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Quality Management System

Quality Management System(QMS) - totality organizational structure, techniques, processes and resources required for general management quality. It is intended for continuous improvement of activities, to increase the competitiveness of the organization in the domestic and world markets, and determines the competitiveness of any organization. . It is part of the organization's management system.

Modern QMS are based on the principles of TQM. The various parts of an organization's management system can be integrated together with the quality management system into a single management system using common elements. This increases the effectiveness of planning, the efficiency of resource use, and creates a synergistic effect in achieving the overall business goals of the organization.

QMS certification according to ISO 9000 is widely used. QMS certification is based on independent audits by a third party (certification body).

Foundation of the organization

Quality management systems are driven by the organization's customer requirements. Consumers need products (services) whose characteristics would satisfy their needs and expectations. Consumer needs and expectations are constantly changing, causing organizations to experience pressure from the competitive environment (market) and technological advances. To maintain ongoing customer satisfaction, organizations must continually improve their products and their processes. An organization's QMS, as one of the management tools, gives confidence to the top management of the organization itself and its consumers that the organization is able to supply products that fully comply with the requirements (of the required quality, in required quantity for a set period of time, spending the established resources). This management tool operates strictly within the so-called iron triangle of the project.

The QMS is based on eight principles of quality management:

Customer Focus- the organization needs to do what the consumer wants now and will want in the future, even if he does not realize it.
Executive Leadership- since the organization always operates within the framework of limited resources and input data in a competitive environment, only a leader with vision and fortitude is able to ensure the achievement of its goals (mission).
Staff Engagement- since the organization’s personnel are its main resource and at the same time the most sensitive stakeholder, the leaders’ reliance on it is the key to success.
Process approach- An organization’s QMS is not a static entity and its elements are processes through which goals are achieved, that is, any changes are ensured through processes.
Systematic approach to management- implies taking into account all factors affecting the external and internal environment of the organization.
Continuous improvement- the basis of modern management, which implies constant adaptation to existing and expected changes in the environment, and sometimes shapes them.
Making fact-based decisions- a reminder that the stability of an organization’s functioning is possible not only on the basis of intuition, but also using measurement data.
Mutually beneficial relationships with suppliers- along with the principle customer orientation involves creating sustainable supply chains based on mutually beneficial cooperation.

Target

Achieving long-term success by maximizing customer, employee, owner and community satisfaction. The purpose of the QMS is to ensure that the results of the company's processes meet the needs of the consumer, the organization and society. (compliance with both explicit requirements and implied needs).

Tasks

Continuous improvement of product quality and reduction of quality assurance costs through the use of the PDCA cycle (Deming cycle), consisting of: planning, action, analysis, adjustment (eliminating the causes of nonconformity, and not just correcting the results obtained);
Creating confidence among consumers that there are no defects through certification of the quality management system.

Principles

Establishment needs and expectations consumers and other interested parties of the organization in the field of quality of products or services.
Availability policies and goals organization (or a dedicated part of the organization) corresponding to meeting the predetermined needs of consumers (external and internal). (see 1.).
Statement Scientific schools and areas of management#Process approach to the management of """processes""" and responsible for them necessary to achieve the goals of the organization (or a dedicated part of the organization). Implementation of a process approach in achieving these goals (see 2).
Determination of necessary resources and providing them with those responsible for the processes to achieve the goals of the organization (or a dedicated part of the organization) (see 2. - 3.).
Development and Application methods for measuring effectiveness and efficiency each process based on key quality indicators (see 1. - 3.).
Determining the mechanisms required for warnings of inconsistencies And eliminating their causes. And the implementation of these mechanisms in QMS processes (see 3).
Development and application of a process for continuous improvement of the entire QMS(see 1. - 2.).

As can be seen from the definition, the primary element of the QMS are the needs and expectations of consumers (internal and external) of products or services, business owners, personnel and society. The organization's policies and goals are a response to the needs and expectations of interested parties. And the subsequent process approach completes the description of the path to achieve goals and implement long-term policies. Each of the points described above is key for any QMS that is in constant cyclical interaction on the path to extremely high quality.

