Top 20 QMS questions and answers

In this article, we will discuss and answer the top 20 frequently asked questions about QMS. If you are starting your journey as a quality professional and looking forward to grasping all aspects of quality management, you should start with this blog. Here are the 20 questions that we will discuss today. To go to any answer quickly, just click on the question here.

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1. 1. What is QMS?
   2. What are the 7 QMS principles?
   3. What is QMS software?
   4. What does QMS software do?
   5. What are the benefits of QMS in an organization?
   6. What is QMS certificate?
   7. How to get QMS certification?
   8. What is QMS audit?
   9. How to audit the process-based QMS?
   10. How to create a QMS / How to implement a QMS /How to set up a QMS system?
   11. What are the different types of QMS?
   12. What does a QMS consist of?
   13. What does QMS measure?
   14. What is a QMS manual?
   15. What is ISO QMS?
   16. What is QMS training?
   17. What is the difference between ISO and QMS?
   18. What is the difference between TQM and QMS?
   19. What is the structure of quality management system QMS?
   20. Why should your QMS be regularly monitored and evaluated?

1. What is QMS?

QMS (Quality Management System) is a set of procedures, processes, and activities that assist a firm in meeting customer requirements, government regulations, and internal standards. It offers businesses a systematic approach to quality management.

A good QMS assists firms in improving their processes so that they can offer products and services faster and cheaper than their competitors – all while maintaining high levels of customer satisfaction and quality!

2. What are the 7 QMS principles?

1. Customer focus: All operations and decisions in an organization revolve around the customer.
2. Employee engagement: Engaged employees are more productive, which can lead to improved revenues for your company.
3. Leadership: Leaders must instill a culture of continual improvement by remaining open-minded and willing to make changes as needed.
4. Process approach: Many industries utilize process approaches to increase performance by focusing on specific tasks or activities inside an organization.
5. Improvement: Assessing performance against key performance indicators (KPIs), setting improvement targets, and monitoring progress, with the information used to promote improvement.
6. Evidence: An important component of the QMS is evidence-based decision-making. It contributes to increased quality, efficiency, and safety.
7. Relationship management: Conflicts between employees or supervisors can also harm relationships, affecting productivity and morale in your firm. A good QMS will aid in the prevention of these issues by establishing clear expectations for conflict management.

3. What is QMS software?

QMS software is a piece of software used to automate the quality management system. It can also be used to help in quality management system design, deployment, and management.

QMS software aids in the improvement of product or service quality by offering a centralized platform for controlling all components of your quality system, such as:

• Document management (including change control)
• Training
• CAPA
• Inventory management
• Inspection

4. What does QMS software do?

Following are some of the most common features of QMS software:

• Document Management: A centralized repository for storing, organizing, and maintaining quality-related documents such as policies, procedures, work instructions, and records. Documents can be kept up to date, managed, and available to authorized individuals using QMS software.
• Process Management: A system that manages and controls quality-related activities such as nonconformance management, corrective and preventive actions, and internal audits. These operations can be automated using QMS software, which also provides a centralized mechanism for tracking and managing them.
• Change Management: A system for managing QMS changes such as policy, procedure, or process workflow adjustments. Change management software can automate operations and serve as a central repository for tracking and managing changes.
• Training Management: A system for managing employee QMS-related training and competencies. Quality management software can provide a centralized system for managing employee training and competency, as well as automating the process of allocating and tracking training requirements.
• Risk Management: A system for managing and mitigating QMS risks. QMS software can help you identify, assess, and manage risks, as well as track risk-related KPIs.
• Reporting and Analytics: QMS software can provide reporting and analytics capabilities for measuring and evaluating quality-related data like as nonconformities, corrective and preventive measures, and customer complaints. These technologies can help firms make data-driven decisions by providing insights into areas for improvement.

