QMS includes. What is included in the concept of quality management system

Quality Management System(QMS), developed in accordance with the standard ISO 9000, is a management system based on a structured set of elements that implement all the functions of the enterprise to achieve quality. The main elements of an effective QMS are:

formulated goal of activity

availability of resources

a formulated algorithm for achieving a goal that allows you to transform resources into what is the goal of the QMS

Information support is a kind of “nervous system” of an enterprise.

The development of QMS documents is only the first step, a necessary, but far from the only condition for obtaining a certificate. The most important problem in creating a QMS is effective motivation and clear information support at all levels of the enterprise. Only if the company's management clearly understands the subject, goals, methodology and practice of implementing a QMS is it possible to achieve a positive result.

The quality management system is part of the overall company management system, which functions to ensure stable quality of products and services provided.

main idea The international standard ISO 9001 is that quality management is not only about monitoring the quality of manufactured products and services provided, but a more complex and multifaceted concept that consists in ensuring the quality of company management as a whole.

The quality management system, described in the international standard ISO 9001, represents the best practices for quality management, collected from the experiences of various companies around the world and combined into one document.

In fact, the QMS is a company’s quality management system, including: interconnected and interacting processes and procedures, organizational and technical measures, goals, plans, competent personnel, fixed assets, documentation, i.e. everything that a company needs to achieve its business goals.

To enable senior management to lead an organization towards improved performance, the standards define eight principles of quality management or total quality management (TQM).

The TQM principle is a comprehensive and fundamental management rule for the promotion and operation of an organization aimed at long-term, continuous improvement of customer-oriented performance while taking into account the needs of all other interested parties. Below are the main points of the 8 principles of TQM.

1.Customer orientation. The consumer has the final say regarding product quality. Businesses depend on consumers and therefore they must understand the needs of current and future consumers and strive to exceed their expectations. In all cases, priority is given to customer satisfaction, followed by consideration of the satisfaction of the interests of all stakeholders.

2.Leadership of executives. This does not mean responsibilities so much as psychological leadership. The role of a leader has changed - from the boss who knows everything and gives orders, to the role of a coach who creates a favorable atmosphere and builds a working team. Management's responsibilities in the new version of the standards are expanded and determined by a whole block of requirements.

3.Employee involvement. People at all levels are the main resource, the main asset of the organization, and their full participation makes it possible to use their abilities for the benefit of the organization.

4. Process approach. The most desirable results are achieved when coordinated activities are managed as a single process. A process is the totality of all actions from the beginning (input) to the end (output). A process is a system of activities that use inputs to transform them into outputs.

5. Systematic approach to management. Understanding, regulating and managing a system of interrelated processes to achieve this goal improves the organization's efficiency and effectiveness. The adoption of this principle suggests that this system has a certain structure, regulates the components of the relationship between them, and this system can be constantly improved through measurements (continuous monitoring) and a self-assessment mechanism. 6.Continuous improvement. Continuous improvement should be the organization's primary goal. The point here is that improvement is not a means to improve something in any particular case, but rather the global goal of the organization.

In terms of products, processes, systems, there is no limit to perfection; this is the culture of correct execution of the process, its improvement, and much more.

7.Making decisions based on facts. Effective decisions can be based on objective information and made only as a result of data analysis of such information. The application of this principle leads to the implementation of the following actions:

apply measurement and control, data and information collection in accordance with the objectives;

ensure the necessary accuracy, accessibility and reliability of information;

use reliable methods for processing data and information;

understand the importance of statistical methods and use them widely;

make decisions and take actions based on analysis and experience

8.Mutually beneficial relationships with suppliers. It is obvious that the enterprise and its suppliers are interconnected and their mutual cooperation enhances the ability of both to create value for the consumer. Mutually beneficial cooperation means:

assessment and selection of key suppliers;

cooperation that balances short-term profits with long-term benefits for the organization and society as a whole;

creating honest and open relationships;

initiatives for joint product and process development;

exchange of information about plans for the future;

recognition of supplier improvements and achievements.

The form of building standards is traditional.

Fig.2. Scheme of operation of the standard

The key task of company management is the creation, practical implementation and subsequent certification of a quality management system (a modern term that replaced the previously used term “quality management system”), ensuring stable, sustainable quality of manufactured and supplied products over a certain period of time (contract validity, term release of products of this type, etc.).

