Mikhail Yurievich Rybakov Business consultant, business coach, senior partner of Just Consulting, certified project management specialist (IPMA)
Alexander Leonidovich Shmailov Leading trainer-consultant for quality management, head of the "Quality Management" direction at Just Consulting
Management News magazine, No. 1 for 2008

“The challenge of the time for enterprises can be formulated as“ faster and more cost-effective mastering of the ever-increasing variety of rapidly changing tasks. ”

Alexander Leonidovich Shmailov


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This article is devoted to the creation and implementation of a quality management system (QMS) in a Russian company. After reading it, you:

  • Find out what benefits your business will receive from the implementation of the QMS
  • Explore modern types of QMS and you can choose the most suitable for you
  • You will be able to understand how to create a QMS in your company and prepare it for international certification

Article bears practical and is based on world practice and many years of experience of the authors in the field of quality in companies such as:

  • Western: BEKO (plant in Russia), Daimler-Benz / Mercedes Benz Avtomobili, Trocal, KBE, TUV EC, Volvo Truck Corporation Russia, Kuhne + Nagel LLC Russia, etc.
  • Russian: BeeLine, Business Process LLC, Corbina Telecom, Moscow Business School, Sawatzky, Yukos NK, etc.

The entire article will be built on a single end-to-end example. We took the conventional Etalon company as our hero. It is a multi-brand car dealer-center for the sale, repair and maintenance of cars of European brands. This example is nice because:

  • firstly, many of us regularly use the services of car service stations (STOA)
  • secondly, this example can be used to illustrate the implementation of QMS in companies involved in sales, production and provision of services.

History of the company. Problems

Etalon was founded in 2001. At that time, she was engaged in the maintenance of Volkswagen cars. Over time, a number of Japanese and Korean brands also began to sell and service. Today Etalon is one of the leaders in the regional market. Recently, however, competition has become increasingly fierce and therefore the company has begun to pay more serious attention to those points that had not previously reached their hands:

  • The workshop staff does not comply with the time norms and standards of the enterprise
  • The Directorate believes that the productivity of the direct labor force (mechanics, electricians, diagnosticians) could be much higher
  • Customers are not entirely satisfied with the quality and speed of service
  • Rare customers turn to services again: they go to competitors

And consequently:

  • The company loses its position in the market
  • Owners and investors are not satisfied with the return on invested capital.

Of course, these problems were not new to management. And, of course, they tried to solve them:

  • Installed video surveillance of the work of mechanics, locksmiths and electricians
  • Increase or decrease the level of premium, linking it to performance
  • Trained acceptors to work with clients
  • And much more

However, all this gave only a temporary improvement. And then one day the owner of the company heard that there is such a science - quality management, and decided to implement it in my company.

What is quality management and what does it give

What are the business benefits?

Advantages that you can get are very diverse:

  • Reduced production costs and increased profits
  • Increasing the capitalization and investment attractiveness of the company
  • Increasing the manageability and transparency of the company for management
  • Increased employee motivation and loyalty, improved team environment
  • Increased customer satisfaction
  • Development of the image and increasing the competitiveness of the company
  • Possibility of entering foreign markets and cooperation with the largest Russian firms
  • Continuous improvement of the company

How is this achieved?

Simply put, quality is about how to build your business "according to the mind"... Distinguish:

Quality management is the same area of ​​management as production, finance, personnel and others. But at the same time, it is more complex, affecting all aspects of the company's work, and therefore being under the jurisdiction of its top management.

And all successful companies in the world (from such giants as Daimler-Benz to small companies) in various business areas are dealing with these issues.

What are the quality management systems?

There was a time when each leading company created its own QMS. However, in order not to “reinvent the wheel” based on the practices of the world's most successful companies (best practices), various quality standards, for example:

  • ISO 9001: 2000
    He talks about how to build an effective, long-term successful company, regardless of the scope of its business. It is also used to assess partners: how risk-free it is to work with them.
    This standard is basic for all QMS created in the world, therefore we will take it as a basis for further presentation. Other standards clarify and detail the requirements of ISO 9001: 2000 for specific countries and industries.
  • ISO QS 9000
    Standard for the assessment of suppliers and contractors in the automotive industry. Adopted by the "big three" American car companies: Ford, General Motors, Chrysler.
  • VDA 6.1 / 6.2
    European standard similar to ISO QS 9000. Adopted by German companies such as BMW, Volkswagen, Mercedes, Siemens.
  • ISO TS 16949
  • An international standard that grew out of the above.

But that's not all. If you have implemented the QMS, then you have reached a certain basic level for the industry. But the competition is growing, and if you want to develop further, your guideline can be programs to further improve, for example:

  • Statistical Process Control (SPC)
    A set of methods for quality control of products at all stages of the life cycle.
  • Quality cost management
    Reducing costs from poor quality (marriage) due to its prevention.
  • Toyota production system - TPS and Lean Production
    Toyota production system. It is one of the most successful quality management systems in the world.
  • State of the art preventive maintenance (TPM) methods
    A system of Japanese methods for evaluating and improving the overall efficiency of production equipment.
  • Six Sigma
    A system originally developed by Motorola. Based on a project-based approach to implementing improvements and a clear organizational structure.

Basic principles of quality management

In the work on quality, one can distinguish 3 levels:

1. Ideology

2. Psychology

3. Tools

"What does this mean? - you ask. - What does ideology have to do with it? In our country, this was more than enough! Look at the results! "

That is so, but the point is that an employee of a company can be given the best tools, machines and equipment, but if he won't want work efficiently, all your efforts will be a waste of money and time.

Ideology needed to form public opinion. For example, in Japan, the principle is promoted: "A good person is ashamed to work badly." In the US, Quality is often compared to religion. A person cannot be forced to believe in God. Also with quality. You cannot force - but you can convince, create the appropriate attitude within the framework of a particular project, company, or the whole society.

Understanding psychology an employee is needed in order to be able to convey the basic principles of quality to employees.

A instruments help to put into practice the principles of quality.

Quality as a discipline was largely created by the efforts of individuals. They are often referred to as "Quality Gurus". It was they who laid the ideological foundation of quality as a management discipline, developed tools that are actively used all over the world.

