qms, quality, quality management, quality management system

Would you like your company to realize better productivity and less waste? How about fewer customer complaints? A quality management system (QMS) may be the solution you’re looking for. Unfortunately, quality management systems are highly complex, and many companies struggle with successfully implementing them.

The Beginner’s Guide to QMS is designed to provide you with the knowledge, tools and resources you need to fully understand what quality management systems are and how they can help improve your business functions in its day-to-day operations. This guide also provides you with tools and resources that can help you learn how to successfully implement a QMS into your business.

Each section outlines an essential element to understanding the QMS along with resource links that provide you with more information. You are encouraged to follow the sections in order and peruse each section’s resources to ensure you fully understand the QMS. If you have any questions, our quality management system specialists are standing by, ready to answer your questions.

Table of Contents

What is a Quality Management System?

A quality management system (QMS) is a documentation of a business’ processes, functions and policies necessary for the continuous improvement of quality aimed to ensure customer expectations and requirements are met or exceeded.

Expressed as a framework of organized structures, methods, techniques, policies, procedures, processes, and resources, quality management systems are also methods by which companies can ensure responsibilities, schedules, relationships, contracts, and agreements are on par with environmental, food, and product safety standards.

History of the Quality Management System: Why it Started and the Most Important QMS Discoveries

Though the quality movement can be traced back to the late 13th century, true quality management systems were originally developed by an American and implemented in Japan in the 1950s. Aimed at communicating to managers how quality could be increased within an organization, the original fourteen points focused on two important concepts:

  1. Common, systemic causes of errors (caused or shared by numerous personnel, machines, or products), such as poor product or service design, unsuitable materials, poor physical conditions, improper bills of lading, etc.;
  2. And special causes of errors (caused by individual employees, products or equipment), such as lack of proper skill or training, poor lot of materials, out-of-order equipment, etc.

Other influential individuals, like Joseph M. Juran, who defined quality as “fitness for use” also began to work with Japanese organizations. He was responsible for the development of a comprehensive approach that focused on the quality of a product for its entire life cycle, all the way from design to the end consumer. He believed that, by dissecting each part and process of quality, companies could create a product that consumers could rely on one hundred percent of the time.

By placing so much focus on quality and the satisfaction of their consumers, the Japanese market began to dominate the manufacturing industry. By the 1980s, American companies had started to realize they would need to make substantial changes in order to survive against their foreign competitors. Ford Motor Company was the first to jump in. They called on Deming to help them transform their organization into a quality-oriented business.

How Companies are Using Quality Management Systems Today to Improve Profitability

While the emphasis of a QMS is not placed on profits, proper implementation can and often does increase a company’s bottom line. In fact, many organizations have successfully used quality management systems to skyrocket their earnings, quite often through the hidden and unconsidered benefits that may not immediately be seen when looking at the framework of a QMS. These benefits include:

  1. Tangible gains in productivity
  2. Increased effectiveness in the use of company resources
  3. Improved customer loyalty that leads to repeat business
  4. Heightened employee and company morale that reduces turnover rates (thereby decreasing costs of training new employees)
  5. Challenging goals and targets that encourage company growth and expansion
  6. A sense of accountability and an understanding of individual contribution that fosters open communication and active participation from employees on all levels
  7. Flexibility that enables fast and appropriate reactions to opportunities and obstacles
  8. Measured and comprehensive tracking and monitoring systems that are capable of detecting defects, gaps in production and customer satisfaction, and core issues within processes, goals, or functions
  9. And much, much more.

The Different Methods to Managing QMS

Every business has its own unique set of products, goals, values, and beliefs. Quality management systems should embrace and reflect those differences. To make this possible, there are many different types of quality management systems, each with their own set of advantages, disadvantages, and abilities. The following are the most commonly used.