Industry QMS

Standardization of the QMS based on the requirements of ISO 9001 provides only the basis for stable customer satisfaction, however, each industry has its own special requirements and specifics. To more fully ensure customer satisfaction, industries are creating their own industry models of quality management systems in the form of separate standards or in the form of Recommendations for the implementation of ISO9001. The most developed models of quality management systems in industries are:

ISO/TS 16949 - Automotive component suppliers.
ISO 13485 - medical device manufacturers.
AS 9100 - Aerospace Component Suppliers.
ISO 29001 - petrochemical and gas industry.
TL 9100 - enterprises in the telecommunications industry.
IRIS is the railway supply chain.
ISO 22000 - food supply chain.
ISO 20000 - service management (this standard is not made according to the structure of ISO 9001, but in general, it corresponds to the spirit of TQM).
IWA 1 - healthcare institutions.
IWA 2 - educational institutions.
IWA 4 - local authorities.

Notes

Literature

Lapidus Vadim Arkadevich, Rekshinsky A. N. Dialogue between a consultant and the head of the company. To senior management on total quality (TQM) and ISO 9000 standards, version 2000, Priority ADM Center LLC, 2005, 88 p.

The key task of company management is to create, practical implementation and subsequent certification of the 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 (validity of the contract, production period of a given type of product, etc. ).

The guarantee 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 systems quality management:

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 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.

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 happen that when translating from in English it will be very difficult to find the right one in Russian Russian word, which 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 English word"management".

The word “management” was introduced into Russian only out of necessity, so as not to lose its basic meaning. semantic load: management is a methodology for detecting and correcting your 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's why we'll start with simple question: - why, ultimately, is a QMS created? The short answer is to increase the likelihood of achieving planned results production activities.

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 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 itself general view and in accordance with the architecture of 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 that it should be done correctly this way. 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 task to set up a resource management system (for example, an ERP system) and 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 in staffing table position of Quality Director.

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 a commercial director, the training system is headed by a personnel director, the finance system is headed by 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 introduction of QMS

7. Implementation of implementation in the form of a project. Must be developed and agreed upon high level the most detailed plan-schedule of the QMS implementation project with responsibility for delay or disruption of 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 ensuring 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, can be 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 should be guidance documents in the company, how records of production, purchases and sales should be maintained, 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 to take, what needs to be analyzed by management, etc. d. 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” fell ill or retired.

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!

One of the serious obstacles to creating a management system at an enterprise is an incorrect or incomplete understanding of its capabilities. The discrepancy between managers' expectations and reality, subjectivity in assessing the usefulness of the system is often due to the lack of accessible and understandable information about it. This fully applies to the quality management system (QMS).

An attempt to find out what a QMS is by referring to the standards of the ISO 9000 series ends in failure: the QMS as a product is rejected. The situation is further aggravated by the fact that the standards are most often read in a translation that is poor and not adapted to domestic terminology. Information on this topic can be found on the Internet. However, there, some authors often try to “cast fog” in order to convince a potential customer to contact them for clarification and advice. Another reason can only be associated with a lack of understanding of the essence of things by the authors themselves.

The purpose of the article is to provide as simple and understandable answers as possible to frequently asked questions related to quality management. Using the terminology of some computer literature publishers, the article could be called “QMS for dummies.” For convenience, the section headings are presented in the form of the most frequently asked questions to the author regarding the development, implementation and certification of a QMS.

What is QMS?

Summarizing the various definitions developed by ISO, we can say that a QMS is a system created in an enterprise for the continuous formation of quality policies and goals, as well as for achieving these goals.

So, first of all, the QMS is a system. And the system, as a rule, is characterized by its purpose, structure, composition of elements and connections between them.

Purpose

The QMS is designed to ensure the quality of the enterprise’s products or services and “adjust” this quality to the expectations of consumers (customers). At the same time, its main task is not to control every unit of production, but to make sure that there are no errors in the work that could lead to defects (poor quality of products or services).

The following principles of quality philosophy help to understand why they act this way to ensure quality. The reason for marriage is always wrong actions. And in order to avoid them, it is necessary to formalize (describe) the correct actions to create quality products or services, develop instructions for performing the correct actions and control these actions.

Structure

The QMS as a system consists of the following elements: organization, processes, documents, resources.

According to ISO definition, organization- this is a group of employees and necessary funds with the distribution of responsibilities, powers and relationships. In other words, the organization is understood as a set of elements of the organizational structure related to quality, the rules of their interaction, as well as the personnel responsible for quality.