The guarantor of such stability is the presence of a quality management system at the manufacturer that meets recognized international requirements.

Quality management is essentially an end-to-end aspect of the enterprise/company management system - similar to time, costs, and personnel management. It is this position that lies at the heart of the fundamental principles that underlie modern quality management systems:

Quality is an integral element of any production or other process (and not some independent management function);

Quality is what the consumer says, not the manufacturer;

Responsibility for quality must be targeted;

To truly improve quality, new technologies are needed;

Quality can only be improved through the efforts of all employees of the enterprise;

Controlling the process is always more effective than the result;

The quality policy must be part of the overall policy of the enterprise.

These principles underlie the most popular and methodologically strong direction in quality management - Total Quality Management - Tota1 Management (hereinafter - TQM).

Quality management is a system of methods, means and activities aimed at meeting customer requirements and expectations for products.

In accordance with clause 3.2.8 GOST R ISO 9000-2001 quality management represents the coordinated activity of leading and managing an organization with regard to quality.

Quality management includes the following elements:

Development of quality policies and goals;

Quality planning;

Quality control;

Quality assurance;

Quality improvement;

Quality control.

Figure 3.2 shows the general block diagram of quality management.

Quality management includes all the functions of general management for developing a quality policy, establishing goals, powers and responsibilities, as well as the planning, control and quality assurance processes through which these functions are implemented within the quality system.

Rice. 3.2. General structure diagram of quality management

The leaders of the organization must formally announce its main goals and objectives in the field of quality, i.e. formulatecompany quality policy, which is an integral element of the general policy of the company. An organization may pursue, for example, goals such as expanding the target market, introducing new products to the market, reducing the level of defects in manufactured products, etc. Quality policy is implemented through quality assurance, quality management and quality improvement.

Quality assurance- this is a planned and systematically carried out activity within the framework of the quality system, necessary to create confidence in the proper quality of the object (product, process, system).

Quality control- an integral part of quality management aimed at meeting quality requirements. Quality management is the methods and activities of an operational nature used to meet quality requirements and aimed at eliminating deficiencies at all stages of the quality loop.

Within the framework of quality management activities, we can talk about the implementation of functions of a strategic and tactical nature. The first group includes the following functions:

Forecasting key quality indicators based on analysis of consumer demand trends;

Determination of the main directions of design and engineering work;

Analysis of the overall results of the organization’s activities to improve product quality. The tactical level is represented, for example, by the following functions:

interaction of the organization with the external environment (suppliers, intermediaries, etc.);

Maintaining a given level of product quality (accounting, control, analysis, regulation of intra-company factors affecting product quality). When solving quality management problems, special attention is paid to such activities as quality planning, quality control, training and motivation of personnel.

Quality planning- an integral part of quality management aimed at establishing quality goals and determining the necessary operational processes of the product life cycle and the corresponding resources to achieve quality goals. Part of quality planning may include the development of quality plans. Quality planning involves determining specific quality indicators for all areas of the company’s activities (examples of such indicators are shown in Fig. 3.3).

Rice. 3.3. Examples of quality indicators in various areas

activities of the organization

Quality control- monitoring specific results of project activities in order to determine their compliance with quality standards and requirements and determine ways to eliminate the causes of real and potential non-conformities.

Quality control requires information on the progress of the project, a quality plan, and quality documentation.

Quality control is carried out using the following methods and tools:

Checks;

Control charts, which are a graphical representation of the results of the process;

Pareto charts, which are histograms of the occurrence of various causes of inconsistencies, ordered by frequency;

Statistical sampling, time series analysis, correlation and regression analysis and other statistical methods;

Diagrams.

Quality control can end with the following decisions:

Quality improvement;

Product acceptance;

Identification of defects and implementation of actions to manage non-conforming products;

Processing of products for the purpose of further presentation for control and testing;

Correction of processes.

