes;
• promoting the use of the process approach and risk-based thinking;
• ensuring that the resources needed for the quality management system are available;
• communicating the importance of effective quality management and of conforming to the quality management system requirements;
• ensuring that the quality management system achieves its intended results;
• engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
• promoting improvement;
• supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

Traits of an auditor

Diplomatic is when we convey the message that we’d like to communicate with the client in a respectful way, that would be understood by the client. For example when the auditee is disagreeing with the auditor that a particular evidence (or lack of) should be considered as a NC – a diplomatic auditor with cordially disagreed with the auditee and read the relevant clause in a way that is perceived as friendly, respectful and professional.      

Not being diplomatic could have on an audit the following impacts:

• Severe the relationship with the client by arguing
• If one the other hand the auditor is agreeable, to avoid being assertive, the downside could be that we do not achieve the intended outcome of the audit which to ensure that the company is complying to the requirements set by the standard.

Conclusion: ISO 9001:2015 – Internal Audit Criteria with examples

We sincerely hope you have enjoyed this post about ISO 9001:2015 – Internal Audit Criteria with examples. We have shared this information with a deep commitment to help you grow your ISO 9001 Certification knowledge. The more companies get ISO 9001 Certified, the better the value-chain will be across the board.

If you are now interested in getting further help and you’d like to know the cost for ISO 9001 Certification , we’d love to help.

If you are seeing the help of an ISO 9001 Consultant in Malta or anywhere in the world, we can help. Alternatively, you might want to consider this ISO 9001 Software that will guide you towards ISO Certification at your own pace.

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ISO 9001 Case Studies

Explore our ISO 9001 case studies to witness real-world examples of how companies worldwide have successfully implemented our products to establish custom quality management systems and achieve ISO 9001 certification. These case studies provide valuable insights into the practical application of ISO 9001 and offer tangible proof of the results that can be achieved when utilizing the resources and expertise offered by 9001Simplified.

Kingpin Dynamics

Certified: November 2023

Operating as a one-person engineering company in Sweden, Kingpin Dynamics required ISO 9001 certification to increase its appeal to potential clients. Leveraging our DIY Toolkit, the company spent only one month to implement ISO and realize multiple operational benefits as well.

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AirportCreators

Certified: March 2021

Located at Schipol Airport in the Netherlands, AirportCreators needed an ISO system that would align with their dynamic and creative culture. With our help, they implemented a lean ISO 9001 system and achieved certification within five months.

Pace Engineering

Certified: October: 2020

Pace Engineering in New Zealand's South Island wanted to use ISO 9001 to achieve ultimate process efficiency in production and administration. With our Do-It-Yourself kit and training, they implemented a versatile ISO system and got certified nine months later.

J.T. Fennell

Certified: September 2020

Operating two steel fabrication plants south of Chicago, J.T. Fennell used our products and services to set up an ISO 9001 system that would earn the full support of all employees. They easily passed the certification audit at their first attempt in September 2020.

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Case Studies

Who: Holbrook Tool & Molding: What do you know about ISO 13485:2016 What: Holbrook Tool & Molding certified their quality management system intending to demonstrate compliance with applicable FDA requirements and ISO 13485:2016. Problem: In their quest for growth in the medical device industry, Holbrook Tool & Molding decided to leverage their ISO 9001:2015 certification and gain an ISO 13485:2016 certification. However, ISO 13485:2016 clauses were not updated to ISO 9001:2015 version. Solution: Since ISO 13485:2016 follows ISO 9001:2008 clauses, it was decided to update this version which was already updated for the release of ISO 9001:2015. A quality manual was developed with less than five work instructions and training was given to different levels of the organization. Since then, internal audits have been conducted and continue today. Result: Fourteen years later, the Quality Manager can successfully maintain and improve a combined ISO 9001 and ISO 13485 quality system. Ownership and commitment have been enabled throughout the organization as the system is now easier to understand. 

