Why does an enterprise need a quality management system (QMS)?

In order to purposefully manage quality at an enterprise, a quality management system (QMS) is required. The QMS performs two important functions:
- on the one hand, a cost-effective QMS makes it possible to reduce costs arising from insufficient quality;
- on the other hand, a company with a good quality image has a credit of trust with the consumer and can therefore charge higher prices for its products compared to competitors if they do not have a corresponding image.
Systematic quality management contributes to:

• continuous improvement of product quality,
• increasing customer satisfaction,
• reducing production costs and, consequently, increasing the competitiveness of the enterprise.

Quality management aims to reduce costly work, continuously improve production processes, work, services and, therefore, products, thereby meeting customer requirements faster and better and improving production results.

2. Why is enterprise QMS certification needed?

The concept of “certification” comes from the Latin “certificare = to do reliably, correctly.” A quality management system certificate is confirmation from an independent organization that the enterprise’s QMS meets the requirements of the ISO 9001 standard.
In other words, this is confirmation that the company can supply products of the required quality on an ongoing basis, taking into account all consumer requirements. QMS certification is a proven means of avoiding multiple audits by different customers.
Since many enterprises, authorities and departments now require a QMS certificate from their suppliers, and even include this requirement in the basis of the contract, a certificate can also give a company a competitive advantage. And, in addition, a certification audit is also a good reason, together with an objective, completely independent expert, to identify weaknesses in the enterprise and eliminate them with the help of an external auditor.

3. What is the advantage of a QMS integrated with several types of quality standards?

Most enterprises that have implemented quality management systems and have felt the economic effect of system management began to seriously look at building systems in other areas of activity. At the same time, enterprise managers follow the simplest path - they include all services of the enterprise in the quality management system, developing procedures that regulate their activities. In practice, the enterprise begins to function according to the same rules: all types of activities are documented in the quality manual, enterprise standards, instructions, etc. All departments are included in audit schedules.
Those managers who were the first to understand the benefits and necessity of mastering and implementing a systematic approach to enterprise management receive undeniable advantages. It is the systems that link into a single whole the interacting and interconnected processes that constitute the essence of the activities of enterprises, and direct the work of departments to achieve the main goal of the business - making a profit by meeting the requirements and expectations of consumers.
At the same time, effective management of quality, environmental aspects, personnel and resources, finances and information, processes and deadlines, risks and safety is ensured, and as a result - increasing the competitiveness of products and the company.
The basic principles of systems management are still concentrated in ISO 9001. The main task of management is the ability to coordinate the activities of various services in order to achieve the main goal of the business. A management system is a mechanism, a management tool for implementing the mission, strategy, policy and achieving the goals of the organization.
If all aspects of activity are managed according to common principles, within the framework of a single integrated management system, the effectiveness and efficiency of such activities is much higher.

4. Who is on the QMS team at the enterprise?

The QMS team includes all employees of the enterprise, from senior management to junior personnel. Main structural elements of the QMS:
- the introduction of a QMS presupposes the desire of the enterprise management to elevate quality to the rank of the highest goal of the enterprise. To communicate and emphasize this desire, management should be sure to formalize its understanding of quality and the corresponding enterprise commitment in the form of a quality policy. Such a written quality policy forms, as it were, the “roof” of each quality management system.
- the management of the enterprise must, in addition, create conditions to ensure the possibility of achieving in practice the goals formulated in the policy
- the most important conditions include a clear regulation of responsibility and authority. The QMS should provide clear information about the organizational structure of the enterprise.
- another important general condition: to establish how individual activities are performed (procedures) and how they interact with each other (processes). The QMS must accurately establish the organization of processes in the enterprise.
- the basis of each system is the resources used by the enterprise to meet quality requirements. This includes finances, people, facilities, equipment, practices and methods. The QMS should also regulate the use of resources.

