Quality management system

Quality management systems in enterprises appeared in connection with the development of quality management activities. Increased competition and awareness of the role of quality as the basis of competitiveness forced enterprises to move from separate disparate elements of quality management to their unification into a single, integrated management system - taking into account all the factors affecting quality. ^[1] As a result, the quality system received the status of one of the enterprise management systems, along with the personnel management systems, production, supply and others. The introduction of a quality system allows you to organize and conduct planned, regular work on quality. With the necessary material base, modern technology and qualified, interested staff, this increases the stability of the quality of all products, not just individual samples for exhibitions and presentations. Such a system serves as an additional guarantee of quality for customers, many of whom practice the testing of quality systems with potential suppliers, the results of which may influence the conclusion of contracts. The proliferation of such supplier relationships with customers in world trade led to the emergence of a series of international standards ISO 9000 ^[2] on quality systems, and then to the emergence and development of certification of these systems by independent bodies.

In ISO 8402-86 ^[2], a quality system (the quality system ) was defined as “a set of organizational structure, responsibilities, procedures, processes and resources, ensuring the implementation of general quality management”. A similar definition of the quality system was given in the next version of the same standard - ^[3] .

In ISO 9000: 2005 ^[4], “a quality management system is a management system for directing and managing an organization in relation to quality”. Additionally, the definition contains references to the incoming terms: “the management system is a system for developing policies and goals and achieving these goals”, and “the system is a set of interrelated and interacting elements”.

Analysis of the above definitions

The Russian-language quality management system was used in the development and implementation of an integrated quality management system (QS UKP) in the former USSR in the 70s of the last century (see Quality Management ). Since 1987, the term quality system has been used in the ISO 8402 standard in the first and second editions of the ISO 9000 series of standards. In the ISO 9000 standard, replacing the ISO 8402 standard in the third edition of the ISO 9000 series, the term quality system has been replaced with a quality management system . As a result, due to the inconsistency of the phrase “ quality management” with the grammar of the Russian language, the new term, instead of understandable quality management, became an example of a foggy science. But since this term has become official in the Russian version of the standard, it is listed above as the current version of the definition of a quality management system.

For the analysis of the term quality management system given above in ISO 9000: 2005, it will be necessary to combine this definition with the definitions of the management system and the system to which references are given. We get the following complete definition: a quality management system is a set of interrelated and interacting elements for developing policies and goals and achieving these goals, for guiding and managing an organization with regard to quality.

In this definition, an impersonal "set of interrelated and interacting elements" is indicated, which refers to the general concept of a system and is not specified in any way as applied to the quality system. As a result, this definition does not disclose the essence of the quality management system, does not answer the question of what this system is.

Better, though not fully, the essence of the quality system was set out in ISO 8402-86 and in the next version of the same standard - ISO 8402-94, where the quality system was defined as “the sum of the organizational structure, methods, processes and resources required for overall quality management. ” These definitions gave a list of elements related to quality systems, including the organizational structure. However, it was not said what the structure is, who or what enters it. Because of this, the quality system did not have a tangible base, hung in the air. In addition, as part of the elements of the quality system, management functions were not mentioned, which should be performed by the quality system as a subject of management when influencing the production process.

It is also important that, according to ISO 8402-94 (clause 3. 6), the quality system was intended “for the implementation of general quality management” (clause 3. 2). But in the same standard, in addition to general management, operational quality management (clause 3. 4) and quality management throughout the company (clause 3. 7) were envisaged, which, when designating a quality system only for general management, remained outside of it.

As a result of the analysis of the previous definitions of the quality system, the first definition given above indicates the main elements that make up the quality system: the structure of the system, including managers at all levels and the order of their interaction, their functions, with which they affect the process of creating products and methods for performing these functions.

These elements determine the content of work on the creation of quality systems in enterprises.

To create a quality system means to develop and implement it in the activity of an enterprise.

