What is the QMS quality management system? Quality management system: how to understand the standards and start the process of their implementation in the company

Any consumer, regardless of his social status, income, age and other factors, needs to receive quality goods or services. A system of rules and techniques has been developed specifically for this purpose, making it possible to always maintain quality at a consistently high level. And the quality management system is responsible for this.

A quality management system is a specialized system developed for an organization, used to formulate the goals and policies of its activities in the field of product/service quality, as well as to achieve its objectives. To explain in a more accessible form, the main task of the QMS is to ensure High Quality of goods or services sold, adapting it to customer expectations. However, the main task is not control, but the development of a special system that helps prevent the emergence of new errors that can negatively affect products or work.

Types of QMS

The quality management system in an organization is divided into two categories:

  • Universal. Its peculiarity lies in the fact that any enterprise has the opportunity to use its principles in practice, regardless of how large the company is, what exactly it does, where exactly it does it, and so on;
  • Industry. The bottom line is that the QMS is developed for a specific type of organization. For example, there are industry standards for aerospace companies, telecommunications studios, agricultural enterprises, and so on.

Purpose, objectives and tactics of quality management

There are many goals and objectives, depending on what kind of management system is used in practice. Usually they come down to the fact that the manager develops a unified system that will work in the enterprise, preventing errors that could negatively affect the quality of products or the efficiency of order fulfillment. QMS tactics: the system must provide a guarantee of product compliance with the requirements of domestic or international standards currently in force.

A positive result can be achieved provided that the working condition of the management system is maintained on an ongoing basis, and if it is created to regularly improve the efficiency of products, taking into account the needs of each party.

In practice, special principles of the quality management system have developed, giving the enterprise the opportunity to develop effectively. These include the following:

  • the organization focuses on customers;
  • the manager is the leader of the entire team;
  • involve people to achieve the goal, thereby increasing the productivity of the enterprise;
  • a process approach is used;
  • applies systems approach to conduct work on enterprise management (see);
  • quality is constantly improving;
  • decisions are made only on the basis of factual information received;
  • there are established relationships between the company and suppliers business relationship on a mutually beneficial basis (see).

By ignoring the principles of quality management, an enterprise will soon face negative consequences - a drop in the level of demand, loss of the target audience, and so on.

Main components of quality management

Any quality management system at an enterprise includes the following elements:

  • Organization– a set of specialists and financial and technical means, where relationships, degrees of responsibility and authority are distributed;
  • Process– the number of interacting and interconnected elements designed to solve local or global problems;
  • Document– significant information that is placed on electronic or paper media;
  • Resources– everything that quality management in an enterprise cannot do without.

The ISO 9000 standard reflects the ideology of quality management as a whole, serving as a full-fledged basis for the creation and development of a QMS in any organization, regardless of its size and field of activity. Practice shows that compliance with ISO 9000 requirements makes it possible to present your own products or services in a light favorable to the organization. If the products or work performed by employees are ISO 9000 certified, this is direct evidence that strict quality management is carried out internally. Accordingly, the product has good characteristics.

Popular areas of quality management

The main directions are processes such as:

  • integration of the QMS in a number of operational aspects;
  • implementation of industry-specific solutions for existing quality systems;
  • implementation of time-tested management tactics;
  • finalization of the QMS in accordance with the recommendations of specialized standards;
  • maximum emphasis on improving the quality of implementation of organizational procedures in accordance with the features of a specific model.

Many people wonder why they need to obtain a certificate and start the verification procedure. If you successfully pass certification, in practice this will mean that the effectiveness of the quality management system used at the enterprise is at a high level. Reminding consumers about successful certification builds trust in them. When inconsistencies are detected, a list of detected problems is generated and ways to solve them are determined.

How is product quality assessed?

In order for the assessment of the quality management system to meet the requirements set by the manager, it is necessary to initiate a procedure for checking the quality of goods/services. To do this, independent experts sample a small batch of goods and conduct laboratory tests. After receiving the results, they are compared with those specified in the standards. A product conformity certificate can only be obtained if all indicators meet the required values.