Who: Holbrook Tool & Molding: A one-size quality manual does not fit all What: A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems. Problem: In their quest for QS-9000 certification, a previous consulting company handed them an off-the-shelf, 100-page quality manual and 20 procedures – which the client could not possibly maintain. Solution: A  policy and procedure quality manual was developed with less than five work instructions. Appropriate training and guidance training were provided to different levels of the organization. Result: Fourteen years later, the Quality Manager was able to successfully maintain and improve the quality management system. Ownership and commitment were enabled throughout the organization as the system is now easier to understand. Holbrook Tool & Molding can maintain their ISO 9001 certification with no findings and no customer requested corrective actions for repetitive years. 

Who: Bra-Vor: One good turn deserves another What: A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems. Problem: Based on a referral from Holbrook Tool & Molding, Bra-Vor also enlisted IQPS to pursue QS-9000 certification and then ISO-9000 certification. Solution: A policy and procedure quality manual was developed with less than five work instructions. Appropriate training was provided to different levels of the organization. Guidance was also provided on effective management reviews. Internal audits were conducted and continue today. Result: Fifteen years later, the Quality Manager was able to successfully maintain and improve the quality management system. Bra-Vor can maintain its ISO 9001 certification with no findings and no customer requested corrective actions for repetitive years. 

Who: Baxter Machine Product: There are two kinds of people – complexifiers and simplifiers What: A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems. Problem: A former employee developed a 100-page quality manual and 20 procedures – which was impossible to maintain. Solution: A policy and procedure quality manual was developed with less than five work instructions. Appropriate training and guidance were provided to different levels of the organization.  Subsequently, an environmental management system (ISO 14001) was integrated into the quality management system (ISO 9001) and morphed into a business management system. 

Result: Ownership and commitment were enabled throughout the organization as it is now easier to understand. Baxter Machine Product can maintain both ISO certifications with no findings and no customer requested corrective actions or incidents for many years.

Who: Blair Strip Steel: If you can’t beat us, join us What: Blair Strip had an established quality system and needed someone to perform its internal audits. After an accredited surveillance audit, Blair Strip Stell hired IQPS to perform internal audits based on QS-9000. Problem: Blair Strip had one person in their quality department performing many tasks, which made it hard to maintain independence and expertise. Solution: The Quality System was upgraded to TS-16949 and integrated with ISO 14001, and internal audits continued to be conducted. Result: Eighteen years later, the Quality Manager can still maintain and improve the quality management system. Blair Strip can maintain its TS-16949 certification with minimal to no findings, and no customers requested corrective actions.

Who: Belleflex: Join us too! What: A new startup company owned by Blair Strip needed to implement a quality management system and obtain ISO-9001 certification as soon as possible. Problem: The Bellflex Quality Manager needed guidance in machine shop implementation. Solution: IQPS provided guidance through discussions regarding best practices, reviews of the system documentation, and appropriate training for all levels of Bellflex.

Result: After six months of startup, Belleflex successfully obtained an ISO-9001 certification. Their quality system and performance were recognized by NASA as an approved supplier to produce parts for the International Space Station. 

Who Blind and Vision Rehabilitation Services of Pittsburgh: We need another consultant What: A quality management system was developed to allow them to quickly respond to customers, solve problems, and eliminate quality-based problems. Problem A previous consultant left them an unfinished quality manual with 20 procedures- which was impossible to maintain. They also needed an ISO-9001 certification to fulfill a Pennsylvania Department of Transportation (PennDOT) supplier requirement.

Solution A policy and procedure quality manual was developed with only one work instruction for office staff. Appropriate training and guidance were provided to different levels of the organization. Internal audits were conducted and continue today. Result Seven years later, the quality system is easily maintained by staff members and the Operations Manager. Blind and Vision Rehabilitation Services of Pittsburgh was recognized as one of the top three non-profit organizations for 2013.