5. What are the benefits of QMS in an organization?

• A quality management system can assist firms in staying ahead of the competition by enhancing product quality, efficiency, cost-effectiveness, and customer happiness.
• A QMS enables an organization to meet customer requirements, comply with legislative or regulatory obligations, and improve business performance.
• It also contributes to the development of a culture of continuous improvement by facilitating transparency and feedback on process performance. This enables firms to identify holes in their systems and take corrective action before production is halted or items are recalled due to product problems.
• Another advantage of having a QMS is that it assists businesses in identifying cost-cutting opportunities by reducing waste through efficient material handling, improving utilization rates through better scheduling and batch sizing strategies, and improving employee performance by utilizing Lean concepts such as ‘one piece flow’.

6. What is QMS certificate?

A QMS certificate is proof that you met the requirements of your selected quality management system. The ISO 9001:2015 standard demands you to keep records of your operations and how they contribute to the achievement of your business goals.

Depending on who issues it, the certificate will appear different. But it will contain some basic information about your firm and its products/services, as well as contact information for additional inquiries or questions about their products/services. It may also incorporate trademarks or insignia pertaining to other standards against which they have been certified (for example if they have achieved BS EN ISO 14001 Environmental Management System certification).

There are two ways to obtain an ISO 9001:2015 certificate: through an accredited certification body or directly from a company such as SGS, which performs independent third-party audits.

7. How to get QMS certification?

To obtain the certificate, the organization must undergo a rigorous audit.

It evaluates the organization’s quality management system and determines whether or not the organization meets standards and regulations. Independent third-party auditors who are accredited by the International Standards Organization (ISO) or any other international accreditation body recognized by them perform audits.

After audit completion, the auditor sends the report to the certifying organization, which checks whether or not everything is satisfactory.

The certification body evaluates if the auditors are qualified professionals who can be trusted to do their duties. When they do an audit, it also checks to see if they are independent and objective. The auditor must be licensed by a government agency and accredited by professional organizations such as the International Organization for Standardization (ISO), the Accreditation Board for Engineering and Technology (ABET), and others.

When the certifying body is satisfied, it issues QMS certification and transmits it to the organization.

The firm can now use the QMS certification as proof of ISO 9001:2015 compliance.

8. What is QMS audit?

Quality Management System auditing is the process of determining if a certain organization’s quality management system complies with ISO 9001 criteria. Internal or external auditors can perform this function.

Internal audits are performed by a company employee who will evaluate if there are any gaps between what has been planned and what has been implemented on the ground level, which could result in the improvement of processes or improvements needed to meet customer requirements as well as expectations set by all stakeholders involved with the project execution phase, such as employees working on projects, suppliers providing services/products, and so on.

External audits are conducted by third-party consultants hired specifically for this purpose; they will assess the overall functioning of various departments within organizations using checklists provided by respective regulatory bodies, such as the ISO 17021:2011 standard, from which the majority of checks originate (but not limited).

9. How to audit the process-based QMS?

Auditing is an essential component of quality management systems. Audits assist you in ensuring that your company has satisfied all regulatory criteria, such as ISO 9001 or AS9100 certifications.

To conduct an effective audit, keep the following points in mind:

• A review of the documentation compiled during the design process for the quality management system. This comprises a review of any documents relating to your QMS (for example, policies and procedures), as well as any supporting paperwork like training materials, results from internal audits, and third-party external audits.
• An evaluation of your quality system’s actual performance in regard to regulatory requirements or industry standards (if applicable).

10. How to create a QMS / How to implement a QMS /How to set up a QMS system?

Explain the vision and mission of the organization.

The first stage in developing a quality management system is to define the vision, mission, and goals of the firm. This will assist you in developing a plan that is in line with the company’s objectives.

List the strategic goals of the organization.

The first stage in developing a quality management system is to identify the organization’s strategic goals. Strategic objectives are goals and objectives that will assist you in achieving your organization’s vision, purpose, and values. These are often multi-year objectives with precise success measures that may be measured at regular times throughout the year.

Determine the items, services, and customers.