Basic requirements for quality management

In order for quality management at an enterprise to meet the requirements, it is necessary to first ensure that:

  • the technical quality of the product meets the established requirements;
  • the company confidently adapts to new changes in terms of product quality dictated by market conditions;
  • specialists are fully trained and have specialized experience, which gives them the opportunity to carry out their assigned tasks smoothly and without problems;
  • the company is constantly searching for new suppliers to gain access to new markets (see) This, in turn, can have a positive effect on the rate of expansion of the target audience and profit generation.

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

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

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 implementing a QMS
  • Study modern types of QMS and you can choose the most suitable one for you
  • You will be able to understand how to create a QMS in your company and prepare it for international certification

The article bears practical nature and is based on world practice and many years of experience of the authors in the field of quality in such companies 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 based on a single end-to-end example. We took the fictitious company “Etalon” as our hero. This is a multi-brand car dealership center for the sale, repair and maintenance of cars of European brands. This example is good because:

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

History of the company. Problems

The Etalon company was founded in 2001. At that time, she was servicing 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. However, recently the competition has become increasingly fierce and therefore the company has begun to pay more serious attention to those points that it had not previously reached:

  • Service station personnel do not comply with time standards and enterprise standards
  • The Directorate believes that the productivity of direct labor (mechanics, electricians, diagnosticians) could be much higher
  • Customers are not entirely satisfied with the quality and speed of service
  • Rare clients seek services again: they go to competitors

And consequently:

  • The company is losing market position
  • 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, mechanics and electricians
  • Increased or decreased the bonus level, linking it to productivity
  • Trained receptionists to work with clients
  • And much more

However, all this gave only 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 provide?

What are the benefits for business?

Advantages, which you can get are very diverse:

  • Reduced production costs and increased profits
  • Increasing the capitalization and investment attractiveness of the company
  • Increasing the company's manageability and transparency for management
  • Increased employee motivation and loyalty, improved team environment
  • Increased customer satisfaction
  • Developing the company's image and increasing its competitiveness
  • Opportunity to enter foreign markets and cooperate with major Russian companies
  • Continuous improvement of company performance

How is this achieved?

To put it simply, quality is about how to build your business wisely. There are:

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 is under the control of its top management.

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

What are the quality management systems?

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

  • ISO 9001:2000
    Talks about how to build an efficient, long-term successful company, regardless of its field of business. It is also used to evaluate partners: how risky it is to work with them.
    This standard is the basis 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 evaluating suppliers and contractors in the automotive industry. Adopted by the “big three” American automobile 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 from those described above.

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

  • Statistical Process Control (SPC)
    A set of techniques for monitoring product quality at all stages of the life cycle.
  • Quality Cost Management
    Reducing costs from low quality (defects) by preventing it.
  • Toyota production system - TPS and lean production (Lean Production)
    Toyota production system. It is one of the most successful quality management systems in the world.
  • Modern preventative maintenance (TPM) methods
    A system of Japanese methods for assessing and improving the overall efficiency of production equipment.
  • Six Sigma
    A system originally developed by Motorola. Based on a project approach to implementing improvements and a clear organizational structure.

Basic principles of quality management

In work on quality we can highlight 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’s right, but the whole point is that a company employee can be given the best tools, machines and equipment, but if he won't want to work efficiently, all your efforts will be a waste of money and time.

Ideology needed for formation public opinion. For example, in Japan the principle “A good person is ashamed to do bad work” is promoted. In the USA, Quality is often compared to religion. A person cannot be forced to believe in God. The same goes for quality. You can’t force it, but you can convince it, create the appropriate mood within the framework of an individual project, a company or an entire society.

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

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

Quality as a discipline was largely created through the efforts of individuals. They are often called “Quality Gurus”. It was they who laid the ideological foundation for quality as a management discipline and 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 began to think 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 US business circles. He tried to find understanding in a number of countries around the world, including the Soviet Union. He almost remained in our country, but the country’s leadership demanded that he publicly declare that Soviet industry is the highest quality in the world. Having familiarized himself with the state of affairs at several factories, he was unable to take such a step, which means 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 that its industry produced were completely uncompetitive due to very low quality. For six years, Dr. Deming lectured and advised Japanese business leaders and government officials. As a result, the Japanese were able to put new management principles into practice 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”, in the book “Overcoming the Crisis” Deming formulated his famous "14 principles of quality", which reflect his many years of successful experience in working on quality in largest companies Worldwide.

