Features of the formation and development of quality management systems in modern organizations. Quality management at the enterprise: standards, stages of implementation, tips Features of the quality management system at the enterprise

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Introduction

1. General information about QMS

Conclusion

Bibliography

Introduction

The problem of quality is the most important factor in improving the standard of living, economic, social and environmental security. Quality is a complex concept that characterizes the effectiveness of all aspects of activity: strategy development, production organization, marketing, etc.

Each organization, acting as a supplier, has five stakeholder groups: consumers, employees, owners, subcontractors (enterprises - suppliers of components) and society. Supplier quality assurance is about balancing the interests of all these stakeholders.

The only way to make a profit, even more so, simply to exist in the market for an organization is the production of quality products, the implementation of a quality management system.

The first methods of quality control were known to be associated with the final control of the already manufactured product (an activity carried out after the product has been produced). Then they began to apply quality management methods covering the production stage (activities carried out during the production of products). The next step was the introduction of methods that ensure quality by shifting the focus to nonconformity prevention (pre-production activities). And finally, the issues of steel quality regulation integral part general management enterprises.

1. General information about the QMS

Management system - a set of interrelated and interacting elements for the development of policies and goals and the achievement of these goals. management quality managerial

A quality management system is a management system for directing and controlling an organization with regard to quality.

QMS is a system that allows:

To protect the consumer from low-quality products and services, to make them impossible in principle;

Make the company transparent for employees, owners, partners, customers and society as a whole;

Build the company's work on the principle of a process approach and manage key processes through key indicators;

Make strategic and tactical decisions based on facts, not opinions;

Ultimately improve business performance through increased customer and partner satisfaction.

The main tasks that managers solve at any level of system management, at any enterprise that produces products or provides services, are mainly the following:

What products the consumer needs today and in the future;

How to ensure the release of products needed by the buyer, of the required quality, within the specified time frame, and how to maintain this quality at a given level for the required period of time;

How to ensure maximum profit from the sale of products.

Any of these tasks is practically related to product quality. The main purpose of the QMS is a conscious, purposeful management of product quality.

The main goal of creating the QMS is striving for the perfection of products.

According to GOST, Quality Management Systems can help organizations improve customer satisfaction.

Consumers want products that meet their needs and expectations. These needs and expectations are usually reflected in the product specification and are generally considered customer requirements. Requirements may be specified by the customer in a contract or defined by the organization itself. In any case, the acceptability of the product is ultimately determined by the consumer. As consumer needs and expectations change, and organizations are also under pressure from competition and technological change, they must continually improve their products and processes.

The implementation of quality management systems encourages organizations to analyze customer requirements, identify processes that contribute to the creation of products acceptable to customers, and also maintain these processes in a controlled state. The quality management system can be the basis for continual improvement in order to increase the satisfaction of both customers and other interested parties. The implementation of this system provides the organization and consumers with confidence in its ability to deliver products that fully comply with the requirements.

2. Basic principles of quality management

The following eight quality management principles have been identified to guide top management in order to improve the performance of the organization:

1 Consumer orientation

The organization must know its customers, be guided by their needs and be ready to adapt to their requirements. To implement the principle of customer orientation, it is necessary to determine the needs of external and internal consumers, as well as the degree of their satisfaction.

Internal consumer: Consumers within the organization in relation to the process owner. External consumer: a person, organization, community, which is influenced by the quality of products (services).

The manufacturer of the product must constantly study the current and future needs of the consumers of the product. Fully fulfill their requirements and, as follows from the main goal of the QMS, is to strive to exceed the expectations of the consumer.

2 Leadership

The head of the enterprise, by personal example, must demonstrate a commitment to quality. This demonstration can be implemented in writing a long-term quality policy.

Seven<Я>leader:

I declare quality as the #1 goal

I lead and am responsible for the development of the quality policy

I organize the development of a quality management system and appoint a person responsible for it

I define the requirements for the quality management system

I oversee the development of the quality management system

I analyze the reports of auditors and managers on the effectiveness and efficiency of the quality management system

I lead the process of improving quality management systems

If the head of the organization is not fully aware of the importance of developing and implementing an effective quality system in the organization and at the same time does not take responsibility for the creation and implementation of the QMS, then in such an organization one cannot expect efficiency from the QMS.

3. Employee involvement.

The most important part of the organization is human resources. The staff of the company must be motivated to quality work and to participate in the process continuous improvement. Each employee must be interested and consciously perform quality work. At some enterprises, the duties of employees are blurred: on the one hand, this negatively affects discipline, on the other hand, it gives rise to irresponsibility and mutual responsibility. It is necessary to delineate powers and determine the degree of responsibility for the results of work. If one employee is not able to solve any problem, it must be solved collectively.