Process- a set of interconnected and interacting elements of activity that transform “inputs” into “outputs”. In this case, the “inputs” of a process are usually the “outputs” of other processes. Processes in an organization are typically planned and executed to add value (from input to output).

The concept of procedure is important in the QMS. Procedure - established method carrying out an activity or process. Thus, a procedure can be called a process (or a set of processes); on the other hand, it is a document formalizing The right way process execution.

Document- information (significant data) placed on the appropriate medium. The main documents of the QMS are listed in. Other organizational and administrative documents of the enterprise must be associated with the quality system documents, for example, “Regulations on divisions” and “Job instructions”.

QMS resources- everything that quality management provides (human, temporary, etc.).

Thus, a QMS is a system consisting of an organization, processes, documents and resources aimed at developing quality policies and goals, as well as achieving these goals.

What is ISO?

ISO (International Organization for Standardization) - International Organization for Standardization, a worldwide federation of national standardization organizations (ISO member committees). The goal of ISO is the development of standardization principles and the design of standards based on them that promote integration processes in different fields and areas of activity. The existence and development of ISO are due to the increasing need to use generally accepted standards to ensure compatibility of the functioning of various (not only technical) systems. The interpenetration of management methods, technologies, tools and markets is currently impossible to imagine without ISO standards.

The principle behind developing ISO standards is quite simple. The initiative to create new standards comes from organizations using the standards (usually manufacturers of products or services that need to integrate them with other products or services). These organizations form basic requirements to the standard and transmit them to their national (by country) representatives in ISO. ISO decides on the feasibility of developing new standards, and after a positive decision, a technical committee is appointed, which will develop a draft standard. The draft standard is circulated to ISO member committees for study and evaluation. After a positive vote, it is adopted as an ISO standard.

What is ISO 9000?

The standards developed by ISO are grouped into families. ISO 9000 is a family of quality standards designed to help organizations of all types and sizes develop, implement and maintain effective QMSs.

A core set of international standards related to quality management was adopted by ISO in March 1987 and has been updated periodically since then. It contained ISO 9000-9004 standards as well as an ISO 8402 glossary of terms and definitions.

In 1994, the second edition of the basic standards of this series was published, which includes almost 25 standards (numbers starting with 9000 and 10000). This series has been widely used to date.

What is ISO 9000-2000?

ISO 9000-2000 is a family of quality-related standards published on December 15, 2000 and used as official standards.

The ISO 9000-2000 family consists of the following standards.

ISO 9000:2000 "Quality management system - Fundamental principles and vocabulary" - provides an introduction to QMS, as well as a glossary of terms and definitions.
ISO 9001:2000 "Quality management system - Requirements" - sets the requirements for quality management systems and defines a process-based QMS model (see figure).
ISO 9004:2000 "Quality management system - Guidelines for quality improvement."

What needs to be done to create an effective and certified QMS?

To create a QMS you must perform the following steps:

conduct an audit of the current system;
train employees;
develop or improve the current QMS;
implement a QMS;
certify the QMS;
maintain the effectiveness of the QMS.

It should be noted that the forms of implementation of these stages depend entirely on the needs and interests of the enterprise.

What is an audit of an existing system?

An audit of the existing system is carried out to determine the scope of work to bring the quality system to the requirements of ISO 9000 series standards. The audit is usually carried out by certified auditors. They can be external consultants or specially trained representatives of the enterprise, the so-called internal auditors. The audit is carried out using a special methodology in the form of studying the organizational and administrative documents of the enterprise, interviews with top and middle managers, as well as with employees whose work affects the quality of products or services. Based on the results of the audit, a report is drawn up. The report describes the extent to which the company's quality system complies with ISO standards, whether there is sufficient experience in documenting quality system procedures, as well as maintaining quality records. A separate section of the report contains recommendations for bringing the existing quality system to the level of requirements of the ISO 9000 series standard.

How to organize employee training?

Training employees in the basics of quality management and related ISO standards is a mandatory stage in creating a QMS. It is necessary primarily because the enterprise personnel are integral part, both the developer and the user of the QMS. Without trained personnel, it is impossible to develop, implement, maintain or develop a system. Trained personnel is a requirement of ISO 9000 standards. Personnel training can be carried out in several ways.

