Oleg Levyakov
WHAT IS QMS?
The material was prepared by Levyakov O.M.
"Those who know do not speak, those who speak do not know." Lao Tzu.
An attempt to find out what a QMS is, by means of a direct reference to the text of the ISO 9000 series standards, usually ends with one thing: the QMS is simply regarded as another "scam" of Western management!
This is due to the fact that the texts of the standards are read most often 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 working class. states.
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 into Russian it will be very difficult to find the right Russian word that would fully reflect the term, especially 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 put into use in Russian only out of necessity, so as not to lose its main semantic load: management is a methodology for detecting and correcting one's mistakes!
And what are the terms validation and verification worth?
In addition, domestic publications are also trying to “blown in additional fog” in order to convince potential customer contact them for clarification and advice.
I did not want to talk about it here, but another reason may simply be related to the misunderstanding of the essence of things by the authors of such publications themselves.
To be honest, this is exactly the attitude I had after the first acquaintance with the previous version of the ISO 9001-1994 standard!
But as I grew 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 it, because everything is constantly focused and “tied” to achieve customer satisfaction! And if you are interested in reducing the cost of production or, for example, reducing the time to bring a new product to the market? What does the “satisfaction” of the Consumer have to do with it, when it is “not yet”?
That is why let's start with a simple question: - what is the QMS for? The shortest answer is to increase the likelihood of achieving planned business results.
Now let's think about what we need to do for this!
From the biology course high school 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 a conditioned reflex. The repetition of these situations allows us to fix the causal relationship between our actions and results.
When hundreds of people pass 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, then!) 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 it so necessary to document knowledge and experience?
Because the circle of direct interaction of top management is 5-10 people, and it is they who “mediate” its management, its decisions, its vision. It is on them that it largely depends whether the desired and actual results of management will coincide. And here, just the “correct” statement of the problem, just the organization and just control, is no longer enough. Here, it is already necessary to agree with all the personnel of the company - about a common understanding, about a common vision, about what we want to have as an output. 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 he also gets is “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 impact of documentation of actions on the quality of production activities.
Rice. 2. The concept of the impact 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 the general view 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 the 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 adoption of these new rules (QMS), the system can easily turn into a fake one. Because without an “agreement” there is no such “transmission” of internal energy and the conviction that this particular thing is the “right” one and that it should be done right in this way. This is where the requirements of the ISO 9001 standard for ensuring staff involvement and management leadership will help you - see Fig. 5.
Rice. 5. Strategy for the implementation of the construction of the QMS
Moreover, the introduction of the QMS should be carried out only on the initiative from above, since this process requires a change in the established order of doing business, the stereotypes of employees of the enterprise.
If there is no interest in the QMS from the management side, then the probability of success tends to zero.
But because the main task of the QMS is not to increase the efficiency of the work of employees. Most often, such changes are the goal of the manager or owner, and this brings an additional headache to the employees themselves. As a rule, labor costs do not decrease with the introduction of QMS. The benefits of 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 meet such changes with hostility.
For at least two reasons.
The first is the system of accounting and document flow that has developed in the company, which is presented to all employees as the “only possible” and, therefore, not subject to revision.
The second is that for the full-fledged work of the QMS, the collection and monitoring of much more information is required (for example, quality records management - which requires greater discipline of employees) than before. Of course, the increase in the volume of work cannot please either ordinary workers or financiers, who are tuned in to savings and reducing staff.
So what to do?
Practice allows us to identify the following main success factors for the implementation of the QMS - see Fig. 6.
Rice. 6. The main success factors for the implementation of the QMS
Let's comment on the main ones.
1. Conducting a preliminary survey and subsequent modeling necessary business processes. Any business consists of interconnected (correlated) actions. The implementation of these processes should be provided with resources (monetary, labor, material, informational, etc.). Each process has its own cost. The totality of enterprise processes makes it possible to calculate the actual actual cost of the business. And then you can competently solve the problems of financial planning, analysis, pricing, product quality, etc.
Achieving business transparency by identifying the business processes of the enterprise in accordance with the set goals is an urgent task for most enterprises, especially those that are actively developing.
