QMS (Quality Management System) is the sum of business processes that focus on achieving the strategic direction, quality policies, and objectives of a company. By executing these procedures, the goal is to fulfill customer requirements and achieve their highest satisfaction. 

Each organization must create its own QMS and include essential policies, processes, and procedures to meet the demands of its users or partners. This system will guide the organization in the process of standardizing and improving its quality control in areas that may include manufacturing, service delivery, and other key processes. 

In summary, the QMS is a way for a company to ensure it delivers what it promises. It allows the entire organization to be aligned and move in the same direction, while enabling different sectors to offer mutual support. 

Importance of a QMS 

It is no secret that excellence is the shared goal of every company with great ambitions. After all, the quality of a product or service is one of the main factors that lead customers to open their wallets and buy that product or subscribe to that service.

For companies in highly regulated industries, the Quality Management System goes from being merely beneficial to becoming a crucial element for the organization’s survival. This is because it allows compliance with the laws of the countries where the company operates, something that will need to be proven during audits by regulatory agencies.

However, the need for a QMS doesn’t stop there, as several benefits go beyond compliance. For example, implementing a QMS improves your company’s reputation, especially as it surpasses the quality benchmarks already established in the market.

Types of Quality Management Systems

Quality Management Systems are divided into four main categories:

• Standardized. They follow established market standards, with codes and regulations determined by entities such as the International Organization for Standardization (ISO). One of the main examples is the famous ISO 9001, created and maintained by ISO itself.
• Total Quality Management (TQM). A comprehensive approach that focuses on the continuous improvement of an organization’s processes, products, and services. It promotes a focus on meeting and exceeding customer expectations in the quest to deliver high-quality products and services.
• Lean Management. Works on maximizing customer value while reducing waste. Tools such as value stream mapping are used to improve an organization’s internal processes in pursuit of maximum efficiency.
• Six Sigma. A data-driven methodology where the organization focuses its efforts on defining, measuring, analyzing, controlling, and improving its processes — thus achieving maximum quality, at least in theory.

ISO 9001 and QMS

ISO 9001 is by far the most popular and widely used international Quality Management System certification. Its most recent version is ISO 9001:2015, which can be applied to any organization, regardless of size or industry.

It offers a process-focused approach to document and analyze a company’s structure, responsibilities, and procedures. The goal of the certification is to enable the organization to achieve excellence in quality management and processes.

In general, the QMS needs to meet seven criteria to obtain ISO 9001 certification:

1. Customer Focus: The company needs to understand its customers’ demands and be able to meet them.
2. Leadership: The company’s top management is responsible for ensuring that its employees achieve their goals while staying motivated.
3. Engagement of People: Employees must be empowered to perform their functions efficiently. To do this, they must be adequately trained and have the necessary skills and knowledge to perform their tasks effectively.
4. Process Approach: The organization must adopt a process-oriented philosophy to manage its activities. This includes identifying key processes, defining their interactions, and managing them to achieve the desired outcome.
5. Continuous Improvement: The company must continuously improve its QMS to keep it adequate and effective in optimizing its processes. Improvement should become a permanent cycle for the business.
6. Evidence-Based Decision Making: Decisions must be made based on data and information analysis. These elements must be collected from diverse and reliable sources so that the organization understands its current performance and identifies areas for improvement.
7. Relationship Management: This deals with the importance of managing relationships with stakeholders, such as suppliers and customers. This includes creating strong relationships with suppliers as well as working on customer satisfaction and loyalty.

Another standard related to Quality Management Systems is ISO 14001, which defines the requirements for an effective environmental management system. It offers a framework for companies that want to become more sustainable, promote efficient use of resources, reduce waste, and comply with environmental legislation.

Benefits of a Quality Management System

The correct implementation of a QMS has the potential to improve all aspects of an organization’s performance. Standardizing processes improves efficiency and increases employee productivity by reducing redundancies and waste—or even eliminating them in more successful cases.

As part of its Quality Management System, the company will conduct audits capable of identifying potential problems before they occur. Implementing such a system results in better record management, facilitating document traceability and process transparency, aiding in compliance.

Check out the main advantages of implementing a QMS:

• Increased customer satisfaction: The system ensures that products meet or even exceed consumer expectations, leading to greater satisfaction and loyalty.
• Greater organizational efficiency: By optimizing processes and reducing waste, the company can save money and better utilize its resources.
• Improved communication and onboarding of employees: ISO 9001 states that top management is responsible for ensuring the implementation of appropriate communication processes.
• Increased productivity: The philosophies of continuous improvement and data-based decision-making allow for efficiency gains and the identification of bottlenecks in production processes.
• Improved decision-making processes: The QMS provides a framework for collecting and analyzing data, enabling leadership to make informed decisions.
• Operational consistency: Without standardized operations, an organization cannot consistently guarantee the quality of its products.
• Increased profits: The International Organization for Standardization conducted a systematic review of 42 studies and concluded that implementing ISO 9001 resulted in improved financial performance for the evaluated companies.
• Risk minimization: Promoting audits allows for the identification of potential errors or problems before they occur, significantly reducing the organization’s operational risks.

