- This is an integral part of the overall enterprise management system, which should ensure the stability of the quality of products or services and increase customer satisfaction. Methodologically, QMS is a system of business processes built on the basis of a process management model and aimed at managing the quality of an organization’s product or service.

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What is quality? Modern management specialists consider the concept of quality in four aspects, which reflect the evolution of the definition of the concept of quality with the development of not only production technologies, but also management science.
Half a century ago, the civilized world considered a product to be of high quality if it met the standards. Over time, it became clear that this was not enough. Then they added to the definition of quality that the product must correspond to consumption, i.e. If a product meets standards, but is not needed by the consumer, then it is not of high quality. Then, in the 80s, they came to the conclusion that a product cannot be called quality if it cannot be used. The quality must match the application. And finally, these days a product is called quality, if, in addition to all of the above, it meets the expected needs of the consumer. Goods and services are produced by businesses to satisfy consumer needs. These needs and expectations by the manufacturer must be formulated in clearly defined requirements - specifications. Specifications– an integral part of the technical specifications. So, if the enterprise management system is not debugged in accordance with QMS standards, then technical conditions often cannot ensure quality in its modern sense.

What does the QMS give to the consumer? First of all, the confidence that the manufacturer is aimed at constantly improving quality and meeting its needs and expectations. Formal confirmation that the enterprise has actually implemented Quality Management System and it meets international standards is management system certificate, issued by an independent certification body.

What will the implementation of a quality management system at an enterprise give?
• the company's resources are concentrated on meeting the needs and expectations of consumers;
• optimization occurs in the control system;
• Having received a certificate according to the ISO 9001 standard, the enterprise has a greater chance of becoming the preferred supplier for large international companies;
• with proper implementation of the QMS, competitiveness in the market increases.

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

Oleg Levyakov

WHAT IS QMS?

The material was prepared by O.M. Levyakov.

“Those who know do not speak, those who speak do not know.” Lao Tzu.

An attempt to find out what a QMS is by directly referring to the text of the ISO 9000 series standards usually ends with one thing: the QMS is simply viewed as another “scam” of Western management!

This is explained by the fact that the texts of the standards are most often read in a “terrible” translation - the so-called “tracing paper” from English into Russian, completely separate from the necessary interpretation of some requirements, which, although they were borrowed from the socialism we lived through, were brought by the pragmatic West to the workers condition.

Moreover, translation from one language to another is much more difficult than it might seem to a non-specialist, because with the help of the same words a language can sometimes reflect completely different processes (including management processes). It may turn out that when translating from English into Russian it will be very difficult to find the right Russian word that would fully reflect the term, especially one born in a capitalist country.

For example, for us the word “management” 100% means strict administration, and this is only one of the possible meanings of the English word “management”.

The word “management” was introduced into use in the Russian language only out of necessity, so as not to lose its main meaning: management is a methodology for detecting and correcting one’s mistakes!

What do the terms validation and verification mean?

In addition, domestic publications are trying to “spread additional fog” in order to convince a potential customer to turn to them for clarification and advice.

I didn’t want to talk about it here, but another reason may simply be related to the lack of understanding of the essence of things by the authors of such publications themselves.

To be honest, this is exactly the attitude I developed after my first acquaintance with the previous version of the ISO 9001-1994 standard!

But as I grew deeper into the topic while working as a consultant, I began to understand the “main military secret” of the QMS!

The paradox is that when reading the standard, even abstracting from the quality of the translation, it is really very difficult to notice because everything is constantly focused and “tied” to achieving Customer satisfaction! What if you are interested in reducing production costs or, for example, reducing the time to bring a new product to market? What does the “satisfaction” of the Consumer have to do with it when it “does not exist yet”?

That is why we will start with a simple question: - why, ultimately, is a QMS being created? The shortest answer is to increase the likelihood of achieving planned production results.

Now let’s think about what we need to do for this!

From a high school biology course we know that in nature there are only two types of reflexes: conditioned and unconditioned. Obviously, the ability to find and sometimes avoid a rake is not given to us from birth - this is a conditioned reflex. Repeating these situations allows us to record the cause-and-effect relationship between our actions and results.