Edward Deming is rightfully considered one of the founders of the world science of quality. In the 1940s. XX century, he worked as a professor of statistics at New York University. At that time, he first had the idea that statistical methods could be used for quality management. He offered his ideas to many American companies, but at that time his ideas were not accepted in the US business circles. He tried to find understanding in a number of countries of the world, including the Soviet Union. He almost stayed in our country, but the country's leadership demanded that he publicly declare that the Soviet industry is the highest quality in the world. Having familiarized himself with the state of affairs at several factories, he could not take such a step, which means that he was forced to continue his search for a country where his ideas would be accepted. Japan turned out to be such a country.

After the Second World War, Japan was in a very difficult economic situation, and the goods produced by its industry were completely uncompetitive due to their very low quality. For six years, Dr. Deming has lectured and advised Japanese business leaders and government officials. As a result, the Japanese were able to put into practice new management principles and become world leaders in the quality of their products.

Much later, in the early 80s, many years after the start of the "Japanese industrial revolution", Deming formulated his famous "14 principles of quality" which reflect his many years of successful experience working on quality in the largest companies around the world.

The essence of Deming's approach is that the reasons for low efficiency and poor quality are most often inherent in the system, and not in the workers... Therefore, to improve operational results, managers must adjust the system itself. Deming paid particular attention to:

  • the need collecting statistical information on deviations from standards
  • reduce deviations in the processes and products of the company
  • at the expense of search, analysis and elimination of the causes of deviations.

So let's consider "The 14 principles of Edward Deming", which to this day are the basis for quality management around the world.

1. Striving for improvement

“Make the drive to improve a product or service constant; your ultimate goal is to become competitive, stay in business and provide jobs. "


Rice. Quality growth in Japan and the USA

The Japanese are very fond of telling how they overtook America in quality. Do you know how they explain their success?

In the United States, quality is improved from time to time when a technological or managerial breakthrough occurs. In Japan, one of the components of any work is its continuous improvement (Kaizen). How this happens, we will consider a little below (PDCA cycle). In the meantime, I suggest you think about the question: how does quality change over time in Russia? Remember the dynamics of change in the quality of many brands that have appeared on the consumer market in recent years ...

Repetitive improvement (PDCA cycle)

One of the main principles in the development of quality is the principle of continuous improvement. He finds practical embodiment in the implementation of the famous PDCA cycle (from English words: plan- to plan, do- make, check- check, act- to act) developed by Edward Deming.

This principle symbolizes the endlessness of the improvement process. Imagine that you are sailing to a certain destination. The boat will periodically be blown away by the current, turned around by the wind. In order to sail towards your intended goal, you will have to regularly adjust your course using the principle of feedback. Note that goals can change ... However, in business people often think that once they find the right solution, they can use it forever.


Rice. PDCA cycle

The PDCA cycle is often depicted as a person pushing the wheel of continuous development up an incline. The circle symbolizes the continuous nature of improvement. This symbol is very popular in Japan, like the technique itself. For example, the PDCA cycle is often the topic of discussion in Quality Circles.

2. New philosophy

“We are living in a new economic era. Leaders must respond to the challenges of this era, must recognize their responsibilities and become leaders to bring about change. ”

If you want to run your company using the old “I'm the boss, you're a fool!” Principle, it's best to leave all the talk about quality right away. The experience of most companies that have successfully implemented a quality management system suggests that everything starts with a belief in the quality of the company's top management. And often at first you have to overcome the wall of misunderstanding and resistance from the bulk of employees and middle-level managers. Quality is “doomed to success” only if top managers accept it as one of the main priorities for the company's development, regularly proclaim its important role, and most importantly, they themselves adhere to the principles of quality in their daily work, by their example convincing employees to follow the new course.

3. Termination of mass checks

“Get over your addiction to quality control. Quality cannot be ensured through mass inspections, it must be the result of a sustainable product manufacturing process. "

Initially, quality as a management discipline arose with the introduction of conveyor production at the beginning of the 20th century. Prior to that, an artisan who produced his products in small batches could control the production process himself from start to finish. And the worker standing on the assembly line became separated from the results of his labor, that is, those "10 nuts" that he screwed every day from morning to evening were very far from the shiny beautiful cars that rolled off the assembly line at the end of assembly and finishing.

Then, for the first time, the idea of ​​creating a quality control department (technical control departments) arose, that is, special divisions arose, whose main task was to control the quality of manufactured products. The main problem with final inspection is that even if some defects in the finished product are found, its elimination can be very expensive for the company, and often there are "hidden defects" that are discovered only when the product reaches the end user.

Also, the disadvantage of mass control is the psychological problems that arise in production when there are a large number of controllers. Who enjoys working when the watchman's watchful eye is constantly watching you?

The opposite of total control is development of the quality of the business process and technological process so much so that the occurrence of marriage will be impossible in principle. Also one of the goals is to achieve reproducibility of processes... For example, one car can be produced in a garage, but in order to make a thousand identical ones, and even with workers of different skill levels, quality management is needed.

4. Caution with cheap purchases

“Stop the practice of buying based on the search for the lowest price, instead, keep the total costs to a minimum. Try to have one supplier for each component, work with him on the basis of a long-term relationship of trust. "

Any company depends on the resources that it acquires on the foreign market. Oftentimes, management forces purchasing managers to focus on minimum prices. However, when choosing suppliers, it is important to pay attention not only to the price of purchased products, but also to total cost of ownership this resource during the entire period of its operation, which includes both the cost of repairs and spare parts, and losses from downtime of cheap resources. Often, a simple economic calculation shows that it is better to buy more expensive but high quality products. You can calculate what is more profitable: invite a team of professionals or a brigade of guest workers to build your cottage, who are sober only at the time of the conclusion of the contract, and the trowel was first picked up a month ago. As the saying goes, "I'm not rich enough to buy cheap things" ...

5. Continuous improvement of systems

"It is necessary to constantly look for the causes of defects in order to improve in the long term all systems of production and provision of services, as well as any other activity associated with the enterprise."

This principle tells us how important it is to analyze the causes of problems that arise during the operation of the company. “There are no failures - there is only feedback,” say the wise. Our mistakes and miscalculations are invaluable experience that will facilitate our path to success in the future. Only a detailed consideration of the reasons that led to a particular problem allows you to eliminate it in the future. It is extremely important from the very first steps of the project development to cultivate in the employees the principle of a detailed analysis of the difficulties that arise in order to take real steps to eliminate them and prevent them in the future.

