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A quality management system (QMS) represents the collection of documented processes, management models, business strategies, human capital, and information technology that are used to plan, develop, deploy, evaluate, and improve a set of models, methods, and tools across an organization for the purpose of improving quality, particularly in-line with the organization's strategic goals. The successful development and deployment of a QMS requires the assessment of organizational resources, customer needs, industry product cycles, and more.[1] A QMS will attempt to establish organizational policy and objectives for resource management, assign responsibility and authority to personnel, and put into place an organizational structure among personnel.[2] The QMS will also be designed to focus on the core elements of quality management: planning, control, assurance, and improvement.[3] However, a QMS should not be confused with product and service standards, which tend to give "explicit requirements that specific products and services should conform to" rather than broad good management practices applicable to any product or service.[4]
A successful quality management system may drive competitiveness in the organization, but competitiveness is not the core goal of a QMS; rather, customer satisfaction and, to a lesser degree, financial performance are tied to a successful QMS implementation.[1] Additionally, a QMS may reduce waste, identify and facilitate training, and improve staff engagement.[5]
The concept of "quality" as we think of it today first emerged from the Industrial Revolution. Previously, goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking of a product to meet quality criteria. Mass production brought huge teams of people together to work on specific stages of production, where one person would not necessarily complete a product from start to finish. This mass production inevitably led to a decline in quality due to its emphasis on driving down prices rather than quality. This led to "a neeed for a more regulated system both in ensuring that machines used by manufacturers were not the real problem for substandard goods as well as checking items as they came off the production line."[6]
In the early 1900s, pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor, utilizing the concept of scientific management, helped separate production tasks into many simple steps (the assembly line) and limited quality control to a few specific individuals, in turn limiting complexity.[7] Ford emphasized standardization of design and component standards to ensure a standard product was produced, while quality was the responsibility of machine inspectors, "placed in each department to cover all operations ... at frequent intervals, so that no faulty operation shall proceed for any great length of time."[8]
Post World War II saw statistician and mathematician William Edwards Deming (after whom the Deming Prize for quality is named), the father of the quality management movement, develop a theory of quality management that focused on the "joy in work," while placing emphasis on quality at each step of a process, not simply on the final inspection.[9] This led to several Japanese scientists and engineers inviting Deming to Japan in 1950 to share his ideas on statistical methods towards improved quality, with several companies seeing productivity and profit gains after adoption.[9] In 1951, engineer and management consultant Joseph M. Juran published the first edition of Juran's Quality Handbook, an influential guide to quality management that focused on "fitness for use by the customer" as a goal of quality. Juran's work, focusing on management's influence on quality, had a similar impact on the Japanese. The combination of Deming's and Juran's influence ultimately led to the Japanese developing their own take on quality management: Japanese Total Quality Control.[9]
In the mid-twentieth century, the focus on quality as a professional and a managerial process saw the quality profession grow from simple engineering controls to systems engineering that took quality into account at its various steps. This was most noticeable in the Japanese strategy to industry, though the U.S. didn't clearly recognize it until the early 1980s. With the decline in price competition and increase in quality competition in the 1970's putting American manufacturing in a difficult position, the early to mid-1980s saw the U.S.' industrial and government leaders recognize Japan's quality strategy[10], committing to a renewed emphasis on quality in order to stay relevant in an expanding and competitive world market. The Malcolm Baldrige National Quality Improvement Act of 1987 spawned the associated National Quality Program, commonly referred to as the Baldridge model[1], and an award program that acted as a standard of excellence to further drive quality innovation in the marketplace. That same year, the ISO 9001, 9002, and 9003 standards were published; based off work from previous British and U.S. military standards, the standards sought to "provide organizations with the requirements to create a quality management system (QMS) for a range of different business activities."[11] Other awards like the Deming Prize were set up by the Japanese, and the first non-Japanese company to win the prize was the U.S.'s Florida Light and Power in 1989.[12] The trend continued into Europe with the introduction of the European Foundation for Quality Management in 1991.[1]