When hundreds of people go through obstacles, one of them can come up with a technology to eliminate them. And if it is documented and everyone is trained, then everyone will achieve their goals faster (without obstacles!) This is the basis of the evolutionary principle of development.

And the basic principle of the QMS - see Fig. 1.

Rice. 1. The concept of the semantic content of the QMS

Why is documenting knowledge and experience so necessary?

Because the circle of direct interaction between top management is 5-10 people, and it is they who “mediate” its management, its decisions, its vision. It largely depends on them whether the desired and actual management results will coincide. And here, it is no longer possible to get by with simply the “correct” formulation of the task, simply with organization and simply with control. Here, we just need to come to an agreement with all the company’s personnel - about a common understanding, about a common vision, about what we want to have as a result. In the absence of this unity, we are faced with a situation where each of the participants in our business process understands it somehow very differently. And the result is also his own, and may even differ significantly from what your company needs.

It is to prevent these dangers that documents arise that define, regulate, distribute rights and responsibilities - internal standards and regulations of the company - see Fig. 2, which shows the concept of the influence of documentation of actions on the quality of production activities.

Rice. 2. The concept of the influence of documentation of actions on the quality of production activities

Rice. 3. System content of the QMS concept

The structural content of the QMS concept in its most general form and in accordance with the architecture of the requirements and principles of the ISO 9000 series of standards is shown in Fig. 4.

Fig.4. Structural content of the QMS concept in accordance with the architecture of requirements and principles of the ISO 9000 series standards

The strategy for the “correct” implementation of the QMS concept shown in Fig. 3 and 4, is shown in Fig. 5.

Agree that without mutual agreement and internal acceptance of these new rules (QMS), the system can easily turn into a sham. Because without an “agreement” there is no “translation” of internal energy and the conviction that this particular thing is “correct” and it should be done this way correctly. This is where the requirements of the ISO 9001 standard for ensuring employee engagement and management leadership will help you - see Fig. 5.

Rice. 5. Implementation strategy for building a QMS

Moreover, the implementation of a QMS should only be carried out on the initiative from above, since this process requires changing the existing order of business and stereotypes of enterprise employees.

If there is no interest in the QMS on the part of management, then the probability of success tends to zero.

But because the main task of the QMS is not to increase the efficiency of workers. Most often, such changes are the goal of the manager or owner, and this brings additional headaches to the employees themselves. As a rule, labor costs do not decrease with the introduction of a QMS. The benefits of a QMS are clear only to top management. Usually they come down to improving the manageability of the enterprise and the possibility of expanding the business. But ordinary employees, with rare exceptions, always greet such changes with hostility.

For at least two reasons.

The first is the accounting and document flow system that has developed in the company, which seems to all employees to be “the only possible” and, therefore, not subject to revision.

The second is that for the full operation of the QMS, it is necessary to collect and monitor a much larger amount of information (for example, managing quality records - which requires greater discipline of workers) than before. Of course, the increase in the volume of work cannot please either ordinary workers or financiers who are determined to save money and reduce personnel.

So what to do?

Practice allows us to identify the following main factors for the success of QMS implementation - see Fig. 6.

Rice. 6. Main factors for the success of QMS implementation

Let us comment on the main ones.

1. Conducting a preliminary survey and subsequent modeling of the necessary business processes. Any business consists of interconnected (correlated) actions. The implementation of these processes must be provided with resources (monetary, labor, material, information, etc.). Each process has its own cost. The set of enterprise processes makes it possible to calculate the real current cost of the business. And then you can competently solve problems of financial planning, analysis, pricing, product quality, etc.

Achieving business transparency by identifying the business processes of an enterprise in accordance with its goals is an urgent task for most enterprises, especially those that are actively developing.

A company's business model is not only the basis for managing an organization. High business transparency, simplicity and accessibility of the system description make it possible to develop the initial technical specifications for setting up a resource management system (for example, an ERP system) and to develop new requirements for improving (adjusting) the resource management system. This allows us to provide the necessary resources, the required quality, in the required quantity, in the right place, at the right time, at an affordable price, and reduce production costs, thus ensuring increased competitiveness of the company.