Personnel need to be oriented towards improving their activities: employees must see in front of them not only the result of their work, but also the final product that will come to the consumer. Accordingly, employees must find opportunities to create additional value for consumers.

It is important to remember that people are the greatest wealth and the most important value of the enterprise. Among the conservative part of the managers there are opinions that the education of personnel is an extra waste of time and money, since these specialists can leave the company and realize themselves elsewhere. But experts are sure that if the company creates acceptable working conditions and career development, then there will be no personnel turnover, and a team of competent specialists can take the company to a new level of development.

4. Process approach.

The design of a quality management system that complies with ISO 9001:2008 is based on a process approach.

The desired result is achieved when activities and related resources are managed as a process. To be successful, an organization must define and manage numerous interrelated activities. An activity that uses resources and is managed to transform inputs into outputs can be considered a process. Often the output of one process directly forms the input of the next. Process inputs and outputs are defined and measured. The consumers of each process are identified, their needs are identified, and their satisfaction is measured. The interaction of all processes with the functions of the organization is established. Each process is managed, rights, responsibilities and authorities are established for the execution of this process.

Loop can be applied to all processes

"Plan - Do - Check - Act" (PDCA). The PDCA cycle can be briefly described as follows:

Planning (plan) - development of the goals and processes necessary to achieve results in accordance with the requirements of consumers and the policy of the organization;

Implementation (do) - implementation of processes;

Check (check) - continuous control and measurement of processes and products in comparison with the policy, goals and requirements for products and reporting on the results;

Action (act) - taking action to continuously improve the performance of processes.

5. System approach.

The principle is to define, understand and manage interrelated processes as a system. Acting according to the described scheme, the company achieves its goal with minimal costs and in the shortest possible time.

First of all, it is necessary to structure the system, for this, specialists must establish and develop a set of processes that can ensure the achievement of the goal in the shortest possible time and with maximum impact. It is also necessary to understand the relationships between the processes in the system and their influence on each other. After the goal is set, it is necessary to adjust the interaction of specific services in the system.

The creation, provision and management of a system of processes related to each other aims to make the company's activities. A systematic approach in the field of quality assurance is effective because it allows you to meet customer requirements. A systematic approach allows you to use feedback with the consumer.

6. Continuous Improvement.

The constant goal of the organization is the continuous improvement of its activities. It must be remembered that it is necessary to constantly improve the quality of products, while reducing its cost as much as possible.

The need for continuous improvement is now recognized as an important means for an organization to achieve and maintain competitiveness. Improvement must be built into the structure and nature of the organization, and continual improvement must be the goal of each individual and the organization as a whole.

Applying the principle of "continuous improvement" usually results in:

Applying a consistent and organization-wide approach to continual improvement of the organization's performance;

Training employees in methods and tools for continuous improvement;

Creating a situation where the continuous improvement of products, processes and systems becomes the goal of each employee of the organization;

Establishing objectives to guide continual improvement and the measurements by which this improvement will be monitored;

Recognition (identification) and recognition of improvements.

7. Decision making based on facts.

According to GOST R ISO 9000:2008, effective solutions based on the analysis of data and information.

International experience shows that from 20 to 90% of all product improvement projects fail only because of an erroneous opinion about the state of the market, on the basis of which a decision is made about the company's business strategy. The explanation for this situation can be the following points:

There is no full assessment of what consumers really want and how much they are willing to pay for it; decisions are not based on specific facts characterizing the market;

Companies have insufficient knowledge about their product in the period leading up to its introduction to the market, and at the same time they neglect to experiment to improve the product and processes at an early stage of their design, thereby missing the opportunity to improve the quality of the product at a lower cost; the fact of non-compliance with the expectations of consumers in terms of the value of the product and its cost should be established, as has been repeatedly emphasized, at the earliest stages life cycle product, and for this it is necessary to have the most complete information based on facts, and then the likelihood that the product will not meet the requirements for it when it appears on the market will be reduced.

8. Mutually beneficial relationships with suppliers.

The implementation of this principle requires the identification of the main suppliers of the organization, the establishment of clear and open direct communications with them for the exchange of information, and the setting of common goals.

Organizations act as consumers when it comes to their suppliers, and it is on the latter that the quality of final goods and services depends. Based on this close relationship, it can be said that mutually beneficial relationships with suppliers are becoming one of the key elements.

The system of relationships with suppliers should be built primarily on the basis of partnership, when cooperation is beneficial and prestigious not only for the consumer organization, but also for its suppliers, in this case, we can expect the organization to work effectively. Relations with suppliers are built on the principles of maintaining and developing cooperation that satisfies the quality, reducing the risk of disruption in deliveries and payments.

3. Quality management as the implementation of management functions

Quality management is understood as the impact on the production process in order to ensure the required product quality. Such an understanding of management includes three elements: the subject of management (who influences), the object of management (what the influence is directed at) and the process of influence itself. Having defined the object of management (the production process), let us dwell on the very process of influence - on the "mechanism", "technology" of quality management.