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How to achieve organizational excellence with ISO 9001: A case study

Business leaders are on a continual quest to maximize profits and customer satisfaction. Unfortunately, many see quality management as an overhead expense. If quality professionals are to be more proactive in organizational success, as suggested in ISO 9001:2015 , we need to address Quality Management System (QMS) implementation using a more business-oriented approach. To find out how, read the following ISO 9001 implementation case study.

The paradigm shift – Learn from the industry leaders

The following is a case study of how Dell Computer implemented their ISO 9001:2000 transition. It was first implemented in their Asset Recovery Business (ARB), which had major challenges in meeting its strategic business goals.

The directive was not merely to implement the 2000 revision for compliance, but to examine each element for creating a return on investment. We created a web-based tool called The Business Management Interactive System (BMIS), which was an enterprise-wide operational control system that embedded the requirements of ISO 9001:2000 into the workflow.

The directive from senior management

“ARB will be successful only by focusing on the management system as a whole.

• ISO 9000-1994 focuses on operations related to production and delivery of goods and service
• ISO 9000-2000 scope will require an enterprise-wide focus

The ARB Business Management System will be designed to address current and future management system requirements by incorporating a continuous process improvement methodology across the enterprise.”

Instead of the quality group conducting training for management, management opened the transition kick-off meeting with the following mandate:

• Ever-improving Value to Customers
• Marketplace Success and Enhanced Competitiveness
• Applicable to Entire Organization
• Process-Focused
• Assessments and Measures of Progress Toward World-Class

Implementation

The implementation team consisted of cross-functional individuals who each focused on their own areas of responsibility. A web programmer incorporated not only the QMS requirements, but all business functions into BMIS on the corporate web.

Every piece of data that anyone in ARB needs to do their jobs would be no more than three clicks away.

The screen saver is a scrolling real-time set of operational performance metrics that alerts the process owners to variations in effectiveness and timeliness.

The outcome

And here are the outcomes:

• Within a year of implementation, the division reported that they had turned around a significant operating loss to profitability.
• They were able to create a 40% business growth.
• They increased unit sales by 145%.
• They consolidated five manufacturing facilities into two.
• They reduced manufacturing costs by 15%.
• They reduced out-of-box audit defect rates from 28% to 7.3%.
• Their transition certification auditors praised BMIS as “best in class.”

These are the metrics that matter to business leaders. In this case, they are particularly significant because Dell amortized the cost of our consulting fees and the cost of the employees who worked on the transition in less than a year.

Making the transition

The table below is an overview of the transition from quality management to a business excellence model based on ISO 9001:2015.

This table is intended to guide the reader into potential enhancements to your QMS if you are striving for a higher level of excellence and greater return on investment.

Meaning of terms

Within the constraints of the blog post, the following are high-level summaries of the meaning of each term used in the crosswalk. Please use the comments section below if you desire more detailed explanations.

• 3.0 – Your organization will need to create definitions of “organizational excellence” processes and tools unique to your environment.
• 4.0 – Beyond the traditional QMS approach to organizational context, identify the contents of the mission and vision you will employ for achieving organizational excellence.
• 4.1 – 4.4 – Consider renaming your management system to Business Management System. It sends a message that the QMS is part of an enterprise-wide model for excellence.
• 5.0 – One of the foundational tenets of highly effective organizations is learning how to lead people and manage processes. Leading creates ownership. Managing people is often punitive.
• 5.1 – 5.3 – In the Dell example, the organization underwent a fundamental cultural renaissance from the top down. This is often not practical in existing organizations, but the traditional quality policy can often be enhanced to create an enterprise-wide mission plan.
• 6.0 – Planning a Business Management System is more holistic than simply implementing ISO 9001:2015.
• 6.1 – 6.3 – Consider a risk-avoidance approach to error-proofing your organization. Focus on identifying opportunities to identify foreseeable risk and include them in your planning.
• 7.0 – Another ambitious undertaking is to consider implementing outcome-based risk and reward metrics for all processes. Encouraging accountability is the basis for defect avoidance.
• 7.1 – 7.5 – If you do not have one, consider empaneling a standing, cross-functional committee to oversee the entire BMS. Conduct regular meetings with specific agendas of maintenance and improvement.
• 8.0 – The ISO 9001-based QMS has always been process-driven. Consider creating similar processes and metrics that do not currently exist in the rest of the organization.
• 8.1 – 8.7 – Within each element of 8, ensure that all process metrics are tied to business key performance indicators.
• 9.0 – Make the focus of improvement more about business excellence than corrective action or traditional process improvement.
• 9.1 – 9.3 – Include risk avoidance and business excellence in the activities of 9.
• 10.0 – Focus on enterprise-level improvement, not just on process improvement.
• 10.1 – 10.3 – There are new paradigms in implementing defect avoidance as a culture, not just nonconformance controls.