There are a number of tools available to help you analyze the causes of emerging or potential problems.

6. Training system

Create a workplace learning system.

Have you noticed that often a young specialist who comes to work after studying at a university has no idea what needs to be done, even if he works in his specialty (which is a rarity these days)? How to raise professionals who will successfully cope with the tasks assigned to them, and will also become the backbone of the company in the future?

World experience shows that a mentoring system can help in solving this problem, when experienced employees train young newcomers. This approach has a triple effect: you educate young people, increase the loyalty of experienced professionals, unite the team, and lay the foundation for respectful relationships between colleagues.

7. Effective leadership

"Modern management methods must be applied to help workers do their jobs better."

The well-known principle says: in order to get a different result, it is necessary to make some changes in the system. That is, if nothing is changed, then the result will be “as always”. Are you satisfied with the work of your employees? No? Then who is responsible for bringing about change in your company?

In the new conditions, when more and more results are expected from the employee, as well as a responsible, creative approach to work, the manager is no longer the overseer over the "negligent employee" that he often was before. The modern approach to management implies a partnership between employees and managers, in which the leader is assigned the role of a mentor, a “senior friend” who can show the employee the way to his professional growth.

8. Eliminating the atmosphere of fear

“It is necessary to foster communication and use other means to eliminate fear among workers. Then people will be able to work effectively in the interests of the company. "

What are workers afraid of? We should start talking about this with the fact that in any company, the number of which exceeds 100 people, the interests of the business are largely supplanted by the interests of building a career within the company. This means that all the actions taken by the employee will be aimed at increasing his merits in the eyes of his superiors and hiding all the mistakes.

What does this lead to? People start to get scared. To be afraid to talk about the mistake made, to turn to the management once again with a proposal for improvement: “How will they look at me? Will they not be punished? Will they not be made responsible for the implementation of my proposal? What if I can't cope? " As a result, a person undertakes only the "safest" jobs, seeks to shift responsibility onto colleagues and managers. And what kind of creative approach to work can you say in such a team environment?

Another negative consequence of the fear of punishment at work, the division of the company into “bosses” and “ordinary workers” is the emergence of mutual responsibility among ordinary employees. There are many negative consequences. This is theft and mutual concealment of inaction and mistakes.

What is the reason for this situation? Fear is usually the main reason for confrontation between employees and management. After all, it often happens that when problems are detected (for example, a marriage occurs), the management is engaged in "looking for the extreme", "so that it is discordant." And the problem often lies in the problems of the organization of labor, the shortcomings of the system.

In a number of successful companies, the following principle has been introduced: if an employee himself admits his guilt in making a mistake, he is not only not punished, but also rewarded if he comes up with a real way to prevent this mistake in the future. After all, now this employee has gained valuable experience! Of course, this is not the case for those who make mistakes day in and day out. However, as practice shows, most workers really strive to do their job as best they can. Do not bother them in this!

9. Removing barriers

“It is necessary to eliminate barriers between individual areas of the company, divisions.”

You have noticed that sometimes in companies you can hear such conversations.

Accounting: “These salespeople are slackers! Not only do they come to the office only in the evening, but also the documents are constantly delayed! "

Sellers: “This accounting department is a continuous swamp! Not only do they sit all day, wipe their trousers, they also constantly make mistakes in calculations, and you won't get documents from them! "

If in your project you hear such conversations, it means that you have developed opposition of divisions... Why does it arise?

The fact is that most of the company's employees are engaged in their own narrow business, do not notice the importance of what other departments are doing, the problems that are in their work. This means that what other departments are doing starts to seem unimportant. As a result, conflicts and recriminations arise.

What to do in such a situation? As a rule, this situation is resolved through a series of procedures aimed at resolving conflicts, establishing constructive interaction between units. Moreover, to conduct such events, people are needed who will not be "theirs" for either side, and often a team of invited consultants acts in this role.

10. Rejection of slogans

“It is necessary to eliminate slogans, appeals and warnings. They only provoke opposition, since in most cases poor quality is caused by the system, and not by the behavior of a particular employee. "

“You have to work efficiently!”, “Five-year plan - in three years!” - We've all heard this somewhere, haven't we? When you hear such a fiery call, what desire arises within? To work well, or to do something different with respect to the one who repeats this slogan day after day?

Does this mean that propaganda is not needed at all? How to be? How to convey the necessary ideas to employees? Moreover, the author spoke above about the “ideology of quality”. Is there a contradiction here?

It is, of course, there, but there are also methods for resolving it. First, modern methods of creating public opinion (PR) are much more subtle than just uttering slogans. Secondly, there are other ways of conveying ideas to the masses, for example, the work of the Quality Circles, which, according to our experience, work very well in Russia (of course, if they are organized correctly).

11. Refusal from arbitrarily established norms (quotas) in production. Change of leadership

a) "Give up quantitative quotas for workers";

b) "Give up the quantitative goals of the administration."

As the practice of implementation of quality management systems shows, there is always a contradiction in companies: to work efficiently or work well. In general, our whole life is woven of contradictions. For example:

Car: Prestigious or Cheap?

Traveling by train or by plane?

Employee: Smart or Compliant?

One of the tasks of the project manager is to resolve such conflicts at the earliest possible stage of planning. Moreover, the situation is often complicated by the fact that the priority quality in work contradicts those quantitative production rates that are set for workers. They would be happy to work well, but at a certain level of load it becomes physically impossible.

How to be? Find compromises between quality and quantity, and not go to one of the extremes.

12. The opportunity to be proud of your work

"Anything that calls into question the ability of every employee and every manager to be proud of their work must be eliminated."

Have you noticed how differently those who go to work “just to make money” and those who are proud of their professionalism, their team, and their company treat their work? And, nevertheless, how many obstacles do managers sometimes create on the way of employees to a sense of pride in their native company! To the extent that employees of recently separated subsidiaries of a very large Russian company, who work side by side with it every day, are prohibited from wearing its symbols! It's hard to see the bitterness in people's eyes when they talk about it! People simply lose heart from such an attitude towards themselves ...