• Goods and services: Explain the goods and services offered.
• Customers: Determine who your customer base is and what their demands are by answering questions such as: Who do we serve? What do they expect of us? How might our products or services better address those needs?

List the departments that produce goods or provide services.

The first stage in developing a quality management system is to identify all of the departments that produce goods or provide services. After that, describe their relationship. For example, the customer service department is in charge of dealing with consumer concerns. Finally, describe how each process works from beginning to end and what information is transmitted across departments along the route.

This is your operations map; list all of the procedures used to generate or provide products and services.

Your operations map outlines the steps your company takes to manufacture or distribute goods and services. It should include all of the processes required to generate your product, from beginning to end, including any outsourced steps.

List all of your quality systems.

Include all of your quality systems (policies, procedures) that are employed in these processes, as well as any forms that personnel or departments must complete in order to keep the firm running smoothly (i.e., checklists, forms). This is your quality management system layout.

Demonstrate how the various quality management tools work together to achieve control throughout the process chain – this is your control map.

It’s time to develop your control map when you’ve chosen the tools that are most appropriate for your firm and have a strong knowledge of how they work together.

If you want to know more about the scope of a QMS, we suggest this blog – Scope of quality management system (with PDF template)

 

11. What are the different types of QMS?

There are various forms of QMS that can be adopted depending on the industry, size, and aims of the business. Some of the most common forms of QMS are as follows:

• ISO 9001 QMS: This is a standard for implementing a QMS that focuses on achieving customer needs and improving continuously. It is the most extensively used QMS standard in the world.
• Lean QMS: This method focuses on identifying and removing waste within processes in order to increase efficiency and save costs. It evolved from the Toyota Production System and is widely employed in the manufacturing and service industries.
• Six Sigma QMS: This methodology uses statistical analysis to detect and eliminate flaws in processes, resulting in higher-quality goods and services. It’s frequently utilized in the manufacturing, healthcare, and finance industries.
• Agile QMS: This methodology entails frequent feedback and collaboration among team members in order to swiftly react to changing customer demands and expectations. It is widely utilized in the software development and information technology industries.
• Integrated QMS: This method combines different management systems, such as quality, environment, and health and safety, into a single system to reduce duplication of work and increase efficiency.

12. What does a QMS consist of?

A QMS typically consists of the following components:

• Quality Policy: A declaration outlining an organization’s commitment to quality as well as its intentions about the quality of its products, services, and procedures.
• Quality Objectives: Clear, measurable goals that an organization establishes in order to implement its quality policy.
• Quality Manual: A document that outlines the organization’s quality management system, processes, and quality objectives.
• Document Control: A method for managing documents like as policies, procedures, work instructions, and records to ensure they are current, correct, and controlled.
• Training and Competence: Procedures that train personnel and make sure they are competent, and aware of their roles and responsibilities in accomplishing the quality objectives of the organization.
• Nonconforming Product/Service Control: Procedures for identifying, controlling, and correcting items or services that do not satisfy quality standards.
• CAPA: Corrective and preventive actions are procedures for identifying, investigating, and correcting the underlying causes of issues and preventing their recurrence.
• Audits: Audits and reviews are procedures for assessing the efficacy of the QMS and identifying areas for improvement.
• Continuous improvement: Methods for finding and implementing improvements to the QMS, products, and services.
• Customer Feedback: Procedures for gathering and acting on customer input in order to increase customer satisfaction.