For more about ISO 9001 benefits, read this article: Six Key Benefits of ISO 9001 Implementation .

Consider alternative approaches to maximize your business objectives

This blog post is a very high-level introduction to The Evolution of Quality Management to Organizational Excellence. To implement it to the level that Dell ARB did requires fundamental cultural changes, bold risk-taking, and extreme commitment to the mission.

Many of you will find the concept overwhelming. You can, however, implement some of the tenets, like linking quality metrics to business key performance indicators, as a test case. You can become educated on the concepts of leading people and managing processes and gradually facilitate the transition.

For more benefits from ISO 9001 implementation, download this free white paper: How can ISO 9001 help your business grow?

To learn what ISO 9001 certification is, and why it is important, see this article: ISO 9001 Certification .

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ISO 9001 Internal Audit Sample Questions 2024

Explore the ISO 9001 Internal Audit Sample Questions 2024 to prepare for your internal audit. Dive into the questions related to understanding ISO 9001 requirements, risk-based thinking, and the context of the organization. Uncover queries about leadership and commitment during internal audits, as well as inquiries concerning planning and objectives.

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• ISO 9001 lead implementer certification
• ISO 9001 Internal Auditor Training
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According to ISO , the U.K. stands in the top 5 countries with 39,682 ISO 9001 Certificates in 2022. Further, this blog will comprehensively list updated ISO 9001 Internal Audit Sample Questions. These questions will help Auditors and organisations ensure their Quality Management Systems are robust, effective, and aligned with the latest ISO 9001 requirements. 

Table of Contents   

1)  Questions on Understanding ISO 9001 requirements 

2)  Risk-based thinking and context of the organisation questions 

3)  Questions on leadership and commitment in Internal Audit   

4)  Questions on planning and objectives in Internal Audit 

5)  Questions on operation and performance evaluation 

6)  Conclusion 

Understanding ISO 9001 r equirements   

Here are some basic questions on ISO 9001: 

What is the purpose of ISO 9001, and how does it benefit organisations?  

ISO 9001 is a recognised standard for QMS. Its primary purpose remains consistent: helping organisations achieve consistent quality while adapting to contemporary business dynamics. The benefits have evolved to align with modern demands. 

ISO 9001 benefits organisations by enhancing competitiveness and resilience  while adhering to ISO 9001 principles .  It promotes customer-centricity, ensuring that products and services meet or exceed customer expectations, which is crucial for fostering loyalty and revenue growth in an era driven by customer satisfaction.  

How does ISO 9001 define the scope of the QMS?  

ISO 9001 defines the content of the QMS by specifying the products, services, and processes it covers specifying the difference between ISO 9001 vs Six Sigma with its focus on statistical analysis and process improvement techniques . A clear scope ensures that quality efforts are focused where they matter most, aligning with customer needs and organisational goals.  

The scope statement should consider the organisation's size, complexity, and stakeholder expectations. It must align with strategic objectives, ensuring the QMS contributes directly to business success through expansion, cost reduction, or sustainability. 

What are the key clauses and sections of the ISO 9001 S tandard?  

