Where to start the implementation of QMS at the enterprise. How to implement a quality management system

June 05, 2007 10:22

Oleg Vishnyakov, Victor Krokhin, Maxim Molodov

Recently, to documents confirming the stability, reliability and prospects of the company, such as reporting under IFRS or a strategic business plan, a certificate has been added for the compliance of the quality management system with the requirements of ISO 9001. The competent implementation of this system will allow you to get a number of advantages: , competitiveness and quality of products and services, reduce costs, make the company customer-oriented. Read about how to create and certify a quality management system in the materials offered.

A quality management system (QMS) is a system that ensures the efficient operation of an enterprise, including in the field of quality management of products. The most effective when creating a QMS are the requirements fixed in the international standards ISO 9000 series.

It should be noted that an effective QMS can be created without focusing on the ISO 9000 series standards. However, in order to certify this system, that is, to obtain a document confirming that the processes carried out in the organization are effective and aimed at continuous improvement of product quality ( services), the system must comply with the requirements of the ISO 9001-2000 standard. Therefore, we will consider the process of creating a QMS from the point of view of the requirements of ISO 9001.

Reference. The ISO 9000 series is part of a set of standards developed by the International Organization of Standartization, an international non-governmental organization. In total, there are about 12 thousand ISO standards. They cover almost all types of economic activities (environmental standards, health and safety standards, etc.).

The ISO 9000 series has gone through several stages in its development. The 2000 version is currently in force, consisting of the following standards:

● ISO 9000 “QMS. Basic Provisions and Dictionary ";

● ISO 9001 "QMS. Requirements";

The main ISO 9001-2000 standard does not provide direct guidance on financial management, but the ISO 9004-2000 standard, which expands the requirements of the ISO 9001 standard, specifies that resource management includes activities to determine the need for financial resources and their sources. Thus, the requirements for quality management apply to the quality of financial resource management.

In the Russian certification system (GOST R), the standards included in the 9000 series are issued in the form of state standards GOST R ISO 9000: 2001, GOST R ISO 9001: 2001 and GOST R ISO 9004: 2001. They are almost entirely consistent with their ISO counterparts.

In order to build a quality management system in accordance with ISO 9001 standards, the following elements of the QMS must be created in the company:

● a document in which it is necessary to formulate the goals and objectives of the QMS, as well as the principles of their achievement ("quality policy");

● a system of interrelated and complementary processes corresponding to the "Quality Policy";

● normative documents describing and regulating the business processes of activities within the framework of the QMS;

● an effective mechanism for the implementation of the requirements regulated by the regulatory framework;

● trained personnel of the organization.

All of these elements should take into account the basic principles of quality management (see box). Let's consider the process of building a QMS in stages.

Stages of building a QMS

Stage 1. Management decision

The manager must decide to start the project, notify the employees of the company, and also create the prerequisites for the rapid implementation of all other stages. You should also formulate the goals of building the QMS, highlight at the top level the QMS processes that need to be monitored, and the criteria for assessing their quality. Subsequently, the objectives of the QMS must be recorded in a document called "Quality Policy", which also describes the principles of their achievement. This document is fundamental in the company's QMS regulatory documentation system.

Stage 2. Staff training

For the further successful work of the QMS, the company's personnel must study the theory of quality management, the ISO 9000 series standards, master the theory of the process approach, as well as the basic requirements for the implementation of the QMS. Training in using the system can be carried out both with the help of consultants and independently, if the company has an employee who has experience in setting up the QMS.

Stage 3. Formation of the QMS implementation program

The implementation of the QMS should be considered as a complex and lengthy project (up to one and a half to two years). Therefore, it is necessary to draw up a QMS implementation program, which should include:

● description of the stages of implementation;

● a list of those responsible for each stage of the project. As a rule, they are chosen from among top managers, as well as specialists who know best the specifics of the work of their departments;

● budget for the implementation of the QMS. It includes both the cost 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 diverting management from the main work for the project. When setting up a QMS, you can do it on your own, however, the distraction of top management from the main work, as well as the training of your own specialists of the required level, can cost more than the services of a consulting company1;

● the procedure for assessing the implementation of the QMS. Indicates the criteria by which management will be able to determine whether the goals set at the beginning of the project have been achieved.

After drawing up the program, you can proceed to the direct setting of the QMS.