The business model of the company is not only the basis for managing the organization. High transparency of the business, simplicity and accessibility of the system description allows you to develop the initial technical task to set up a resource management system (for example, ERP systems) and develop new requirements for improving (tuning) the resource management system. This allows you to provide the necessary resources, the required quality, in the required quantity, in the right place, at the specified time, for acceptable price, and reduce production costs, thus increasing the 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 movement 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 first persons of the organization in the results of implementation. In any case, the staff experiences some stress when implementing the QMS. Without the strong will and power of leaders, implementation cannot be successful.
3. Work with management - the formation and coordination with the top officials of the company of its mission, goals and objectives in the field of quality - the invisible and visible presence of the manager in the framework of the implementation of the system is a must, and his role simply as an interested person may not be enough.
This is especially evident when developing indicators and metrics for the work of departments.
An example of the concept of setting goals, for example, a project business - see Fig. 7.
Rice. 7. An example of the concept of defining goals, for example, a project business
4. Formation of the implementation team and its training - no comments are needed here.
One can only add an example of personnel training for an external audit as a way of additional training.
5. Availability in staffing the position of Quality Director.
His alternative in the form of a representative of the management in the field of quality is just a crafty cover for the irresponsibility of the management itself.
For example, it is already accepted that the procurement system is headed by the commercial director, the training system is headed by the personnel director, and the finance system is headed by the financial director. It is quite logical to conclude that the quality system should be headed by the Quality Director!
6. Staff motivation.
This is a delicate matter and is solved in each specific case in different ways.
Rice. 8. The concept of creating a system of personnel motivation
But for all that, it is very important to explain to the staff that the implementation of the system will only make the whole company better - see Fig. 9, and thus 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 of the QMS Implementation Project should be developed and agreed at the highest level with liability for delay or failure to implement it.
Now it's time to “link” everything you read to the most important thing - to the concept of the quality of the company itself.
Rice. 10. Architecture of the concept "Quality of the company"
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 the planned results and, ultimately, improving the quality of the company - see. Fig.10.
But the staff is far from always able to get to the bottom of this essence!
But if you planned as a result to achieve only complete satisfaction of your Consumers, then we can say that you have built a QMS in accordance with the ISO 9001 model!
So QMS is a way of organizing production processes ensuring the achievement of planned results.
Thus, the QMS resembles an “iceberg in the ocean”: it has a tiny surface part in the form of a very small text of ISO 9001 and a huge underwater part of reengineering and business modeling, motivation systems, corporate culture, standards development, etc. - see Fig.11
Rice. 11. "Iceberg" SMK
But very often in the CIS, specialists from consulting firms who provide training in the implementation of the QMS do not reveal the essence of this entire “iceberg” well, limiting themselves to formally following the standard.
Resume (in a simple and understandable language for the staff).
The quality management system serves to improve the quality of business management.
It is called QMS and is a company's business process management system - see Fig. 4.
The QMS provides clear instructions for all occasions of the employee's life: what, where, when and why. Moreover, when a quality system is introduced, an 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 the 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 effectiveness of the enterprise, what corrective and preventive actions to take, what management needs to analyze, 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 links and relationships aimed at the disappearance of interfunctional barriers, since quality is often lost precisely at the junction of functional units.
After internal and external audits, analysis by management or at the initiative of the employee, these instructions can (and should) be improved and optimized. The meaning of all this is to leave the owner of the enterprise with a documented algorithm for the most effective actions of the employee, in case the old experienced master "Uncle Vasya" fell ill or retired.
In order for the regulation to be not just clear, but also good, corrective and preventive actions are taken to improve processes and such actions should be carried out on a regular basis.
Thus, the QMS turns out to be not a "stupid bureaucratic machine" for stupid foreigners who cannot take a step without instructions, but in fact a very effective tool for improving the quality of business.
And quite simply: The QMS turns a heroic guerrilla unit into a well-trained regular army battalion!
The quality management system at the enterprise should operate on the principle of continuous improvement of the quality of all organizational processes. The main thing is to monitor not only the quality of the product itself, but also the level of qualification of the staff, how the adopted development strategy is being implemented. Quality, on the other hand, can be quantified: by the company's financial performance and the ratio of positive and negative customer reviews.