ISO 9001 comprises essential clauses and sections, including:  

ISO 9001 comprises essential clauses and sections: 

a)  Scope : Defines the QMS boundaries  

b)  Normative references : Lists external ISO Quality Standards referenced

c)  Terms and definitions : Provides term definitions 

d)  Context of the organisation : Considers internal and external context  

e)   Leadership : Emphasises leadership's role in QMS  

f)  Planning : Focuses on risk assessment, objectives, and action plans 

g)   Support : Addresses resource management and communication  

h)   Operation : Covers operational planning and control  

i)  Performance Evaluation : Details monitoring and analysis processes 

j)  Improvement : Encourages continual QMS enhancement  

Empower your team with ISO 9001 T raining for enhanced Quality Management and organisational excellence. Join today!  

Risk-based thinking and context of the organi s ation questions   

Here are some ISO 9001 audit sample questions on risk-based thinking and the context of the organisation

How does ISO 9001 emphasise the importance of risk-based thinking in Q uality M anagement?  

ISO 9001 emphasises the importance of risk-based thinking by requiring organisations to identify and evaluate risks and opportunities that could affect the organisation's ability to meet its quality objectives. This means that organisations need to identify potential problems and take steps to mitigate them proactively. Risk-based thinking is also essential for identifying and taking advantage of opportunities to improve the organisation's performance. 

What steps should an organisation take to identify and assess risks and opportunities in its context?  

The following are some steps that an organisation can take to identify and assess risks and opportunities in its context: 

a)  Understand the organisation's context, including its internal and external environment. 

b)  Identify and assess all risks and opportunities that could affect the organisation's ability to meet its quality objectives. 

c)  Prioritise the risks and opportunities for treatment. 

d)  Implement appropriate controls to mitigate the risks and take advantage of the opportunities. 

How can an Internal Audit o r ensure that an organisation effectively implements risk-based thinking?  

An Internal Auditor can ensure that an organisation effectively implements risk-based thinking by: 

a)   Reviewing the organisation's Risk Management process to ensure that it is aligned with the requirements of ISO 9001 

b)  Evaluating the effectiveness of the organisation's risk controls 

c)  Making recommendations for improvement to the organisation's Risk Management process 

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Questions on l eadership and c ommitment i n Internal Audit  

Here are some questions on leadership and commitment in Internal Audit: 

What are the leadership responsibilities according to ISO 9001?  

The leadership responsibilities according to ISO 9001 are: 

a)  Be a role model for others in the organisation by demonstrating your commitment to quality 

b)  Ensure that the QMS is aligned with the organisation's strategic direction 

c)  Promote a culture of continuous improvement 

d)  Provide resources for the QMS 

e)  Communicate the importance of the QMS to all employees 

f)  Promote the involvement of all employees in the QMS 

g)  Ensure that the QMS is effective and efficient 

h)  Review the QMS regularly and make improvements as needed 

How can an A uditor evaluate top management's commitment to the QMS?  

An Auditor can evaluate top management's commitment to the QMS by: 

a)  Reviewing the organisation's quality policy and objectives 

b)  Observing the behaviour of top management 

c)  Interviewing top management and other employees 

d)  Reviewing the organisation's ISO 9001 Documentation

What evidence should be sought to determine if leadership effectively supports the QMS?  

The following is some evidence that an Auditor should seek to determine if leadership effectively supports the QMS: 

a)   The organisation has a documented quality policy and objectives that are aligned with the organisation's strategic direction. 

b)  Top management is actively involved in the QMS 

c)   Top management provides resources for the QMS. 

d)  Top management communicates the importance of the QMS to all employees. 

e)  Top management promotes the involvement of all employees in the QMS. 

f)  The organisation has a process for reviewing the QMS regularly and making improvements as needed. 

Join now in our ISO 9001 Lead Auditor Training to enhance your auditing skills and advance your professional journey!  

Questions on p lanning and objectives in Internal Audit  

Here are some questions on planning and objectives in Internal Audit:  

What does the ISO 9001 S tandard require regarding planning and setting quality objectives ?  