By 1994, the ISO 9000 standards saw a new iteration, putting a new focus on preventative action.[11] At least 150 countries adopted the ISO 9000 standards by the end of 1999, with the associated third-party registration industry having a total economic impact of $4 billion. The number of adopting countries had climbed to 161 by the summer of 2002[13], after the major update of the ISO 9001:2000 standard, which merged 9002 and 9003 into it and added new process-based changes.[11] Changes in 2008 were minor, but the 2015 revision saw major revisions in structure and how common requirements were aligned with other relevant standards, with more of a focus on risk-based thinking.[11]
Many standards are used internationally for designing, implementing, and auditing quality management systems, though ISO 9001:2015 is the most well recognized and used. Other standards include[5]:
While quality management systems may vary by industry and by company policy, most typically share the same base-level elements, including[5]:
These items should be an expression of senior management's desire to commit to a QMS, based on the standard(s) used and the company's vision and mission. The policy will largely focus on customers and other interested parties, using a process approach that uses evidence-based decision making and encourages improvement. Quality objectives are derived from the policy and cover all functional levels of the business.[15]
A quality manual is the first set of documentation primary to a QMS, and it's used to communicate management's expectations towards quality, how to conform to them, and how to measure that conformity. The manual typically contains a full description of the QMS, describing the standard-based requirements, quality procedures, exclusions, interactions, and granular quality policies. A successful quality manual further guides a business towards continual improvement.[16][17]
Quality procedures don't have a set format but should include a series of consistent elements, including title, purpose, scope, responsible parties, resulting records, document controls, activity descriptions, and appendices. Any instructions should be similarly structured but also include "details of activities that need to be realized, focusing on the sequencing of the steps, tools, and methods to be used and required accuracy."[18] A record of proofs provide traceability of the various actions taken to comply with those quality procedures and instructions, providing tools for continual improvement and corrective action.[19]
From creating the policies and procedures to tracking conformance to them, files records of various sorts are inevitably created. Being able to integrate those documents and related data across the enterprise can be tricky but beneficial. Strong data management policies applied to quality data help businesses can not only mitigate risk and determine trends but also help them maintain regulatory compliance. Setting up data management policies and systems requires planning, however, including determining data types, data ownership, data quality, and metadata availability. Additional, any quality data management policy and system should meet organizational goals while identifying what should be included and excluded, and they should include a clear roadmap for how it will be implemented. Quality data management systems should be able to hand normalization, versioning, archiving, and compliance-related security.[20]
Keeping a QMS process-based allows the various inputs and outputs of a business stay connected and unified in quality. By recognizing that "the output of one process becomes the input of another process,"[15] a single integrated process that depends on quality is revealed. Derived from procedures and instructions, a process map is built, detailing resources, authority, risks, and evaluation methods that are associated with those processes.[21]
Product and/or service quality that leads to customer satisfaction is a primary goal of a QMS. This focus often comes down from senior leadership, who encourages personnel to take a similar focus through the management of relevant requirements, the management of relevant risks and opportunities, and the commitment to improving customer satisfaction.[21] Overall company policies should include this focus, which should then make it's way into more effective process management, and by extension, higher customer satisfaction, measured using a set of principles that include data collected directly from customers and an additive formula that aggregates all that data into a global picture of satisfaction.[22]
A major part of a QMS is evaluating and improving processes and procedures to improve overall quality. Part of this process may include defect analysis for products, customer satisfaction analysis for services, and corrective action planning. Also included is overall product testing, tests that, for a product, may measure material, electrical, stressed, etc. characteristics to ensure functionality for the end-user. Even the business' own operations may be scrutinized to identify points in the system where physical or economical impact is most negatively felt.