Use of the ISO 9000 quality system
QMS can be certified according to the ISO 9000 standard, which includes a whole series of standards.
The system involves an external audit by the certifying body at the enterprise. Now in our country this procedure is not obligatory, but the presence of such a certificate indicates the reliability of the company and its customers, partners, and the state. Participation in international and national tenders, for example, without ISO certificate 9000 is unimaginable. The certificate, which is issued in Russia, is issued according to the GOST R ISO 9000 standard. To obtain it, you will need a whole set of documents: PSRN, certificates from the tax office on registration of changes in the company's constituent documents, TIN, OKVED codes, an extract from the Unified State Register of Legal Entities, the charter of the organization and all the changes that were made to it, the memorandum of association and licenses with the types of activities permitted to the company. The documents will need to indicate information about the organization (address, bank details), as well as describe the full block diagram companies, including various divisions. Also required detailed description personnel of the organization, indicating the education and work experience of employees. Registration of the certificate will take from three weeks to two months.
Obtaining a document valid for three years will cost 100-500 thousand rubles. depending on the system in which it is issued.
The introduction of a quality management system in an enterprise will help not only improve the company's reputation. QMS helps to avoid errors in production, in addition, by optimizing all the life processes of the enterprise, costs are reduced. If done right it should get better financial condition firms. Openness to external audit forces managers to reckon with the opinion of ordinary employees, which leads to team cohesion and a greater focus on a specific result.
Basic principles of the enterprise quality management system
There are several principles on which the quality system of any enterprise should be based:
The desire of the client is the main thing. The focus is on customer needs. The company must not only monitor momentary demand, but anticipate the desires of consumers. The foresight of the management will make it possible to change some parameters of the product in time, which can make the company a leader in the market segment.
The leader is the main driver of change. The head of the company must motivate employees to achieve the most positive result.
The approach to management should be systematic. This means that the manager must evaluate both external and internal factors that affect the operation of the company.
Striving for continuous improvement. This should be the main motive for the activities of a company that implements a QMS. Of course, the costs of research and ongoing audit require material costs, but new technology, which as a result will be used in production, on the contrary, can reduce costs and give the company a new impetus to development.
Employees must be involved in the quality management process. The staff must be interested in the work. Employee motivation is one of essential elements quality management systems.
Relations with partners and suppliers should be mutually beneficial. Issues related to the supply of raw materials, or, for example, logistics (which ensures the timely delivery of goods to the consumer), should be singled out in a separate area for which a specific employee will be responsible.
The quality management system (QMS) is part of the overall company management system, which operates to ensure the stable quality of products and services provided. .
The methodology of the quality management system (QMS) is based on the principles of system and process approaches. The principle of consistency is implemented in the management of the company as a system of interrelated processes aimed at achieving the set goals. The process approach allows you to identify the processes that have the greatest impact on the achievement of goals. It identifies and measures process inputs and outputs, internal and external customers, suppliers and other interested parties. Thus, the running processes within life cycle products determine the construction organizational structure enterprises. The execution of all processes for all elements of the organizational structure is documented. At the same time, the effectiveness of the functioning of the quality system at each level is confirmed by the relevant quality data. Respectively, modern system quality management combines the organizational structure, the documentation structure and the information structure, as well as the processes that affect quality. Obviously, for the effective functioning of the QMS at the enterprise, these structures must be interconnected, fully cover the organization and all processes.
The organization of the QMS involves the creation of the following documentation structure:
- Quality quide;
- Policy and objectives in the field of quality;
- Mandatory documented procedures;
- Regulations of processes and procedures, work instructions;
- Quality records.
The quality manual is a general guiding document that describes the interaction of all elements of the quality system. The policy and goals in the field of quality determine the direction of movement, the path of development of the company. Regulations of processes and procedures and work instructions - regulatory documents that the employees of the enterprise are guided by in their activities. Quality records are carriers of information that appears in the course of the organization's activities, they record all the events that have taken place. Quality records provide information about the functioning of the quality management system and determine new, more advanced ways for the development of an enterprise in the field of quality. Thus, the QMS documentation reflects the principles of organization and development of an integrated quality management system in an enterprise.
quality management enterprise
Basic principles
System (from other Greek - a whole made up of parts, connection) - a set of elements that are in relationships and connections with each other, which forms a certain integrity, unity. In any system, you can select separate parts that perform certain functions and interact with each other. Any system can be considered as an element (component) of a larger system.