The essence of Deming's approach is that the reasons for low efficiency and poor quality most often lie in the system, not in the employees. Therefore, for improvement production results managers must adjust the system itself. Special attention Deming paid:

  • necessity collecting statistical information about deviations from standards
  • reducing deviations in company processes and products
  • due to search, analysis and elimination of causes of deviations.

So let's consider "Edward Deming's 14 Principles", which to this day form the basis for quality management throughout the world.

1. Commitment to improvement

“Make sure that the desire to improve a product or service becomes constant; your ultimate goal is to become competitive, stay in business and provide jobs.”


Rice. Rising quality in Japan and the USA

The Japanese love to talk about how they have surpassed America in quality. And do you know how they explain their success?

In the USA, quality is improved from time to time when some technological or management breakthrough occurs. In Japan, one of the components of any work is its continuous improvement (Kaizen). We will look at how this happens below (PDCA cycle). In the meantime, I invite you to think about the question: how does quality change over time in Russia? Remember the dynamics of changes in the quality of many brands that have appeared on the consumer market in recent years...

Iterative Improvement (PDCA Cycle)

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

This principle symbolizes the infinity of the improvement process. Imagine that you are sailing on a boat towards a certain goal. The boat will periodically be carried away by the current and turned around by the wind. To sail to your intended goal, you will have to regularly adjust your course using the principle of feedback. Note that goals can also 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 a wheel of continuous development up an incline. The circle symbolizes the continuous nature of improvement. This symbol is very popular in Japan, as is the technique itself. For example, the PDCA cycle is often a topic of discussion at Quality Circles.

2. New philosophy

“We live in a new economic era. Leaders must rise to the challenge 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 the fool!” principle, it’s best to leave all talk about quality right away. The experience of most companies that have successfully implemented a quality management system suggests that it all starts with faith in the quality of the company's top management. Moreover, often at first you have to overcome a wall of misunderstanding and resistance on the part of the bulk of employees and middle-level managers. Quality is “doomed to success” only if senior managers accept it as one of the main priorities for the company’s development and regularly proclaim it important role, and most importantly, in daily work adhere to the principles of quality, persuading employees to follow the new course by their example.

3. Stopping mass inspections

“Overcome dependence on quality control. Quality cannot be achieved through mass testing, but must be the result of a sustainable manufacturing process.”

Initially, quality as a management discipline arose with the introduction of assembly line production at the beginning of the 20th century. Before this, an artisan producing 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 quality control departments (technical control departments) arose, that is, special units, whose main task quality control of manufactured products began. The main problem with final inspection is that even if some defects in finished products are found, their elimination can be very expensive for the company, and often “hidden defects” arise that will only be discovered when the product reaches the end user.

Another disadvantage of mass control is the psychological problems that arise in production in the presence of large quantity controllers. Who enjoys working when you are constantly being watched by the watchful eye of a supervisor?

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

4. Be careful with cheap purchases

“Stop purchasing based on seeking the lowest price and instead minimize total costs. Try to have one supplier for each component, work with him on the basis of long-term, trusting relationships.”

Any company depends on the resources it acquires on the foreign market. Management often forces purchasing managers to focus on minimum prices. However, when choosing suppliers, it is important to pay attention not only to the price of the purchased products, but also to total cost of ownership given resource throughout its entire service life, which includes the cost of repairs, spare parts, and losses from downtime of cheaply purchased 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 team of guest workers to build your cottage, who are sober only at the time of concluding the contract, and who first picked up a trowel a month ago. As they say, “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 production and service systems, as well as any other activities associated with the enterprise.”

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

There are a number of tools that allow you to analyze the causes of existing or potential problems.

6. Personnel training system

“Create a system of on-the-job training.”

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 rare these days)? How to raise professionals who will successfully cope with the tasks assigned to them, and also become the backbone of the company in the future?

World experience shows that a mentoring system, when experienced employees train young newcomers, can help solve this problem. This approach gives a “triple effect”: you train young people, increase the loyalty of experienced specialists, unite the team, and lay the foundations for respectful relationships between colleagues.

7. Effective leadership

“Modern management techniques must be adopted to help employees do their jobs better.”

A well-known principle says: in order to get a different result, it is necessary to make some changes in the system. That is, if you don’t change anything, then the result will be “as always.” Are you satisfied with the work of your employees? No? Then who is responsible for making changes happen in your company?