Based on the business model, managers receive the necessary administrative documents (job descriptions, regulations, other management regulations, operational and strategic reports on the availability and flow of resources in the company, etc.).

This modeling work also forms the basis for the implementation of process management.

2. The key condition for success is the personal interest of one of the top officials of the organization in the results of implementation. In any case, staff experience a certain amount of stress when implementing a QMS. Without the strong will and power of leaders, implementation cannot be successful.

3. Working with management - forming and agreeing with the top officials of the company on its mission, goals and objectives in the field of quality - the invisible and visible presence of the manager as part of the implementation of the system is mandatory, and his role as an interested party may not be enough.

This is especially evident when developing indicators and metrics for the performance of departments.

An example of the concept of defining goals, for example, project business - see Fig. 7.

Rice. 7. An example of the concept of defining goals, for example, project business

4. Formation of an implementation group and its training - no comments needed here.

We can only add an example of training personnel for external audits as a way of additional training.

5. Availability of the position of Quality Director in the staff list.

Its existing alternative in the form of a management representative in the field of quality is simply a crafty cover for the irresponsibility of management itself.

For example, it is already accepted that the procurement system is headed by the commercial director, the training system by the HR director, and the finance system by the financial director. It is quite logical to conclude that the quality system should be headed by a Quality Director!

6. Staff motivation.

This is a delicate matter and is decided differently in each specific case.

Rice. 8. The concept of creating a personnel motivation system

But with all this, it is very important to explain to the staff that the entire company will only get better from implementing the system - see Fig. 9, and thereby hint at the “inevitability” of change.

Rice. 9. The concept of improving production activities after the implementation of the QMS

7. Implementation of implementation in the form of a project. The most detailed schedule for the QMS Implementation Project must be developed and agreed upon at the highest level with responsibility for delays or failures in its implementation.

Now it’s time to “link” everything you’ve read to the most important thing - to the concept of quality of the company itself.

Rice. 10. Architecture of the concept “Company Quality”

Thus, the QMS is not a “scam” at all, but a proven tool for organizing production activities, and aimed primarily at increasing the likelihood of the company achieving planned results and, ultimately, improving the quality of the company - see. Fig. 10.

But staff are not always able to get to the bottom of this on their own!

But if you planned to achieve only the complete satisfaction of your Consumers as a result, then we can say that you have built a QMS in accordance with the ISO 9001 model!

So, QMS is a way of organizing production processes that ensures the achievement of planned results.

Thus, the QMS resembles an “iceberg in the ocean”: it has a tiny surface part in the form of a very small ISO 9001 text and a huge underwater part of reengineering and business modeling, motivation systems, corporate culture, standards development, etc. - see Fig. 11

Rice. 11. “Iceberg” QMS

But very often in the CIS, specialists from consulting firms who provide training in the implementation of QMS do not reveal the essence of this entire “iceberg” well, limiting themselves to formal adherence to the standard.

Resume (in simple and understandable language for staff).

The quality management system serves to improve the quality of business management.

It is called QMS and is a system for managing the company’s business processes - see Fig. 4.

The QMS provides clear instructions for all occasions in an employee’s life: what, where, when and why. Moreover, when a quality system is being implemented, an employee writes his own instructions.

So that different companies, when working with each other, are sure that there will be no surprises from the partner and there is a certification procedure according to the ISO 9001 standard, which clearly defines what governing documents should be in the company, how records of production, purchases and sales should be kept, how Traceability and identification of products should be carried out, how suppliers should be selected, how to measure the efficiency of the enterprise, what corrective and preventive actions should be taken, what needs to be analyzed by management, etc. and so on.

The QMS provides for the creation of a business model of a company, where each service or process of obtaining a product is considered as a link in a continuous chain, at the end of which stands the Consumer. The model assumes the emergence of new horizontal connections and relationships aimed at eliminating interfunctional barriers, since quality is often lost precisely at the junction of functional units.

