The Toyota Production System (TPS) and lean are probably the first things that come to mind when one is asked about the origin of today's quality management system (QMS). Although these manufacturing approaches have made significant contributions to the process of improving quality management and overall quality, there is a much longer history behind how QMS first got its start.

In this article, we take a trip through time to investigate the true beginning of quality management systems (QMS) and how it has developed over the past few years into a widely adopted cloud-based enterprise solution that assists highly regulated businesses in achieving success in new product development and introduction (NPDI). This model of handicrafting, which placed an emphasis on inspections and quality control, persisted well into the early years of the industrial revolution.

Frederick Winslow Taylor, a mechanical engineer, developed a new method in the late 19th century that was centered on increasing productivity and profitability without increasing the number of craftsmen or the strain on workers. This approach was a departure from the traditional European quality practices that had been in place up until that point.

Engineer Walter Shewhart developed statistical quality control methods in the 1920s to assist businesses in improving their production processes by reducing the amount of variation that was present in those processes. William Deming, an engineer and statistician, worked closely with Shewhart and was able to successfully apply Shewhart's methods to the production of military goods during World War II thanks to their close collaboration. This made it possible for the armed forces to speed up inspections without sacrificing the quality or safety of the products. Japanese manufacturers sought out the assistance of Deming and engineer Joseph Juran for their quality expertise with the intention of producing consumer goods of a higher quality while also reducing the amount of raw material waste. Because of this novel approach to total quality, Japan was able to produce goods of ever-increasingly high quality at ever-lower prices, which contributed to the country's economic expansion in the decades that followed.

Around the same time, the Japanese automobile manufacturer Toyota presented the Toyota Production System (TPS), which was centered on the idea of steadily enhancing the manner in which value is delivered to customers.

UNITED STATES OF AMERICA ADOPTS TOTAL QUALITY MANAGEMENT
In the 1980s, the United States economy struggled as a result of its inability to compete successfully with that of Japan. This encouraged top executives in various companies to join the total quality management (TQM) movement.

INTRODUCTION TO THE ISO 9000 SERIES AND THE SIX SIGMA SYSTEM
As more time passed, the fundamentals of TQM began to lose their significance, and new quality management strategies came into existence. Six Sigma made it possible for businesses to enhance their processes and get rid of manufacturing defects by providing qualitative and quantitative tools such as control charts and process mapping. Six Sigma is a quality management system that has become increasingly popular among businesses in recent years.

The International Organization for Standardization (ISO) released the first standard in its ISO 9000 series of quality management guidelines in the year 1987. These standards were developed to assist businesses in documenting and managing the various components of a quality management system in order for those businesses to achieve higher levels of customer satisfaction, conform to the requirements of relevant regulatory agencies, and show a commitment to ongoing improvement. In the year 2000, a revision to the ISO 9000 series of quality management standards was implemented to place a greater emphasis on satisfying the needs of customers. In addition, the ISO 9001 standard underwent a revision in 2015 that placed a greater emphasis on risk management. Manufacturers are being forced to collect more extensive technical data in order to demonstrate compliance with increasingly stringent regulations that are being implemented all over the world. And despite the fact that the various regulations adhere to the same fundamental concepts, manufacturers are still required to keep a close eye on them in order to stay abreast of the ongoing alterations and complexities that have an effect on their company.

Companies can quickly resolve quality issues and drive continuous improvement by adopting cloud-based enterprise quality management system (eQMS) solutions. These solutions eliminate data silos and communication barriers, allowing for quicker resolution of quality issues. Innovative solutions, such as Arena's product-centric Quality Management System (QMS), connect the product records and quality records in a single digital platform. Companies have a greater level of confidence in their ability to pass audits and meet their commercialization milestones as a direct result of the application of automated change processes and revision controls to this information.4 billion by the year 2030, businesses are looking to quality maturity to assist them in having a positive impact on their total cost of quality. In the field of medical technology, numerous businesses must contend with the difficulties of GxP* readiness and compliance, in addition to the ever-changing requirements of regulations such as the EU MDR. The objective is to advance to higher stages of maturity as quickly as possible so that increased compliance, improved product quality, and decreased overall quality costs can be realized.

THE FOLLOWING ARE THE 5 COMPONENTS THAT SHOULD BE PRESENT IN A NEXT-GENERATION CLOUD QMS Compliance Readiness:
Because of the stringent requirements that must be met, it is essential that your quality management system (QMS) be ready for compliance and closed-looped to ensure accuracy and efficiency. A purpose-built, integrated Cloud QMS should be able to assist in the elimination of siloed systems, the promotion of collaboration, the reduction of overall quality costs, and the facilitation of informed, data-driven decision-making as your company works to comply with industry regulations such as ISO 9001, 21 CFR Part 820, and ISO 13485.

Quality in both the Intelligence Gathered and the Reporting:To make decisions that are both informed and driven by data, you need easy access to data that is both complete and accurate regarding the quality system. With the assistance of robust business intelligence that is integrated with standard reports, your teams should be able to make the most informed decisions possible at the appropriate time.

Protecting the information related to your quality management system in a manner that is in accordance with the standards set by the industry requires a cloud environment that is highly reliable, secure, and efficient.

Expertise in the Industry: The QMS solution provider ought to have in-depth expertise and an understanding of your industry in order to support your company's goal toward process collaboration and proactive quality, which will help improve your next-generation Cloud QMS deployment. An intuitive user interface offers a number of benefits, including a reduction in cycle times and error rates as well as a reduction in the amount of training that is required. The user interface needs to be approachable for everyday users, while also being robust enough for administrators and experts.