5. How and by what means are the costs of creating and using a QMS at an enterprise recouped?

The highest goal of any responsible enterprise manager is to ensure the long-term profitability of the enterprise. Therefore, every major change and investment in the enterprise is analyzed first by senior management to determine what costs are associated with it and what (financial) effect can be expected. The introduction of a QMS is an investment for the future.
Cost estimates largely depend on the size and complexity of the enterprise. When calculating costs, in any case, it is necessary to take into account the following expense items: time costs of participants; costs of possible missing resources, such as standard controls, electronic data processing programs, etc.; training expenses; costs of improvement activities; external consultation costs; expenses for the declared certification body. The amount of costs for the above items depends on the following factors: the size of the enterprise; scope of the QMS; range of products or services of the enterprise; the volume of existing QMS elements; volume of own or attracted services; number of employees involved; the period of time spent on introducing the system; employee motivation; loyalty to the goal and assistance from the top management of the enterprise.
Beneficial effect: increasing the economic efficiency of the enterprise. It is much more difficult to assess in advance the financial effect of a QMS. A full preliminary calculation is not possible, because the beneficial effect of QMS is always formed over a long period of time and provided that QMS is applied systematically and continuously.
The QMS is aimed at achieving long-term improvements in the enterprise. But these improvements can only be established and measured over time. However, it is undeniable that the introduction of a QMS has a positive impact on the financial results of the enterprise. The beneficial effect of QMS can be expressed in the fulfillment of five fundamental goals:
1. increasing the transparency of the enterprise’s activities: with the introduction of the QMS, an internal system for streamlining enterprise management is formed, ensuring transparency of the goals and processes of the enterprise and regulating clear areas of competence and responsibility. Thanks to the transparency of organizational and information structures, the enterprise reduces the number of problems associated with the interaction of departments, the number of errors in the process of operations and proceedings regarding the distribution of competencies. All this has a positive effect on the overall process of the enterprise and, consequently, on its financial results.
2. reducing the costs of nonconformities: errors in any area of ​​the enterprise constantly require corrective actions, accompanied by high financial costs. These are the costs of defects, rework, warranty service, business pleasantries and contractual penalties. Experience shows that the costs of non-conformities amount to up to 10–20% of turnover. But experience also shows that the costs of non-conformities with the introduction of a QMS can be halved in about four years. Such an improvement is unlikely to be achieved by other measures with similar use of resources.
3. reduction of capital investments: errors at the enterprise affect both compliance with deadlines and the time of product production and storage in the warehouse. The more discrepancies there are, the worse the deadlines are met and the longer the duration of production and storage in the warehouse. The QMS allows you to eliminate inconsistencies in the enterprise and optimize production processes. Production and storage cycles in the warehouse are shortened, creating the opportunity to better meet deadlines. As a result, capital investments are reduced. As reports from enterprises in various sectors of the economy show, product manufacturing cycles after the introduction of QMS are reduced by 30–40%. The deadlines become more reliable, because they do not suffer from unplanned repairs and improvements. This leads, in certain circumstances, to the exclusion of contractual penalties or time-consuming urgent work. In addition, the reduction in product manufacturing time allows design and production work to begin later. Therefore, you can respond more flexibly to changes in the market, which gives you a significant advantage over your competitors in the face of rapidly changing market demands. This aspect, although of great importance for the entrepreneur, is almost beyond financial calculation.
4. increasing turnover and market volumes: the goal of achieving customer satisfaction is today in first place among other goals for almost all enterprises. As processes are focused on customer requirements, nonconformities are reduced, and deadlines are met, customer satisfaction increases. As a result, fewer customers leave and it becomes easier to acquire new ones. And this aspect - despite its exceptional importance for the existence of the enterprise - can hardly be quantified in terms of its effectiveness.
5. increased efficiency: motivated employees produce greater returns than frustrated employees. They have less time wasted and fewer inconsistencies in their work. According to experienced managers, the difference in productivity between motivated and frustrated employees is more than 25%. The QMS contributes to greater transparency of processes and a reduction in the number of inconsistencies. As a result, dissatisfaction with everyday work decreases, the number of accusations and unexpected overtime work decreases. This increases employee motivation and, consequently, the efficiency of the enterprise.