Principles of building a QMS.When building a QMS, one should be guided by the following principles of quality management, formulated in the ISO 9000 standard.

● Consumer orientation. Organizations depend on their customers, so they must understand their current and future needs, fulfill their requirements and strive to exceed their expectations.

● Leadership of the leader. Leaders ensure the unity of purpose and direction of the organization. They should create and maintain an internal environment in which people can be fully involved in the tasks of the organization.

● Involvement of workers. Workers at all levels are the backbone of the organization, and their full involvement in the work of the company enables it to capitalize on their capabilities.

● Process approach. The desired result is achieved more efficiently when activities and associated resources are managed as a process.

● A systematic approach to management. Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.

● Continuous improvement. Continuous improvement of the organization as a whole should be seen as its permanent goal.

● Making decisions based on facts. Effective decisions are based on the analysis of data and information.

● Mutually beneficial supplier relationships. An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both parties to create value.

Stage 4. Description and optimization of business processes

The basis of the quality management system is the process approach. First of all, it is necessary to describe those business processes, the management of which the management considers the most important for the QMS. For example, for a manufacturing enterprise, this will be the process of manufacturing and selling a product, as well as service and purchasing. The description is carried out using specialized computer tools based on information obtained during interviews with performers, etc.

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

Stage 5. Development of QMS regulatory documents

At this stage, normative documents, regulations and procedures are formed to ensure the operation of the quality management system. 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, on the basis of the Quality Policy, a document is prepared called the Quality Manual. It contains the main provisions governing activities within the QMS: delineation of areas of responsibility, requirements for the quality service, a description of quality assurance procedures, the procedure for maintaining the QMS document flow, a description of the complaints procedure, etc.

The next level of documents is called "System-wide documented procedures". There are six procedures to be followed in accordance with ISO 9001:

● document management;

● data management (records);

● management of the QMS audit;

● management of products that do not meet standards (the process of identifying defects and the procedure for their disposal);

● management of actions to correct nonconformities;

● management of measures to prevent the occurrence of nonconformities.

The next level documents describe the rules for the effective planning, implementation and management of processes. Such documents include working methods, job descriptions of employees, process flow charts.

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

When drawing up regulatory documents, it is necessary to take into account the requirement of the ISO 9001 standard on the competence of personnel performing work within the QMS. This means that regulatory documents should describe the process of employees' access to regulatory documents, as well as requirements for the competence of personnel (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 of the QMS requires the presence of electronic document management systems in the organization.

Stage 6. Testing of the QMS and internal audit

After the development of all regulatory documents, the trial operation of the quality management system begins. It is possible to launch processes within the new system gradually, for example, first introduce control over the procurement process, then production, etc. The trial operation is accompanied by an internal audit, special procedures for checking the work of the QMS. At the beginning of operation, they are carried out often (perhaps once a week), then less often (once a month or even a quarter).

For internal audit purposes, it is necessary to record quantitative indicators of quality, for example, scrap rate, customer satisfaction rate, return rate, etc., which should be aimed at. To determine the value of such indicators, similar indicators of industry leaders are usually used. 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, the work of employees, as well as regulatory documentation, is adjusted in order to avoid deviations in the future. All this work should also be documented in the appropriate QMS procedures.

Stage 7. Obtaining a certificate

In order to certify the QMS, you must submit an application to the certification body (see the sidebar "Who and how can certify the QMS"). Initially, a number of documents should be submitted to the certification body:

● statement of certification;

● all documents on the QMS ("Quality Policy", "Quality Manual"; a diagram of the company's organizational structure, documented procedures and other developed QMS documents);

● a 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 quality system in operation. Based on the results of the audit, a protocol is drawn up, in which all inconsistencies between the QMS and the requirements of ISO 9001 are recorded. Usually, according to the results of the first stage of the audit, more than a hundred inconsistencies are found, and the task of the enterprise is to eliminate them as soon as possible and prove it to the certification body. As a rule, these operations take 1-4 months.

After that, the actual certification is carried out. If all significant inconsistencies are eliminated, the company is issued a certificate (it is drawn up for about a month). The certification body conducts repeated (supervisory) audits of the QMS with a certain frequency. They confirm that the company has not only implemented a quality management system, but is also constantly improving it. The cost of such an audit is about a third of the cost of the initial certification.