In the new conditions, when increasingly greater results are expected from an employee, as well as a responsible, creative approach to work, the manager is no longer the overseer over the “careless employee” that he often was before. A modern approach to management implies a partnership between employees and managers, in which the manager plays the role of a mentor, a “senior comrade” who can show the employee the path to his professional growth.

8. Eliminate the atmosphere of fear

“It is necessary to promote mutual 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? It’s worth starting a conversation about this with the fact that in any company with more than 100 people, business interests are largely replaced by the interests of building a career within the company. This means that all actions taken by the employee will be aimed at increasing their merits in the eyes of their superiors and hiding all mistakes.

What does this lead to? People are starting to be afraid. Be afraid to talk about a mistake you made, to once again turn to management with a proposal for improvement: “How will they look at me? Won't they punish me? Won't they make me responsible for implementing my proposal? What if I can’t handle it?” As a result, a person takes on only the “safest” jobs and strives to shift responsibility to colleagues and managers. What kind of creative approach to work can we talk about 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. Negative consequences- a bunch of. This is both theft and mutual concealment of inaction and mistakes.

What is the reason for this situation? The main reason for confrontation between employees and management is usually fear. After all, it often happens that when problems are discovered (for example, a defect occurs), management is engaged in “searching for the last resort,” “so that it is discouraging.” And the problem often lies in labor organization problems and system shortcomings.

A number of successful companies have introduced the following principle: if an employee himself admits his guilt in making a mistake, he is not only not punished, but is also rewarded if he has come up with a real way to prevent this mistake in the future. After all, now this employee has gained valuable experience! Of course, this does not apply to those who make mistakes every day. However, as practice shows, most workers really strive to do their job as best as possible. Don't interfere with this!

9. Removing barriers

“It is necessary to eliminate barriers between individual areas of the company’s activities and divisions.”

Have you noticed that sometimes you can hear such conversations in companies.

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

Sellers: “This accounting department is a complete swamp! Not only do they sit there all day, wiping their pants, but they also constantly make mistakes in their calculations, and you won’t get any documents from them!”

If you hear similar conversations in your project, this means that you have developed confrontation between units. Why does it happen?

The fact is that the majority of company employees are busy with their narrow business and do not notice the importance of what other departments are doing or the problems that exist in their work. This means that what other departments are doing begins to seem unimportant. As a result, conflicts and mutual accusations arise.

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

10. Refusal of slogans

“Slogans, calls and warnings must be eliminated. They only cause opposition, since in most cases poor quality is caused by the system, and not by the behavior of a particular employee.”

“You must work efficiently!”, “Five-year plan - in three years!” - we’ve all heard this somewhere before, haven’t we? When you hear such a fiery call, what desire arises inside? Do quality work, or do something different in relation to the one who repeats this slogan day after day?

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

Of course, it exists, but there are also methods for resolving it. Firstly, modern methods of creating public opinion (PR) are much more subtle than simply uttering slogans. Secondly, there are other ways to convey ideas to the masses, for example, the work of Quality Circles, which, in our experience, work great in Russia (of course, if they are organized correctly).

11. Refusal of arbitrarily established standards (quotas) in production. Management change

a) “Abandon quantitative quotas for workers”;

b) “Give up quantitative goals for the administration.”

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

Car: prestigious or cheap?

Go by train or fly by plane?

Employee: smart or flexible?

One of the tasks of the project manager is to resolve such contradictions at the most early stage planning. Moreover, the situation is often complicated by the fact that priority quality in work contradicts those quantitative production standards, which are set for employees. They would be happy to work well, but at a certain load level this becomes physically impossible.

How to be? Find compromises between quality and quantity, rather than going to one of the extremes.

12. Being able to be proud of your work

“Anything that calls into question the ability of every front-line worker and every manager to take pride in their work must be eliminated.”

Have you noticed how differently those who go to work “just to earn money” and those who are proud of their professionalism, their team, and their company have different attitudes in their work? And yet, how many obstacles managers sometimes create on the way for employees to feel proud of their company! To the point that employees of newly spun off subsidiaries of one 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 just give up because of this attitude towards themselves...