Like any management process, quality management is carried out by implementing management functions. To build the concept of quality management, the process approach to management is of particular importance as one of the approaches considered in management theory. This approach allows organizing and presenting quality management as a continuous chain of logically interconnected functions that affect production in order to ensure quality. Having determined the composition of the functions, it is possible to formulate a concept and build a visual conceptual model of quality management, and then, in accordance with it, set out the methods for performing each function (quality management methodology).

When using the process approach in the management of an enterprise, the following functions are used: making deals, making decisions, planning, organizing, motivating, recruiting, directing, controlling, communicating, researching, evaluating, coordinating, etc.

By analogy with these functions, it is logical to start the quality management process with interaction with external environment, primarily with customers and sales markets, as a result of which the supplier determines the required properties and characteristics (quality) of his products. Based on these requirements, the supplier analyzes its technological capabilities and determines the quality policy, as well as the requirements for its subcontractors - suppliers of materials and components. Based on this policy, quality planning is carried out. Then, within common organization work at the enterprise, work is organized to achieve the required quality in the production process with the release necessary resources, training and motivation of personnel is carried out. Further, directly in the management of the production process, product quality control is carried out and the information received is analyzed. Based on the results of the analysis of the information received, appropriate measures are developed and the management of the enterprise makes the necessary decisions.

The final stage in quality management is the implementation of measures. As a rule, these activities are aimed at eliminating identified deviations from the intended properties and characteristics of the product and improving the production process. But, in addition, they can be aimed at adjusting previously adopted plans, changing the organization of work, improving the training and motivation of personnel, as well as choosing other, more qualified suppliers of materials and components.

After the implementation of the measures, the products can be delivered to the customer or to the market, and the quality management cycle ends with the performance of the same function with which it began - interaction with the external environment. After that, the supplier receives information from the market or from the customer about the quality of the delivered products.

Of course, this is a scheme, a control principle. In life, from the acceptance of an order to its fulfillment, more than one management cycle described above is implemented. If you think about it, such cycles are repeatedly implemented at every stage of product development: in the process of development, production, testing, installation and commissioning. At the same time, the same functions noted here are performed each time, which, if implemented sequentially, constitute, in our opinion, the quality management process.

Thus, the concept of quality management can be formulated as follows. Quality management is a continuous process of influencing production through the consistent implementation of logically interrelated functions in order to ensure quality. These functions include: interaction with the external environment, quality policy and planning, training and motivation of personnel, organization of work on quality, quality control, quality information, development of activities, decision-making and implementation of activities.

4. Features and benefits of the QMS

The international standard ISO 9000 defines a QMS as a management system for directing and controlling an organization with regard to quality. The QMS is designed to organize the activities of the enterprise in such a way as to guarantee the quality of the products or services of the enterprise and<настраивать>it is the quality of the expectations of consumers (customers). At the same time, its main task is not to control each unit of production, each operation, but to make sure that there are no errors in the work that could lead to inconsistencies. The QMS emphasizes the prevention of problems, confirming the common sense of the assertion that fire prevention is more effective than fire fighting.

The quality management system in accordance with the requirements of ISO standards should have:

· a policy in which its goals and objectives are formulated, as well as the principles for their achievement;

· A policy-compliant system of interrelated and complementary processes;

a normative framework corresponding to a system of interrelated and complementary processes, and representing a set of consistent normative documents;

an effective mechanism for implementing the requirements regulated by the documents of the regulatory framework;

· The personnel of the organization should have knowledge of the policy, regulatory framework, the mechanism for implementing its requirements, as well as the ability to apply this knowledge in practice. Requirements driven by the policy and regulatory framework of the system must be respected and followed.

What can the head of the organization expect from the QMS? First of all, it is worth noting that the QMS is not a panacea, but just a tool, a tool that allows you to achieve certain success in business. But such successes are possible only if the QMS is truly effective. In this case, the organization receives the following benefits:

· High probability of stable product quality;

Demonstration of the company's capabilities to the customer, creation of a favorable image;

· Interest of suppliers in long-term cooperation. (Implementation of the eighth quality management principle:<взаимовыгодные отношения с поставщиками: организация и ее поставщики взаимозависимы, и отношения взаимной выгоды повышают способность обеих сторон создавать ценности>;

· Ability to compete on an equal footing with certified companies;

· Concentration of activity of personnel on achievement of the purposes of the company and expectations of clients;

· Achieving and maintaining the desired quality of products and services;

· Efficient coordination of work, increasing productivity, reducing costs;

· Elimination of duplication of functions, optimization of information flows, improvement of performance indicators and business efficiency.