6. How and why is internal and external audit of the QMS carried out?

“I walk around the plant once every day.” This is a typical statement from a boss, especially in small and medium-sized enterprises. What is hidden behind these words? Behind them is an interest that you know from the practice of the enterprise: the boss wants to know “how things are going.” He reviews products, talks with employees about the job, or asks targeted questions. The boss's visit has something parallel to the audit. During audits, it is also checked “how things are going and whether everything is in order.” This is a structured, systematic and independent study, more highly structured and formalized than a walk-through of the boss. In short, an audit examines: “Is everything going the way we wanted it to?”
Let's start with a general definition. ISO 9000 defines audit as a systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria have been met.
Internal audits serve for self-control, external audits are third-party control. External audits are used to evaluate the products, technology and QMS of an enterprise from the consumer or an independent third party. A quality audit checks quality-related activities and their results (FACT) in comparison with planned values ​​(PLAN). This objectively shows where the causes of non-conformity are and, accordingly, the potential for improvement. The results should be used by enterprise management to improve the organization's productivity. Therefore, audits become tools for success.
Quality audits have, based on the Latin original word, much in common with “listening”. They are not raids to find the culprit. An audit rather tries to improve existing situations with an accurate look and attentive listening. Audits can also cover completely different areas, such as accounting or the environment. Quality audits can be internal or external, internationally they are divided into First-Party-Audit (one-party audit), Second-Party-Audit (second-party audit) and Third-Party-Audit (third-party audit). This immediately explains which institution is being audited and who is conducting the audit.
Depending on the subject of the study, they are also classified as product audit, production process audit and system audit. Internal quality audit is designated as FIRST-PARTY-AUDIT (with the participation of one party or participant). It is carried out at the direction of the management of the enterprise by the employees of the enterprise. The employees who conduct this audit are called internal auditors and are appointed by the management of the enterprise. Internal auditors participate in appropriate training in the field of quality management. This could be, for example, the quality manager, as well as any other appropriately trained employee.
When choosing an auditor, it is not the position of the relevant person in the workplace that is important. The personal qualities of the auditor are more important. Internal auditors check whether the enterprise's quality objectives are being achieved based on existing processes.
There are two types of external quality audit: supplier audit (SECOND-PARTY-AUDIT) and certification audit (THIRD-PARTY-AUDIT). In a supplier audit, the consumer examines the supplier's quality capabilities. This audit involves two parties, namely the consumer and the supplier. Therefore, supplier audit is also called SECOND-PARTY-AUDIT. A certification audit is also an external audit. He checks whether the enterprise's QMS meets the requirements of the standard. It is carried out not by the consumer (second party), but by employees (auditors) of an independent authorized (accredited) certification body, an independent third party, replacing the consumer. Hence the name THIRD-PARTY-AUDIT (third party audit).
Internal quality audits are a means of identifying weaknesses. Each area of ​​the enterprise's activity should be interested in conducting an internal audit. Because it can be used to achieve continuous improvement of production processes. We have already learned about the impact of internal audit and how it functions in the general definition of the concept “quality audit”: just like any other type of audit, internal quality audit checks whether the actual data of the enterprise coincides with pre-established planned values. If this compliance is confirmed, then these results are documented and communicated to interested departments. The internal quality audit is considered to be successfully completed. If the check ultimately shows that there are discrepancies between the FACT and the PLAN, then these deviations are also documented, but without a positive or negative assessment. Evaluation of the audit results occurs only at the second stage. This means that only after a neutral fixation of the state, in which deviations of the FACT from the PLAN are noted in writing, is it checked what is best for the enterprise in the long term and promises greater success: the planned PLAN indicators, or the actually realized FACT values. This decision determines which corrective and preventive measures will be established and implemented next.
Fundamentally, an enterprise has two options for correcting PLAN-FACT deviations identified during an audit and preventing them in the future: the enterprise can adhere to the planned PLAN value and, through appropriate measures, ensure that the FACT value in the future corresponds to the desired PLAN indicator. And if the evaluation of the audit results ultimately shows that the implemented FACT value is, in principle, better suited to achieve its quality objectives, the enterprise can also adjust the original plan target and declare the existing FACT measure as the new plan target. If an internal quality audit results in deviations between actual (FACT) and target values ​​(PLAN), then the deviations must be corrected using measures intended for this.