But sometimes it is necessary to take very simple actions to maintain self-respect in an employee, pride in his profession. Methods such as honor boards and awards are still relevant today. And how fully grown-up serious people rejoice when they receive a postcard signed by their manager for their professional holiday!

13. Encourage learning

"It is necessary to create a comprehensive training program and an environment in which self-improvement becomes a need for every employee."

Do your employees often receive training? No? And you want them to keep up with the changes that are taking place in our life?

It is said about Japanese companies that everyone teaches everyone there, and this is one of the reasons for the rapid growth of the Japanese economy. In our country today there is such a situation that up to 70% of the population do not work in their basic profession. Engineers are in charge, psychics treat, and all those who could not find a place in other areas go to salesmen. And what do you expect from such workers? It is surprising to see what hopes the head of such a newly-made sales department places on his "eagles", one of whom wanted to become a doctor, but quit, the other is looking for a job after a culinary college, and the third has just come from the army. Of course, these can be quite decent people, however, it never occurs to anyone to put a peasant in a pilot's seat and send him across the Atlantic!

Create such conditions in which it will be prestigious for the employees of your company to study. For example, you can associate career growth with the passage of certain trainings, or getting a "second higher".

14. Transformation is everyone's business

“Get every worker involved in a transformation program.”

The people say: "One is not a warrior in the field." Well, what will you achieve in the field of quality, if your employees in the smoking room will giggle at you, discussing "the next whim of the boss"?

One of the first tasks of a project manager is to involve all employees in quality improvement work. And to make sure that people participate in it voluntarily and with enthusiasm.

It should be noted here that although Deming's principles have proven their effectiveness in Japan and other countries of the world, they were developed for a long time, and the Japanese mentality is significantly different from the Russian one.

That is, when borrowing any advanced experience, you should creatively process it under the conditions of your reality. What principles will you develop for your company based on the best world experience?

Creation of QMS

So how is the QMS created? As with everything, there is at least two ways:

  • do it yourself;
  • order on the side.

Americans call it "make or buy". Both have advantages: in the first case, you will learn a lot, fill your bumps, and get the most adapted system, but it will take you a lot of time. In the second, you will spend more money, but you will save time and get a quick professional-level result.

Most choose the second option. We will consider it on the example of the company "Etalon".

There are a few milestones:

  • Preparation
    • Analysis of the "as is" state
    • Quality management training for managers and staff
  • Development of documentation
    • Formation of QMS documentation
  • Implementation
  • Internal audit
    • Internal auditor training
    • Internal audits
  • Quality management report to top management
  • QMS certification
  • Re-audits, continuous improvements, recertifications.

Preparation

Analysis of the "as is" state

To begin with, the consulting company conducts preliminary rough estimate of the client in order to determine the contours of the future project. Evaluated:

  • Industry of the company and directions of its business
  • Organizational structure, management structure, number of staff
  • Does the client need certification, if so, which one, why and in what time frame
  • And other parameters.


Rice. Organizational structure of the workshop

It is worth mentioning here that certification is different... There are different ways to classify the offers of companies. For example:

  • "Sale of the certificate" + QMS as a bonus. Wishful thinking.
  • Assistance in creating organizational maturity of the company (speed, accuracy, quality of fulfillment of customer orders) + a certificate as its confirmation.

The first option is more widespread on the market, and the second, alas, is often reduced to the first in the course of implementation. A truly professional consultant can do both, but initially focuses on the second. Its benefits have been described above in the “What are the business benefits?” Section. It is about him that we will talk further.

Certification also happens:

  • Western(TUV, Lloyd register, BVQI, DNV, SGS, etc.)
  • Russian(GOST-R, VNIINMASH, Russian register, etc.)

Western certification bodies are good because they have many years of experience and reputation, transfer successful experience from other companies, but their services are very expensive.

At the same time, the Russian ones are cheap, but the emphasis during implementation is placed more on the administrative resource, coercion.

Based on preliminary assessment the consultant makes an offer to the client, where he describes the goals of the project, its stages, cost. Typically, the client arranges a competition (explicitly or not) among the consultants. A contract is concluded with the winner, in which the terms of reference (TOR) and the project plan are included in the appendices. This is very important because allows "on the shore" to agree on mutual expectations and requirements, scope of work. Otherwise, the project tends to "grow", which leads to dissatisfaction on both sides.

It is also worth mentioning that the success or failure of a project is largely dependent on the client... So, often he seeks to complete the most expensive stages on his own, and does not perform, or does it poorly. And sometimes the project is greatly delayed due to the lack of key persons of the client (business trip, etc.), delay in providing information.

It also happens in the preliminary stages "Grinding" the consultant and the client... After all, mutual trust is important for success: a consultant often learns a lot of confidential information about a company. It is not for nothing that the preservation of trade secrets is an important point of any consulting contract.

For the success of the creation and operation of the QMS, the support of the key persons of the company, incl. her senior management. Therefore, it is useful to carry out the so-called starting ("kick-off") training, which describes the key benefits of creating a system, how it works and the stages of its creation.

  • identify weaknesses and risks in the client's business (non-compliance with the standard)
  • identify improvement potentials that can be implemented, preferably at minimal cost. Sometimes they are also called "low hanging fruit".

A step-by-step survey of the company's personnel is carried out, ranging from senior management to performers.

Further implementation largely depends on the literacy of this stage. If the consultant is competent, then already at this stage seeing "as it should be", and not only for him, but also for the client.

This stage ends the formation of a project for the implementation of the QMS in company.

An example is provided at the beginning of this section. You can supplement it with a network graph, a Gantt chart and a responsibility matrix.

Development of documentation

Identification of the main processes of the Company

At the next stage, it is necessary to implement the concept that has developed after analyzing the current state of the company. And, first of all, it is necessary to develop a “principle diagram of the company”, and not so much “as it is”, but rather “as it should be”, taking into account the requirements of the ISO 9001: 2000 standard. In quality management, this scheme is usually called "Process landscape": it contains the names of the processes taking place in the company and, possibly, the connections between them.

Processes are usually divided into three groups:

  • Company management processes
  • Core processes (which add value to the customer and bring profit to the company)
  • Supporting (auxiliary) processes.

However, we follow the approach suggested by Austrian consultant Karl Wagner (ProCon), who also highlights:

  • Measurement, analysis and improvement processes.