The first of them is to attract to the enterprise (or train your own) an expert in the field of quality management so that he can then independently train the rest of the personnel and establish a quality service. The main risks of this method are that the qualifications of the attracted expert may be insufficient for successful training of personnel, and the training of your own specialist, corresponding to the level of the expert, may be too long.

The second method is associated with the training of one’s own internal auditors (one way or another they need to be trained and certified in order to create a QMS). This is done by special training organizations affiliated with certification bodies, as well as consulting organizations. Trained internal auditors can lead the quality service and train staff. However, even here there remains a contradiction between the acquired qualifications and the timing of auditor training.

The third way is as follows. Many consulting companies offer to organize staff training directly at the enterprise. At the same time, classes are held separately for top and middle managers, as well as for the so-called promoters - the direct developers of the QMS. This method training also does not eliminate the noted contradiction. The acquired level of knowledge may not be enough to independently develop the system.

The fourth method involves training personnel in the process of developing a QMS jointly with consultants. Before this, it is advisable to train one or two internal auditors. The qualifications of consultants will be sufficient for the correct design and implementation of the system, and the qualifications of internal auditors will increase in the process of creating the system.

Each of these methods has a right to exist. Which one to choose is decided by the managers of the enterprise.

What needs to be done to develop a QMS?

Design (development) of a QMS is the most labor-intensive process of creating a system. To design a QMS, it is recommended to perform the following steps.

Based on the “Report on the analysis of the existing system”, develop a plan for creating the system.
Develop and approve the order “On improving the quality system at the enterprise.”
Develop and approve regulations on the project manager.
Develop and approve regulations on the promoter.
Develop and approve a regulation on the representative from the quality system management, describing his responsibility and powers.
Determine the functions and responsibilities of the permanent quality system service.
Develop a project implementation program.
Develop a matrix of responsibility for the implementation of procedures.
Define and document responsibilities officials for procedures or elements of the quality system.
Management should formulate a “Quality Policy”.
Develop quality system procedures.
This process is perhaps the most labor-intensive. A procedure is an established way of carrying out an activity or process. In order to formulate a procedure, it is necessary to determine the rules (algorithm) for executing the process, and then formalize them. Procedures must not only meet quality standards, but also be interconnected. The set of procedures must correspond to the model shown in the figure.
Coordinate procedures among themselves and ensure their compliance with the Quality Policy.
Develop work instructions in accordance with procedures.
Formulate and formalize the “Quality Manual”.

In each specific case, the list and order of work may differ from the above list.

How to implement a QMS?

This stage, like the previous one, is characterized by high complexity. After identifying, formalizing and approving the required ways of carrying out activities, they need to be implemented in practice. Often the development and implementation of a QMS are iterative procedures: some proposed methods of action are immediately tested in practice.

The complexity of this stage largely depends on the training of personnel. Trained and competent employees are able to implement the procedures themselves, otherwise implementation will require significant effort from management and consultants.

The fact of implementation is mandatory for certification. Many certification bodies do not make a positive decision on the status of the QMS if it has not been implemented and operated within 9-12 months.

What needs to be done for QMS certification?

Before deciding on QMS certification, it is advisable to conduct a series of internal audits. When management is convinced that the company has done everything it could in terms of preparing for certification, it is advisable to conduct a preliminary audit with the help of consultants - a “dress rehearsal” for the certification audit. Many enterprises take a different path: they order a certification audit in order to determine the necessary improvements, but receive a certificate only after a second certification audit, since the first one reveals a large number of errors.

Certification is usually carried out in the following way. First, the auditors of the certification body get acquainted with the documentation of the enterprise’s quality system and prepare a report based on the results of this work. Then a plan for a certification audit at the enterprise is agreed upon and the certification audit itself is carried out. If the certification body makes a positive decision based on the results of the audit, the enterprise has the opportunity to pay a registration fee and receive the desired certificate.

How to ensure support for the effective functioning of the QMS?

The developed system must function correctly: the activities and processes of the enterprise must comply with the developed QMS documents. The certificate you receive is only valid for a certain period of time. For confirmation, repeated (semi-annual and annual) surveillance audits are required, as well as re-certification once every three years. For a positive decision by auditors regarding the current QMS, it is necessary to show not only its performance, but also its development. All this requires some effort and knowledge. However, the costs of enterprise resources at this stage are significantly lower than at the stages of development and implementation of the system.

What organizations are involved in the creation and certification of the QMS?