But sometimes it is necessary to take very simple actions to maintain an employee’s self-respect and pride in his profession. Methods such as honor boards and award certificates are still relevant today. And how happy serious adults are when they receive a postcard signed by their manager for a professional holiday!

13. Encourage learning

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

Do your employees undergo frequent training? No? And do you want them to keep up with the changes that are happening in our lives?

They say about Japanese companies that everyone there trains everyone, and this is one of the reasons rapid growth Japanese economy. In our country today the situation is such that up to 70% of the population do not work in their basic profession. Engineers lead, psychics treat, and everyone who couldn’t find a place in other areas becomes a salesperson. And what do you expect from such employees? It can be surprising to see what hopes the head of such a newly minted sales department places on his “eagles,” one of whom wanted to become a doctor but gave up, another is looking for a job after culinary school, and the third just came from the army. Of course, these may be quite worthy people, however, no one would think of putting a peasant in the pilot’s seat and sending him across the Atlantic!

Create conditions in which it will be prestigious for your company’s employees to study. For example, you can link career with completion of certain trainings, or obtaining a “second higher education”.

14. Transformation is everyone's business

“Make sure every employee is part of the change program.”

People say: “Alone in the field is not a warrior.” Well, what will you achieve in the area of ​​quality if your employees in the smoking room giggle at you, discussing “another whim of the boss”?

One of the first tasks of a project manager is to involve all employees in working to improve quality. And 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 a long time ago, and the Japanese mentality is significantly different from the Russian one.

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

Creation of a QMS

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

  • do it yourself;
  • order on the side.

Americans call this “make or buy”. Both have advantages: in the first case, you will learn a lot, gain your skills, and get the most adapted system, but it will take you a lot of time. In the second - spend more money, but save time and get quick, professional results.

Most people choose the second option. We will look at it using the example of the Etalon company.

There are a few main stages:

  • Preparation
    • Analysis of the “as is” condition
    • Training of managers and personnel in quality management
  • Documentation development
    • Formation of QMS documentation
  • Implementation
  • Internal audit
    • Internal auditor training
    • Conducting internal audits
  • Quality management report to senior management
  • QMS certification
  • Repeated audits, continuous improvements, recertifications.

Preparation

Analysis of the “as is” condition

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

  • The company's industry and areas of business
  • Organizational structure, management structure, number of personnel
  • Does the client need certification, if so, what kind, why and in what time frame?
  • And other parameters.


Rice. Organizational structure of the service station

It is worth mentioning here that certification varies. Companies' offers can be classified in different ways. For example:

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

The first option is more widespread on the market, and the second, alas, often comes down to the first as implementation progresses. A truly professional consultant can do both options, but initially focuses on the second. Its advantages were described above in the section “What are the benefits for business?”. This is what we will talk about next.

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, Russian ones are cheap, but the emphasis during implementation is more on administrative resources and coercion.

Based on preliminary assessment consultant makes an offer to the client, where he describes the goals of the project, its stages, and costs. As a rule, the client arranges a competition (explicitly or not) among consultants. A contract is concluded with the winner, in which technical task(TOR) and project plan are included in the appendices. This is very important because... allows you to agree “onshore” on mutual expectations and requirements, and the 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 largely depends on the client. Thus, he often strives to complete the most expensive steps on his own, and does not complete them, or does them poorly. And sometimes the project is greatly delayed due to the absence of key client persons (business trips, etc.) and delays in providing information.

The same thing happens in the preliminary stages “grinding in” between consultant and client. After all, mutual trust is important for success: a consultant often learns a lot of confidential information about the company. It’s no wonder that maintaining trade secrets is an important point in any consulting contract.

For the success of the creation and operation of the QMS, the support of key persons in the company is critical, incl. its senior management. Therefore, it is useful to carry out the so-called kick-off training, which describes the key benefits of creating the system, the mechanisms of its operation and the stages of its creation.

  • identify weaknesses and risks in the client’s business (non-compliance with the standard)
  • identify potential improvements that can be implemented, preferably at minimal cost. They are sometimes also called “low hanging fruit.”

A step-by-step survey of company personnel is conducted, starting from senior management to performers.

Further implementation largely depends on the competence of this stage. If the consultant is competent, then already at this stage a vision of “how it should be”, and not only from him, but also from the client.