Standardized Systems:

Standardized systems are any quality management systems that follow a set of federal codes and regulations. These include ISO certifications, such as ISO 9000/9001, ISO 13485, ISO 14000/14001, ISO 14971, ISO 17025, ISO 22000, HACCP, TS 16949; TL 9000; AS9100; cGxP, 21 CFR Part 11, QSR Title 21 Part 820, A2LA, or OHSAS 18001. Organizations that attempt to follow these standards must meet all criteria and pass detailed audits. In some industries, it is a requirement. In others, it may provide specific benefits that appeal to the company’s goals and overall objectives.

Total Quality Management (TQM):

TQM is a management approach in which quality is emphasized throughout every aspect of a business. The objectives focus on the long-term development of quality products and service by breaking down each individual process and activity to determine if it contributes or detracts from the company’s productivity and quality goals. Deviant processes and functions are aligned with the company’s goals, values, and beliefs through the development of flexible strategies.

Continuous Quality Improvement (CQI):

CQI is a quality system that is never satisfied. Its focus of continual and constant improvement focuses less on the processes and functions and places more emphasis on the role that teams and individuals play in the road to quality. Rewards are an integral part of this quality management system. Its “Plan, Do, Check, Act” approach has been adapted to fit many industries and companies, including those that may not use CQI as their sole or primary quality management system.

Six Sigma:

Six Sigma is a disciplined, data-driven approach and methodology that aims for perfection in quality. It focuses on the process of improvement and reduction of deviation through the application of specifically outlined processes: define, measure, analyze, improve, and control. Used by multimillion dollar companies such as Motorola and General Electric, aspiring Six Sigma businesses typically undergo intensive and specialized training processes to learn how this QMS works.

The Biggest QMS Obstacles and How to Avoid Them

Quality management systems clearly have many benefits to offer, but they are not without obstacles. In fact, unsuccessful implementation of a QMS could very easily place a company even further away from their quality and profitability goals. Awareness of these obstacles and a clear understanding of how to avoid them can help businesses in avoiding such a fate. The following is a list of the biggest (and most detrimental) obstacles that can obstruct the implementation of quality management systems.

The Disorganized Organization:

While disorganization can affect nearly any part of a company, document control is often the most critical. Responsible for regulating and controlling crucial systems, processes, functions, and procedures, documents drive nearly every action within a company. When organizational issues in this area exist, the tracking, monitoring, updating, accessing, locating, and distributing of those key documents becomes difficult and tedious. Errors become a tangible problem. Time is wasted. Employees become frustrated, confused, and disgruntled. And your company’s goals for productivity, quality, and profitability crumble.

Overcoming this obstacle:

Document control management software programs can offer a solution for some of the most commonly experienced document control issues. However, it is important to understand that not all document control solutions are equally beneficial. Some will provide more functionality and security than others, and some may not work with your current operating system. A clear understanding of your company’s needs and goals will be crucial in choosing the best document control software for your business.

Too Much Work, Not Enough Staff:

Although the competitive market has pushed many companies to improve the quality of their products and services, it has also created a disparity between the amount of work that must be done and the funds available to employ workers to complete that work. Staffing issues may also be present in industries with high turnover or accident rates.

Regardless of the reason behind it, businesses that struggle with staffing are likely to experience a number of issues that range from general employee dissatisfaction and even higher turnovers to unfinished work and an increase in errors. The results are far-reaching and can include issues like poorer quality, deviation from the quality management system, failed audits, decreased customer satisfaction, and a decline in sales and profits.

Overcoming this obstacle:

Staffing issues can be tricky to resolve. On one hand, you can hire more employees, but if the budget simply does not allow for it, then you must come up with other solutions. Think outside of the box. Consider the “Do More with Less” mentality and find ways to improve the efficiency of your company so that employees are not being overworked. Implement such a plan successfully and you could very well see improved morale, fewer errors, and increases in both productivity and quality.

The Trouble with Change:

Implementing a quality management system means making a lot of changes—some are big, and some are small. But they all need one key ingredient to be successful: the cooperation and assistance of your employees. Unfortunately, humans are resistant to change by nature. This can apply, even when the change is positive. So how do you combat human nature and get your employees on board with all the changes that are about to happen? The trick is to understand that it is less about changing human nature and more about addressing the core reason behind the resistance.