13. What does QMS measure?

A Quality Management System measures many areas of a company’s quality-related activities to ensure that they are meeting customer expectations and accomplishing their quality goals. A QMS typically includes the following critical measurements:

• Customer Satisfaction: The degree to which customers are satisfied with the organization’s products or services, as measured by surveys, feedback, and other customer communication channels.
• Quality Objectives: Specific, measurable goals for accomplishing the organization’s quality policy, such as reducing defects, boosting efficiency, or enhancing customer happiness.
• Process Performance: The effectiveness and efficiency of an organization’s processes in reaching quality goals, as assessed by measures like cycle time, error rates, and throughput.
• Product/Service Conformity: The extent to which products or services meet client requirements and specifications, as determined by inspections, testing, and other quality control operations.
• Nonconformities and Corrective Actions: The quantity and severity of discovered nonconformities, as well as the effectiveness of corrective and preventive activities taken to resolve them.
• Audit and review findings: The findings and recommendations for improvement from internal and external audits and reviews of the QMS and related procedures.
• Training and Competence: The effectiveness of training programs and employees’ competency in carrying out their QMS-related duties and obligations.
• Continual Improvement: The efficacy of the organization’s attempts to enhance its QMS and related processes, as assessed by indicators such as the number of improvement projects, their impact on quality targets, and the effectiveness of the improvement process.

14. What is a QMS manual?

A manual for the Quality Management System is a document that describes the QMS. It’s a reference document. It covers all of your company’s rules and procedures for putting its quality management system into action.

It also serves as system documentation, such as how you’ll implement control measures and monitor them over time. Therefore it instructs those who utilize it on how to carry out those operations efficiently.

15. What is ISO QMS?

ISO 9001:2015 is a standard for quality management systems. It is an international standard that sets the standards for a written and implemented system that consistently provides products and services that meet the expectations of consumers, including after-sales support needs while being cost-effective and sustainable.

ISO 9001:2015 offers four major advantages:

• Increased customer satisfaction as a result of better product or service delivery
• Improved employee motivation and commitment to meeting high-performance criteria
• Decreased waste due to less rework or corrective action required on low-quality work (this can be measured using statistics)
• Decreased costs incurred as a result of process improvements

16. What is QMS training?

QMS training is critical for ensuring that employees understand the value of quality as well as their roles and responsibilities.

• QMS Overview: An overview of the QMS, including its purpose and components. This training teaches participants about the organization’s quality policy, quality objectives, and processes.
• Document Control: Instruction on document control processes such as document creation, review, approval, and distribution. This training teaches employees the value of document control in keeping policies, processes, and other documents up to date, correct, and managed.
• Process Control: Instruction on how to control and manage quality-related processes such as nonconformance management, corrective and preventative actions, and internal audits. This course teaches participants how to identify, report, and correct nonconformities, as well as how to conduct internal audits to verify that procedures are effective and efficient.
• Quality Tools and Techniques Training: Instruction on the many tools and techniques used to manage quality-related activities, such as statistical process control, root cause analysis, and failure modes and effects analysis. This workshop teaches participants how to utilize these tools to identify and address quality issues.
• Risk Management: Training on risk management principles and methods, including how to identify, assess, and mitigate risks connected to the QMS. This program teaches participants how to manage risks in order to meet quality objectives.
• Training on the principles and techniques of continuous improvement, including how to identify and apply changes to the QMS, products, and services. This training teaches staff the need to constantly upgrade the QMS in order to meet client expectations and meet quality targets.

17. What is the difference between ISO and QMS?

• ISO is a global standard-setting organization that creates and publishes standards for a variety of industries and sectors. On the other hand, QMS is a framework that firms use to manage and improve their quality-related operations.
• ISO 9001 is a specific ISO standard that gives guidance for implementing a QMS. But QMS is a broader concept that incorporates multiple quality management methods, tools, and techniques.
• ISO 9001 is concerned with customer satisfaction, continuous improvement, and effective process management. But QMS is concerned with quality-related activities such as document control, corrective and preventive actions, and internal auditing.
• ISO 9001 is a certification standard that organizations can get by showing conformity with the standard’s standards. But QMS is a management system that organizations can deploy regardless of whether they seek certification to enhance their quality-related activities.

In summary, ISO is a standards development body that creates standards such as ISO 9001, which gives recommendations for implementing a QMS. In contrast, a quality management system is a framework to manage and improve quality-related operations, which may include applying ISO 9001.