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

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

Documentation development

Identification of the Company's main processes

At the next stage, it is necessary to implement the concept that emerged after analyzing the current state of the company. And, first of all, it is necessary to develop “ schematic diagram company”, and not so much “as is”, but “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 (that add value to the customer and bring profit to the company)
  • Supporting (auxiliary) processes.

However, we adhere to the approach proposed by the Austrian consultant Karl Wagner (ProCon company), who also highlights:

  • Measurement, analysis and improvement processes.

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


Rice. Interrelation of processes in the company.

Displayed first main processes, as the most important for the company. We trace the entire path from receiving a customer’s order to issuing him a finished product or service. For example:

  • Searching and attracting clients
  • Conclusion of contracts
  • Fulfilling orders
  • Development of new products (R&D).

Note that the division of processes into groups is very arbitrary and controversial, and primarily depends on the scope of 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
  • Life support of the office, technical processes
  • Safety.

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

  • Strategic management
  • Tactical Control
  • Operational management.

You can control it in different ways. It can be based on the intuition of managers, or it can be based on facts, preferably expressed in digital form. To do this it is necessary to produce measurements, then analyze received information. And based on the analysis - improve the work of the entire company or individual processes. Let’s say, in our example, the workshop manager set the price of an hour of work for the paint shop at 40 euros. Based on what: competitor analysis, customer surveys? Such a manager is at great risk if, for example, the cost of an hour is 37 euros: pretty soon his business will collapse, and he may not even suspect 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 simple flowcharts: they are less scientific and easy for everyone to understand.


Rice. Description of the order processing process at the Etalon service station

During the description, processes are repeatedly adjusted and improved. Their landscape may also change. It is convenient to identify 4 working groups from among the company’s employees, each of which describes the processes of one of the groups listed above.

Determination of QMS management procedures

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

  • 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 formulate some of its structure and document templates.

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


Rice. Example entries. “Car acceptance form for repairs”

Discrepancy management is working with customer complaints: both external and internal.

Internal audits are necessary in order to evaluate what cannot be measured in a normal measurement system. For example, the quality of documentation. First of all, performers are questioned regarding compliance with specified regulations.

If during the audit non-compliance with the requirements of the standard was identified, it is necessary to take corrective measures to correct them.

To ensure that inconsistencies do not arise in the future, preventive measures are taken.

Formation of QMS documentation

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

Application area

Sets benchmarks in the field of quality

Entire enterprise

To all employees

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

Entire enterprise

Internally: at the departmental level

Outside: 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 more departments

Consists of detailed working documents

Department, individual workplaces

Only within one department

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

Quality Policy

  1. Customer Focus
    We focus on the needs of our customers and work with them in a friendly and helpful manner in order to achieve long-term partnerships reliably and in the long term.
  2. Economical
    We are committed to acting from an economic point of view. We clarify our company's processes from the point of view of their economic sense and efficiency. For our clients, we maintain current technologies and fundamental knowledge and guarantee this. We strive to further cover costs and competitive cost of our products.
  3. Quality of services
    Our activities are defined within processes that must ensure highest quality our services. Responsibility and competence are clearly defined in order to ensure clear information flows and 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.
    Above is an example of a process description
  • On the bottom- work instructions, job descriptions, drawings, operational instructions, document forms, etc.

Implementation

Once the QMS has been created, it must be implemented. To do this you need:

  • Share 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 we need to check how much what we planned corresponds to what 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 inclined to authoritarian control, but to looking for opportunities to improve the system.

Then carry out education, both audit procedures and necessary skills, such as asking effective questions, listening, identifying the causes of problems, suggesting improvements, separating problems from specific people, etc.

Then carry out exam, where the future auditor demonstrates his skills.

Conducting internal audits

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

  • Everything is described and works. Everything is fine here.
  • If it is described, but does not work, then they decide whether a description is needed.
  • If it is not described, but it works, then they evaluate whether a description is needed to make the processes repeatable or whether it is enough to create a “checklist” or conduct a simple briefing under signature.
  • Not described and doesn't work. If a process is needed, then we come up with an optimal algorithm, otherwise we throw away the process.

