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What is a QMS?

Get to Know the Quality Management System

A quality management system (QMS) is a collection of business processes designed to manage risk and productivity with consistent, repeatable outcomes.

What does QMS mean?

A quality management system, or QMS, is a formalized system of processes and procedures designed to improve quality throughout an organization — with the end goal of better meeting customer requirements and improving customer satisfaction.

In particular, effective quality management systems help businesses to implement practices like Total Quality Management (TQM) and comply with regulatory standards like ISO 9001.

QMS vs. QMS software

Don’t confuse the QMS with QMS software.

A quality management system is a set of processes and procedures — and many QMS systems are still based in pen and paper or ad-hoc spreadsheets. But organizations are increasingly digitizing quality management software, also known as EQMS. 

Typical quality management software platforms are workflow-based and provide intelligent routing to move quality-related events through different areas of the business to ensure product or service quality.

Most quality management software systems consist of a variety of apps, including:

  • Document control
  • Audit management
  • Nonconformance tracking
  • Corrective action
  • Employee training 

 

However, more comprehensive QMS software solutions encompass critical processes like supplier quality, quality events, and new product introduction (NPI).

Each designed to accomplish a specific task. For example:

  • A document management application stores and organizes controlled documents.
  • A corrective action (CAPA) application helps quality managers direct correction of nonconformances of all types. 
  • A training management app stores and distributes training data while tracking workers’ progress against the required courses to operate equipment and safely navigate the industrial environment.

 

QMS software also enables quality automation, which minimizes human error across repeatable processes and ensures quality throughout product and business life cycles for companies of any size. Quality automation is a dynamic process that deploys highly integrated technology solutions to improve organizational efficiency, reduce costs, deliver higher quality products, and better services across your organization’s business divisions.

Achieve Total Quality Management with a QMS system

Total Quality Management is a management approach businesses can adopt to achieve long-term success through customer satisfaction. Under this approach, all members of an organization participate in improving processes, products, services, and the culture in which they work.

The American Society for Quality (ASQ) defines eight principles of total quality management. Companies that adopt these principals — and other process excellence methodologies — rely on a variety of QMS tools to deliver.

1. Customer focus

Quality is defined from the customer’s perspective, and a proactive quality culture leverages QMS tools aimed directly at increasing customer satisfaction, such as, complaint management processes, risk management, compliance tracking.

2. Empowered employees

An engaged workforce is the engine that drives TQM. The QMS helps all employees take ownership of quality by providing data and feedback on how their efforts impact quality. 

3. Process approach

Like many quality philosophies, TQM draws from the process approach aimed at understanding the link between process inputs and finished quality. A QMS supports the process approach by addressing every element of the Plan-Do-Check-Act cycle.

4. Integrated Systems

TQM emphasizes the connection of different functions and process areas into an integrated business system. A fully integrated QMS ties together the full range of quality processes, also moving data to and from other business systems (like ERP and MES).

5. Strategic management

Companies must have a strategic plan that makes quality a top priority. That means including quality and risk data in management reviews, including quality initiatives in the budget, and communicating results regularly.

6. Continuous improvement

The QMS supports continuous improvement, but only if you have a closed-loop process to address issues you find. An automated QMS holds a distinct advantage over manual tracking and follow-up methods.

7. Data-driven decision-making

TQM focuses on making decisions based on performance data. A proactive organization will collect and analyze data on an ongoing basis, using integrated Reporting tools to analyze trends and take action.

8. Communication

The final element of TQM is communication. QMS automation can help here, ​​so that all employees know about updates, policy changes, and new processes. This prevents information silos, and it helps more accurately measure the effectiveness of current policies and procedures. The communication process must include all front-line employees, to whom performance data matters just as much as it does to leadership.

The final element of TQM is communication. QMS automation can help ensure that all employees know about updates, policy changes, and new processes. The communication process must include all front-line employees, to whom performance data matters just as much as it does to leadership.

An advanced QMS system helps companies to realize a variety of benefits, such as the following.

Streamlining the transition from quality as a cost center to quality as a driver of enhanced financial performance.

Connecting elements of quality across departments and breaking down data silos to improve production inefficiency.

Providing structure for a worker-focused approach to training, safety, and operations.

Leveraging customer complaints to inform product improvements and messaging.

Serving as catalyst to organization-wide digital transformation through enterprise integration and advanced, actionable analytics.

Helping the business to develop healthy, productive, and honest relationships with suppliers and customers.

How to select a QMS: 7 factors to consider

As demand for QMS solutions grows, so does the vendor landscape, complicating decisions over the right choice that ensures a successful implementation and facilitates mission-critical quality initiatives. 

In fact, research shows 71% of software rollouts fail, are late or are over budget.

To make sure you find the right QMS solution, make sure you clearly define your needs up front, and consider the following factors in your prospective vendors.