Management is the management of an organization operating in the market conditions in the "autonomous navigation" mode and associated with the need to make independent decisions in any unexpected circumstances. Within its framework, it is determined what, when and to whom to produce, how to plan, distribute and efficiently use resources, with the help of what procedures and methods to manage people. The goal of management is the achievement by the object of management of a certain desired state, qualitatively or quantitatively different for the better from the existing one. Management is a collection of scientific knowledge and practical experience interdisciplinary nature from such areas as economics, organization, sociology, psychology, pedagogy, law.
In accordance with the international standard ISO 9000:2000 content modern management quality is defined as:
“Quality management is the complete set of processes used in a quality management system.
A quality management system is a system for establishing a quality policy, quality objectives and for achieving these objectives.
Quality management system (QMS) - a set of organizational structure, methods, processes and resources necessary for general guidance quality. It is designed to continuously improve performance, to increase the competitiveness of the organization in the domestic and world markets, determines the competitiveness of any organization. It is part of the organization's management system.
To date, there are quite a large number of definitions of a quality management system developed by ISO. If we combine them, we can get the following definition The term quality management system according to ISO is a system created in an organization to form a policy in the field of quality and achieve its goals.
Thus, we can say that the quality management system, first of all, is a system. And it is characterized by such features as a certain purpose, its own structure, the presence of certain elements and their relationship.
The ISO quality management system has a specific structure. This system contains the following elements: organization, processes, documents, resources.
According to ISO, an organization is a group of people and necessary funds with the distribution of responsibilities, powers and relationships. In other words, the organization is understood as a set of elements of the organizational structure related to quality, the rules for their interaction, as well as the personnel responsible for quality.
Process - a set of interrelated and interacting elements of activity that transform "inputs" into "outputs". The "inputs" of a process are usually the "outputs" of other processes. Processes in an organization are typically planned and executed with the goal of adding value (from "input" to "output").
The concept of procedure is of great importance in the QMS. A procedure is an established way of carrying out an activity or process. Thus, a procedure can be called a process (or a set of processes); on the other hand, it is a document that formalizes the correct way to carry out a process.
Document - information (meaningful data) placed on the appropriate medium. Other organizational and administrative documents of the enterprise, for example, "Regulations on subdivisions" and "Job instructions", should be associated with the documents of the quality system.
QMS resources - everything that quality management provides (human, temporary, etc.).
The ISO 9000 standard defines 8 basic principles of a quality management system on which it is based and which can be used by the top management of an organization to improve its performance.
Table 1.1.1 displays 8 quality management principles.
Table 1.1.1 - Quality management principles
These eight quality management principles form the basis of all ISO 9000 quality management system standards.
1) Orientation to the consumer.
Consumer - an organization or person receiving a product.
The principle of consumer orientation implies such activities of the company, in which the enterprise or firm will anticipate the needs of its customers and will be aimed at studying this demand, fulfilling the requirements of consumers or customers of its services.
Organizations depend on their customers, so they must know and understand their needs, which exist now and may arise in the future, meet their requirements and strive to exceed their expectations.
The application of the principle of customer orientation is an activity aimed at:
Studying and understanding all the needs and expectations of consumers, including requirements for quality, packaging, delivery time, price, services etc.;
Studying the needs of other stakeholders (owners, shareholders, personnel, suppliers, government, region and society as a whole);
Ensuring awareness and optimization of the balance of all requirements, needs and expectations of all interested parties and their documentation;
Ensuring that the goals and objectives of the organization meet the needs and expectations of consumers;
Reflection of the principle of customer orientation in the Quality Manual, policy, goals of the organization;
Communication of these requirements to the attention of all personnel of the organization;
Introduction of mechanisms for interaction with consumers;
Organization of measuring and evaluating the degree of customer satisfaction;
Development of corrective actions to improve customer satisfaction.
2) Leadership or leadership role.