This makes it possible to ensure that the created QMS will actually fulfill its functions: contribute to the prosperity of business. If these processes do not exist, the QMS is just a declaration.


Rice. The interrelation of processes in the company.

First displayed main processes as the most important for the company. We trace all the way from the receipt of the customer's order to the issuance of a finished product or service. For example:

  • Search and attraction of clients
  • Concluding contracts
  • Execution of orders
  • Development of new products (R&D).

Note that the division of processes into groups is very conditional and controversial, and primarily depends on the scope of the business and the goals of the company. For example, for a bank, financial management is the main process.

  • Selection and evaluation of suppliers
  • Work with personnel
  • Office life support, technical processes
  • Security.

In order for the core and supporting processes to function successfully, they need to be managed. For this there are governance processes... For example:

  • Strategic management
  • Tactical control
  • Operational management.

You can manage in different ways. It can be based on the intuition of managers, or it can be based on facts, preferably expressed in digital form. For this it is necessary to produce measurements, then analyze the information received. And already based on the analysis - improve the work of the whole company or individual processes. For example, in our example, the workshop manager has set the price of an hour for a paint shop to be 40 euros. Based on what: competitor analysis, customer surveys? Such a manager runs a very high risk if, for example, the cost of an hour is 37 euros: pretty soon his business will collapse, and he may not even be aware of it, because it does not have a system for collecting and analyzing evidence.

Detailed description and development of processes

  • Name
  • Owner (responsible)
  • Process boundaries (start and end)
  • Inputs and Outputs (starting with outputs)
  • Process execution logic

There are many ways to describe processes, from the simplest to the most complex, such as IDEF0 and ARIS. However, we recommend using the simplest block diagrams: they are less scientific and easy for everyone to understand.


Rice. Description of the order processing process in STOA "Etalon"

In the course of the description, the processes are repeatedly corrected and improved. Their landscape can also change. It is convenient to single out 4 working groups from among the company's employees, each of which describes the processes of one of the groups indicated above.

Determination of QMS management procedures

In order for the processes to be efficiently executed taking into account the requirements of ISO 9001: 2000, it is necessary to develop six mandatory procedures for managing the QMS:

  • Document management
  • Records management
  • Non-conformity management
  • Internal audit management
  • Corrective actions
  • Preventive measures

To documentation The QMS was convenient to use, it was necessary to form some of its structure and document templates.

Recordings are necessary in order to record how this or that work was performed. Think of the sheet on which a cleaning lady marks the time of cleaning a restaurant toilet - this is an example of records.


Rice. Sample records. "Form of acceptance of the car for repair"

Non-compliance management is about handling customer complaints, both external and internal.

Internal audits are necessary in order to assess what does not lend itself to a normal measurement system. For example, the quality of documentation. First of all, the performers are interviewed for the implementation of the specified regulations.

If in the course of the audit nonconformities were identified with the requirements of the standard, it is necessary to take corrective actions that correct them.

And so that in the future inconsistencies do not arise in principle, preventive (preventive) measures are taken.

Formation of QMS documentation

Of course, the QMS must be documented. The documentation is arranged in a pyramid:

Application area

Sets benchmarks in the field of quality

The whole enterprise

All employees

Describes the quality system in accordance with the established quality policy and objectives and the applicable standard

The whole enterprise

Inside: at the department level

Outside: to the project participants

Describes the activities of individual functional units necessary for the implementation of elements of the quality system

One or more departments of the enterprise

Only within one or several departments

Consists of detailed working papers

Department, individual workplaces

Only within one department

  • At the top level- the company's policy and objectives for quality, which are detailed in the Quality Management Manual. This documentation is presented in its most general form and is of an "advertising" nature. It is provided to clients, suppliers, partners. However, it contains links to the next level, which contains the company's know-how, which means that access to it should be limited.

Quality policy

  1. Customer orientation
    We focus on the needs of our customers and work with them in a friendly and helpful manner in order to achieve permanent partnerships reliably and long-term.
  2. Profitability
    We are committed to acting economically. We find out the processes of our company in terms of their economic sense and efficiency. For our clients, we support the latest technology and fundamental knowledge and guarantee it. We strive for subsequent coverage of costs and competitive cost of our products.
  3. Service quality
    Our activities are defined within the framework of processes that should ensure the highest quality of our services. Responsibility and competence are clearly defined in order to ensure clear information flows, regulations for the regulation of interfaces.
    Preventing or quickly resolving nonconformities is part of our process oriented QMS.
  • On average- descriptions of processes and procedures. These are documents regulating the company's activities: how to analyze the market, how to work with suppliers, create new products, etc.
    The above was an example of a process description
  • At the bottom- work instructions, job descriptions, drawings, operational instructions, document forms, etc.

Implementation

After the QMS is created, it must be implemented. This requires:

  • Distribute responsibility for the implementation of the created processes between managers and employees.
  • To train... It is recommended to train managers first, who then train their employees.

Internal audit

Now it is necessary to check how much what we have planned corresponds to what it actually is. The main goal is to improve the created system.

Internal auditor training

First of all, it is important to determine who will be the internal auditors... A good auditor can be a person who is not tuned in to authoritarian control, but to look for opportunities to improve the system.

Then spend education both the audit procedures and the necessary skills, for example, asking effective questions, listening, identifying the causes of problems, suggesting improvements, separating problems from specific people, etc.

Then spend exam where the future auditor demonstrates his skills.

Internal audits

The audit is carried out about a week after the end of the implementation. When conducting it, the following options are possible:

  • Everything is described and works. Everything is good here.
  • If described, but does not work, then decide if a description is needed.
  • If it is not described, but it works, then it is assessed whether a description is needed for repeatability of the processes, or whether it is enough to create a "checklist" or conduct a simple instruction against signature.
  • Not described and doesn't work. If a process is needed, then we come up with an optimal algorithm, otherwise we discard the process.

Implementation of audit-based improvement actions

Based on the results of the internal audit, it is written report, has the following structure:

  • General information about the state of affairs in the company in terms of quality management
  • Critical non-conformities to the requirements of the standard
  • Remarks
  • Recommendations

Based on the report, list of events to improve the QMS.