7. QMS has been implemented - what next?

With the end of QMS implementation, everyday life begins. Often they turn out to be even more difficult than the implementation of a QMS, because An enterprise is a dynamic structure subject to various factors (society, customer requirements). Therefore, it is necessary to constantly analyze the QMS and bring it into line with changing circumstances. Internal audits should be carried out at regular intervals to ensure that the system is up to date. They are also required to maintain the system in a certified state. The next step in the development of QMS at the enterprise is to improve the functioning of the existing QMS and introduce TQM (Total Quality Management) - total quality management. Total quality management means: monitoring and continuously improving the quality of products and processes in an enterprise, thereby: achieving greater customer satisfaction, reducing costs, achieving better production results. The addition of "total" means: a more persistent, more intensive, more comprehensive, in a word, more "total" approach than in quality management. A feature of TQM is the generalizing nature of this concept, which involves in the process of working on quality all persons related to the enterprise - clients, employees, suppliers and contractors.

8. Where and how can specialists be trained for the QMS of an enterprise?

Specialists (managers) for the implementation and subsequent functioning of the QMS are trained by our institute in 3 courses conducted with the issuance of certificates: “Understanding and interpretation of the ISO 9001:2015 standard”, “Development of documentation for ISO 9001:2015” and “Conducting internal audits ISO 9001:2015 " Tuition fees - see the corresponding section of our website. In addition, training can be completed at any educational institution whose programs include training topics on quality management.

9. What documents are needed to start preparing for QMS certification?

Firstly: we need a decision from top management to start implementing the QMS. If management has decided to introduce a QMS, then the first steps in the work remain theirs. After all, the introduction of a QMS begins with the development or revision of the first document - the enterprise quality policy. It defines the meaning of the enterprise’s existence (why are we needed?) and its long-term goals. Quality policy and enterprise policy cannot always be clearly distinguished, and in most cases they are set out in one official document. The next step is to determine the goals by which the quality policy can be implemented. These goals are called enterprise quality goals (second document). In some companies they are also called quality principles. They serve as guides that each employee can refer to. The following document is an action plan for the development, implementation and subsequent certification of the QMS at the enterprise. These are the main documents to begin preparing for the implementation of the QMS. Directly for QMS certification, many documents are required, here are just a few: - quality manual; containing the scope of the QMS, including details and justification for any exceptions; description of the interaction of QMS processes; description of the procedure for fulfilling the requirements of sections of the ISO 9001 standard; — documented procedures and records required by ISO 9001; - documents, including records, determined by the organization as necessary to ensure effective planning, implementation and management of QMS processes (job descriptions, regulations on departments, enterprise standards, work and technological instructions, regulatory documentation, organizational and administrative documentation, etc.). The scope of documentation is determined at the stage of development and implementation of the QMS. The extent to which one organization's quality management system is documented may differ from another, depending on the size of the organization and type of activity, the complexity and interaction of processes and the competence of personnel.

10. Which QMS certification bodies are preferable to invite to the enterprise for certification? Specialization of certification bodies, differences in requirements, differences in cost of work, etc.

The enterprise itself decides which certification body to undergo a certification audit, based on consumer requirements. It is important that this body is accredited by the international organization ISO and recognized throughout the world. There is no specialization or differences in the requirements of certification bodies; they have one task - to verify compliance with the requirements of ISO 9001 in the enterprise’s QMS.

11. International and Russian QMS certification bodies - their advantages and differences.

The most well-known international bodies are TUV NORD (Germany), Lloyd's Register (Great Britain), Bureau Veritas (France). Domestic QMS certification bodies - Gosstandart, Gazpromsert - do not have accreditation in the international organization ISO. The advantages of international bodies are that they are known throughout the world and are recognized by an international certification body.

12. What should the enterprise QMS team do during the inter-certification period?

Do not stop at the achieved result, carry out constant work to improve the functioning of QMS processes, improve the quality of products and services provided. The certification body will conduct annual surveillance audits to confirm the validity of the certificate and look for improvements.