How to implement a QMS

The journey of implementing a QMS is neither easy nor quick, but it is very rewarding. To get there, time, planning, and careful execution are necessary.

See the complete step-by-step guide to implementing a QMS in your organization:

1. Define and Map Processes

To start, it is necessary to identify and document the procedures associated with existing quality processes. According to Renaud Anjoran, CEO of Sofeast Ltd., it is ideal to start by drawing a map of all the stages of your process.

This first step will help identify inefficiencies and propose changes. At this stage, it is ideal to seek to reduce the number of steps in each process or subprocess—provided it makes sense, of course. It is common to have steps that can be combined, semi-automated, or even eliminated.

Here is an example of a process map:

With this, the organization can determine which areas are most important for customer satisfaction. Additionally, it is already possible to get a sense of their needs and design a system to meet them.

2. Cultivate Your Quality Culture

The culture of your organization should reflect your commitment to quality. Therefore, your main goal should be to communicate to all employees the importance of focusing on the customer.

Gather your team and discuss the effectiveness of current processes and what could be improved in them. Conduct analyses to understand what changes need to be made.

3. Create Quality Controls

After that, it is time to create controls to maintain the quality of the processes. A good tip is to take advantage of the experience of your production team.

For example, for the process of manufacturing a tablet, it is necessary to control the granulation time, compression force, drying temperature, humidity levels, and the properties of the active pharmaceutical ingredient (API).

Of course, the more complex the process, the more difficult the decisions managers will need to make are. Some processes may require experiments with multiple factors at once.

In turn, this may require the analysis of a large amount of statistics. If this happens, it is recommended to focus only on the variables that most affect the outcome of the process.

At this stage, something that can help in the implementation of your QMS is the adoption of quality management software. With such a program, you avoid the accumulation of spreadsheets, emails, or even paper forms. After all, all control information will be gathered in one place.

4. Develop Procedure and Protocol Documentation

Now that you have controls for your processes, it is time to create the documentation to support them. This includes standard operating procedures (SOPs), training materials, quality policies, among other things.

At this point, it is even worth experimenting with new things: why not try dynamic video training instead of making new employees read long and boring PDFs? The most important thing is that the documents can be easily accessed and are always up to date.

This is one of the reasons why you will need a document control procedure. Without it, your employees may use outdated versions of these files. If you are developing a new product, this control should go hand in hand with the engineering team’s change request procedure.

5. Implement Key Performance Indicators (KPIs)

It is only possible to achieve the highest levels of operational quality when results are measured. To this end, it is recommended to use key performance indicators (KPIs).

Some of the best KPI options are:

• NPS (Net Promoter Score): evaluates customer loyalty and satisfaction.
• CAC (Customer Acquisition Cost): how much an organization spends to acquire new customers.
• Cycle Time: the period needed to produce a process partially or in its entirety.
• ROI (Return on Investment): measures the profitability of investments. 
• First Pass Yield (FPY): the number of units produced that meet quality standards without rework.
• OTIF (On Time, In Full): a measure of deliveries made correctly at the location and time expected by the customer.

6. Promote Frequent Reviews and Continuous Improvement

Even after implementing the QMS, your work is not over. After all, the philosophy of continuous improvement presupposes a culture of audits and reviews of documentation and processes.

Therefore, it is essential to conduct internal audits to review your procedures and verify if they are operating correctly. It is also necessary to regularly evaluate the performance of the Quality Management System, making improvements if necessary.

In the case of a factory, for example, it is necessary to ensure that the equipment is functioning and in good condition. Another beneficial point is to look at basic tools such as a Control Plan and Failure Mode and Effects Analysis (FMEA). They are very useful in quality management but often get overlooked because they are not part of ISO 9001.

Conclusion

The QMS is a powerful tool for those seeking to improve their organization’s performance. Through it, it is possible to improve your company’s efficiency, increase productivity, and make customers more satisfied.

However, to achieve these results, a lot of time and planning is needed. Your company needs to map its processes, create quality controls, and implement key performance indicators—the famous KPIs.

Even after all this, the efforts do not stop there. The organization must continue with a philosophy of continuous improvement, promoting internal audits and reviews of its processes.

By following these steps, you put your company on the best path of all: profitability. In other words, investing in a QMS is investing in the future and success of the company.