A QMS that meets the requirements of ISO 9001:2000 is a guarantee of the stability of the organization's activities, as well as the fact that no force majeure circumstances will affect the organization's ability to provide consumers with products/services of the required quality.

Development and implementation of the QMS, like any other innovation process, may be accompanied negative points:

· Necessity of expenses of the organization for the development and implementation of the QMS;

· Emergence of an additional amount of work, and as a result, significant time costs;

The occurrence of risk<неоправданных надежд>;

· Increased bureaucracy;

Staff resistance to change.

The solution to the above problems depends largely on:

How serious are the managers and staff of the company on the implementation of the project for the creation and implementation of the QMS;

whether they have special knowledge in the field of quality management;

Do they have experience in project management?

An analysis of the requirements of the ISO 9000 series allows us to identify two priority tasks in relation to personnel management, the solution of which will significantly improve the effectiveness of the QMS:

1. Determination and formalization of requirements for personnel, for example, by building competency models for positions and/or business roles. Competence is the ability and knowledge acquired or improved through developmental activities (training, instruction, self-education, etc.).

The constructed competency models allow:

o Clearly regulate future requirements for the competence of all company personnel by obtaining a register of competencies. The formulated register contains strategically important information, which is subject to significantly less changes over time than the organizational structure, for example. It's obvious that this register should be constantly updated and updated;

o Determine the set of competencies required to perform each process. This establishes the relationship between the processes of the organization and the competence of its employees;

o Establish cause-and-effect relationships between the strategic goals of the company and the requirements for personnel.

In general, work on building competency models should include the following steps:

o Definition of strategic goals, for example, by using the BSC methodology;

o Development of processes that support the achievement of formulated goals, using the ARIS toolkit;

o Formulation of requirements for positions and/or business roles in the organizational structure;

o Determining the competencies required to perform the designed processes within the designed organizational structure;

o Develop an organizational structure that supports the execution of processes.

2. Development of personnel motivation systems. One of the most effective ways involvement of personnel in the work of the QMS is the development of a clear system of motivation, built on the principles of management by objectives based on the BSC methodology.

For each employee or their homogeneous groups, goals are identified, including in the field of quality, indicators of the degree of achievement of these goals (key performance indicators - KPI), their target values are determined, and a mechanism for periodic monitoring of current KPI values is developed. On the priorities of the KPI, a motivation scheme is developed for each employee (or their homogeneous groups).

In conclusion, a few words about the specific steps to create a QMS in accordance with the requirements of the ISO 9001 standard. First, a clear, if you like, hard-won, management decision on the creation and implementation of a QMS is required. For example, issuing an order, which is a necessary but not sufficient condition. Top management must demonstrate its commitment to quality management in order to involve all personnel in the creation of the QMS.

Secondly, it is necessary to prepare all the personnel of the organization by teaching the philosophy of quality management, quality management methods, business process theory and activity modeling tools. This step concerns both managers and executive staff. It is worth noting that training within the framework of the QMS should be continuous, targeted and comprehensive.

Conclusion

The growth of the technical level and quality of products is currently the most characteristic feature of the work of enterprises in industrialized countries. In the context of prevailing non-price competition and a saturated market, it is high quality products is the main success factor. From all the work done, we can conclude that the development and implementation of a QMS in any organization is simply necessary. The main purpose of the QMS is a conscious, purposeful management of product quality.

Only the quality of products with all the variety of similar goods produced can attract the consumer and ensure profit. The quality of labor largely determines the results of the organization's activities, and the quality of life is an integral characteristic of modern society.

Each organization is looking for new ways, approaches and methods that would allow it to develop, to be a leader in a competitive environment. Most modern concepts of improving the efficiency of organizations are based on the theory, methodology and practice of quality management.

Quality management becomes the basis for managing the activities of any organization. Management leadership, employee engagement, customer focus and supplier partnership development, systems and process approaches, fact-based decision making and continuous performance improvement - all these principles of quality management are now the basis for implementing an effective development strategy. industrial enterprises, organizations in the service sector, healthcare and education institutions, banks, public authorities, etc.

In this regard, approaches to the training of specialists capable of solving problems are also changing. strategic objectives and make effective decisions aimed at improving the quality of the organization as a whole.

Bibliography

1 GOST R ISO 9000-2008 Quality management systems. Basic provisions and vocabulary: approved. By order of Rostekhregulirovanie dated December 18, 2008 No. 470-st / 2008 “Pricing and estimated rationing in construction” - No. 4 p. - M.: Standartinform, 2009. - 51 p.

2 Gissin V.I. Product quality management: textbook. allowance / V.I. Gissin - Rostov-on-Don: Phoenix, 2007. - 256 p.

3 GOST R ISO 9001-2008. Quality management systems: approved. By order of Rostekhregulirovanie dated December 18, 2008 No. 471-st / 2008 “Pricing and estimated rationing in construction” - No. 4 p. - M.: Standartinform, 2009. - 46 p.