The processing of biological materials in laboratories or other settings is essential for many industries, from RT to disease diagnostics to pharmaceutical and scientific research. But it is obvious that there are also dangers. Effective management of biohazardous materials risk means reduced likelihood of accidents, less environmental impact, and more efficient use of time and other resources. A new international management system standard has recently been published.

On January 16 – 17, 2020, a two-day seminar was held at our company on the topic: “Management system for quality and product safety based on hazard analysis and critical control points (HACCP System (STB 1470-2012)). Requirements. Internal auditor of the food safety management system (HACCP (STB 1470-2012), ISO 19011:2018, GOST ISO 19011:2013). The participants of the seminar were specialists from such enterprises as: OJSC “Gomelkhleboprodukt” branch of “Gomel Bread Products Plant”, LLC “LibretikGroup”, LLC “Fistaris”.

Dear colleagues, partners and friends! The outgoing year 2019 has become an important stage in the life of our company. On the way to creating management systems that we had already well-tested and mastering completely new standards for our market, it was full of fruitful work and a series of exciting events, in which hundreds of specialists from enterprises from Belarus, Russia, Kazakhstan, Latvia, Moldova and other countries took part .

We do not stand still - the geography and professional focus of our activities are constantly developing and expanding. And we are sincerely glad that through the development and improvement of safety and quality systems, our work benefits more and more enterprises in strengthening the economic sustainability of business and obtaining new competitive advantages.

On December 12-13, our company organized and conducted a two-day training seminar “Lean Production as a tool for the continuous development of effective business” in the city of Gorki, Mogilev region, for specialists from two enterprises: OJSC “Milk Hills” and IOO “Goretsky Food Plant” .

The event took place at the Milk Hills base. The training was conducted by Alexander Voronin, Candidate of Technical Sciences, practitioner in operational and strategic management.

PC LLC "Belkosmex" is one of the largest Belarusian manufacturers of cosmetics for the care of facial skin, body and hair, whose products, since 1995, have managed to conquer not only the Belarusian market, but also the markets of the CIS countries and foreign countries. The company's two own research laboratories allow us to develop cosmetic formulas and formulations, focusing on the highest quality and the discerning taste of customers.

Through the joint efforts of specialists from BelProjectConsulting LLC and the Minsk Branch of the Belarusian Railway, a company quality management system was developed and implemented over the course of 7 months, which at the end of November 2019 successfully passed certification according to the requirements of the national standard STB ISO 9001-2015.

During the month of September and October, expert auditors of the international certification body "DQS GROUP" (accreditation of the national accreditation body of Germany "Dakks") in two stages conducted a certification audit of our company's information security management system for compliance with the requirements of ISO/IEC 27001:2013 . Based on its results, the ISMS of BelProjectConsulting LLC was recognized as meeting the requirements of the standard, and in early November the corresponding certificate was issued.

In the first ten days of November, through the efforts of our company’s specialists together with experts from YURS-Rus LLC (representative office in the CIS

In order for an organization to function successfully, it must be managed in a systematic and visible manner.

Managing an organization, along with other aspects of management, includes quality management.

A QMS is a system created in an organization to formulate policies and goals in the field of quality, as well as to achieve these goals. A QMS, like any system, is characterized by its purpose, structure, composition of elements and connections between them. A university's QMS is a set of organizational structure, methods, processes and resources necessary to implement the quality policy through planning, management, quality assurance and improvement.

The quality policy is the main document of the system. It determines the purpose of the construction and operation of the QMS, as well as the obligations of top management to achieve the goals.

The QMS covers such areas of the university’s activities as pedagogical, scientific, educational, administrative, and economic. These areas are interconnected and in most cases overlap.

The functioning of the QMS is carried out through the involvement of all personnel, while senior management (university rector) takes full responsibility for achieving quality goals.

Administrative influence on the QMS is based on process management based on actual indicators. Its main goal is to create conditions capable of ensuring continuous improvement of the process. At the same time, the assessment of changes in the quality of the process is carried out on the basis of criteria.

The process of development and implementation of a quality management system includes the following stages:

• choosing a QMS model;
• comparison of the university’s activities with the requirements of the selected model;
• restructuring the activities of the university where necessary;
• development and implementation of QMS documentation confirming compliance of the university’s activities with the requirements of the model;
• QMS certification in order to increase the efficiency of business processes;
• improvement of activities based on continuous process improvement.