Rice. Internal audit report outline


Rice. Internal audit report form

Quality management report to top management

When the QMS is established and internal audits have been carried out, the Quality Management Commissioner submits a report to the top management of the company that analyzes:

  • Customer complaints
  • Market share of the company
  • Corrective actions
  • Preventive measures
  • Internal audits
  • Dedicated resources
  • Work with personnel
  • Corporate culture
  • Etc.

During this procedure, the authorized person “sells” the created system to the first person of the company, demonstrating to him all the benefits of using the QMS. Based on the results of the report, top management makes decisions on the final adjustment of the system, sometimes very drastic.


Rice. Agenda of the "Report to senior management"

QMS certification

When the QMS is completely ready, they carry out its certification, i.e. confirmation by an accredited body that the created system complies with the standard. Simply put, some reputable independent organization guarantees that your company is doing well and consistently.

Certification has a number of steps:

  • The QMS is being developed
  • Certification body selected
  • Application is being submitted
  • Documentation (quality manual) is sent to the certification body and verified in absentia
  • Certification audit time assigned
  • Auditors check the working system. The number of auditors depends on the size of the audited company. During the audit, auditors identify "critical deviations", comments and recommendations. If there are more than 3 critical deviations, then the certification is interrupted, the payment "burns out", and the time of the next audit is assigned. However, this is extremely rare.

It should be noted that the cost of certification depends on the size of the company and the number of man-days of the auditor's work. The cost of one man-day of work of a Western certification body is equal to the monthly salary of an average Russian manager.

Re-audits, continual improvements, recertifications

Since the principle of continuous improvement was initially laid down in the QMS, so-called control audits are carried out annually, and every third year there is a mandatory recertification of the system.

So, the QMS has been created and is working. What did this give our company Etalon? A very simple and important thing - it has become more competitive and successful. And no matter what changes take place in the market, its shareholders and management are now confident that the company will be able to quickly adapt to them: not only preserve itself, but also reach a qualitatively new level.

With quality management, the wind of change becomes favorable!

What else?

Of course, there are other important aspects when implementing quality management in a company.

  • So, for example, one cannot do without tools, of which more than 600 have been developed to date: from the simplest to the very complex.
  • It is very important to work correctly with personnel so that your QMS is not just a pile of paper, but a really working mechanism for increasing the company's competitiveness.

1 W. Evards Deming, "Out of the Crisis." - Tver: Publishing house "Alba", 1994

A quality management system (QMS) is a style of enterprise management in which managers, engineers and technicians and workers strive to improve the quality of products and the enterprise management system itself. The requirements for the QMS are set out in the international standard ISO 9001: 2008, which is called “Quality management systems. Requirements". The standard was developed by the international organization for standardization (ISO, Geneva, Switzerland) and summarizes the world's best management practices.

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

The question is often asked: "Tell us in a nutshell what the QMS is."

To answer this question, it is necessary to carefully read the ISO 9001 Standard. However, we must honestly admit that the Standard is written in a complex language, and it is not easy to understand its contents without additional training. Therefore, we will take the liberty of retelling the basic requirements of the Standard in accessible language. The list of requirements for the activities of the enterprise and each employee will be numbered not in the usual order 1,2,3, but according to the clauses of the Standard containing the relevant requirements.

4.1. It is necessary to present all the activities of the enterprise as a chain of processes or sub-processes.

Depending on what we expect at the end of each process (drawing up a production plan, making a batch of finished products, etc.), we must learn to numerically measure the state of the process, establish a demarcation mark between the concepts of "what is good" and "What is bad." For example, it was decided to measure the quality of the plywood manufacturing process using indicator (indicator) "The share of high grades in the total production" ... The line between good and bad is performance criterion process, equal to 52% (this figure is taken as an example) ... If it turns out 52% or more grades of plywood, then we say that the process is effective. If it turns out to be 51% or less, then this means that the process is going badly and needs to be improved. Thus, it is necessary to measure all activities that determine product quality. Continuous process improvement is product quality management.

4.2. It is necessary to manage information that contains requirements for products and processes and data on the state of production.

The carriers of such information are the documents on paper and electronic media and records, also on paper and electronic media.

4.2.3. Requirements for products, semi-finished products, as well as for processes (technological modes) are contained in the DOCUMENTS.

It is necessary to use only up-to-date documents. Our company has strict rules for the use of documents of external origin (for example, GOSTs) and internal origin (instructions, procedures, drawings). A new concept "Procedure" is introduced. This is a document that provides a sequence and description of actions, indicating the positions responsible for each action.

4.2.4. Evidence of fulfillment or non-fulfillment of requirements is contained in RECORDS(magazines, order-orders, invoices, acts, reports).

If a recording is in progress, then the date and the person who performed the recording must be indicated. All records are kept neatly and stored in designated locations so that they can then be found again and reviewed.

5.3. The company's management has written a short but important document "Quality Policy".

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

5.4.1. The management of the enterprise has established the "Goals of the enterprise", which must be achieved by the enterprise as a whole in the short term (1 year), as well as goals for each head of departments and services.

The company's management values ​​its employees, first of all, for the fact that they know how to find ways to achieve the goal. For some, this is the commissioning of new equipment on schedule, for others - the timely implementation of the plan for the development of technological documentation for products, for workers it is the ability to produce high-quality products.

5.5.1. The management of the enterprise must decide how to communicate to employees what they are responsible for (responsibilities and authorities).

These can be: an employment contract, procedures, regulations on services and departments, job descriptions, orders, oral instructions. Each employee should know what he is responsible for and what powers (rights) he has.

5.6. The management of the enterprise should periodically analyze how well the enterprise management system is functioning.

For this purpose, extensive information is collected - both positive and negative - about various aspects of the company's activities. This analysis is carried out at meetings on product quality and service interactions.

6.2.2. For each employee whose activities affect the quality of products, the requirements for his competence should be established: basic education, additional training, skills and experience.

The company must ensure that the competence of its employees is constantly improved. It is necessary to record the results of the assessment of the competence of employees in writing.... This assessment should be carried out periodically by managers in relation to their subordinates.

6.3. The management of the enterprise must take care of the serviceability of the equipment so that it does not stand idle in unscheduled repairs and is safe.

It is necessary to carry out the planned repairs, observe the rules for working on the equipment. An indicator of the quality work of mechanics is a small number of equipment downtime.

