What Is QMS? A Guide on Quality Management System

From creating to-do lists at the start of the work day to creating a plan of action to meet friends, good planning and processes go a long way.  

Creating a formalized system of business processes is one of the best ways to reduce waste, lower costs, and improve working conditions for your staff.

By having standardized documentation for a wide range of business practices, businesses are enabled to identify trends in production. You can also market more effectively and improve the performance of your employees. 

How do you effectively organize all important documentation in one place when it can be in any number of systems across your company? The answer lies in quality management system software (QMS). 

Implementing a QMS is one of the best ways to document all company processes, procedures, and responsibilities in one central location. Users should think of a QMS as a one-stop shop for these resources. 

QMS also offers automated solutions that can be accessed from anywhere, making it easier to collaborate remotely. It promotes continuous improvement and allows the organization to make informed decisions and act on the areas that may require optimization. 

Difference between QMS and quality assurance 

While the concepts may seem similar, there is a difference between QMS and quality assurance. QMS is a broader concept that includes the four components of quality management - quality planning, quality control, quality assurance, and quality improvement. In comparison, quality assurance is a part of or a component of this larger concept. 

Components of QMS

A quality management system (QMS) streamlines the supply chain by maintaining the four main components of quality management: quality planning, quality control, quality assurance, and quality improvement. They refer to the plans created to provide quality products and services to the customers; the steps taken to ensure quality standards.

QMS encompasses the above processes and creates a framework for a structured approach. It ensures quality assurance through a standardized procedure for quality control. It also helps improve functionality and ensures that the processes work well together. 

Quality planning

Quality planning identifies quality standards and plans for how to satisfy them. For example, an automotive company manufactures car parts. Throughout this manufacturing process, the company must set standards for the material and outline the production process for the workers. All of this documentation can is stored in a quality management system.

Sometimes, a new quality plan may arise in response to a customer request. Since every customer is different, it’s important to plan how to satisfy those needs. By planning concrete steps, businesses ensure a good customer experience. 

Quality assurance and quality control

Quality assurance and quality control are integral to implementing your plan. During this process, businesses must account for corrective and preventive actions (CAPAs). CAPAs occur when you need to change your production process in response to requests. A QMS helps manage and track CAPAs by automatically routing corrective and preventive actions to quality managers. They can then quickly identify the main cause of the issue. Over time, collected data can be analyzed to determine areas for process improvement, such as equipment or materials changes, process redesign, or safety initiatives.

Quality improvement

Quality improvement involves analyzing the data collected from QMS and identifying areas for improvement. This lets businesses identify roadblocks and provide solutions. A quality management system revolves around continuous improvement and change. It will always be changing to reflect new and improved procedures.

Types of QMS

There are multiple types of quality management systems to choose from. Each industry has its own set of standards; depending on your organization, the QMS standards would thus vary. The most commonly recognized quality management system and one implemented internationally is ISO 9001. The international organization for standardization (ISO) first published ISO 9001 in 1987 and is widely used across industries to improve communication at every level of the supply chain, ensuring customer satisfaction.

ISO 9001 has served as a template for other ISO standards that cater to a specific industry, including the ISO series, such as ISO 13485 for medical device manufacturers, ISO 4000 for environmental management systems, ISO 19011 for auditing management systems, and IATF 16949 for automotive-related products. 

Some of the other common quality management system examples are: 

• FDA 21 CFR Part 820 (medical devices)
• ISO 17025 
• ICH Q10 
• GxP (medical devices) 
• EU MDR & EU IVDR (medical devices)

There are certain non-standardized approaches to QMS. They are: 

• Continuous quality improvement (CQI): Focuses on continuous improvement.
• Total quality management (TQM): Focuses on quality management throughout an organization. 
• Six Sigma: Focuses on improving quality by minimizing defects.

Benefits of quality management system 

Implementation of QMS affects every aspect of an organization's performance. Without tracking customer satisfaction, it isn't easy to know which area of the supply chain to improve or which areas require streamlining. 

Quality management systems have several benefits; they improve the overall documentation process, ensure a unified procedure, and improve the quality of a company's products and services.

Let's look at some benefits.  

• Compliance with quality standards
• Improved quality 
• Increase in customer satisfaction
• Improved efficiency  
• Reduction in costs
• Improved collaboration and communication
• Coherent standardized policies
• Ease in training future employees
• Risk prevention 
• Improved documentation 
• Maintain strong customer relations 
• Supplier management 

QMS by industry

The International Organization for Standardization (ISO) sets the parameters for quality management systems across various industries. These quality management systems maintain a high level of regulation and the integrity of goods and services. We will explore how industries use quality management systems in their day-to-day operations and ensure asset management.

Food

An effective food QMS allows food and beverage companies to communicate to their customers that they supply a high-quality product and maintain compliance. One way it does this is through supplier requirement documentation. Within a QMS, users can keep a document containing a complete checklist of what to look for when assessing the risk of a new supplier. A step-by-step process for auditing a new supplier allows companies to avoid missing potential issues.

QMS also aids the food industry by helping inspect incoming materials. This allows companies to develop a record system of inspections and keep track of information such as the date received and quantity of goods. Within the QMS, companies can track the quality of supplier goods. These reports help companies see how to improve their food safety.

Automotive industry

Warranty management and reducing car material waste are just a few ways a QMS can help the automotive industry. These demands are evolving as car manufacturers focus on corporate social responsibility and how their manufacturing practices affect the environment.

Beyond this, car safety is the most important customer demand from automotive manufacturers. A QMS can help car manufacturers improve this by providing a standardized step-by-step process for safety testing. A QMS has built-in auditing features that allow users to schedule safety audits and alert the appropriate workers. It then stores these audit forms and creates reports to analyze the data. This ensures that proper safety testing is conducted, with documentation to prove it. This instills more customer trust and results in better safety ratings and fewer fatal car accidents.

Health Care

ISO 13485 is the standardized QMS for medical devices. It demonstrates that all medical devices consistently meet customer and regulatory requirements. Being certified with ISO 13485 lets healthcare providers improve surgical operations and communicate a level of commitment to both their customers and regulators.

Aim for the stars (5/5)

An improvement in overall supply chain processes, products, and services, who doesn’t want that? Opting for the right quality management system software can substantially reduce costs, increase efficiency, and increase customer satisfaction. Aiming to get those 5-star reviews is the way forward. 

You can also improve operational efficiency by choosing the right warehouse layout that works for your business. 

This article was originally published in 2019. It has been updated with new information.