4 Korotkov E.M. The concept of management / E.M. Korotkov - Moscow, 2005. - 18 p.

5 Voskoboynikov V. New approaches to product quality management. Economy and life / V. Voskoboynikov - M .: Certification, 1993. - No. 50. - 15 s.

6 TCH 5.1.10. - 2004 National system of confirmation of conformity of the Republic of Belarus. The procedure for maintaining the register. - Instead of STB 5.1.07-96, introduced. 2005-01-11. - Mn.: BelGISS Publishing House, 2004. - 11 p.

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SMC is...

The quality management system is a system that ensures the effective operation of the company, including in the field of product quality management. The most effective when creating a QMS are the requirements fixed in the international QMS standards ISO 9000 series.

Note that an effective system can be created without focusing on the ISO 9000 series standards. However, in order to certify it, that is, to obtain a document indicating that the company's processes are effective and aimed at constantly improving the quality of products or services, the QMS must comply with the requirements ISO 9001-2000 standard. Therefore, we will consider its creation from the point of view of the requirements of ISO 9001.

In order to build a QMS in accordance with ISO 9001 standards, it is necessary:

develop a document that formulates the goals and objectives of the QMS, as well as the principles for achieving them (“quality policy”);
develop regulatory documents describing and regulating business processes ();
think over an effective mechanism for implementing the requirements regulated by the regulatory framework;
prepare staff.

When forming all these elements, the basic principles of quality management should be taken into account. Consider the implementation of the QMS in stages.

Principles of building a quality management system

When building a QMS, one should be guided by the principles formulated in the ISO 9000 QMS standard:

consumer orientation,
leader leadership,
employee involvement,
process approach,
continuous improvement,
fact-based decision making
mutually beneficial relationships with suppliers.

The model of a quality management system based on a process approach looks like this:

Stages of QMS implementation in the company

Let us consider in detail all the stages of the implementation of the QMS in the enterprise.

Stage 1. Management decision

The manager must decide on the start of the project, notify the company's employees, and also create the prerequisites for the rapid implementation of all other stages. At this stage, it is necessary to formulate the goals of building the system, highlight the processes that need to be controlled at the top level, and the criteria for assessing their quality. Subsequently, the goals must be recorded in a document called "Quality Policy", which also describes the principles for achieving them.

Stage 2. Personnel training

Personnel must understand the theory of quality management, ISO 9000 series standards, master the theory of the process approach, as well as the basic requirements for the implementation of the QMS. Training in the use of the system can be carried out both with the help of consultants and independently, if the company has an employee who has experience in setting it up.

Stage 3. Formation of the QMS implementation program

Implementation of the QMS is a complex and lengthy project for up to one and a half to two years. Therefore, it is necessary to draw up a program that should include:

description of implementation stages;
a list of people responsible for each stage of the project. As a rule, they are chosen from among top managers, as well as specialists who know best the specifics of the work of their departments;
implementation budget. It includes both the costs of certification and the payment of consultants, if they are involved, as well as the cost of further staff training and the cost of diverting management from the main work for the project. When setting up, you can do it on your own, however, distracting top management from the main work, as well as training your own specialists of the required level, can cost more than the services of a consulting company;
procedure for evaluating the implementation of the QMS. The criteria by which management will be able to determine whether it was possible to achieve the goals set at the beginning of the project are indicated.

After compiling the program, you can proceed to the direct formulation of the QMS.

Stage 4. Description and optimization of business processes

The described business processes must be optimized, that is, all non-compliance with the requirements of the standard and duplicative ones should be eliminated, as well as new ones should be developed in accordance with the rules of the standard. Most often, companies do not have a “Customer Satisfaction Assessment”, which is required by the standard. Therefore, it is necessary to develop a system of indicators, as well as procedures necessary for the implementation and monitoring of this process.

Stage 5. Development of regulatory documentation

At this stage, normative documents, regulations and procedures are formed that ensure the work of the QMS. The basis for them is usually a set of documents already existing in the enterprise, which is modified and supplemented in accordance with the requirements of the standard.

First, based on the "Quality Policy", a document called "Quality Manual" is prepared. It contains the main provisions governing activities: the delineation of areas of responsibility, requirements for the quality service, a description of the procedures for ensuring it, the procedure for maintaining the QMS document flow, a description of the complaint handling procedure, etc.

The next level of documents is called "System-Wide Documented Procedures". According to the ISO 9001 standard, six procedures should be carried out:

document management,
data management (records),
audit management,
management of products that do not meet standards (the process of identifying defects and the procedure for their disposal),
management of actions that correct nonconformities,
management of measures to prevent the occurrence of nonconformities.

Documents of the next level describe the rules for effective planning, implementation and management of processes. These documents include working procedures, job descriptions workers, flow charts.