Implementation of improvement activities based on audit

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 from the point of view of quality management
  • Critical non-compliance with the requirements of the standard
  • Notes
  • Recommendations

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


Rice. Internal audit report outline


Rice. Internal audit report form

Quality management report to senior management

Once the QMS has been established and internal audits have been carried out, the Quality Management Officer submits a report to the company's senior management that contains an analysis of:

  • Customer complaints
  • Company market shares
  • 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, senior management makes decisions on the final adjustments to the system, sometimes quite radically.


Rice. Agenda for the “Report to Senior Management”

QMS certification

When the QMS is completely ready, it is certified, i.e. confirmation by an accredited body that the created system complies with the standard. Simply put, some reputable independent organization provides a guarantee that your company is operating well and stably.

Certification has a number of steps:

  • QMS is being developed
  • A certification body is selected
  • Application submitted
  • Documentation (quality manual) is sent to the certification body and checked in absentia
  • Time for certification audit is scheduled
  • Auditors check the working system. The number of auditors depends on the size of the company being audited. 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 is “burned”, and the time for the next audit is set. However, this happens extremely rarely.

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

Repeated audits, continuous improvements, recertifications

Since the principle of continuous improvement is inherent in the QMS from the very beginning, so-called control audits are carried out annually, and every third year - mandatory recertification of the system.

So, the QMS has been created and is working. What did this give to our company “Etalon”? A very simple and important thing - she has become more competitive and successful. And no matter what changes occur 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 winds of change become favorable!

What else?

Of course there are others important aspects when implementing quality management in the company.

  • For example, it is impossible to 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 competitiveness of the company.

1 W. Edwards Deming, “Exiting the Crisis.” - Tver: Alba Publishing House, 1994

WHAT IS QMS?

The material was prepared by O.M. Levyakov.

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

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

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

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

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

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

What do the terms validation and verification mean?

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

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

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

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

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

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

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

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

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

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

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

Why is documenting knowledge and experience so necessary?

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

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


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


Rice. 3. System content of the QMS concept

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

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

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

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


Rice. 5. Implementation strategy for building a QMS

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

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

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

For at least two reasons.

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

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

So what to do?

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


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

Let us comment on the main ones.

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

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

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

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

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

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

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

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

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


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

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

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

5. Availability in staffing table position of Quality Director.

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

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

6. Staff motivation.

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


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

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


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

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

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


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

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

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

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

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

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


Rice. 11. “Iceberg” QMS

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

Resume (in simple and understandable language for staff).

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

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

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

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

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

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

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

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

The quality management system (QMS) is part of the enterprise management system. Its goal is to ensure stable quality of services or products that the company produces. In this article we will understand what a quality management system is. in simple words, let's give step-by-step algorithm its implementation and consider the role of the financial director in this process.

To the documents confirming the stability, reliability and prospects of the company, such as reporting in accordance with IFRS or , a certificate has been added for compliance of the QMS with the requirements of the ISO 9001 standard. Proper implementation of the QMS will allow the company to receive a number of advantages:
  • improve controllability, competitiveness and quality of products and services;
  • reduce costs;
  • make the company customer-oriented.

What is a quality management system

A quality management system is a system that ensures effective work companies, including in the field of product quality management. The most effective when creating a QMS are the requirements set out in the international QMS standards ISO 9000 series.

Note that an effective system can be created without focusing on ISO 9000 series standards. However, in order to certify it, that is, obtain a document indicating that the company’s processes are effective and aimed at constantly improving the quality of products (services), the QMS must comply requirements of the 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 sets out 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 efficient mechanism implementation of requirements regulated by the regulatory framework;
  • prepare staff.

When forming all these elements, the basic principles of quality management must be taken into account. Let's consider the implementation of the QMS in stages.

Principles of building a quality management system

When building a QMS, you must be guided by the following principles formulated in the ISO 9000 QMS standard.

  1. Customer focus.
  2. Leader leadership.
  3. Employee involvement.
  4. Process approach.
  5. Continuous improvement.
  6. Fact-based decision making.
  7. Mutually beneficial relationships with suppliers.

Stages of QMS implementation in a company

Let us consider in detail all the stages of implementing a QMS at an enterprise.

Stage 1. Management decision

The manager must decide to start the project, notify company 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 at the top level the processes that need to be controlled, 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. Staff 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 a QMS. Training in using the system can be carried out either with the help of consultants or independently if the company has an employee who has experience in setting it up.