When creating a quality system, a significant amount of work is required, which will depend on the size of the enterprise, the specifics of production and the nature of the products produced, and on how well the organization of quality work corresponds to the recommendations of ISO 9001 ^[5] , or the corresponding industry standard.

Baselines

In addition to the ISO 9001 standard, a general document on the use of the ISO 9000 family of standards ^[6] and separately on the use of the 9001 standard in small business ^{[7] has been} issued to guide the creation of ISO / TC 176 quality systems. Work on the creation of a quality system can be carried out either independently by the quality service and departments of the enterprise, or with the involvement of third-party specialists, guided by the ISO document on the choice of consultants ^[8] . It is advisable to invite consultants for methodological assistance, but not for developing ready-made documents of the quality system. These documents should be developed by employees of the enterprise, if necessary with the help of consultants. Only then the quality system will be maximally adapted to the specific conditions of the enterprise and will become a sought-after area of ​​activity, organizing work on product quality management.

When creating a quality system, it is also important to take into account the specifics of the enterprise, which is recommended in the ISO 9001 standard itself (in the introduction, in subclause 1.2 and in note 2 to 4.2.1).

In addition, when creating a quality system, one should follow the principle of management as the subject's influence on the control object, as well as follow the definition of the general concept of “system”. Without this, it is impossible to create a logically sound, understandable quality system that is useful for business.

In ISO 9000: 2005, the term “system” is defined as “a set of interrelated and interacting elements”.

In the Soviet Encyclopedic Dictionary ^{[9] the} term "system" is defined as "a set of elements that are in relationships and relationships with each other, forming a certain integrity, unity."

G. Kunz and S. O'Donnell in their book ^[10] note three key positions of the systems:

1. The system is not a simple sum of parts, but a new formation, in which all components are interdependent and, interacting with each other, form a new whole, the properties of which are not reduced to the properties of components.
2. Systems can be both closed and open.
3. In order for a system to be perceived as a system, it must have its limits.

These definitions and characteristics of the concept of "system" must be considered:

• In the formation of the organizational structure of the quality system as a “whole,” where the order of interaction between the managers of the enterprise and the departments in the field of quality should be established.

• When using a systematic approach to quality management, which is specified in the ISO 9000 standard as one of the principles of quality management. The meaning of this approach in management science ^[11] is not only to control using the system, but also to consider the control object as a system consisting of interconnected elements, so that when acting on one element, take into account the reaction of other related elements, and the object as a whole.

The principle of management as the impact of the subject on the object should be considered:

• When separating the quality system as a subject of management with the object of management - the process of creating products, on which the system affects its functions. The quality system can not include the processes of development and production. And this in practice is often the case, causing confusion in determining the responsibilities of employees in the field of quality. Unfortunately, there is no such clear separation in section 7 of ISO 9001.

• In determining the boundaries of the quality system with other management systems with which it interacts. To do this, the quality system must have a clear list of its functions.

Implementing a quality system

After the development of a new or improved quality system, it is necessary to check whether it fits into the practical work of the enterprise in ensuring product quality.

For this, a quality service organizes and conducts a series of internal quality system audits. Checks are carried out in accordance with clause 8. 2. 2 of ISO 9001 and the documented procedure developed for internal audits, as well as taking into account the requirements of ISO 19011 for management system audits ^[12] .

According to the results of checks it is determined:

• Is the quality system of functions (processes) sufficiently provided for effective product quality management?
• whether the performers of the quality system functions are defined;
• Are all stages of production covered by the impact of the quality system;
• have all the necessary work methods been developed and have they been documented for their proper implementation
• whether the quality system functions are performed at the workplace;
• whether the structure, functions and documentation of the quality system need to be adjusted.

According to the results of these checks, as a rule, the quality system documentation is adjusted, after which the system is adopted for operation.