The basis of the "pyramid" of documents is data confirming that the requirements of the QMS are implemented in practice. These are reports on the work done, entries in the operation logs, etc., that is, the documentary basis of the daily work of employees.

When preparing regulatory documentation, it is necessary to take into account the requirement of the ISO 9001 standard on the competence of the personnel performing the work. This means that the regulatory documents should describe the process of employees' access to regulatory documentation, as well as the requirements for personnel competence (level of knowledge, work experience), a program to improve the level of employees if necessary, an employee motivation system, etc.

It should be noted that effective use a large number of regulatory elements requires the presence in the organization.

Stage 6. Testing and internal audit of the quality management system

After the development of all regulatory documents, trial operation begins. You can start processes gradually, for example, first implement control over the procurement process, then production, etc. Pilot operation is accompanied by internal audit, special procedures for verification of work. At the beginning of operation, they are carried out frequently (perhaps once a week), then less frequently (once a month or even a quarter).

For internal audit purposes it is necessary to fix quantitative indicators of quality, for example, rejection rate, customer satisfaction rate, return rate, etc., to which it is necessary to strive. To determine the value of such indicators, similar indicators of industry leaders are usually used. The internal audit should identify discrepancies between current work and the requirements of the standard. These deviations must be recorded. Then, based on the results of the audit, adjust the work of employees, as well as normative documentation to avoid future deviations. All this work should also be documented.

Stage 7. Certification

In order to certify the QMS, it is necessary to submit an application to the certification body. Initially, a number of documents should be submitted to the certification body:

certification statement,
all documents (“Quality Policy”, “Quality Manual”; company organizational chart, documented procedures and other developed documents),
list of the main consumers and suppliers of the enterprise.

Specialists of the certification body conduct an examination of the submitted documents within a month. The examination may include a visit by representatives of the certification body to the enterprise to check the QMS in action. Based on the results of the audit, a protocol is drawn up in which all inconsistencies between the system and the requirements of the ISO 9001 standard are recorded. Usually, according to the results of the first stage of the audit, more than a hundred inconsistencies are found, and the task of the enterprise is to eliminate them as soon as possible and prove it to the certification body. As a rule, these operations take 1-4 months.

After that, the actual certification of the QMS is carried out. If all significant discrepancies are eliminated, the company is issued a certificate, it is issued for about a month. Repeated (observational) audits of the QMS are carried out by the certification body with certain periodicity. They confirm that the company has not only implemented the system, but is constantly improving it. The cost of such an audit is approximately one third of the cost of primary certification.

The role of the financial director in the implementation of the QMS

Majority Russian enterprises have existed for a long time and work according to historically established rules. In order to change these rules in accordance with the QMS, a strong administrative resource is needed: the CEO and CFO must not only take an interest in such changes, but also manage them. Often financial directors act as a coordinator of the process of building a system and are directly involved in the description and systematization of procedures within the framework of this work.

QMS staging sometimes pushes financial service to the preparation of accounting and management reporting in accordance with international standards. After all, accounting under IFRS and financial management in accordance with ISO are very close in their idea.

Alexander SHADRIN

THE CONCEPT OF IMPROVING THE QMS FOR PROJECT IMPLEMENTATION

A fairly common situation in Russia has developed at the Enterprise: it was formed in the first half of the 20th century, in the last 15 years it received orders from the ministry and from private firms, retained a trade union organization and a staff of almost a thousand people. And in last years The company is increasingly participating in tenders for individual projects, including together with Western competitors, fulfills orders from foreign companies. In this situation, naturally, there are acute questions about the quality, efficiency, prestige of the Enterprise and, accordingly, about QMS certification.

At the same time, it is very difficult to “improve the system” in which the trade union and several hundred qualified, mostly middle-aged specialists, each of whom is really a master of his craft, within an acceptable time frame. These people have gone through more than one, including (as everyone now admits) inadequate, reform, and to convince them today to work differently than they have been accustomed to for decades is an almost impossible task (By the way, a similar situation occurs in many Russian universities, namely therefore, the effective practical implementation of ISO 9000 series standards in universities is a very difficult problem, despite the huge number of publications on the topic of education quality.).

Without going into details of the current situation, we only emphasize that, unfortunately, the high qualifications of many Russian specialists does not imply knowledge of effective management, and knowledge of quality is limited to product quality. In market conditions, this is no longer enough (for more details, see).

Organizations performing innovative projects, often huge, difficult to manage, they have an unreasonably large overhead (ministries, corporations, research institutes, universities, etc.). Projects in the conditions of fierce competition must be carried out in a short time and at competitive prices, and the output should be high-quality products.