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

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

The cause of all errors is always incorrect actions. In order to avoid mistakes, it is necessary to determine the correct sequence of actions, describe (formalize) them, and develop instructions for performing and monitoring the correct actions. In other words, management of the quality of training of specialists should be structured so that deviations from the specified requirements are, if possible, prevented, and not corrected after they are discovered.

In this way, it is possible to ensure the university's reputation as a reliable supplier of high-quality specialists with minimal risk for those enterprises, organizations and individuals who can be considered consumers of services.

Purpose of the QMS

The QMS is designed to ensure the quality of the services provided and “adjust” this quality to the expectations of consumers. At the same time, the main task of the QMS is not to control each individual service, but to create a system that will prevent the occurrence of errors leading to poor quality of services.

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

Success can be achieved by implementing and maintaining a management system designed to continually improve operations while taking into account the needs of all stakeholders.

QMS structure

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

According to ISO definitions, an organization is a group of people and necessary facilities, with a distribution of responsibilities, powers and relationships.

A process is a set of interconnected and interacting elements of activity that transform “inputs” into “outputs”. Very often, the “inputs” of a process are the “outputs” of other processes.

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

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

QMS resources are everything that quality management provides.

What is needed to create an organization's QMS?

• identify the main processes of activity;
• establish the sequence and interaction of processes;
• determine the criteria and methods necessary to ensure the effectiveness of both work and process management;
• ensure the availability of resources and information necessary to support work and monitor processes;
• observe, measure and analyze processes;
• take measures necessary to achieve planned results and continuously improve processes;

What is ISO?

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

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

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

ISO is an international organization for standardization and is a worldwide federation of national standards bodies (ISO member bodies).

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

The standards developed by ISO are grouped into families. ISO 9000 is a series of ISO standards that are used to create and improve quality management systems of organizations and enterprises.

• ISO ISO 9001. Contains a set of requirements for quality management systems. The current version is ISO 9001:2008. Quality management systems. Requirements".
• ISO 9000. Glossary of terms about the management system, set of principles of quality management. The current version is ISO 9000:2005. Quality management systems. Fundamentals and vocabulary."
• ISO 9004 Provides guidance for any organization to achieve sustainable success in a complex, demanding and constantly changing environment through a quality management approach. The current version is ISO 9004:2009. Management for achieving sustainable organizational success. Approach based on quality management."
• ISO 19011. Standard describing methods for conducting audits in management systems, including quality management. The current version is “ISO 19011:2011 Guidelines for auditing management systems”.

Russian versions of standards:

GOST ISO 9000-2011 - analogue of ISO 9000:2005 (prepared by the open joint-stock company "All-Russian Scientific Research Institute of Certification" (JSC "VNIIS") based on the application of GOST R ISO 9001-2008)
GOST ISO 9001-2011 is an analogue of ISO 9001:2008 (prepared by the open joint-stock company All-Russian Scientific Research Institute of Certification (JSC VNIIS) based on the application of GOST R ISO 9001-2008).

One of the most important aspects of these standards is their universality and their use by enterprises of various forms of ownership. All of them contain standards and requirements that the quality management system must comply with, regardless of whether it is certified or not. It is for these purposes that the International Standards ISO 9000, ISO 9001, ISO 9004 are used. GOST R ISO 19011-2012 is used to regulate the organization and conduct of audits.

(QMS, - ed.) is a set of measures and constantly implemented operations that are used in an organization to achieve the required quality of services or products - what is the result of the activities of this organization. The most important difference between a quality management system and isolated and random actions aimed at improving product characteristics or preventing production defects is that the operation of the system is not random, but systematic and comprehensive, leading to consequences that are predictable in advance. As usual, they are being implemented on the basis of the 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 (International Organization for Standardization - ed.) comes down to difficulties in translation, that is, it is almost absent. But, let's return to the definition. What does “required quality” mean? An object in itself cannot be either good or bad, and it receives an assessment only from a person’s point of view. Quality is what is recognized as such by consumers. For this reason, it is usually added to the definition of a quality management system to satisfy the quality requirements that arise from external stakeholders: ordinary clients, partners, government agencies, and other market players interested in the activities of an organization implementing ISO 9001.

