In the present paper, a Quality Systems Theory is presented. Certifiable Quality Systems are treated and interpreted in accordance with a Thermodynamics-based approach. Analysis is also conducted on the relationship between Quality Management Systems (QMSs) and systems theories. A measure of entropy is proposed for QMSs, including a virtual document entropy and an entropy linked to processes and organisation. QMSs are also interpreted in light of Cybernetics, and interrelations between

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... on Theory and quality are also highlighted. A measure for the information content of quality documents is proposed. Such parameters can be used as adequacy indices for QMSs. From the discussed approach, suggestions for organising QMSs are also derived. Further interpretive thermodynamic-based criteria for QMSs are also proposed. The work represents the first attempt to treat quality organisational systems according to a thermodynamics-related approach. At this stage, no data are available to compare statements in the paper. Entropy 2017, 19, 418 2 of 20 into conventional definitions of system, being "sets of elements standing in interaction", according to von Bertalanffy, or "integrated set(s) of elements ( . . . ), that accomplish a defined objective", or even a "combination of assembled and interconnected elements . . . which have a defined goal" [6] [7] [8] . Additionally the lack of theoretical foundations for quality has been reported [9] . To the writer's knowledge, in fact, not many publications exist on this topic and recently works have attempted a theoretical approach on (total) quality management systems based on a broad range of frameworks, e.g., based on a constructivist and pragmatic framework [10] . The aim of the present paper is to provide quality systems with a broad, thermodynamics-related theoretical background. After a first interpretive step aimed to frame quality in the proper system model, quality assumptions are discussed according to Thermodynamics and related disciplines, such as Cybernetics and Information Theory. Ways to evaluate the entropy and information of organisations, processes, and documents are proposed. The paper also attempts further the interpretive suggestions for QMSs. Aware of the risk of "jumping onto the bandwagon", for (maybe) overusing the terms entropy and information in inappropriate contexts, as Shannon feared, this reasoning is conducted as closely as possible to the original meaning of such terms [11] . To the author's knowledge, the present work represents the first attempt to treat QM organisational systems according to a Thermodynamics-related approach. At this stage, no analogue data are available to compare statements in the paper. Quality Certifiable quality is a means of attesting to the attitude of an organisation in providing a service or products matching the requirements of a given (international) standard. The three standards of the ISO 9000 family (ISO 9000, ISO 9001, and ISO 9004) represent the keystone of certifiable quality [1, 12] . They provide a reference guide for companies that intend to organise a quality system or service. ISO 9001 specifies the requirements against which a QMS can be certified. The standards of specific certifiable fields are generally written in line with the ISO 9001 scheme and updated accordingly, e.g., ISO/IEC 17025 in the field of testing and calibration laboratories and ISO 15189 for medical laboratories [12] [13] [14] . A third-party certification (or accreditation) body is required to attest that the organisation meets the requirements of the standard. According to ISO 9001, quality is based upon seven quality management principles (QMPs), the basic beliefs of the theory, which are: (i) customer focus, which drives the company to pay great attention to the needs of customers and other interested parties, a crucial element for the organisation's adequacy (customers and interested parties represent its environment); (ii) leadership, necessary to ensure unity of purpose as well as quality policy and objectives; (iii) engagement of people in order to promote shared participation; (iv) process approach since "managing interrelated processes as a system contributes to the organisation's effectiveness and efficiency in achieving its intended results"; (v) improvement, which is important, not only to maintain high levels of performance, but also to adapt to changes in internal and external conditions; (vi) evidence-based decision making since decisions should be based on the analysis of data and information; and (vii) relationship management since, for sustained success, an organisation manages its relationships with the exterior (e.g., interested parties and suppliers). QMPs intertwine with all areas covered by the specification. The standard (especially the most recent 2015 version) draws particular attention to the fact that the organisation should understand its external and internal context [12] . External context can be defined as the complex interaction of influences arising from social, legal, and economic aspects, government regulations, competitors, and evolutions in technology. The organisation is required to "understand the needs and expectations of interested parties" (identifiable in e.g., customers, suppliers, corporate partners, regulatory bodies, etc.). In accordance, organisations periodically review all important (internal and mainly external) issues. Entropy 2017, 19, 418 3 of 20 The way to determine the context is not clarified, but devices to perform such a requirement do belong to classical management and could consist in competitor and SWOT (Strengths, Weaknesses, Opportunities, and Threats) analysis, market research, and economic reports. The scope of a quality management system should thus be consistent with the organisation's context (the needs of customers). A process-based management system is required [12] . Leadership ensures that resources, quality policy, and objectives are established and are consistent with the strategic direction undertaken. This section also deals with customer focus, which is the effort addressed to customers' needs, thus representing the point towards which business activities are focused. It is a crucial element for an organisation's survival (customers represent the environment to which companies have to be attuned) [12] . A quality policy is a strategic document issued to disclose an organisation's directive and purpose with respect to quality [12] . According to ISO 9001, it is a written document to be communicated to and applied within the whole organisation [12] . Moreover, for reasons of clarity and organisational order, roles are to be assigned and responsibilities allocated, communicated, and understood within the organisation [12] . An organisational chart is the best way to comply with this prescription. Planning in QMSs is an accomplishment fundamentally based on risk analysis. Once identified, risks and opportunities are properly addressed, thus planning mainly consists of preventive action conducted in a systemic way, with the aim of avoiding resorting to ad hoc corrections of undesired effects already in action. It should obviously be developed and balanced according to the organisation's context and objectives in order to find the best way to achieve the intended results [12] . Clearly defined quality objectives consistent with quality policy are thus to be established [12] . ISO 9001 Clause 7 requires adequate resources to ensure that objectives and essential elements of quality (establishment, implementation, and improvement of the system) are provided, viz. people, infrastructure, and environment for operations [12] . Moreover, the organisation should be aware of the knowledge (information) necessary for carrying out its processes and, maybe more importantly, the organisation should consider how to acquire and improve any necessary additional knowledge to enhance competence. Knowledge thus consists of information gained from experience (internal knowledge) or imported from the exterior (e.g., methods, standards, technology) [12] . Documented information, viz. instructions and registrations, is to be maintained. Some standards specifically prescribe a "Quality manual" and procedures (e.g., ISO/IEC 17025, ISO 15189) [13, 14] . It is important to underline that the latest version of ISO 9001 has replaced the previous terms "documents" and "records", focusing on the single term of "information". Operation, dealt with in Clause 8, represents the core of the organisation's activity. It can be stated that the whole of the surrounding system governs this section. It foresees adequate process and controlling criteria. The organisation should, in fact, design, implement and control processes, as well as establish criteria for their acceptance. Feedback should be acquired from the customer in relation to products and services provided. To be in tune with the standard requires that the company ensure the conformity of externally provided processes, products, and services, mainly if they are intended for incorporation into the organisation's own domain. The organisation must also apply criteria for the selection and monitoring of external providers [12] . The evaluation of performance is actuated by monitoring customer satisfaction as well as the outputs of internal activities aimed at satisfying it, then through internal audits and management review [12] . Planned audits, together with non-conformity managements (see [12] ), are one of the most important control mechanisms adopted to maintain the set requirements. Management review is a high level integrated control, according to which top management, at planned intervals, reviews the whole system. It is conducted by analysing the most important indices of adequacy, e.g., information on performance, feedback on customer satisfaction and from interested parties, the management of