For an organization to function successfully, it must be managed in a systematic and visual manner.

Organization management, along with other aspects of management, includes quality management.

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. QMS, like any system, is characterized by its purpose, structure, composition of elements and connections between them. QMS of a university is a set of organizational structure, methods, processes and resources required to implement quality policy through planning, management, ensuring and improving quality.

The quality policy is the main document of the system. It defines the goal of building and operating the QMS, as well as the obligations of top management to achieve the set 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 due to the involvement of all personnel, while the top management (university rector) takes full responsibility for achieving quality goals.

Administrative influence on the QMS is based on the management of processes according to actual indicators. Its main goal is to create conditions capable of providing continuous process improvement. 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 developing and implementing a quality management system includes the following stages:

  • selection of the QMS model;
  • comparison of the university's activities with the requirements of the chosen model;
  • restructuring the activities of the university where necessary;
  • development and implementation of QMS documentation confirming the compliance of the university with the requirements of the model;
  • QMS certification in order to improve the efficiency of business processes;
  • performance improvement based on continuous process improvement.

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

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

All errors are always caused by incorrect actions. In order to avoid mistakes, it is necessary to determine the correct sequence of actions, describe (formalize) them, develop instructions for the implementation and control of the correct actions. In other words, the management of the quality of training of specialists should be structured so that deviations from the specified requirements, if possible, are prevented, and not corrected after they have been detected.

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 "tune" 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 appearance of errors leading to poor quality of services.

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

Success can be achieved by implementing and maintaining a management system designed to continually improve performance, taking into account the needs of all interested parties.

QMS structure

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

According to ISO definitions, an organization is a group of people and the necessary means, with the distribution of responsibilities, authorities and relationships.

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

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

QMS resources are all 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 control;
  • ensure the availability of resources and information necessary to support operations and monitor processes;
  • observe, measure and analyze processes;
  • take actions necessary to achieve planned results and continuous improvement of processes;

What is ISO?

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

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

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

ISO is an International Organization for Standardization and is a worldwide federation of national standards bodies (ISO member bodies).

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

Standards developed by ISO are grouped into families. ISO 9000 is a series of ISO standards that are used in the creation and improvement of quality management systems for 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, a set of quality management principles. 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 by adopting a quality management approach. The current version is “ISO 9004: 2009. Management for the sustainable success of the organization. Quality Management Approach ”.
  • ISO 19011. A standard that describes methods of auditing 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 is an analogue of ISO 9000: 2005 (prepared by the All-Russian Scientific Research Institute of Certification (JSC VNIIS) based on the application of GOST R ISO 9001-2008)
GOST ISO 9001-2011 is an analogue of ISO 9001: 2008 (prepared by the All-Russian Scientific Research Institute for 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 of various forms of ownership. All of them contain norms and requirements that a 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 as regulating the organization and conduct of audits.

And ultimately it came. In addition to (QMS, - ed.), The models of business excellence (ed.), Lean management (ed.), Paradigm, are heard. Thanks to the low Russian materials on the topic: it can be difficult for a top manager to understand what to choose for himself from the listed arsenal. The problem arises and how to use it. (QMS - Quality Management Systems - QMS, - Ed.) Is the most developed mechanism of scientific and practical management in the Russian market. Suffice it to say that, according to the survey, which is referenced by the brochure of the Ministry of Industry and Trade (Ministry of Industry and Trade - Ed.) "Lean Manufacturing and Quality Management Systems", 97% of domestic industrial enterprises covered by the study are according to the international standard ISO 9001. For comparison , only 36% of the sample worked with lean tools. But even most managers are not very versed in the opportunities that are available to them in the field of QMS. They make a system for them, and issue certificates. But the staff quickly rejects foreign and incomprehensible "Western things". This says only one thing: even if you bought something on a turnkey basis, you still need to be able to use it, otherwise there will be no sense in purchasing it. Inside the QMS you will be greeted by the same as in general in business management systems.

Types of QMS

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

Initially, there was a certain antagonism between industry and universal standards. The International Organization for Standardization (- Ed.) Was afraid that the development of certain standards would make ISO 9001 meaningless. It was probably not so much about the ambitions of ISO, but about the fact that the absence of more or less well-known QMS standards make it is impossible to formulate uniform requirements for everyone in this aspect on the international market. Ultimately, this is a blow to the development and integration of global trade. Industry standards, such as QS 9000, cannot facilitate cross-border communications by definition - as highly specialized regulations, they can be of interest to a relatively narrow circle of companies. However, it was not possible to solve the problem of the absence of important details for the industries in any other way than through separate standards of industry associations. There have been attempts by ISO to release adaptations of ISO 9001 for different industries. It is in line with this trend that the International Organization published ISO / TS 16949 - this is the same ISO 9001, only with parts for the automotive industry. But such attempts cannot be considered successful. One way or another, in the end, it was possible to reach a compromise, when groups of professional associations and stakeholders at the national level still accept their QMS standards, but they are written in accordance with ISO on the basis of the universal requirements of ISO 9001. The new standards reproduce the text of the universal document, and then add those details that are missing but that are important to the industry. However, a number of standards of "rebels" that are devoted to the problems of QMS in a particular industry, but ignore ISO 9001 still exist.

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

What to choose QMS, lean management, some business excellence model or ERP system?

To do this, you need to understand what each of these tools can give you. Business Excellence Models - Today the Baldrige Model and the European Business Excellence Model (EFQM - Ed.) Are strategic, global approaches to management. If quality systems are focused on achieving the quality of products and services, then, for example, for EFQM, this is only part of the problem. This model is focused not even on quality, but on performance. Quality according to models of business excellence is only part of the problem, and in the standards, where their requirements are enshrined, many other aspects are touched upon: sustainable development, social responsibility, and so on. It is easy to say that the requirements of ISO 9001 cover 20-30% of the requirements of the European Business Excellence Model. Each professional has a different methodology, but some experts in the field of management consulting believe that the implementation of a QMS is a good preparatory procedure for working with business excellence models.