The functioning of the quality system is the fulfillment by the management of the enterprise and the units of its functions in the quality system. This is the content side of the system, that is what it is intended for. But since practically all departments of the enterprise are involved in the implementation of the quality system functions to one degree or another, there is a need for planning, coordination and methodological support of the units in the quality system. In addition, it is necessary to carry out internal checks and improve the system, organize the activities of quality circles, represent the quality system at negotiations with customers, and also conduct product certification and quality systems. In other words, it is necessary to solve a whole range of tasks on the “maintenance” of the quality system itself. In this regard, one should be wary of excessive interest in this activity on the part of the quality service to the detriment of the fulfillment of meaningful functions.

Quality Service Functions

The duties of the quality service include both the performance of the substantive functions of the quality system, as stipulated by the ISO 9001 standard, and auxiliary tasks. Among the main objectives of the quality service:

1. Organization of work on quality - development, implementation, maintenance of operation and improvement of the quality system.
2. Development in conjunction with the departments of the project quality policy.
3. Product quality control during its manufacture, testing.
4. Metrological provision of production.
5. Work on standardization.
6. Conduct claim work.
7. Current planning, preparation of events and organizational and administrative documents in the field of quality, monitoring and analysis of their implementation.
8. Organization and participation in the conduct of internal and external quality system audits.
9. Organization of work on product certification and quality system and the provision of inspections by certification bodies.
10. Participation in staff training in the quality system.
11. Development of quality guidelines and regulatory documents of the quality system related to the competence of the quality service.
12. Methodological support and coordination of work of departments in the quality system.
13. The organization of innovation work and "quality circles", if they are created.
14. Preparation of materials for the analysis and evaluation of the effectiveness of the quality system by the management of the enterprise.

Functions of units in the quality system

The functions of the units in the quality system, as well as the functions of the quality service, are determined on the basis of the recommendations of ISO 9001 and include:

• self-control and analysis of the quality of work performed;

• development and implementation of measures to eliminate inconsistencies and continuous improvement of product quality;

• participation in internal and external quality system audits;

• participation in the preparation and implementation of proposals to improve the quality system;

• participation in product certification and quality systems;

• development and adjustment of quality system documentation, participation in the development of a quality policy and a quality manual;

• staff development and motivation;

• participation in rationalization work and in the work of quality circles.

Analysis and evaluation of the effectiveness of the quality system

During the operation of the quality system, the management of the enterprise in accordance with the ISO 9001 standard (clause 5. 6) should conduct a periodic analysis and assessment of the effectiveness of the quality system. To do this, use feedback from customers, the results of internal audits, as well as audits by customers and certification authorities. The main criteria for the effectiveness of the quality system are: ensuring and continuous improvement of product quality based on the existing material base and personnel, reduction of losses from marriage and claims, the pace of modernization and renewal of products, the introduction of science and technology, positive feedback from consumers and customers.

Improving the quality system

One of the principles of quality management, adopted in ISO 9000: 2010, is “the continuous improvement of all the activities of an organization, which should be considered as a constant goal”. As already mentioned, the quality system is a combination of enterprise managers and departments that perform their functions in this system using established methods. But structures, functions, and methods are not something that has been established once and for all. They change in accordance with changes in the internal and external conditions, including due to new developments in production technology and work organization. New structures are changing, dying out and being born, working methods and the content of the functions performed are changing. All this requires changes in the quality system, its improvement. In this regard, the improvement of the quality system, as a rule, provides for:

• clarification of the list of functions and elements of the quality system;

• redistribution of functions among the contractors;

• changes in the composition and content of regulatory documents and the adjustment of the “Quality Manual”;

• increasing the pace of modernization and renewal of manufactured products;

• development of metrological support of production;

• the introduction of more effective methods of control and testing;

• introduction and use of local computer networks and the Internet;

• training employees in new quality assurance methods;

• the use of new forms and methods of staff motivation;

• activation of marketing and promotional activities;

• closer collaboration with material suppliers;

• development of the initiative of workers and their involvement in quality circles,

The work on improving the quality system is organized by the quality management department. It should be borne in mind that the fact of this work is easily verified by customers and auditors on the availability of relevant action plans and their implementation, on the frequency of revisions and changes in documents of the quality system.

Improving the quality system is an indispensable condition for its effective functioning in changing conditions.