The principle of leadership or the role of management involves active work to implement and establish the work of the QMS of the head of the company, he must create everything the necessary conditions to train employees and ensure the operation of the system within the organization.
Leaders achieve unity of goals and directions for the development of the organization. They create and maintain internal environment an organization that allows employees to be fully involved in the achievement of the organization's goals.
The implementation of this principle requires:
Demonstration of commitment to the principles of the QMS by personal example;
Understanding and responding to external changes;
Orientation to the needs of all stakeholders;
A clear definition of the prospects for the development of the organization;
Ensuring an atmosphere of trust and work without fear;
Providing personnel with the necessary resources and freedom of action within the framework of responsibility;
Recognizing and rewarding employee contributions;
Training and promotion of people;
Maintain open and honest relationships.
3) Staff involvement
Employees at all levels form the backbone of every organization, and their full involvement enables the organization to use their abilities to their maximum advantage.
The principle of involving the company's personnel implies that each employee of the organization should take part in the work of the quality system and is aimed at increasing its level.
This principle requires staff to:
Ensuring staff understand the importance of their own contribution and role in the organization;
Determining the responsibility of each for the results of their activities;
Involving staff in problem solving;
Continuous improvement of knowledge, experience and competence;
Creation of conditions for free exchange of knowledge and experience.
The management of the organization is required to ensure the conditions under which the staff will receive job satisfaction and take pride in their organization. Using material and moral incentives, it is necessary to encourage staff to proactively seek improvement opportunities in order to create additional value for consumers.
4) Process approach to management.
The essence of the process approach is that the performance of each work is considered as a process, and the functioning of the organization - as a chain of interrelated processes necessary for the production of products. The process is considered as a set of interrelated and interacting activities that transform input into output.
The application of this principle is the implementation at the enterprise of activities aimed at:
To determine the processes necessary for the release of products;
Definition of inputs and outputs (results) of processes;
Establishing the sequence and interaction of processes in the enterprise;
Establishing clear responsibilities and authorities for process management;
Definition of criteria for measurement and analysis of processes;
Definition of internal and external suppliers and consumers of processes;
Determination of methods for ensuring the effectiveness and efficiency of the implementation of processes;
Definition of internal and external relationships between the functions of the organization;
Definitions and provision of necessary resources, methods and materials;
Assessing the risks, consequences, and impact of processes on customers, suppliers, and other interested parties.
5) System approach to management.
The principle of a systematic approach is closely related to the principle of a process approach and implies that all the processes that were identified in the organization were included in the overall system of processes with control over their implementation and clear guidance. Defining, understanding and managing a system of interrelated processes improves the effectiveness and efficiency of an organization.
The application of a systematic approach is an activity of an organization aimed at:
On the structuring of the system by establishing and developing a system of processes that ensure the achievement of the specified goals of the organization;
Creation of such a system in which the set goals are achieved in the most effective way;
Understanding the interdependence of processes in the system;
Continuous improvement of the system through measurement and evaluation;
6) Continuous improvement.
The principle of continual improvement provides for continuous monitoring of all inconsistencies in the system operation with the subsequent elimination of these inconsistencies by improving the quality of the system.
The constant goal of the organization is the continuous improvement of all its activities.
Continual improvement is a repetitive activity to increase the ability to meet requirements.
The application of the principle of continuous improvement is the activity of the enterprise aimed at:
Formation in each employee of the need for continuous improvement of products, processes and the system as a whole;
Continuous improvement of the efficiency of all processes;
Training of all employees in the methods and means of continuous improvement, such as the Deming cycle, statistical methods, etc.;
Periodic assessment of compliance with established excellence criteria to identify areas of potential improvement;
Confessions of improvements.
7) Fact-based decision making.
The principle of making decisions based on facts implies the complete exclusion of making rash intuitive decisions. All management decisions should be backed by factual information and based on it.
Effective decisions are based on the analysis of data and information.
Measurement and collection of data and information related to the task;
Ensuring the reliability and accuracy of data and information;
Use of proven methods for data and information analysis;
Understanding the value of appropriate statistical methods.
8) Mutually beneficial relationships with suppliers.
The principle of mutually beneficial relationships with suppliers is based on mutually beneficial relationships not only with external suppliers, but also with internal ones who are also involved in the system.