A big problem for a manager is the choice between QMS and ERP systems or the integration of both, that is, simultaneous implementation. No dispute, and QMS and ERP are dedicated to performance and compliance. But these two approaches differ in what is the focus. The main thing for QMS is the automation of quality-related processes throughout the company, not only in the quality department. ERP, in turn, focuses on interactions on quality issues and on data in the supply chain and manufacturing processes. there are some elements that overlap and entrepreneurs will inevitably have to choose which approaches to focus on. These are the following structural elements:

  • Management and documentation of nonconformities.
  • Handling complaints.
  • Supply quality, internal and external audits.
  • Change management.
  • Corrective and preventive actions.
  • Education.
  • Calibrate and maintain tools for preventive action.

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

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

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(QMS, - Ed.) Is a set of measures and constantly implemented operations that are used in an organization to achieve the required quality of services or products - what is the result of the activities of this organization. The most important difference between a quality management system and isolated and random actions in the direction of improving product characteristics or preventing production defects is that the system's operation is not random, but systematic and complex, leading to predictable consequences in advance. According to the current situation, they are being introduced on the basis of an international standard, which, moreover, has been adapted in our country as a national standard under the designation. The difference between the national copy and the original created by (International Organization for Standardization - Ed.) Comes down to translation difficulties, that is, almost nonexistent. But back to the definition. What does “required quality” mean? By itself, the subject can be neither bad nor good, and receives an assessment only from the point of view of a person. Quality is what is recognized as such by consumers. For this reason, the definition of a quality management system is usually added to meet the quality requirements that arise from external stakeholders: ordinary customers, partners, government agencies, other market players interested in the activities of an organization that implements ISO 9001.

The types of activities that the quality management system combines in itself can be very different. Education takes an important place among them. We can say that everything starts with him, since before the implementation of the QMS, the top management must study in detail the philosophy and practical aspects of the work of modern QMS, otherwise it will not be able to lead the process and give adequate orders to situations. Before, and especially during the operation and implementation of the QMS, training is carried out for middle management and ordinary employees of the company. They study both the ISO 9001 standard itself and the internal one, which was developed to implement innovations within the framework of the quality management system. In addition, direct performers learn to understand the needs of the consumers of their labor. The ISO 9001 standard takes into account the close relationship between the processes in the enterprise and the outside world, which, on the one hand, supplies raw materials for the organization, on the other, is the goal of its efforts. Depending on the chosen strategy for implementing the QMS, certain categories of employees study special software, the most modern tools for scientific analysis of certain issues related to quality at the enterprise. This is the fundamental position of the ISO 9001 standard. According to this normative document, decisions must be made on the basis of facts. If you adhere to this principle, the adoption of many decisions in the company should be preceded by a meticulous collection of information and a comprehensive analysis.

The creation, management and periodic updating of QMS documentation plays a huge role in the success of the implementation of a quality management system. This includes the development of a quality manual - a generalized document intended to familiarize all employees, a kind of overview of the entire QMS, external documents on which any commercial structure is forced to rely: laws, the ISO 9001 standard itself, state standards. Among the QMS documents are internal quality standards, for example, TU (technical specifications, ed.). Below the quality manual in the hierarchy is a whole string of permanent documents, rarely edited and constantly updated. also exist as separate documents. Development of documentation begins with marketing, revising the goals of the organization, its resources and capabilities, structuring the activities of the enterprise in accordance with the process approach.

Scientific concept, and proposing to consider any organization as a set of interrelated and interacting processes, the joints of which are of paramount importance. process approach, according to the standard, at the enterprise, which allows you to establish the sequence of QMS operations that require constant repetition. The cycle proposed in ISO 9001 allows not only maintaining quality at the level, but also improving it. Naturally, before "launching", what specific processes are the activities of a company that has decided to create a QMS. This is usually very difficult. As a universal document, ISO 9001 cannot provide a diagram of processes and their interactions for a particular enterprise. On the other hand, it provides a classification that contains the key to independent division into processes. The standard divides all activities into those related to organization management, resource management, life cycle processes, measurement, analysis and improvement. One of the most difficult aspects of working with a process approach is the following feature. Sometimes the conscientious application of this method leads to a revision of the entire organizational system of the enterprise. The processes can, of course, coincide with the structure of the departments of the organization, but a detailed analysis is also able to reveal unnecessary activities, an ineffective administrative organization. If the management of an enterprise has difficulties in understanding or implementing the provisions of ISO 9001, it has a whole series of guidelines that the International Organization for Standardization has issued on various details of creating a QMS: ISO 10006, ISO10007, ISO 10012, ISO \ TO 10013, ISO \ TO 10014, ISO 10015, ISO \ TU 16949, ISO 19011, ISO 10006 and a number of others. These documents relate to the internal audit of the QMS and certification, the implementation of the QMS and its adaptation to a specific industry, the improvement of the system and other important issues. In addition to these guidelines, the management of the enterprise still has the opportunity to resort to the help of numerous consulting organizations that have been professionally helping to implement the QMS for more than one year.

Let's talk separately about scientific tools for analyzing and changing the situation with quality in an organization, as well as electronic systems that can support the work of the QMS. Most of the former are based on statistics - their common name is statistical quality control methods: graphs, Ishikawa diagrams, scatter plots, tables QFD... Note that cyclic operations need not be based only on PDCA... There are at least two alternatives: the Juran triads and the Taguchi methods. They can replace in certain circumstances, and can complement the PDCA model.

As for electronic systems that facilitate and organize the QMS document flow, it is worth mentioning here APQP(Advanced Product Quality Planning, - ed.) And ERP(Enterprise Resource Planning, - ed.), IDEF(Integrated definition, - ed.), FMEA(Failure Mode and Effects Analisis, - ed.).

The ISO 9001 standard does not establish a strict form in which the QMS document flow can be established, it can be embodied in paper form in the old-fashioned way, but if an electronic document flow system is used, then the use of the capabilities of IT technologies will be invaluable.

So, the creation of a QMS consists of the implementation of a process approach and PDCA, in accordance with the ISO 9001 standard, training management in methods and approaches in management, marketing, developing an organization's strategy with a plan, goals and accounting for resources, developing and implementing a project for transforming the organizational system of an enterprise, permanent professional development of employees, development of curricula for them, development of process design methods, development of documented procedures and enterprise standards. Anything else? Yes, as much as necessary. The quality management system is a very flexible mechanism capable of accepting new techniques and methods and its potential in no way can be reduced only to the requirements of the ISO 9001 standard.

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