When implementing a QMS at any enterprise, changes occur that are aimed at establishing technological transparency of all types of activities. In other words, the introduced rules allow you to trace the entire path of a product within the enterprise: receiving an order from a client, purchasing raw materials, manufacturing products at each stage, checking, storing and shipping products to the client. With such technological transparency, product defects and technology shortcomings are easily identified, as well as the reasons for their occurrence. And not everyone likes this. The peculiarities of the history of our country and the imperfection of human nature have led to the fact that sometimes workers try to hide defects and perform technological operations with deviations from the requirements. For them, the introduction of QMS is associated with negative experiences, “struggle” with innovations, even hidden or obvious sabotage. For other workers who are accustomed to working “conscientiously”, the introduction of a QMS is a long-awaited and desired restoration of order, an opportunity for self-realization in work, an opportunity to gain satisfaction from work, which, moreover, is usually financially encouraged by the management of the enterprise.

The question is often asked: “Tell me in a nutshell what a QMS is.” To answer this question, you need to carefully read the ISO 9001 Standard. However, we must honestly admit that the Standard is written in complex language, and understanding its contents without additional training is not easy. Therefore, we will take the liberty of retelling the main requirements of the Standard in accessible language. The list of requirements for the activities of the enterprise and each employee will not be numbered in the usual order of 1,2,3, but according to the paragraphs of the Standard containing the relevant requirements.

4.1. It is necessary to present all enterprise activities as a chain of processes or subprocesses. Depending on what we expect at the end of each process (drawing up a production plan, producing a batch of finished products, etc.), we must learn to numerically measure the state of the process, establish a demarcation mark between the concepts of “what is good” and "what is bad." For example, they decided to measure the quality of the plywood manufacturing process using indicator (indicator) “Share of high grades in total production” . The boundary between “good” and “bad” is performance criterion process, equal to 52% (this figure is taken as an example) . If 52% or higher grades of plywood are obtained, then we say that the process is effective. If it turns out to be 51% or less, then this means that the process is going poorly and needs improvement. Thus, it is necessary to measure all activities that determine product quality. Continuous improvement of processes is product quality management.

4.2. It is necessary to manage information that contains product and process requirements and production status data. The carriers of such information are documentation on paper and electronic media and records, also on paper and electronic media.

4.2.3. Requirements for products, semi-finished products, as well as for processes (technological modes) are contained in DOCUMENTS. You must use only current documents. Our enterprise has established strict rules for the use of documents of external origin (for example, GOSTs) and internal origin (instructions, procedures, drawings). A new concept “Procedure” is introduced. This is a document that provides a sequence and description of actions, indicating the positions responsible for each action.

4.2.4. Evidence of compliance or non-compliance is contained in RECORDS(magazines, work orders, invoices, acts, reports). If a recording is made, be sure to indicate the date and who made the recording. All records are kept carefully and stored in designated places so that they can later be found and reviewed again.

5.3. The management of the enterprise wrote a short but important document “ Quality Policy" EVERY employee of the enterprise must read this Policy to the end at least once and understand what in this Policy concerns him personally. The Policy sets out the long-term (strategic) goals of the enterprise. Not all enterprises have such a document. The presence of a clear Policy indicates that the owners and management believe in the successful future of their enterprise, try to ensure its stability, for which they invest in the development of the enterprise and in the selection of the best personnel. By reading the Policy, each employee must understand what contribution he personally can make to achieve the strategic goals of the enterprise.

5.4.1. The management of the enterprise established " Enterprise goals", which must be achieved by the enterprise as a whole in the short term (1 year), and goals for each head of departments and services. The management of the enterprise values ​​its employees, first of all, because they know how to find ways to achieve goals. For some, this is the commissioning of new equipment on schedule, for others, it is the timely implementation of the plan for the development of technological documentation for products; for workers, it is the ability to produce high-quality products.

5.5.1. The management of the enterprise must decide how to communicate to employees what they are responsible for ( responsibilities and powers). This could be: an employment contract, procedures, regulations on services and departments, job descriptions, orders, oral instructions. Each employee must know what he is responsible for and what powers (rights) he has.

5.6. Enterprise management must periodically analyze how well the enterprise management system is functioning. To do this, extensive information is collected - both positive and negative - about various aspects of the enterprise's activities. This analysis is carried out at meetings dedicated to product quality and service interaction.

6.2.2. For each employee whose activities affect the quality of products, there must be established requirements for his competence: basic education, additional training, skills and experience. The company must ensure that the competence of its employees is constantly improved. It is necessary to record in writing the results of assessing the competence of employees. Such an assessment should be periodically carried out by managers in relation to their subordinates.