Who and how can certify the QMS... As a rule, companies operating in markets with high competition (software and computer production, food industry, pharmaceuticals), as well as needing to attract large foreign investments or trading in international markets, seek to certify the quality management system.

Depending on the goals pursued by the certified company, a certificate can be obtained from different organizations. So if a company needs to present its certificate to Western partners, then it needs the conclusion of an authoritative Western certification body. For example, in the countries of the European Union, declarations have been adopted, according to which the importer is considered a reliable supplier only if he has a certificate for QMS compliance with the requirements of the ISO 9001 standard.

Well-known Western certification bodies:

● Bureau Veritas Quality International (Great Britain) (www.bvqi.ru);

● BSI (British Standard Institute) Group (UK) (www.bsi-global.com);

● Lloyd "s Register Quality Assurance Ltd (UK) (www.lrqa.com);

● Det Norske Veritas (Norway) (www.dnv.ru);

● Societe Generale de Surveillance (Switzerland) (www.sgs.com);

In Russia, the national certification system is the GOST R system, created within the framework of the State Committee of the Russian Federation for Standardization and Metrology (Gosstandart of Russia), which on a voluntary basis includes Russian QMS certification bodies. Information about them can be obtained from the State Standard of Russia (www.gost.ru). The most famous certification bodies include:

● VNIIS-SERT-SK (based on the All-Russian Research Institute of Certification) (www.vniis.ru);

● AOZT TKB-Intercertifica (www.icgrp.ru);

● Research Institute of Economics, Communications and Informatics "Interecoms" (www.interecoms.ru).

Obtaining a certificate from a Western certifying organization without taking into account the costs of preparing and implementing a QMS for a machine-building enterprise with 1000 employees will cost from 5 to 15 thousand US dollars, in a Russian - from 5 to 10 thousand US dollars. On average, the costs of certification in Russian and international bodies differ by 2-2.5 times and depend on factors such as the number of personnel, the presence of unified technological processes, the size of the enterprise, the presence of branches, and most importantly, the popularity of the certification organization. In most cases, you will have to add the amount of consulting costs to the cost of the certificate.

An example of building a QMS according to ISO 9001: 2000

Stanislav Sharipov, Director of AVRO-BUS LLC (Moscow)

Julia Tolstova, Head of Quality Department, AVRO-BUS LLC (Moscow)

The implementation of the quality management system in the AVRO-BUS company took about a year and was carried out by the company's specialists. Let's consider the main stages of QMS implementation in the company (see Table 1).

Development of regulatory documents

Work on the implementation of the QMS began with the description of existing and development of new business processes that were required in accordance with ISO 9001: 2000 (see Table 2).

To simplify the implementation of the process approach in the corporate information system, a reference book "Processes" was created, which contains the characteristics of the processes: name, code, brief description, owner. From this directory you can get to other directories that store the following information:

● regulatory documents describing each process;

● quality records to be maintained within each process;

● data on the skills and knowledge that should be possessed by employees performing work on each of the processes;

● a list of requirements for each process;

● a description of the goals to be achieved for each process;

● information about the “inputs” and “outputs” of each process (materials for processing and documents that are used to start the process, and the products obtained as a result of its operation), etc.

Then a “Quality Manual” and instructions for its use were developed. For this, the documentation available in the company, as well as documentation from the standard quality system of the franchisee, which was developed by 1C for its partners, was analyzed for compliance with the requirements of the ISO 9001: 2000 standard. As a result, a list of changes in the company's work was compiled, which can be conditionally divided into the following groups:

● new processes (for example, management review, regulatory document management, internal audit, etc.);

● new forms (documents that must be filled out by employees when performing work);

● additional stages in the implementation of processes (analysis of the contract and documenting its results; analysis, verification and approval of projects, etc.).

To ensure the unification of documents on the QMS, rules for their creation, as well as templates, were prescribed for each type of documents.

The description of the processes, procedures and the preparation of work instructions were entrusted to the most experienced specialists - the direct executors of these processes. This made it possible to complete the work quickly and accurately, and also to reduce the difficulties in the implementation of the QMS, since the employees described the process exactly as it would be convenient for them to perform it (or how they perform it).