Stage 3. Formation of a QMS implementation program

The implementation of a QMS is a complex and lengthy project lasting 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 those responsible for each stage of the project. As a rule, they are selected from among top managers, as well as specialists who best know the specifics of their departments;
  • implementation budget. It includes both the costs of certification and payment for the services of consultants if they are involved, as well as the cost of further training of personnel and the cost of distracting management from their main work to conduct the project. When setting it up, you can do it yourself, but distracting top management from their 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 assessing the implementation of the QMS. The criteria by which management will be able to determine whether the goals set at the beginning of the project have been achieved are indicated.

After drawing up the program, you can begin directly setting up the QMS.

Stage 4. Description and optimization of business processes

The basis of the QMS is the process approach. First of all, it is necessary to describe those business processes that management considers the most important to manage. For example, for manufacturing enterprise this will be the production and sale of the product, as well as service maintenance and procurement.

The described business processes need to be optimized, that is, eliminate all inconsistencies and duplicates with the requirements of the standard, and also develop new ones in accordance with the rules of the standard. Most often, companies do not have a “Customer Satisfaction Assessment”, which is necessary according to the standard. Therefore, it is necessary to develop a system of indicators, as well as the procedures necessary to implement and monitor this process.

Stage 5. Development of regulatory documentation

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

First, based on the Quality Policy, a document called the Quality Manual is prepared. It contains the main provisions regulating the activities: delimitation of areas of responsibility, requirements for the quality service, description of procedures for ensuring it, procedure for maintaining QMS document flow, 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 followed:

  1. Document management.
  2. Data (record) management.
  3. Audit management.
  4. Management of products that do not meet standards (the process of identifying defects and the procedure for their disposal).
  5. Management of activities that correct nonconformities.
  6. Management of measures to prevent the occurrence of inconsistencies.

Documents at the next level describe the rules for effectively planning, implementing and managing processes. Such documents include working methods, job descriptions of employees, and technological maps.

The basis of the “pyramid” of documents is data confirming that the requirements of the QMS are implemented in practice. These are reports on work done, entries in transaction 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 requirements of the ISO 9001 standard on the competence of the personnel performing the work. This means that regulatory documents must describe the process of employee access to regulatory documentation, as well as requirements for personnel competence (level of knowledge, work experience), a program for raising the level of employees if necessary, a system of employee motivation, etc.

It should be noted that the effective use of a large number of regulatory elements requires the presence of electronic document management 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 launch processes gradually, for example, first introduce control of the procurement process, then production, etc. Trial operation is accompanied by an internal audit and special procedures for checking work. At the beginning of operation, they are carried out frequently (perhaps once a week), then less often (once a month or even a quarter).

For internal audit purposes It is necessary to record quantitative quality indicators, for example, defect rate, customer satisfaction rate, return rate, etc., to which to strive. To determine the value of such indicators, similar indicators of industry leaders are usually used. The internal audit should identify inconsistencies 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 regulatory documentation, in order to avoid deviations in the future. All this work should also be documented.

Stage 7. Certification

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

  • application for certification;
  • all documents (“Quality Policy”, “Quality Manual”; diagram organizational structure company, documented procedures and other developed documents);
  • list of the main consumers and suppliers of the enterprise.

Specialists of the certification body carry out an examination of the submitted documents within a month. The examination may include a visit of representatives of the certification body to the enterprise to check the QMS in action. Based on the results of the inspection, a protocol is drawn up, which records all the inconsistencies between the system and the requirements of the ISO 9001 standard. Usually, based on the results of the first stage of the inspection, more than a hundred inconsistencies are found, and the enterprise’s task is to eliminate them as quickly as possible and prove this to the certification body. As a rule, these operations take 1–4 months.

After this, the actual QMS certification is carried out. If all significant inconsistencies are eliminated, the company is issued a certificate, which takes about a month to complete. The certification body conducts repeated (surveillance) audits of the QMS at a certain frequency. They confirm that the company has not only implemented the system, but is also 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 quite 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 required: the general and financial directors must not only show interest in such changes, but also manage them. Very often, financial directors act as coordinators of the system construction process and are directly involved in the description and systematization of procedures as part of this work.

Setting up a QMS sometimes pushes finance to prepare accounting and management reporting according to international standards. After all, accounting according to IFRS and financial management in accordance with ISO are very similar in idea.

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