After internal and external audits, analysis by management or on the initiative of the employee himself, these instructions can (and for good reason should) be improved and optimized. The point of all this is to leave with the owner of the enterprise a documented algorithm for the most effective actions of the employee, in case the old experienced master “Uncle Vasya” gets sick or retires.

In order for the regulations to be not only clear, but also good, corrective and preventive actions are taken to improve processes and such actions must be carried out on a regular basis.

Thus, the QMS turns out to be not a “stupid bureaucratic machine” for stupid foreigners who cannot take a step without instructions, but in fact a very effective tool for improving the quality of business.

And quite simply: SMK turns a heroic partisan detachment into a well-trained battalion of the regular army!

To obtain a certificate of an implemented quality management system for participation in tenders and competitions, a company often contacts a consulting firm, pays for the order, and the firm prepares the necessary documents and issues a certificate. The company presents the certificate to the customer and continues to work as it worked before, without changing anything in its activities. This has very little to do with the quality system.

About the life cycle in detail

An organization that makes a strategic decision to follow the requirements of GOST R ISO 9001 must take into account the following main points and document them.

• Everything that happens in the organization in the course of its activities must follow the provisions of GOST R ISO 9001, which must be specifically stated in the “Quality Manual”, in the instructions and regulations describing the design (production) processes. Thus, internal documents should reflect changes in the size and structure of the organization, changes in the goals of production of goods and services, and changing production processes.
• The requirements for the quality management system established in GOST R ISO 9001 are additional to the requirements for manufactured products. (This is very important, since the customer's requirements are paramount.)
• An organization's quality management system can be used by internal and external parties. For example, certification bodies can use the system to assess whether a company is able to meet customer and regulatory requirements.

The main provisions of the standards mentioned above are listed in the names of the sections of these standards. The main thing is the concept of the product life cycle (including software, automated systems), on the basis of which all the details of the process within the framework of work on the project are built.

To compare and analyze a large number of standards and regulations, consider the diagram below (Figure 1). This is an attempt to classify various life cycle (LC) formulations as they apply to software and automated systems development.

Figure 1. Life cycle stages in the development of automated systems in the interpretation of various current standards. The picture is clickable.

The top two rows represent a list of life cycle stages within the framework of the new GOST R ISO 9001-2015 (first row) and GOST R ISO 9001-2001 (second row). Despite some differences in wording, the life cycle stages in these standards are almost identical.

The differences between the standards appear only in detailed explanations for each stage of the cycle. Note that the new standard includes the concept of “Organizational Context”. Its meaning is to study how the external or internal environment affects the prospects of an enterprise. GOST R ISO 9001-2015 in paragraphs 4.1 and 4.2 requires the identification of external and internal factors and associated risks and opportunities. Thus, the meaning of in-depth analysis or study of “context” is to collect and analyze data about the external environment and the current state of the business, about the key success factors (what determines victory and loss), about the state of the market sector, its structure, dynamics, etc. . To decipher this concept and specify activities in accordance with this requirement, it is necessary to carefully analyze all possible risks arising in the process. You can read more about the concept of “context” in the article by R. Ibragimov.

The third row of the diagram shows the stages of the life cycle in software development in the interpretation of GOST 12207, which was created specifically for software development processes. There are also no fundamental differences in the interpretation of the life cycle compared to previous standards.

GOST 12207 is indeed a rather strict standard. Fulfilling all its requirements during software development is not an easy task. But it is important for us to note that a frightening number of quality management system standards and requirements in them come down to careful documentation of the entire design, development and maintenance process.

Let's look at the fourth row of the diagram. Life cycle processes are presented here as interpreted by GOST series 34, published back in 1990. This series of standards was developed so specifically and carefully that they are still used almost without any changes to this day. Many customers, when formulating documentation requirements for automated systems, mainly refer to GOST standards of this particular series. Since the stages of the life cycle in the interpretations of ISO 9001, GOST 12207 and GOSTs of the 34th series coincide, this means that by fulfilling the requirements of the last of the listed GOSTs, that is, by presenting the listed documents to the customer, we automatically work in accordance with the quality system according to ISO 9001.

The last row in the diagram is an approximate list of documents that are necessary to organize a quality system in the company.