6.3. The management of the enterprise must take care of the serviceability of the equipment so that it does not stand idle during unscheduled repairs and is safe. It is necessary to carry out scheduled repairs and follow the rules for working on equipment. An indicator of the high-quality work of mechanics is a small number of equipment downtimes.

And ultimately, profits. In addition to (QMS, - ed.), the most popular models of business excellence (ed.), lean production (lean-management, - ed.), paradigm, . Thanks to the low number of Russian materials on the topic: it can be difficult for a top manager not only to understand what to choose for himself from the listed arsenal. The problem arises and how to use it. (QMS - Quality Management Systems - QMS, - ed.) is the mechanism of scientific and practical management most mastered by the Russian market. Suffice it to say that, according to the survey, which refers to the brochure of the Ministry of Industry and Trade (Ministry of Industry and Trade - ed.) “Lean Manufacturing and Quality Management Systems”, 97% of domestic industrial enterprises covered by the study comply with the international standard ISO 9001. For comparison , only 36% of the sample worked with lean tools. But even most managers are not well versed in the opportunities available to them in the QMS field. A system is made for them, and certificates are issued. But the staff quickly rejects alien and incomprehensible “Western things.” This only says one thing: even if you bought something “turnkey”, you still need to be able to use it, otherwise there will be no sense in the acquisition. Inside the QMS you will find the same thing as in general in business management systems.

Types of QMS

Crystallizes into national or international standards. According to them, established approaches are reproduced with new ones after independent audits. There are universal and industry-specific QMSs. Universal ones, which claim to be able to be implemented in any company, regardless of size, field of activity and point of the world where they operate, are represented by the famous ISO 9001 standard “Quality management systems. Requirements". enjoys a monopoly status among universal standards. Other documents are well-known enough for them to become truly in demand. Versatility has a number. Of these, the first in importance is that introducing detailed information into the standard, with methods and examples, is impossible if it is universal. The fact is that the more details appear, the greater the role played by the specific situation of a particular implementing organization. It is impossible, for example, to write how to work within a system with the specifics of creating auto components, since universality means that according to the same standards, quality systems will be created at enterprises that do not work with auto components at all. This is how the QMS standard QS 9000 “Requirements for a quality system” appeared. Now this standard has already been canceled, but earlier the giants approved it for themselves - they adopted their own automobile standard for quality management systems. Today there are many such industry standards: TL 9000 - QMS for the telecommunications industry, AS/EN 9110 - aerospace industry, ISO/DIS 22006 and UNI 11219 - QMS for agriculture, ASQ E2014, IRAM 30100, HB 90.3 - construction, IRAM 30000, ISO IWA 2, Guide 44, are standards for systems in education. Such standards exist today in almost every industry. Look what yours are.

At first, there was a certain antagonism between industry and universal standards. The International Organization for Standardization (–International Organization for Standardization, – ed.) was afraid that the development of individual standards would make ISO 9001 meaningless. It was probably not so much about ISO’s ambitions, but rather about the fact that the lack of more or less well-known QMS standards makes It is impossible to formulate uniform requirements for everyone in this aspect on the international market. Ultimately, this is a blow to the development and integration of global trade. Industry standards such as QS 9000 cannot by definition facilitate cross-border communications - because, as highly specialized regulatory documents, they may be of interest to a relatively narrow range of companies. However, it was not possible to solve the problem of the lack of details important for industries other than through individual standards of industry associations. There have been attempts by ISO to produce adaptations of ISO 9001 for different industries. It is in line with this trend that the International Organization published ISO/TS 16949 - this is the same ISO 9001, only with parts for the automotive industry. But such attempts cannot be considered successful. One way or another, in the end, a compromise was reached when groups of professional associations and stakeholders at the national level still adopted their QMS standards, but they were written in agreement with ISO based on the universal requirements of ISO 9001. The new standards reproduce the text of the universal document, and then add those details that are missing from it, but that are important to the industry. However, a number of “rebel” standards, which are devoted to the problems of QMS in a particular industry, but ignore ISO 9001, still exist.