Continual improvement recognizes that customer needs change over time and that an incremental innovation process should always be in place to address those changing needs. "Small steps, high frequency and small change cycles seen separately have small impacts but, added up can bring a significant contribution to the company’s performance."[23] Optimally the idea of continual improvement should also be promoted by senior leadership, finding its way not only into the quality manual but ultimately also into the work culture.[23]
Several guidelines apply to laboratories, whether they conduct testing, calibration, or other activities. The most commonly used standard that discusses the use of a quality management system is ISO/IEC 17025. Originally focused on calibration and testing activities, a revised version of the standard is set to be published at the end of 2017 with a broader scope of all laboratory activities.[14] The revised standard will also be more inline with the process approach of ISO 9001 (already used in research and development laboratories[24]), ISO 15189 for medical laboratories, and ISO/IEC 17021-1 for bodies auditing and certifying management systems.[14] ISO/IEC 17025 essentially lays out the management and technical requirements for a laboratories quality management system and how it should be implemented and assessed.[25]
Additionally, ISO 15189 addresses quality management systems in four major components: management responsibility, resource management, service realization, and continual improvement.[26] Also related is the Clinical and Laboratory Standards Institute's (CLSI) GP26-A3 and HS1-A2 standards on quality management system models, which offer 12 quality system essentials and are compatible with the associated ISO standards.[27]
The two primary guidelines for medical device manufacturer quality management systems in the United States are the ISO 13485 standard and the U.S. Food and Drug Administration's (FDA) 21 CFR Part 820 regulations. The two have a great deal of similarity, and many manufacturers adopt a QMS that is compliant with both guidelines. Outside the U.S., ISO 13485 has synergies with the European Union medical devices directives (93/42/EEC and 90/385/EEC; superseded by Regulation (EU) 2017/745 in May 2017[28]) as well as the in vitro diagnostic medical device directive (98/79/EC and 2010/227/EU; superseded by Regulation (EU) 2017/746 in May 2017[28]). The ISO standard is also incorporated in regulations for other jurisdictions such as Japan (JPAL) and Canada (CMDCAS).
According to current good manufacturing practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply relevant sections standards, regulations, and guidelines that are applicable to their specific products and operations. As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.
Because the FDA's 21 CFR Part 820 regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left up to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement procedures tailored to their particular processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there is only one label to each product, then it's not necessary for the manufacturer to comply with all of the GMP requirements under device labeling.
As businesses and organizations have begun converting to digital data management methodologies and bringing data sources together for improved workflow and insights, the quality management system has moved from the paper realm to the electronic realm. This change allows for a more dynamic QMS that can be analyzed and updated more readily while digitally serving up a quality message to everyone in the organization.[29] An electronic QMS (eQMS) also provides more real-time data management, including automatically keeping track of any trend-related metrics that management require, record retention policies, inspection data, training records, and risk analysis data.[30][31]
The eQMS may also integrate features from other software systems, including[32][33]:
Organizations can participate in a continuing certification process to ISO 9001:2015 to demonstrate their compliance with the standard, which includes a requirement for continual (i.e., planned) improvement of the QMS, as well as more foundational QMS components such as failure mode and effects analysis.[34]
In the U.S., the national Baldrige Performance Excellence Program educates organizations in improving their performance and administers the Malcolm Baldrige National Quality Award. The Baldrige Award recognizes U.S. organizations for performance excellence based on the Baldrige Criteria for Performance Excellence. The Criteria address critical aspects of management that contribute to performance excellence: leadership; strategy; customers; measurement, analysis, and knowledge management; workforce; operations; and results.[35] Other state and local Baldrige programs can be found via the non-profit Alliance for Performance Excellence.[36]
Since 1984, Canada's National Quality Institute has presented the Canada Awards for Excellence on an annual basis to organizations that have displayed outstanding performance in the areas of quality and workplace wellness and have met the institute's criteria with documented overall achievements and results.[37]
In Europe, the European Foundation for Quality Management's EFQM Model supports an award scheme similar to the Baldrige Award for European companies.[38] Additionally, the European Quality in Social Services (EQUASS) sector-specific quality system addresses quality principles that are specific to personal services providers in the social and vocational education and training (VET) sectors.[39]
This article reuses a few elements from the Wikipedia article.
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