The types of activities that a quality management system integrates can be very different. Training occupies an important place among them. We can say that it all begins with him, since before implementing a QMS, senior management must study in detail the philosophy and practical aspects of the work of modern QMS, otherwise they will not be able to manage the process and give orders that are adequate to the situation. Before, and especially during the operation and implementation of the QMS, training is carried out for middle management and ordinary employees of the company. They study both the ISO 9001 standard itself and the internal one, which was developed to implement innovations within the 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 processes within an enterprise and the outside world, which, on the one hand, supplies the organization with raw materials, on the other, is the goal of its efforts. Depending on the chosen QMS implementation strategy, certain categories of employees study special software, the most modern tools for scientific analysis of certain issues related to quality at the enterprise. This is the fundamental position of the ISO 9001 standard. According to this normative document, decisions must be made based on facts. If you adhere to this principle, many decisions in a company should be preceded by meticulous collection of information and 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 with 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 technical specifications (technical conditions, ed.). Below the quality manual in the hierarchy there is a whole string of permanent documents, edited infrequently and updated constantly. also exist as separate documents. The development of documentation begins with marketing, a review of the organization’s goals, its resources and capabilities, and structuring the enterprise’s activities in accordance with the process approach.

A scientific concept that proposes to consider any organization as a set of interconnected and interacting processes, the joints of which are of paramount importance. process approach, according to the standard, at the enterprise, which allows you to establish the sequence of QMS operations that require constant repetition. The cycle proposed in ISO 9001 allows not only to maintain quality at the level, but also to improve it. Naturally, before “launching”, what specific processes consist of the activities of the company that has decided to create a QMS. This is usually very difficult. Being a universal document, ISO 9001 cannot provide a diagram of processes and their interactions for a specific enterprise. On the other hand, it provides a classification that contains the key to independent division into processes. The standard divides all activities into those related to organizational management, resource management, life cycle processes, measurement, analysis and improvement. One of the most difficult aspects of working with a process approach is the following feature. Sometimes conscientious application of this method leads to a revision of the entire organizational system of the enterprise. Processes may, of course, coincide with the structure of the organization’s departments, but a detailed analysis can also identify unnecessary activities and ineffective administrative organization. If the management of an enterprise has difficulties understanding or implementing the provisions of ISO 9001, it has at its disposal a whole series of guides that the International Organization for Standardization has issued on various details of creating a QMS: ISO 10006, ISO10007, ISO 10012, ISO\TO 10013, ISO\ TO 10014, ISO 10015, ISO\TU 16949, ISO 19011, ISO 10006 and a number of others. These documents relate to internal audit of the QMS and certification, implementation of the QMS and its adaptation to a specific industry, improvement of the system and other important issues. In addition to these manuals, enterprise management also has the opportunity to resort to the help of numerous consulting organizations that have been professionally helping to implement a 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 operation of the QMS. Most of the former are based on statistics - their general name is statistical methods of quality control: graphs, Ishikawa diagrams, scatter plots, tables QFD. Note that cyclic operations do not have to be based solely on PDCA. There are at least two alternatives: Juran triads and Taguchi methods. They can replace or complement the PDCA model in certain circumstances.

As for electronic systems that facilitate and organize the document flow 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 Analysis, – ed.).

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

So, the creation of a QMS consists of introducing a process approach and PDCA, in accordance with the ISO 9001 standard, training management in methods and approaches in management, marketing, developing an organization strategy with a plan, goals and taking into account resources, developing and implementing a project for transforming the organizational system of the enterprise, constant advanced training 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 like. The quality management system is a very flexible mechanism, capable of accepting new techniques and methods, and its potential cannot in any case be reduced only to the requirements of the ISO 9001 standard.

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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 it 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;
• a systematic approach is applied to the management of the enterprise (see);
• quality is constantly improving;
• decisions are made only on the basis of factual information received;
• There are established business relationships between the company and suppliers 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 certain 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.