I really hope that the above diagram has made your life much easier. Since you now have a complete list of life cycle stages, there is a list of work that must be completed at each stage, and a list of documents that must complete each stage. Of course, this list, at the request of the customer, can be adjusted towards reduction or addition of new documents not specified in GOST. But this is the right of the customer, and the contractor is obliged to follow his recommendations.

Unfortunately, this is not all. So far we have only dealt with the production component, i.e. the process of software or AS development.

Business processes - the basis

The following processes remained behind the scenes: contract work, organization and management of the project and quality assurance itself. This is also an independent organizational process. Describing these processes in text format is a thankless task; all descriptions are already in numerous manuals. Therefore, we will try to display the listed business processes in the form of another diagram (Figure 2).

Each of these processes (vertically) is marked in the figure with its own color. Positions that complete individual stages or the entire process as a whole are highlighted separately. Intermediate process steps or documents remained colorless. All processes run in parallel. They are inseparable, as indicated by the arrows-connections between individual elements.

In the diagram I tried to display a certain generalized version of the process. Each specific case, of course, may have its own nuances and differences.

The contractor, using the above diagram, needs to analyze his specific business processes and identify those elements that require regulation. For example, the products of any IT company obviously undergo testing. Does your company have regulations that stipulate what is considered critical bugs and what is non-critical and in what timeframe they need to be fixed? Surely there are certain instructions in this regard. The approved regulations for this position are the quality management system. Moreover, testing affects both production and administration, since management must monitor the timely correction of errors.

Having done similar work on all processes, you can prove to the customer how “SMKashnye” and “ISOshnye” you are. It would be even better if the company, from the very beginning of the next project, draws up a similar scheme for its specific conditions and uses it in work and for control.

Figure 2. Business processes in the development of automated systems: documentation according to the quality system. The picture is clickable.

We are moving towards the goal

So, here are the steps that need to be taken to implement (not just formalize) a quality management system in an organization.

1. Create division, group or assign an individual executor so that he deals with QMS issues.

2. Develop and design Quality program, including the “Quality Manual” for the organization (department, development group of a specific project). The Program and Manual must contain the sections listed in GOST R ISO 9001-2015 and the explanation of these sections. They must declare the organization's readiness to meet the requirements of the standard in the specific conditions of that organization or within the framework of a project.

3. Regulate the processes of development and creation of software or automated systems. To do this, you need to draw up organizational standards (or instructions) that specify all activities related to the design, development, testing and implementation of the project, organization and management of the project, quality assurance and contract work.

4. Regulate reporting and responsibility performers and management for each stage of the project life cycle.

5. Submit a package of developed documents to a consulting firm that has the appropriate license, for inspecting documentation and issuing a conclusion on the compliance of the work with the QMS within the framework of the GOST R ISO 9001-2015 standard. Correct the comments and receive a certificate.

6. Continue project work, strictly following the developed regulatory documents.

We have not yet touched upon the issues of annual confirmation of ISO certification, external audit confirming work on the QMS. Unfortunately, the result of mastering a quality management system can rarely be assessed in monetary terms. As a rule, it manifests itself in the stability of the team’s work and the reliability of the results obtained. And this work is worth it.

Literature

1. GOST R ISO 9001-2015. Quality management systems. Requirements. - M.: Standartinform, 2016.
2. GOST R ISO 9001-2001. Quality management systems. Requirements. - M., Standartinform, 2001.
3. Ibragimov R., ISO 9001:2015 and practical analysis of the “context” and construction of strategies. - Management, No. 2 (34), 2015. - pp. 13-18.
4. GOST R ISO IEC 12207 Information technology. Software life cycle processes. - M.: Gosstandart of Russia, 1999.
5. Information technology. A set of standards and guidelines for automated systems. - M.: Standards Publishing House, 1991.
6. Gludkin O.P., Gorbunov N.M. etc. Total quality management. Textbook for universities. Ed. O. P. Gludkina. - M.: Hotline - Telecom, 2001. - 600 p.
7. Kruglov M.G. Innovative project. Quality and efficiency management. - M.: RANEPA, 2011. - 350 p.

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.