The ISO 9001 Standard requires organisations to plan their QMS and set quality objectives that are: 

a)  Specific: The goals should be unambiguous  

b)  M easurable: The goals should be quantifiable or measurable to track progress  

c)  A chievable: Given the organisation's resources and capabilities, the objectives should be realistic and achievable 

d)    Relevant: The purposes should be relevant to the organisation's strategic goals and objectives 

e)  Time-bound: The purposes should have a specific timeframe for completion 

How can an Internal Audit o r assess if the organisation's objective s are based on SMART goals ?  

An Internal Auditor can assess if the organisation's objectives are based on SMART goals by: 

b)  Interviewing the organisation's management and employees 

c)  Reviewing the organisation's documentation 

d) The auditor should seek evidence from the ISO 9001 audit checklist

What role does the quality policy play in the planning process?  

The quality policy is a statement of the organisation's commitment to quality. It provides the foundation for the planning process by setting out the organisation's overall goals and objectives for quality. The quality policy should be communicated to all employees to guide the planning process. 

Questions on o peration and p erformance e valuation   

Here are some questions on operation and performance evaluation :    

What are the critical components of the ISO 9001 S tandard related to product and service provision?  

The critical components of the ISO 9001 Standard related to product and service provision are:  

a) Planning and control of production and service provision 

b)  Identification and management of customer property 

c)  Preservation of product and service conformity 

d)  Control of monitoring and measuring devices 

How can an Internal Audit or assess the effectiveness of processes and controls?  

An Internal Auditor can assess the effectiveness of processes and controls by: 

a)  Reviewing the organisation's documentation 

c) Observing the organisation's operations 

d) Reviewing the organisation's data and records 

What performance indicators should an A uditor consider when evaluating the QMS's performance?  

The performance indicators that an Auditor should consider when evaluating the QMS's performance include: 

a) Customer satisfaction 

b)  Number of defects 

c)  Time to market 

d)  Cost of quality 

e)  Employee satisfaction  

Conclusion   

Staying informed about the latest ISO 9001 Standards and Internal Audit practices is paramount for organisations committed to Quality Management. These updated ISO 9001 Internal Audit Sample Questions provide a valuable tool for Auditors and businesses to ensure compliance, drive improvement, and meet customer expectations effectively. 

Begin your journey towards ISO 9001 excellence by joining our ISO 9001 Foundation Course today!  

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Case study solution help required as per ISO 9001 : 2015

• Thread starter MDGMG
• Start date Jul 6, 2020

Posts Moderated

• Jul 6, 2020

Request to guide us for the following case study scenarios : 1) During an audit of an insurance company, you ask the Training Manager to show you the training records for three people who work in the Claims Department. You see from the training records that each has attended a course on customer care. You ask the Training Manager how they evaluated the training and are told “We ask every person who attends a training course to complete a questionnaire on whether they enjoyed the course, how useful they found the training and how good the tutor was. This information helps us decide whether to send other staff on the course”. You examine the questionnaires completed by the three people who attended the customer care course. All three awarded high marks on how enjoyable they found the course and the usefulness of the course. All three also awarded a satisfactory score for the tutor. Question : a) There is sufficient evidence to report your findings as a nonconformity with evidence: b) ISO 9001:2015 clause and requirement c) If there is not a non-conformity , reason for same d) Audit trails y, including, evidence sought and purpose  

John Broomfield

• Jul 23, 2020

A fruitless line of audit investigation unless we are concerned by the effectiveness of the criteria used to select a training provider. Customer care is best considered while gathering and evaluating evidence of actual claims handling.  

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Become a certified CQI IRCA Certified Lead Auditor  with our top notch ISO 9001 QMS , 14001 EMS , and 45001 OHSMS courses. Enroll now!

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ISO 9001 Lead Auditor Sample Exam Questions and Answers

Cqi irca certified iso 9001 lead auditor sample exam questions and answers.