18. What is the difference between TQM and QMS?

Organizations utilize Total Quality Management and Quality Management System to improve the quality of their products, services, and processes. There are, however, some significant differences between the two:

• TQM is a management philosophy that emphasizes continual product, service, and process improvement. On the other hand, QMS is a framework for managing and regulating quality-related processes.
• Total quality management stresses all employees’ participation in the quality improvement process. But a quality management system focuses on certain quality-related procedures such as document control, corrective and preventive actions, and internal audits.
• TQM focuses on customer happiness and addressing customer requirements. On the other hand, QMS focuses on meeting quality objectives and adhering to quality standards.
• Total quality management covers tools and techniques for quality improvement such as statistical process control and root cause analysis. On the other hand, a quality management system contains processes for managing and controlling quality-related activities.
• TQM is more adaptable to varied company cultures and structures. But QMS is frequently more standardized and focused on quality standard compliance.
• Total quality management is a larger management concept that emphasizes continuous improvement and the participation of all employees in the quality improvement process. On the other hand, a quality management system is a more particular framework for managing and regulating quality-related procedures.

19. What is the structure of quality management system QMS?

A QMS structure typically includes the following components:

• Quality Policy: Quality policy is a high-level statement of an organization’s commitment to quality and customer satisfaction.
• Quality Objectives: Clear, measurable, realistic, relevant, and time-bound targets established by an organization to meet its quality policy.
• Quality Manual: A document that outlines the quality management system of a company, including its rules, procedures, and processes.
• Organizational Structure and Responsibilities: A clear explanation of all personnel involved in the QMS’s roles, responsibilities, and authority.
• Document Control: A system for developing, evaluating, approving, disseminating, and controlling all QMS-related documents.
• Processes: A collection of interconnected actions that convert inputs into outputs in order to supply goods or services to clients.
• Risk management:  It is the process of detecting, assessing, and controlling risks to the QMS.
• Training and Competency: A program that ensures that personnel have the information, skills, and abilities needed to complete their given jobs.
• Monitoring and measurement: A system for monitoring and measuring the performance of the QMS and the processes it comprises on a regular basis.
• Continuous improvement: A continuous improvement culture entails creating improvement goals, recognizing possibilities for improvement, executing changes, and monitoring the success of those improvements.

20. Why should your QMS be regularly monitored and evaluated?

• Ensuring Compliance: Frequent monitoring and evaluation can assist in ensuring that the QMS complies with applicable legislation, standards, and client expectations. Organizations may stay in compliance and avoid costly penalties and other negative repercussions by reviewing and updating their QMS on a regular basis.
• Finding Opportunities for Improvement: Frequent monitoring and assessment can assist in identifying aspects of the QMS that are not performing optimally and may require improvement. Organizations may improve their operations, increase efficiency, and improve customer happiness by recognizing and addressing these areas.
• Tracking Performance: Monitoring and evaluation can assist in tracking the performance of the QMS and its separate components over time. Organizations may detect trends and patterns, quantify the success of their improvement efforts, and make data-driven decisions by tracking performance.
• Enabling Continuous Improvement: A major part of QMS is continuous improvement. Frequent monitoring and evaluation can offer organizations with useful input that they can utilize to continuously improve their QMS and its processes.
• Improving Customer Satisfaction: A QMS’s ultimate purpose is to assure customer satisfaction. Frequent monitoring and assessment can assist in identifying areas where the QMS falls short of customer expectations and implementing remedial actions to increase customer satisfaction.

Conclusion

You should have a better idea of what a quality management system is and how it works now that you’ve read this article.

These are some crucial considerations to keep in mind:

QMS is not a department; it is a method of managing quality throughout your organization.
QMS is about more than simply products or services. It’s about improving all elements of your business, from customer service to accounting processes.
The goal of implementing a successful QMS isn’t just to meet legal requirements. It also allows employees to focus on doing their jobs well rather than worrying about whether they’re producing bad workmanship or false reports!

 

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