An organization and its suppliers are interdependent. If their relationship promotes the mutual benefit of both parties, then their ability to create value is enhanced.
Following this principle requires:
Identification of the main suppliers;
Establishing long-term relationships with suppliers;
Establishing clear and open communications;
Joint actions in order to clearly understand the needs of consumers;
Exchange of information and plans for the future;
Recognition of supplier achievements and improvements.
Successful implementation and implementation of the eight principles of the quality management system described above leads to the qualitative implementation of the system as a whole and the prerequisites for its improvement in the future in any organization.
(QMS, - ed.) is a set of measures and ongoing operations that are used in an organization to achieve required quality services or products - what is the result of the activities of this organization. The most important difference between a quality management system and disparate and random actions in the direction of improving product characteristics or preventing manufacturing defects is that the operation of the system is not random, but systematic and comprehensive, leading to predictable consequences in advance. Traditionally implemented on the basis of 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 the difficulties of translation, that is, it is almost absent. But, back to the definition. What does "required quality" mean? By itself, an object can be neither good nor bad, but it 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 can be very different. Education plays an important role among them. We can say that it all starts with it, since before the implementation of the QMS, top management must study in detail the philosophy and practical aspects of the work of modern QMS, otherwise it will not be able to manage the process and give adequate orders to situations. Before, and especially during the functioning and implementation of the QMS, training is provided 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 quality management system. In addition, direct performers learn to understand the needs of consumers of their labor. The ISO 9001 standard takes into account the close relationship between the processes in the enterprise and outside world, which, on the one hand, supplies raw materials for the organization, on the other hand, is the goal of its efforts. Depending on the chosen QMS implementation strategy, certain categories of employees study special software, the most modern instruments scientific analysis any issues related to quality in the enterprise. This is the principle position of the ISO 9001 standard. According to this normative document, decisions must be made on the basis of facts. If we 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 for familiarization of 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. QMS documents also include internal quality standards, for example, specifications ( specifications, ed.). Below the quality manual in the hierarchy is a string of permanent documents, edited infrequently and updated constantly. also exist as separate documents. The development of documentation begins with marketing, revision of the goals of the organization, its resources and capabilities, structuring the activities of the enterprise in accordance with the process approach.
A scientific concept that proposes to consider any organization as a set of interrelated and interacting processes, the junctions 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 consist of the activities of a company that has decided to create a QMS. This is usually very difficult. Being a universal document, ISO 9001 cannot offer a scheme of processes and their interactions for a particular enterprise. On the other hand, it gives a classification that contains the key to independent division into processes. The standard divides all types of activities into those related to organization management, resource management, life cycle processes, measurements, analysis and improvements. One of the most difficult aspects of working with the 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 may, of course, coincide with the structure of the organization's departments, but a detailed analysis can also reveal unnecessary activities, an inefficient administrative organization. If the management of an enterprise has difficulties in comprehending or implementing the provisions of ISO 9001, it has a whole series of guides that the International Organization for Standardization has released 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 concern internal audit QMS and certification, implementation of QMS and its adaptation to a particular industry, system improvement and others critical 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 many years.
Let's talk separately about scientific tools for analyzing and changing the quality situation in an organization, as well as about electronic systems that can support the work of the QMS. Most of the former are based on statistics - their common name statistical methods quality control: plots, Ishikawa plots, scatter plots, tables QFD. Note that cyclic operations need not be based solely on PDCA. There are at least two alternatives: Juran's triads and Taguchi's methods. They can replace, in certain circumstances, or complement the PDCA model.
With regard to electronic systems that facilitate and organize the workflow of the QMS, 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 workflow can be established, it can be embodied in the old fashioned way in paper form, but if an electronic document management 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, teaching management methods and approaches in management, marketing, developing an organization strategy with a plan, goals and accounting for resources, developing and implementing a transformation project organizational system enterprises, continuous professional development of employees, development of training plans for them, development of process design methods, development of documented procedures and enterprise standards. Anything else? Yes, as much as you want. The quality management system is a very flexible mechanism, capable of accepting new techniques and methods, and its potential can by no means be reduced only to the requirements of the ISO 9001 standard.
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