The main stakeholder, the customer enterprise, participates in all stages of system creation and certification. It determines the composition and degree of participation of other organizations.

Training company is engaged by the customer to train internal auditors and staff training.

Consulting company can be involved by the customer at all stages of creating a QMS. She can participate in the development and implementation of the QMS, train personnel during the development process, conduct preliminary audits, participate in internal audits and support the effective functioning of the QMS. The only thing a consulting company cannot do is conduct a certification audit (consultants can only be invisibly present at this).

Certification body- an organization accredited by the relevant authorities, engaged in the certification of quality management systems for compliance with ISO 9000 series standards.

In Russia, the leading certification body is traditionally considered to be VNIIS-SERT-SK at the All-Union Scientific Research Institute of Certification.

Since certificates enjoy unconditional recognition in the countries of accreditation of the certification body that issued them, it is advisable to select it based on information about in which countries of the world it is accredited. In Russia, the most active are world-famous certification bodies, accredited for certification in most developed countries: Bureau Veritas Quality International (France); Det Norske Veritas (Norway); Lloyd Register (UK); SGS (Switzerland); TUV-CERT (Germany).

How much does QMS cost?

The answer to this question depends on a large number of factors. These primarily include: the size of the enterprise; number of staff; readiness (effectiveness) of the existing QMS; certified types of activities; selection of a certification body.

Each of these factors significantly affects the following components of the total cost:

cost of training (consultations) of personnel;
cost of design (development) of the QMS;
cost of QMS implementation;
cost of certification;
cost of surveillance audits.

The cost of personnel training depends primarily on the competence of employees in the field of quality management and their readiness to independently develop a QMS. In our experience, developing procedures requires a sufficiently large number of trained employees, equal to at least half the number of procedures. Costs various options training of personnel in methods of creating a QMS differ significantly.

We do not consider the option of attracting or preparing our own expert, since the amount of time and money spent in in this case very difficult to predict. This is due to the fact that certification of an expert requires many years of experience in this field.

Let's consider the option of training internal auditors who will actively participate in managing the development and implementation of the QMS. Training can be organized and conducted by the management of the enterprise initially for a limited (two to three people) number of specialists. They need to be prepared so well that they can then not only train other people without outside help, but also make the most important decisions in the process of creating a QMS. And for this you also need to have practical experience in developing and implementing the system. This method can be implemented if there is large quantity resources - temporary (the company is in no hurry to develop and certify the QMS) and human (the company has people capable and inclined to system analysis and synthesis, as well as teaching). This method presupposes the need for double training of specialists: first, the basics of quality management, and then (after they have acquired practical experience) the rules for conducting internal audits with subsequent certification.

The duration of the first courses (fundamentals and principles of quality management) is three to seven days, the cost is 400-2000 dollars. The duration of courses for training internal auditors is 4-12 days, the cost is 1200-3000 dollars. To certify specialists as internal auditors, it is necessary confirmation of work experience in the field of quality management.

Of course, the offer of training companies to train all personnel related to the development and implementation of a QMS is attractive. Exist good examples organization of training, when consultants go to the enterprise and conduct seminars there separately for top managers (about three days), for middle managers (about five days) and for promoters (direct developers) of the QMS (about ten days). The cost of such classes is $500-600 per day per consultant.

It is quite difficult to estimate the cost of a method when training is carried out by consultants directly in the process of designing and implementing a QMS (the development and training processes are combined). This method is used when an enterprise does not have enough time and human resources to create a QMS, but has the financial resources to attract external consultants. In this case, certified and experienced consultants train managers and promoters in the process of developing orders, regulations and procedures, while conducting internal audits. The cost of such services is determined by the same prices as the cost of designing or implementing a system, namely the prices of a consulting firm, and depends on the qualifications and experience of the consultants.

The cost of design and implementation, in addition to the listed factors, depends on what part of the work the enterprise is ready to perform itself, and what part it trusts to external consultants. The design period depends significantly on the size of the enterprise and can range from one to three months.

The implementation period is longer. According to representatives of most certification bodies, the QMS must work successfully after its design for 9-12 months, and only after that can it be submitted for certification. Therefore in this period It is not practical for consultants to be constantly present at the enterprise. The most rational way (from the standpoint of minimizing costs), in our opinion, is the close involvement of consultants only at the stages of design and internal audit, followed by independent implementation. Before certification, it is advisable to invite consultants to conduct a preliminary audit.