In the process of creating and operating a quality system, many problems have to be solved. The main ones are associated with flaws in the concept, terminology and methodology of ISO 9000 standards, including in their Russian versions.

Clause 3. 1. 1 of ISO 9000: 2010 gives an erroneous definition of the term quality (see Product Quality ). A number of terms in the standard are not clear, for example, quality assurance (clause 3. 2. 11) (see Quality Assurance ) . The term quality management (clause 3. 2. 8) violates the grammar of the Russian language. The term correction (paragraph 3. 6. 6) contrary to common sense does not correspond to corrective actions (paragraph 3. 6. 5).

All this hinders the understanding of the essence of the matter by the performers of the work, requires the employees of the quality service to constantly “translate” the wording of the standard into understandable Russian.

Section 7 of ISO 9001 does not have a clear separation between the management functions of the quality system and production processes, that is, between subjects and objects of management, which violates the management principle and complicates the distribution of work and responsibility in the field of quality among employees of the enterprise.

In ISO 9000: 2005 and ISO 9001: 2008 standards, an incomprehensible “Model of a quality management system based on a process approach” is given. It does not show quality management as a process of successively performing interrelated functions and therefore does not conform to the meaning of the process approach described in ISO 9000 (clause 2. 4) and in the aforementioned ISO Guide to the application of the process approach. This model does not reflect the meaning of the quality system and does not contribute to its understanding.

One of the possible models of a quality system based on the process approach can be the quality management process presented in the article Quality management .

The idea of ​​introducing quality systems in enterprises that increase the stability and level of quality of products or services has spread widely throughout the world. However, these problems in the concept, terminology and methodology of the ISO 9000 standards make it difficult to implement working quality systems and their understanding as one of the necessary factors for quality assurance, along with the material base and personnel (see Quality Assurance ). The situation is aggravated by the irresponsibility of many consulting organizations and certification bodies, which, in pursuit of easy money, are powerfully lobbying for the introduction and certification of their formally developed systems, with the result that in many enterprises these systems have remained on paper. As noted in the article of the director of VNIIS ^[13] , according to estimates made by ISO / TC 176 specialists, out of a million enterprises in the world that have a certificate of conformity of the quality system to the ISO 9001 standard, approximately 50-60% (according to some specialists, up to 80%) of them did not get the expected results in terms of achieving the goals in the field of product quality, that is, they essentially implemented the system formally. As a result, within eight years after the introduction of the ISO 9000: 2000 standards, a financial “bubble” of $ 86.4 billion, not secured by real values, was thrown into the world economy.

Nevertheless, it is possible to introduce an efficient quality system. For this, it is necessary to use the possibilities of adapting the ISO 9001 standard to the peculiarities of an enterprise and common sense in interpreting its requirements, as well as the provisions of management science (management).

As a result, a quality system can be created, with the help of which, with the necessary material base, technology and personnel , it is possible to organize and carry out effective work, increasing the stability and level of product quality, and hence its competitiveness.

In the future, according to the message on the ISO website, to create quality systems in 2015, a new version of ISO 9001 will be released. However, the adjustment of ISO 9001 without reworking ISO 9000 is based on sound management principles and quality assurance, and without mistakes in terminology (see Product Quality , Quality Assurance , Quality Management ) will not lead to overcoming the crisis of these standards. Most likely this will lead to the fact that the crisis of their use will become irreversible ^[14] .

• Product quality
• Quality assurance
• Quality control

• Meskon M.H., Albert M., Hedouri F. Fundamentals of Management. - M .: Delo, 1992. - 701 p. - ISBN ISBN 0-06-044415-0 , ISBN 5-85900-015-4
• Kuntz G., O'Donnell S. Management. System and situational analysis of management functions. In 2 tons. - M .: Progress, 1981
• Ogozdin V. Yu. Quality management. Fundamentals of theory and practice. - 6th edition. - M .: Business and Service, 2009. - 304 p. - ISBN 978-5-8018-0334-0