The quality management systems that organizations create for themselves stand out. The fact is that some large organizations prefer not to rely on universal approaches, but to build something on their own, formalizing everything in the form of, for example, enterprise standards. These organizations are very proud of their own corporate-based quality systems, and sometimes they export their experience to other companies. For example, a well-known quality organization (American Society for Quality - ed.) promotes connections between its members who are just implementing systems with other participants in the work who are ready to show and talk about their experience.

Should I choose a QMS, lean management, a business excellence model or an ERP system?

To do this, you need to understand what each of these tools can give you. Business Excellence Models - the most well known today are the Baldrige Model and the European Business Excellence Model (EFQM - ed.) - these are strategic, global approaches to management. If quality systems are focused on achieving the quality of products and services, then, for example, for EFQM this is only part of the problem. This model is not even focused on quality, but on the results of work. Quality, according to business excellence models, is only part of the problem, and the standards that set out their requirements touch on many other aspects: sustainable development, social responsibility, and so on. It is not too much of a stretch to say that the requirements of ISO 9001 cover 20-30% of the requirements of the European Model of Business Excellence. Each specialist has his own methodology, but some experts in the field of management consulting believe that implementing a QMS is a good preparatory procedure on the way to working with business excellence models.

The big problem for a manager is the choice between QMS and ERP systems or the integration of both, that is, simultaneous implementation. There is no doubt, both QMS and ERP are dedicated to work and compliance. But the two approaches differ in what is the focus. The main thing for QMS is: automation of quality-related processes throughout the company, not only in the quality department. ERP, in turn, focuses on quality interactions and data in the supply chain and production processes. There are some elements that overlap and entrepreneurs will inevitably have to choose which approaches to emphasize. We are talking about the following structural elements:

• Management and documentation of nonconformities.
• Dealing with complaints.
• Quality of supplies, internal and external audits.
• Change management.
• Corrective and preventive actions.
• Education.
• Calibrate and maintain tools for preventive action.

To decide whether to prefer QMS or ERP elements, you must first of all study well the needs of stakeholders in the organization and have a good understanding of work processes.

Lean management and the quality management system relate to each other as the particular to the general. Lean is a set of specific tools, and ISO 9001, according to which quality management systems are usually implemented, is a set of requirements, and this regulatory document does not fundamentally spell out the methods and tools by which compliance with the requirements is achieved. This issue is left to the discretion of the heads of specific organizations. Another thing is that lean tools, that is, they can be part of the current QMS according to the international standard. We can even say for which elements of the ISO QMS model lean tools are suitable as a mechanism for meeting established requirements: process approach, continuous process improvement, reducing variability, improving quality.

In order for an organization to function successfully, it must be managed in a systematic and visible manner.

Managing an organization, along with other aspects of management, includes quality management.

A QMS is a system created in an organization to formulate policies and goals in the field of quality, as well as to achieve these goals. A QMS, like any system, is characterized by its purpose, structure, composition of elements and connections between them. A university's QMS is a set of organizational structure, methods, processes and resources necessary to implement the quality policy through planning, management, quality assurance and improvement.

The quality policy is the main document of the system. It determines the purpose of the construction and operation of the QMS, as well as the obligations of top management to achieve the goals.

The QMS covers such areas of the university’s activities as pedagogical, scientific, educational, administrative, and economic. These areas are interconnected and in most cases overlap.

The functioning of the QMS is carried out through the involvement of all personnel, while senior management (university rector) takes full responsibility for achieving quality goals.

Administrative influence on the QMS is based on process management based on actual indicators. Its main goal is to create conditions capable of ensuring continuous improvement of the process. At the same time, the assessment of changes in the quality of the process is carried out on the basis of criteria.

The process of development and implementation of a quality management system includes the following stages:

• choosing a QMS model;
• comparison of the university’s activities with the requirements of the selected model;
• restructuring the activities of the university where necessary;
• development and implementation of QMS documentation confirming compliance of the university’s activities with the requirements of the model;
• QMS certification in order to increase the efficiency of business processes;
• improvement of activities based on continuous process improvement.

Solving the problem of improving the quality of educational services is associated with the need to create an integrated management system. Building such a system based only on assessing the results of any process is fundamentally untenable.