To successfully complete CQI IRCA Certified ISO 9001 QMS Lead Auditor course , learners must pass both the continuous evaluation and the final examination.

1. Continuous Evaluation

It is a formative assessment that will be held throughout the 5 days course. You will undergo audit activities, and be provided daily feedback on your progress which will help you increase your knowledge in performing audits. The activities of each delegate are graded by the tutor. You need to successfully complete all the activities and score a minimum passing grade in the continuous evaluation .

2. Final Examination

Here are some of the key details you need to know before appearing for the final examination.

1. The duration of the exam is 120 Minutes, however, if you are a non-native speaker you will be given an extra 24 Minutes in addition to the 120 Minutes. 

2. The exam is conducted both in class or online depending on the mode of your training. (3FOLD Training conducts the entire training and the final exam online )

3. The only resource that you can use during the exam is the relevant ISO Scheme standard ISO 9001:2015. It is not permissible to use ISO 19011 standard.

4. English dictionary is allowed, however, it is not found useful by many of the participants.

ISO 9001 Lead Auditor Sample Exam Questions and Answers:

There are 4 sections in the ISO 9001 QMS Lead Auditor examination as illustrated in table 1 below. In this ISO 9001 lead auditor sample exam questions and answer article, we will examine one question per section and provide their answers.

In table 1 you can find the question break-ups and the passing scores. 

Table 1: ISO 9001 Exam Section and Question break-up

Table 1 shows us the total available and minimum marks to pass each section. It is mandatory to pass each section. For example: if you have scored 6 marks on section 1, 18 marks on section 2, 10 marks on section 3 & 30 marks on section 4, your subtotal would be 64 marks. Though you have scored a total of 64 marks, since you haven’t scored the minimum passing marks on section 3, it will still be considered a failure. 

Now let’s look at a few sample exam questions in each section. 

Section 1 : This section has 5 questions and each carries 2 marks, minimum passing score on section 1 would be 4.5 marks out of 10 marks.

Sample Question: Define Process & Process Mapping. (2 marks)

Sample Answer:

Process: A set of interrelated or interacting activities which transforms inputs into outputs

Process Mapping : The purpose of process mapping is for organizations and businesses to improve efficiency

Note: CQI IRCA provides ATP a grading scheme. However, while grading the paper it is not necessary that your answer must match exactly as per the grading scheme. Trainers will use their discretion while grading the paper according to the answer you have provided. Questions that relate to identifying the clause numbers are objective in nature and should match the grading scheme.

Section 2: This section has 4 questions and each carries 5 marks, minimum passing score on section 2 would be 9.5 marks out of 20 marks.

Sample Question: Provide any five risk factors that are associated with a poorly designed audit program. (5 marks)

• Planning, e.g. failure to set relevant audit objectives;
• Resources, e.g. allowing insufficient time;
• Selection of the audit team, e.g. the team does not have the collective competence to conduct audits effectively;
• Implementation, e.g. ineffective communication of the audit program;
• Records and their controls, e.g. failure to adequately protect audit records to demonstrate audit program effectiveness;
• Monitoring, reviewing, and improving the audit program

Section 3: This section has 3 questions and each carries 10 marks, minimum passing score on section 3 would be 14.5 marks out of 30 marks.

Sample Question:

Take any organization of your choice and answer the following two questions (10 Marks)

1. Write Five Quality Objectives for an Organization (5 marks)

2. Write Five agenda items for a Management Review Meeting (5 marks)

Sample Answer A:

Note: Depending on the organization the quality objectives are set. However, there are certain basic requirements in setting up the quality objectives that will be taught in the training. Here are a few examples of the Quality Objectives of a Construction Organization mentioned in table 2 please refer.