The cost of a certification audit is determined differently by different certification bodies. In any case, it depends on the number of days spent by auditors at the enterprise. The cost of one day of work by an auditor is 600-1000 dollars (of course, for internationally recognized certification bodies accredited in most developed countries of the world) and does not include travel expenses. For the most approximate assessment of labor costs for a QMS certification audit, a table of average labor costs of auditors is provided, compiled based on the results of work at enterprises with different numbers of workers and employees.

The cost of the registration fee is not very high compared to the cost of auditors' services in the certification process, so when calculating costs it is sometimes included in the cost of the certification audit. The cost of a consultant's day's work, as a rule, depends on the prices of the certification body and for the foreign certification bodies listed above is 600-1000 dollars.

What areas of activity can be certified?

Enterprises have the opportunity to certify almost all areas of activity. As an example, here is a list of areas of activity in which the domestic certification body VNIIS-SERT-SK is accredited:

food, beverage and tobacco processing;
textile industry;
production of leather and leather products;
production chemical substances, chemical products and chemical fibers;
production of pharmaceuticals, medicinal chemicals and herbal products;
production of rubber and plastic products;
metallurgical industry (production of basic metals and metal products);
production of machinery and equipment not included in other categories;
production of electrical and optical equipment;
production of transport equipment, vehicles, trailers and semi-trailers;
mining and quarrying, crude oil and natural gas;
Research and development;
production of pulp, paper and cardboard products;
production of coke oven products and petroleum products;
production of other non-metallic mineral products (glass, ceramic products);
furniture production and finished products, not included in other categories;
wholesale and retail; repair of cars, motorcycles, household goods and personal items;
hotel and restaurant services, transport, warehousing and communications;
activities in the field of architecture and civil engineering and related technical consultations; other commercial activities.

(Of these areas for managing the quality of information services, the area of “Research and Development” may be of primary - and perhaps only - interest. Note ed.). For comparison, let's say that the scope of accreditation of the certification body TUV CERT includes 39 areas of activity. In addition to the 19 mentioned above, they include, in particular, such important areas for information directors as “Communications and information transfer” and “Electronic data processing”.

Please note that this is not subject to certification. financial side activities of the enterprise, since it is believed that it does not directly affect the quality of products. However, activities such as banking services may be certified.

When do enterprises create a QMS?

In Russia, there are practically no projects for creating a QMS without the task of its subsequent certification. For domestic enterprises, apparently, the fact of obtaining a certificate is more important than the use functionality systems. This is explained by the fact that in most cases the certificate itself is in great demand by the market: for example, the customer requires a certificate; it is needed to win a major tender, etc. Reasonable compromises often occur. Many managers understand that by creating current system, you need to extract maximum benefit from its functioning.

In most cases, enterprises create and then certify a QMS, setting themselves the following goals: supporting the export of products; stabilization of positions in the domestic market; participation in competitions and tenders; promotion of own trademark. It is safe to assume that in the near future the QMS will turn from an element of an enterprise’s competitive advantage into a mandatory factor of its existence in the market.

What does QMS give to an enterprise?

Let's consider four characteristics of an enterprise's activities that are largely influenced by the creation and effective functioning of a QMS: transparency; controllability; development; competitiveness.

QMS increases transparency enterprise in terms of its organizational structure, business processes and functions. When developing procedures that represent an algorithm for quality-related activities, both the organizational structure (as obligations, powers and relationships, presented in the form of a diagram according to which the enterprise performs its functions) and business processes and functions are determined or clarified. It should be noted that this does not apply to financial transparency, since the QMS does not address financial activities enterprises.

Controllability The enterprise is improved due to the fact that when designing a QMS, responsibility for the implementation of procedures is strictly distributed. Most procedures provide for the maintenance of quality records (reports), which are generated by responsible persons after performing the established actions. In the process of creating a QMS, regulations on departments, job descriptions and work instructions are revised. This also improves the manageability of the enterprise.

Development enterprise is determined by several factors. These include increasing the competence (mandatory training) of personnel, their involvement in the process of creating a system, increasing production efficiency by eliminating unnecessary functions and reducing the share of low-quality products, concentrating efforts on what is essential, as well as improving relations with consumers and suppliers.