Effective quality management can only be achieved by managing procedures within the process itself. In relation to the university - through quality management of the provided scientific and educational services at all stages of specialist training

The cause of all errors is always incorrect actions. In order to avoid mistakes, it is necessary to determine the correct sequence of actions, describe (formalize) them, and develop instructions for performing and monitoring the correct actions. In other words, management of the quality of training of specialists should be structured so that deviations from the specified requirements are, if possible, prevented, and not corrected after they are discovered.

In this way, it is possible to ensure the university's reputation as a reliable supplier of high-quality specialists with minimal risk for those enterprises, organizations and individuals who can be considered consumers of services.

Purpose of the QMS

The QMS is designed to ensure the quality of the services provided and “adjust” this quality to the expectations of consumers. At the same time, the main task of the QMS is not to control each individual service, but to create a system that will prevent the occurrence of errors leading to poor quality of services.

As a result of creating the necessary conditions, the QMS must ensure that university graduates comply with the requirements of state educational standards, wishes and recommendations of stakeholders. With the proper functioning of the QMS, the costs of training specialists should be optimal.

Success can be achieved by implementing and maintaining a management system designed to continually improve operations while taking into account the needs of all stakeholders.

QMS structure

The QMS consists of the following elements: organization; processes; documentation; resources.

According to ISO definitions, an organization is a group of people and necessary facilities, with a distribution of responsibilities, powers and relationships.

A process is a set of interconnected and interacting elements of activity that transform “inputs” into “outputs”. Very often, the “inputs” of a process are the “outputs” of other processes.

The concept of procedure is important for the QMS. A procedure is a stated way of carrying out an activity or process. A procedure can be called a process (a set of processes). On the other hand, it is a document that describes the rules for executing the process.

Document - information (significant data) placed on an appropriate medium.

QMS resources are everything that quality management provides.

What is needed to create an organization's QMS?

• identify the main processes of activity;
• establish the sequence and interaction of processes;
• determine the criteria and methods necessary to ensure the effectiveness of both work and process management;
• ensure the availability of resources and information necessary to support work and monitor processes;
• observe, measure and analyze processes;
• take measures necessary to achieve planned results and continuously improve processes;

What is ISO?

In the 90s of the last century, the world community moved to a new stage in the development of quality management - quality planning.

The main task facing manufacturers of products and services at this stage is complete consumer satisfaction.

This trend is reflected in the new version of the ISO (International Organization for Standardization) 9000 family of standards.

ISO is an international organization for standardization and is a worldwide federation of national standards bodies (ISO member bodies).

The goal of ISO is the development of standardization principles and the design of standards based on them that promote integration processes in various fields and activities.

The standards developed by ISO are grouped into families. ISO 9000 is a series of ISO standards that are used to create and improve quality management systems of organizations and enterprises.

• ISO ISO 9001. Contains a set of requirements for quality management systems. The current version is ISO 9001:2008. Quality management systems. Requirements".
• ISO 9000. Glossary of terms about the management system, set of principles of quality management. The current version is ISO 9000:2005. Quality management systems. Fundamentals and vocabulary."
• ISO 9004 Provides guidance for any organization to achieve sustainable success in a complex, demanding and constantly changing environment through a quality management approach. The current version is ISO 9004:2009. Management for achieving sustainable organizational success. Approach based on quality management."
• ISO 19011. Standard describing methods for conducting audits in management systems, including quality management. The current version is “ISO 19011:2011 Guidelines for auditing management systems”.

Russian versions of standards:

GOST ISO 9000-2011 - analogue of ISO 9000:2005 (prepared by the open joint-stock company "All-Russian Scientific Research Institute of Certification" (JSC "VNIIS") based on the application of GOST R ISO 9001-2008)
GOST ISO 9001-2011 is an analogue of ISO 9001:2008 (prepared by the open joint-stock company All-Russian Scientific Research Institute of Certification (JSC VNIIS) based on the application of GOST R ISO 9001-2008).

One of the most important aspects of these standards is their universality and their use by enterprises of various forms of ownership. All of them contain standards and requirements that the quality management system must comply with, regardless of whether it is certified or not. It is for these purposes that the International Standards ISO 9000, ISO 9001, ISO 9004 are used. GOST R ISO 19011-2012 is used to regulate the organization and conduct of audits.