Table 2: Quality Objectives for an Organization

Sample Answer B:

Note: Depending on the organization the meeting agenda is set. Here are a few examples of management review meeting agenda items.

a) The status of actions from previous management reviews;

b) Changes in external and Internal Issues that are relevant to the quality management system;

c)  Information on the performance and effectiveness of the quality management system, including trends in:

1)  customer satisfaction and feedback from relevant interested parties;

2)  the extent to which quality objectives have been met;

3)  process performance and conformity of products and services;

4)  nonconformities and corrective action;

5)  monitoring and measurement results;

6)  audit results;

7)  the performance of external providers;

8)  the adequacy of resources;

9)  the effectiveness of action taken to address risk and opportunities ;

10) opportunities for improvement.

Section 4: This section has 3 questions each carries 10 marks, minimum passing score on section 4 would be 14.5 marks out of 30 marks. (10 marks)

Questions in this section are designed to test your ability to analyze audit situations, evaluate audit evidence and apply knowledge of the audit criteria correctly.

You are required to either:

1. Complete the non-conformity report template (or) 2. Complete the audit investigation template 

Depending on the case, you have to determine whether to use a non-conformity or audit investigation template.

Non-Conformity template grading rubric:

1. For correctly identifying the scenario as non-conformity (2 Marks) 2. Description of the nonconformity (3 Marks) 3. Relevant Evidence (3 Marks) 4. ISO 9001:2015 Clause and requirement (2 Marks)

Audit investigation template grading rubric:

1. Their reasons for why there is not yet sufficient evidence to report nonconformity. (2 marks) 2. Write four audit trails they would follow and specific examples of audit evidence. (8 marks)

Sample Question 1 – Case study

During a surveillance audit of JEB Manpower (a company that supplies manpower to shipping & logistic companies), it is observed that while verifying documented information in the customer complaint register, at varying occasions and ongoing for many years, workers were returned due to lack of experience and knowledge. 

As an auditor, you interviewed the manager to know why this has been happening and he confirmed that he is well aware of the situation, and it is so because of insufficient funding and low profit margin. You inquired further to know what viable action has been taken to supply skilled manpower to the customer and to ensure their satisfaction. The manager replied that before sending workers to the customer, they conduct awareness training as it is economical. 

Sample Answer: 

Based on the given scenario, we will now see how to fill the non-conformity template.

1. You need to correctly identify the scenario as non-conformity. (2 Marks)

2. Description of the nonconformity (3 Marks)

The organization does not meet the requirements of its customer, even though the customer had complained several times.

3. Relevant Evidence (3 Marks)

The customer complaint register shows that the services provided to the customer are not meeting acceptance criteria.

4. ISO 9001:215 Clause and requirement (2 Marks)

8.5.1 Control of production and service provision The organization shall implement production and service provisions under controlled conditions.  Monitor & measure activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.

Note: The QMS Exam is a closed book, only the ISO 9001:2015 standard will be allowed during your exam.  

As part of the ISO 9001:2015 QMS Lead Auditor training program, participants will get a full-length specimen examination with answers and grading rubrics. This will help facilitate the preparation for the final examination. 3FOLD Training tutors can help you to understand each element of the final examination .

What if you don’t pass the final examination?

We have a stellar passing track record. In the unlikely event of you not passing the final exam, the second attempt is completely free of cost. However, this will likely change because CQI IRCA is planning to administer the exam through a third-party testing partner.

Hope this ISO 9001 Lead Auditor sample exam questions and answers article has helped to ease the tension that you may have regarding the ISO 9001 final exam and show you that with our guidance and hard work, you can pass the ISO 9001 final exam!

Why 3FOLD? 

3FOLD provides world-class training resources, including mock and specimen exam patterns for ISO 9001 QMS Lead Auditor course, this will help you know the type of questions to expect in the final exam.

Interested in knowing more?

Enroll in 3FOLD ISO 9001:2015 QMS Lead Auditor Course to gain access to our Learning Management System ( LMS ) where we have more ISO 9001 Lead Auditor sample exam questions and answers to help you in your final exam.

Have questions on this topic? Contact us through the contact us form , WhatsApp , or email .

• ISO 14001:2015
• ISO 45001:2018
• ISO 9001:2015

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