Most clearly, certification and the effective functioning of the QMS affect competitiveness enterprises. The presence of a certificate significantly increases the authority of the enterprise and its brand. This allows you to change the pricing policy of the enterprise (obviously quality products should cost more). Having a certificate increases the likelihood of success when participating in competitions and tenders. In some cases it is even prerequisite competition or tender. The listed circumstances directly and indirectly affect the effectiveness economic activity enterprises. There are cases where the successful functioning of the quality system and the availability of a certificate allowed enterprises not only to significantly improve their position in the market, but also to take a leading position.

What can you expect from consultants?

The participation of consultants in the process of creating a QMS and preparing it for certification can provide some additional benefits that make it easier to achieve the goals of the enterprise.

Some consultants provide complexity creation of a QMS, meaning by this the additional (at the request of the customer) provision of the following services:

full cycle of preparation for certification;
integration with an enterprise management system and other automated systems;
services to improve the organizational structure, business processes, document flow.

The first additional service involves the participation of consultants at all stages of system creation: training (or training in preparation), design, implementation and preparation for certification. In this case, we can say that the consultants deliver the turnkey system to the customer.

The offer of the second service is due to two circumstances: the QMS is only part of the enterprise management system, and the automated system that supports the QMS is only part of the enterprise information management systems. The work of consultants in performing this service is to ensure the integration of the QMS with other components of the enterprise management system, as well as the integration automated system, supporting the QMS, with other information and management systems.

The third additional service is that consultants, in the process of creating a QMS, improve elements of business processes, organizational structure, document flow, regulations on departments and job descriptions, not directly related to the quality system.

Some consultants consider the main characteristic of their work reduction of implementation time. Reduction of time is ensured by an established and automated method of designing QMS documents, experience in the development and implementation of systems.

Of no small importance are the connections of consultants and their ability to provide access to an authoritative certification body.

Some consultants additionally offer this service, how to support the system with appropriate IT tools.

What to do after QMS certification?

After certification, it is important to extract all the benefits from the certification and operation of the QMS. To achieve these goals, in our opinion, the following recommendations will be useful.

Under no circumstances should company managers show staff that main goal The entire successful campaign was the receipt of a certificate. Managers must continue to continually monitor the performance of the system after receiving certification. If this condition is not met, the performance of the QMS will be paralyzed in the most short time, and the enterprise may not have enough resources (human, time, etc.) to rehabilitate it by the time of the surveillance audit, which will occur in just six months.
It is necessary not only to maintain the QMS in working order, but also to develop it. It is necessary to think about what else the QMS can provide to the enterprise, what functions it can perform. In this case, the enterprise will receive all the advantages described above and will be insured against failures during subsequent surveillance audits.
It is necessary to ensure the widest possible dissemination of information about the certification of an enterprise, and not only among its customers and suppliers. To distribute it, it is advisable to use as many channels as possible. Such advertising cannot be superfluous: the wider it is, the higher the popularity of the company’s trademark.

Conclusion

Of course, the material presented cannot claim to be complete and deep enough for the creation and certification of a QMS. The main purpose of the article is to answer the most general issues arising at the planning stage of these works.

Quality management system documents

Orders and regulations for the enterprise related to the QMS ("On improving the quality system", "On the management representative", "On the project manager", "On the quality system service")
Project implementation program revealing the responsibility of officials for procedures
Quality policy - the main directions and goals of the organization in the field of quality, officially formulated by management
Quality system procedures
Quality manual - a document setting out the quality policy and describing the quality system
A quality plan is a document that defines which procedures and their corresponding resources, by whom and when, should be applied to a specific project, product, process or contract
Quality related work instructions
Quality-related control instructions

Eight management principles to help achieve quality goals

Customer Focus
Leadership leadership
Employee Engagement
Process approach
Systematic approach to management
Continuous improvement
Fact-based decision making
Mutually beneficial relationships with suppliers

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 top management(university rector) takes over 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 integrated system management. 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 errors, it is necessary to determine correct sequence actions, describe (formalize) them, 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 the creation necessary conditions The QMS must ensure that university graduates meet government requirements educational standards, wishes and recommendations of interested parties. 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 new version ISO (International Organization for Standardization) 9000 family 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 open joint stock company"All-Russian Scientific Research Institute for 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 points of these standards is their universality, their use by enterprises various forms property. 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.

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