Quality management system facts for kids

Kids Encyclopedia Facts

A Quality Management System (QMS) is like a special plan that helps companies make sure their products or services are always good. It focuses on making customers happy and meeting their needs. A QMS helps a company reach its goals by setting clear rules, steps, and keeping good records.

In the past, QMS mainly checked if products from factories were all the same. Later, it became more about teamwork and finding problems early. This helped companies keep making things better. Today, QMS also includes ideas like being good for the environment and being open about how things are made. This is because customers and investors care about these things too. The ISO 9000 family of standards is a very popular set of rules for QMS around the world.

The idea of "Quality Management System" and the short name "QMS" were first used in 1991 by Ken Croucher. He was a consultant who helped design a general QMS for the computer industry.

What Makes Up a QMS?
How Quality Ideas Started
Quality for Medical Devices
Organizations and Awards for Quality
How a QMS Works
Quality Management Software
See also

What Makes Up a QMS?

A good Quality Management System has several important parts. These parts work together to make sure a company delivers great products or services.

Quality Goals: What the company wants to achieve with its quality.
Quality Handbook: A guide that explains the company's quality rules.
Team Structure and Jobs: How the company is set up and who is responsible for what.
Managing Information: How the company keeps track of important facts and figures.
Work Steps: All the steps involved in making a product or providing a service, including buying materials.
Happy Customers: Making sure products are good so customers are pleased.
Always Getting Better: Finding ways to fix problems and improve things all the time.
Quality Tools: Special equipment or methods used to check quality.
Document Control: Making sure all papers and records are correct and easy to find.
Staff Training: Making sure all employees know how to do their jobs well.
Supplier Quality: Checking that the materials bought from other companies are good.

How Quality Ideas Started

The idea of "quality" as we know it today began during the Industrial Revolution. Before that, one person or a small team made a whole product by hand. They could easily check and fix things as they went.

When factories started making things in huge numbers, many people worked on different parts. No one person made a whole product. This led to products having different levels of quality.

In the late 1800s, people like Frederick Winslow Taylor and Henry Ford saw this problem. They started Quality Departments to check products and fix mistakes. Henry Ford also made sure designs and parts were standard. This helped make sure every product was the same. At first, quality was mainly about inspecting products at the end to find problems.

Later, during World War II, new ways of checking quality using math (statistics) became popular. A statistician named W. Edwards Deming helped develop these methods. The Deming Prize for quality is named after him. Another expert, Joseph M. Juran, focused on how to manage quality. He wrote a famous handbook in 1951. Juran also created the "Juran's trilogy," which includes planning for quality, controlling quality, and improving quality.

Over the last 70 years, quality management has grown a lot. It started with simple checks and became a full profession. Just like doctors or engineers, quality experts now have a recognized job. Many companies today work hard to improve how they make products and services.

Quality for Medical Devices

Making sure medical devices are safe and work well is very important. Two main guides for companies that make medical devices are the ISO 13485 standards and the US FDA 21 CFR 820 rules. These two guides are very similar. Many companies follow both to make sure their devices are safe.

The ISO 13485 rules are used in many places, including Europe, Japan, and Canada. Since the 1980s, it has been known that good quality systems help make medical devices safe and effective. The U.S. Food and Drug Administration (FDA) found that many problems with medical devices could have been stopped if good quality systems were in place.

Companies that make medical devices must use good judgment when setting up their quality system. They need to follow the FDA's Quality System (QS) rules that apply to their specific products. Each company must make sure its devices are safe and effective. They also need to have ways to design, make, and sell devices that meet quality rules.

The FDA has listed 7 key parts of a quality system for medical devices:

This image shows the different parts of a quality system working together.

How management controls things.
How designs are checked.
How products are made and processes are controlled.
How problems are fixed and prevented.
How materials are handled.
How records, documents, and changes are managed.
How facilities and equipment are controlled.

All these parts are watched over by management and checked by quality audits. Because the QS rules cover many types of devices, companies have some freedom. They can decide how much of each quality part they need. For example, if a company only uses one label for each product, they might not need to follow all the rules about mixing up labels.

Organizations and Awards for Quality

Many groups and awards help companies improve their quality.

The International Organization for Standardization has the ISO 9001:2015 standards. These standards describe how a QMS should work for designing, developing, and delivering products or services. Companies can get certified to ISO 9001:2015. This shows they follow the rules and are always trying to make their QMS better.

Other ISO standards, like ISO 9000:2005, explain basic terms. ISO 9004:2009 gives advice on how to manage quality for long-term success. These two standards are for guidance only and cannot be used for certification.

The Baldrige Performance Excellence Program helps organizations improve. It also gives out the Malcolm Baldrige National Quality Award. This award recognizes U.S. organizations that show excellent performance. The award looks at how well a company handles leadership, strategy, customers, data, employees, and operations.

In Europe, the European Foundation for Quality Management's EFQM Excellence Model has a similar award. Canada also has the 'Canada Awards for Excellence'. These awards go to organizations that show great quality and good workplace health.

The European Quality in Social Service (EQUASS) is a special quality system for social services. It focuses on quality for helping people who need support.

How a QMS Works

A QMS works by using different steps, or "processes," within a company. The ISO 9001 standard asks companies to clearly define these processes. They also need to show how these steps connect and work together.

Here are some examples of processes in a QMS:

How customer orders are taken.
Plans for making products.
Checking products or services to meet specific needs.
Making sure measuring tools are accurate.
Doing internal checks to see if the QMS is working.
Fixing problems and stopping them from happening again.
Finding and controlling products that don't meet standards.
How materials are bought and how suppliers are chosen.

ISO 9001 also requires companies to measure how well these processes are working. They need to look at the results and always try to make them better. This information is then used by management to review the QMS.

Quality Management Software

Quality management software helps companies manage their quality tasks easily. It provides tools, steps, and resources to handle quality issues well. This software helps companies check, control, and record quality steps electronically. It makes sure products are made correctly and have no flaws.

This type of software is often used in factories. It helps find problems before they even happen.

Some good things about using quality management software are:

Checking information in real-time.
Stopping problems before they start.
Managing risks.
Working faster and better.
Making sure steps are always the same.
Getting more employees involved.

Quality management software can also work with other factory systems. For example, it can link with a MES. An MES is a system that tracks and controls the whole making process. When QMS and MES work together, they can:

Help follow rules.
Make quality programs stronger.
Reduce waste.
Have fewer product recalls.
Lower the cost of each product.
Make products better quality.
Give real-time information for quality control.
Create realistic production plans.
Keep inventory up-to-date.
Track products easily.

Quality management software focuses on four main areas:

Managing Documents: It helps companies keep all their product and quality records in one place. This includes product details, instructions, and training records. This helps meet strict rules.
Following Rules: It helps companies make sure they follow rules like ISO, OSHA, and FDA. This software helps fix problems and stop new ones from happening.
Getting Feedback: Employees can share ideas or problems through the software. This helps managers get ideas from the factory floor.
Training and Skills: The software can provide a clear way to train employees. It also makes it easier to track what skills each employee has.

Most quality management software is cloud-based. This means it works over the internet, like a service you use online.