  1. Flexibility. Operational excellence demands a QMS flexible enough to change as your processes continue to evolve in the future. 
  2. Web-Based vs. web-enabled. Web-based software allows users to access all forms, workflows and applications — including administration — through a web browser. This allows anywhere access. Web-enabled software may use third-party tools or middleware to mimic a web-based experience, but still requires installation on every computer.
  3. Secure collaboration with external partners. It’s vital to be able to streamline your supplier quality process with controlled access to your QMS.
  4. Accessible reports and analytics. For many vendors, reporting is an afterthought that involves third-party tools with limited QMS integration. A more robust QMS will have reporting tools embedded in the software, allowing you to pull data across the system for actionable insights.
  5. Integration. From production to financial to quality systems, collaborating and sharing information enterprise-wide is key to uncovering process gaps and maximizing the business value of a QMS.
  6. Scalability. Even if it’s not an immediate need, the ability to expand your QMS to other facilities, suppliers and customers makes a huge difference in overall value. 
  7. End user experience. Make sure your selection process takes into account the user’s experience, including customizing your QMS with your organization’s visual guidelines.The user experience should be intuitive and holistic, and enhance productivity.

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FAQ: What is a QMS?

What is a QMS?

A quality management system, or QMS, is a program designed to enforce and improve quality throughout a manufacturing or industrial system. Although many QMS systems are still based in pen and paper or ad-hoc spreadsheets, organizations are increasingly turning to quality management software, also known as EQMS.

What is the purpose of a QMS?

Over time, quality has moved from being a cost center to a profit center for manufacturing organizations. Quality management systems evolved as a way for companies to systematize and formalize their approach to quality, automating elements of record-keeping, data analysis, corrective action and supplier quality.

What are the features of QMS software?

Quality management software systems can serve many functions. They can help increase productivity, improve worker safety, distribute training materials, discern the root cause of quality incidents, manage suppliers and intake of raw materials, document efforts to comply with regulations, fulfill audit requests, and more.

How can companies benefit from a quality management system?

Quality management systems help streamline the transition from quality as a cost center to quality as a driver of enhanced financial performance. One key example is that QMS helps connect elements of quality across departments and breaks down data siloes that are a factor in production inefficiency. Customer complaints can help inform the designs of the next version of a product, and sales can use these improvements to sell more units. A QMS serves as an engine for continuous improvement.

What does QMS software do?

Quality management software speeds up many of the otherwise repetitive tasks involved with supporting and promoting quality. For example, it can take a very long time to assemble the documentation required to fulfill an internal or external audit demand. With a QMS, these documents are stored and tagged for automatic retrieval, condensing the task from hours to minutes.

What is EQMS?

EQMS is enterprise QMS—that is, QMS software that’s hosted either on-premises or in the cloud. EQMS can further automate quality within organizations while incorporating advanced technology elements, such as machine learning or artificial intelligence to serve the entire enterprise.

How do companies use QMS management software?

There are many ways to use QMS software, and these largely depend on the kind of company using it. A company in a heavily regulated industry, like life sciences, may use quality management software to comply with regulatory standards, manage audit requests or pursue recalls. Meanwhile, consumer products companies may use QMS to reduce nonconformances or improve productivity.

What are the steps for creating an effective QMS?

First, instead of creating a QMS from scratch, we recommend working with a qualified vendor such as ETQ. That is because homegrown QMS systems tend not to scale with the increasing need for quality. Instead, your best bet is first to understand your need for a QMS, meet with your stakeholders, and then work with your vendor to design a QMS implementation that best fits your needs.

What is QMS documentation?

QMS documentation is all the paperwork needed to make the quality aspect of the business functional. That may include organizational charts, training documents, material safety data sheets, support tickets, blueprints, operating manuals, and more.

What does a QMS do?

When implemented correctly, a QMS can dramatically streamline how quality is managed, implemented and tracked within an organization. Imagine a process that involves writing down on a clipboard and then transposing the written document into Excel. Imagine taking that process and replacing it with a tablet that automatically places results into a searchable database. That is just a fraction of the convenience QMS can offer.

What is an effective QMS?

An effective QMS is one designed for the end-user. Many companies can’t use a one-size-fits-all QMS approach. Instead, they need a system that includes custom modules and integrations that help them navigate their unique processes and application environments.

What does a QMS consist of?

A QMS consists of several applications, each designed to accomplish a specific task. A document management module stores and organizes quality data. A corrective action (CAPA) application helps quality managers direct correct ion of nonconformances of all types. A training management module stores and distributes training data while tracking workers’ progress against the required courses to operate equipment and safely navigate the industrial environment.

What are the 7 quality management principles?

  • Engagement of people: Implementing a bottom-up, worker-focused approach to training, safety, and operations
  • Customer focus: Designing products and processes to ensure the end-user is both safe and happy
  • Leadership: Quality managers must have clear goals and objectives
  • Process approach: Design a formalized workflow for each quality management task you encounter
  • Improvement: Don’t just rebound from mistakes—make every process better, no matter what
  • Evidence-based decision making: Take a scientific approach to quality, safety, training, and management
  • Relationship management: Develop healthy, productive, and honest relationships between both customers and vendors

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