Overcoming this obstacle:

Any number of reasons can be responsible for a resistance to change—fear, cynicism, skepticism, feelings of a lack of sincerity—the list is truly endless. In order to combat these issues, you must embrace human nature. You also have to be an effective communicator and a leader worth following. Most importantly, recognize that change is difficult by celebrating small gains and expecting failures.

Not Having the Best-Laid Plans:

You wouldn’t travel to a foreign country without knowing at least some basic language, nor would you venture into a location you’ve never visited without a map. So why is it that so many businesses attempt to implement a quality management system without a proper plan? Maybe it’s that they are uncertain of how to create such a plan? Or maybe they are unaware of the need for one? Or maybe they aren’t fully clear on why it is they want to implement a quality management system in the first place. Regardless of the reason, it is a formula for disaster.

Overcoming this obstacle:

The solution to this common problem is rather obvious: you need to create a plan. Of course, when you are new to quality management and its sometimes obscure rules, regulations, guidelines, and concepts, this can seem like an impossible task.

Focus instead on what your company goals and values are, and what it is that your customers want. These are the touchstones for your quality management implementation plan. They are what you will use to determine how a guideline, rule, concept, or regulation applies to your business. And if you ever need help, don’t be afraid to ask a specialist.

How to Avoid Automating a Mess

Because organization is such a key factor in successful implementation of a QMS, and companies must “do more with less,” it makes sense to consider automation and organizational tools that could help improve business functions. However, you must proceed with caution when automating processes, functions, schedules, procedures, or other aspects of your QMS. If not done correctly, you can literally automate yourself into a mess—necessary documents become impossible to find or altered, schedules do not go out on time or the wrong maintenance ticket is sent, corrective actions become clogged or critical actions end up being delayed.

In contrast, well-implemented, well-planned, effective automation systems have the potential to improve everything from productivity to employee morale. Best of all, the right automating systems can make everyday duties easier, better organized, and practically seamless without negatively affecting quality, productivity, or profits.

Our List of Practical Problem Solving Tools

Looking for more tips? These practical problem-solving tools may not fully fit into any one of the previous categories, but they may help you in your journey to developing, planning, and implementing a new quality management system.

  1. Quality Digest discusses waste and how to use the QMS to reduce it.
  2. Learn About Advanced Product Quality Planning, why it works, and how to make it work for your business.
  3. iSixSigma covers the “four pillars of quality” and how you can use them to create better quality products.
  4. The American Society for Quality explores the seven basic quality tools for process improvement, and how you can use them.
  5. Inc.com shares some additional quality management tools.
  6. TutorialsPoint discusses measurement tools that can help ensure your QMS is working for you.

QMS Resources

Need a better understanding of the QMS? Check out these resources:

  1. The Federal Aviation Administration explains the difference between Quality Management Systems and Safety Management Systems
  2. QualityManagementSystem.com defines quality management elements as interacting activities that cannot (and should not) be isolated.

For a more in-depth look at the history of quality management systems, check out these resources:

  1. The Arab British Academy for Higher Education provides an in-depth look at how QMS has changed and evolved over several decades.
  2. The American Society for Quality traces quality management concepts back to the 13th century.
  3. The Process Excellence Institute discusses the influence of other key contributors that have aided in the development and evolution of quality management systems.
  4. The Reference for Business provides a chronology of quality management development and its influencers.

For a more in-depth look at how quality management systems can improve company profitability check out these resources:

  1. BizFilings discusses how quality management systems can deliver big rewards with little expense
  2. ISO.org examines key principles of quality management and their benefits
  3. The American Society for Quality examines how a customer-based approach improves profit outcomes
  4. Quality Management System Education and Resources gives a brief description of other key benefits to an effective QMS.
  5. EuropeanCEO presents three case studies that prove there is profitability in a successfully implemented QMS
  6. Emerald Insight shares a case study that shows how even small businesses can benefit from successful implementation of a QMS

Concerning the different quality management systems, and their benefits and applications, here are the following resources:

  1. ISO.org offers an in-depth explanation of ISO standards and their requirements
  2. Cryotech, a world leader in acetate technology, explains why use ISO certification within their organization.
  3. Reference for Business  explains the advantages of ISO quality management systems
  4. The American Society for Quality covers the benefits of TQM
  5. Demand Media breaks down the advantages and disadvantages of Total Quality Management systems
  6. USA Today examines the benefits and potential obstacles of TQM for small businesses
  7. A study published in Oxford Journals examines how CQI could lead to better outcomes in the healthcare industry
  8. The National Commission on Correctional Health Care clarifies some of the commonly misunderstood elements of CQI
  9. The Arab British Academy for Higher Education examines all three quality management systems and their key elements
  10. General Electric shares the basics of Six Sigma and why they chose to implement it.
  11. Demand Media outlines to advantages and disadvantages of Six Sigma

For more information on document control and management, check out these resources:

  1. Quality Digest covers the basics of document control.
  2. Six Sigma Online discusses document control challenges and solutions specific to the Six Sigma QMS. 
  3. Business News Daily offers some considerations that may help you in choosing the best document control software system for your business.
  4. The Department of Health and Human Services offers an overview of document control in the healthcare industry.

The following resources offer information on working with limited human resources:

  1. The Self Growth Community offers some straightforward solutions to managing more work with fewer employees.
  2. The Center for Association Leadership shares seven hidden (and common) reasons employees might leave a company.

Still not sure how to make change happen? The following resources may give you some ideas:

  1. Peoria Magazines shares some other reasons change management often fails.
  2. Harvard Business Review discusses how to celebrate small wins (and why this technique is so successful in change management).

Need more information on developing a quality management system implementation plan? Check out these resources:

  1. Quality Management System Education and Resources provides some important things to consider when creating a QMS implementation plan.
  2. The Thriving Small Business offers some steps to creating your QMS implementation plan.
  3. Quality Digest provides three strategies that can help you align policies, business objectives, and current processes to create your QMS implementation plan.

Want more information on automating your business? Here are some resources:

  1. Quality Magazine offers discusses some benefits to automating document control.
  2. Quality Digest explains the benefits of effective corrective action software.
  3. When I Work offers some additional ideas for automating your business.
  4. HIT Consultant shares the benefits of applying automation in the healthcare industry.
Dominic Tramontana has over 20 years of leadership experience in manufacturing software and technology and is an expert in the management, design and development of quality management systems. He joined QAD in 2012 as Development and Customer Support Manager, moved to Director of Technology and then into his current role as Director of R&D for the EQMS solution in 2018. As a member of the strategic planning team, Tramontana designs solutions for global organizations in Automotive, Industrial, High Tech, Food and Beverage, Consumer Products, and Life Sciences, helping manufacturers reduce their cost of quality and improve margins and profitability. He is an evangelist for quality and is driven to build a quality culture within every organization by having quality designed from the start, disciplined use of improvement tools, awareness of quality’s financial impact, full ownership of quality by everyone in the organization and the use of cross-functional teams. Tramontana has a Bachelor of Science in Business and Information Systems from the University of Phoenix.

12 COMMENTS

  1. Hi Dude

    Thanks for the customized quality management software & system uses in this articles , very clear description highly useful for all users, so many unique information ,thanks for the blogs . Kindly update more articles .

  2. It really interests me to read such articles, thanks for sharing Blogs like yours and info. It really helps me learn more day by day

  3. Thank you for sharing very fruitful information about Guide to Quality Management Systems. To make a QMS system more effective, ISO 9001 lead implementer training can help you to know about the QMS system.

  4. Fantastic sharing, I appreciate you supplying this kind of knowledge. I have very little knowledge of it. I also like to recommend QMS awareness training which provides ISO 9001 QMS certification. This training will provide all aspects of ISO 9001, including ISO 9001 awareness, benefits of implementing Quality Management System, its procedures, and much more.

  5. Thanks for the amazing content. As we all know that QMS can be implemented in many industries like food, health, safety, environment, laboratory, etc. Do you think ISO 15189:2022 lead implementer training is required before implementation?

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