To the credit of the leaders of the Enterprise, they studied the problem, consulted with consultants and decided to create a quality management system based on the ISO 9000 series and ISO 10006 standards, using the following features of these standards and the long-term practice of the Enterprise itself:

ISO 9001 states the requirements for an "organization"; an organization's QMS can only be certified for compliance with ISO 9001, and ISO 10006, following ISO 9004, is advisory in nature;

ISO 9000 defines an "organization" as a group of people and necessary means with responsibilities, powers and relationships, assuming that it is part of a firm or institution and not necessarily a legal entity;

The enterprise has been carrying out projects for many years (since Soviet times, when "complex creative teams" existed), forming for this purpose certain, limited (optimal) groups of employees; moreover, it is prestigious to work in these groups and management (management system, motivation and relationships) in these groups is always more effective than in the Company as a whole;

ISO 10006 distinguishes between "originating organization" and "project organization" and gives numerous recommendations regarding their relationship, and within the framework of fulfilling the requirements of ISO 9001. Further, some of these recommendations are given in quotes in small print in the article.

"The originating organization decides to develop the project. The originating organization appoints a project organization to carry out the project. The originating organization can undertake several projects, each of which can be assigned a different design organization.

The design organization carries out the project. The project organization may be part of the originating organization.

In this situation, the Enterprise decided to develop, implement and submit for certification a quality management system for the implementation of the Enterprise's projects (ISO 10006 uses the term "project quality management system.") (hereinafter referred to as ISCM). At the same time, the organization from the point of view of ISO 9001 is each design organization of the Enterprise, and the initiating organization is always the Enterprise itself. In accordance with the recommendation of ISO 10006 (clause 4.4.2), the ISCM is interconnected with the quality management system of the Enterprise: as will be shown below, a number of organizational and control functions in the ISCM are performed by officials Enterprises that are not part of the design organization. The QMS complies with the requirements of ISO 9001, and for QMS Enterprises(Recall that, according to the definition, a quality management system is available at any operating enterprise, regardless of its compliance with a particular document.) In general, such a conformity assessment is not carried out.

KEY ASPECTS OF ISO 10006 USED IN THE QMS

ISO 10006 contains a number of recommendations that exceed the requirements of ISO 9001 (i.e. their implementation is not mandatory for obtaining a certificate of conformity) and are largely innovative in nature, i.e. are new, sufficiently substantiated and quite acceptable for practical implementation(Recall that in the world economic literature "innovation" is interpreted as the transformation of potential scientific and technological progress into real, embodied in new products and technologies.). Let us briefly list some of these recommendations and note how the Enterprise used them in practice.

1. Noteworthy are paragraphs. 5.2.2-5.2.9 of ISO 10006, which reveal the well-known eight principles of quality management. Quite often in the literature, these principles are described in general terms. The authors of ISO 10006 specified the concepts of "quality culture" (clause 5.2.3), "process identification" (clause 5.2.5), "systems approach" (clause 5.2.6) and a number of others that are often repeated in the specialized literature. The enterprise directly used excerpts of this text in the documentation of its ISCO (The author also considers it appropriate to directly use the text of clauses 5.2.2-5.2.9 of ISO 10006 in various methodological and teaching aids on quality management).

2. The concept introduced in ISO 10006 seems to be successful: "progress evaluation" - an assessment of progress towards achieving the project goal. Notes: 2. The results of progress evaluations may lead to a revision of the project management plan.

Obviously, it is advisable to evaluate progress during any work, using the clear recommendations of clause 5.3.2 of ISO 10006, including a description of: a) the purpose of the assessment, b) the procedure (plan) for conducting the assessment, c) the list of actions performed during assessment, d) a list of post-assessment activities.

In the QMS Quality Manual, this item is given almost entirely in the section "Management review".

3. Let us note Sec. 6.2 ISO 10006 (Human Resources Processes), whose recommendations are also used in the QMS Quality Manual.

4. Attention should be paid to the content of a number of paragraphs of Sec. 7 of ISO 10006 ("Manufacture of products").

So, for example, sect. 7.3 ISO 9001, Design and development, begins with: “The organization shall plan and control the design and development of products. In design and development planning, the organization shall establish: a) design and development stages; b) review; c) responsibility and authority: "etc. In other words, the organization should, as if without much thought, "actively act." The corresponding section 7.3 ISO 10006 begins with Concept Development (clause 7.3.2).

Of course, the recommendation that any work should start with a concept cannot be considered innovative. However, in the context of the content of ISO 9001 (which does not contain the word "concept" at all), and most importantly, in the context of the practice of applying ISO 9001 (as you know, not always successful), the recommendation to formulate a concept at the beginning of work is extremely relevant7.

At the same time, the organization is invited to clearly (“in the form of documented requirements”) formulate why (for whom and for what) this project: "Other interested parties must be identified and their needs established. They must also be presented as documented requirements and agreed with the customer" . Naturally, at the end of the project period, it is necessary to publicly assess the degree of satisfaction of the needs of all identified stakeholders, i.e. proper quality. The fulfillment of this simple requirement alone will certainly significantly increase the effectiveness of projects carried out by organizations.

5. The recommendations of paras. 7.3.4 ("Definition of actions"), 7.3.5 ("Control of actions") and related clauses. 7.4.4 ("Schedule development") and 7.4.5 ("Schedule monitoring") of ISO 10006. These clauses are not about planning and controlling processes (generally a large number actions) and products (the result of the actions performed, when perhaps "the train has already left"), as required by ISO 9001 (Example that the question of the concept QMS development causes bewilderment and even indignation of some "quality management specialists" due to the absence of such a requirement in ISO 9001, see p. 128.), but about planning and controlling exactly each "smallest identified element of action". “The results of the review should be used to evaluate progress, evaluate process outputs and plan remaining work. A revised plan for remaining work should be documented” (, 7.3.5).

It is obvious that such planning, control and analysis are quite laborious and practically impossible without the use of modern information technologies. In ISPO information Technology used as described in . In doing so, the Enterprise shall also follow the recommendations of clause 7.6 of ISO 10006 ("Processes associated with the exchange of information").

8. As you know, the requirements of ISO 9001 are contained in five sections of this standard and relate to the organization of the process approach, management responsibility, resource management, product life cycle processes, measurement, analysis and improvement. ISO 10006 and following it, ISCOs have retained this sequence.

PROCESS APPROACH IN THE PROJECT ORGANIZATION

ISO 10006 elaborates on the process approach in design organization. Section 4.1.3 refers to 11 process groups. Appendix A provides, in principle, a very good (concise and informative) "Process Flow Chart for Design", which identifies 13 process groups, including 37 processes with a brief description.

When identifying processes, the Enterprise did not exactly follow the recommendations of ISO 10006 - for the following reasons.

First, ISO 10006 separates "resource-related processes" from "personnel-related processes", which is odd, since ISO 9001 quite reasonably considers people as a resource.

Secondly, the Enterprise did not distinguish between "processes related to time", as recommended in ISO 10006. Of course, planning and time control are the most important components of any project. But, in our opinion, appropriate actions should be "built into" each process.

Thirdly, it is not clear that ISO 10006 moved purchasing processes to the last place in the sequence of product manufacturing processes (clause 7.8). While in ISO 9001 "Purchase" (clause 7.4) comes logically directly after "Design" (clause 7.3).

Fourth, unfortunately, in sec. 7 of ISO 10006 ("Manufacture of products" ()), which deals in detail with the preparation and provision of the project, there is no section on the actual implementation of the project.

In particular, one of the disadvantages of ISO 10006 is the lack of attention to processes whose results cannot be verified through consistent monitoring or measurement. Since any project is a process, the shortcomings of which become apparent only after the start of using the products of this project.

Fifth, the disadvantages of ISO 10006 include the absence of a separate section (process) devoted to internal audit, as well as clause 8.2.2 in ISO 9001. True, ISO 10006 mentions audit in several paragraphs. Internal audit is only referred to in 5.2.7, Continual improvement, and ISO 10006 emphasizes that it "complements the ISO 9004 guidelines" where sufficient attention is paid to internal audit. However, the absence of a separate process and guidance for internal audit in design undermines the integrity of this standard.

CONCLUSION

We have already noted that after the advent of the ISO 9000 series, there was no objective need to develop "industry" international standards in the field of management (automotive, medical, oil and gas industry, education, municipal government etc.) . The principles of the ISO 9000 series are universal. In the introduction to ISO 9001 there is a fairly clear statement: "An organization can adapt its existing system management to establish a quality management system that meets the requirements of this international standard". And organizations "adapt" - it is hardly possible to find two absolutely identical management systems in the world. This means that no one interfered and does not interfere with the enterprise, guided only by the requirements of ISO 9001, to establish for its management system and those requirements or recommendations that formulated, among other things, in ISO 10006.

However, today the issue should be considered more broadly. From the specialized literature on economics, in particular, it is known that the basic question of economics, in fact, consists of three parts: what should be produced? how should it be produced? how to distribute the results of labor?

It is easy to see that these issues stem from the need to meet the needs of all stakeholders in an environment of limited resources. The degree of this satisfaction is quality. It is (!) these three questions that constitute the essence of quality management.

In other words, if we understand quality as it is considered by the ISO 9000 series standards, namely, as the degree of satisfaction of the requirements of all interested parties, then it is obvious that quality is the main subject (problem, theme) of the economy. In turn, quality management is the core (core, quintessence) of the economy.

It follows that the project, the purpose of which is excellent quality as a high degree of satisfaction of the requirements of all interested parties, is the main (single initial) project of any organization - a manufacturing enterprise, a medical one, and educational institution, and the city administration, and the state.