Then, for each process, forms of records were created, in which the performers enter information about the progress of the process. After that, an electronic document "Employee's Guide" appeared in the company's information system, which allows not only to receive information about the processes related to the competence of a specialist, requirements and quality goals for them, but also to open instructions and record forms related to these processes directly from databases (see Table 3).

QMS implementation

At this stage, conditions were created for the work of personnel in accordance with the approved "Quality Manual":

● it was announced that the company began to work using the QMS;

● employees were provided with access to the regulatory documents that are necessary to carry out work using the new technology (“Employee's Manual” and other documents in the company's database);

● internal audit was carried out by a specially appointed employee from the quality service at certain periods (at the initial stage - after a week);

● In the course of internal audit, inconsistencies between the functioning of processes, the work of employees and regulatory documents were identified and then corrected.

This approach made it possible at any time to receive information about the work of all processes, identify requirements that are not being met, and eliminate emerging inconsistencies by training employees, revising regulatory documents and even changing requirements. For example, one of the problems was that the company's employees did not respond to customer requests in a timely manner. Now every customer request is registered in the database. This allows you to control the number of requests and quickly respond to them.

To implement processes directly related to the quality service, the work of the employees of this service was immediately automated, so they began to perform their duties without delay. Now data on QMS indicators - customer satisfaction, complaints, inconsistencies, corrective and preventive actions, audit results, etc. - are recorded automatically.

Assessment of the degree of implementation of the QMS

When building a QMS, it is very important to choose indicators that can be used to assess the degree of its implementation. Requirements for the work of the company, corresponding to the ISO 9001: 2000 standard, must be described in the "Quality Manual". When these requirements are not met, inconsistencies arise between the existing activity and this document. Thus, by the number of inconsistencies registered in the organization, one can judge how the implementation of the QMS is going.

At the initial stage of the QMS in the company "AVRO-BUS", a large number of inconsistencies were registered, which were revealed in the course of work and internal audit. After about 2-3 months, the number of current inconsistencies began to decline: the number of newly identified inconsistencies was less than those that were eliminated.

In addition, the company monitored changes in the quality of its services. Some goals in the field of quality, adopted by LLC "AVRO-BUS", are shown in table. 4. These indicators are assessed based on the results of regular checks of the work of the QMS and with their help the work of the divisions is adjusted.

Obtaining a certificate

In May 2001, the company "AVRO-BUS" submitted documents to the Russian branch of the international certification body Det Norske Veritas (DNV). On May 24, 2003, a certification audit was carried out in the company. Since at that time only 7 employees worked in the company "AVRO-BUS", the auditor talked with everyone to find out whether all the specialists are familiar with the requirements of the QMS and whether their work meets these requirements. The company passed the test and in June 2003 received a certificate for QMS compliance with the requirements of the ISO 9001: 2000 standard.

The preparation and implementation of the QMS took almost a year, nevertheless, the working time of the company's employees and the money to pay for the services of the certifying authority were not wasted. The level of satisfaction of the company's clients has grown: if before the introduction of the QMS it was 80-90%, now this figure is at a stable level of 95-98%. The number of complaints dropped from 1-2 per month to 1-2 per quarter. At the same time, the number of employees of the company has doubled, the turnover of the company and the number of clients have also grown. The net profit of AVRO-BUS LLC for the year after the implementation of the QMS increased almost three times. The share of income received from the largest client in the company's total revenues fell 5-10 times, that is, the company has become much more stable. In addition, following the implementation of the QMS, the company's specialists issued a number of training manuals and were able to provide services for setting up the QMS at other enterprises.

Reference.The company "AVRO-BUS" provides services for the automation of financial and economic activities of enterprises (assistance in choosing software, installation, implementation, after-sales service and user training) and is a partner of the company "1C". The total headcount of the company is 15 people. The market in which "AVRO-BUS" operates is highly competitive, since there is a large selection of software suppliers for automating accounting and production functions. In order to increase its competitiveness and promptly respond to the changing needs of customers, in 2000 the management of "AVRO-BUS" decided to improve the work of the company by building a quality management system in accordance with the international standard ISO 9001: 2000

"QMS helps to manage deviations from the budget"

In large manufacturing companies, the quality management system can only affect production processes and not apply to service departments. However, most CFOs are involved in coordinating the QMS. We talked about the role of the financier in this process with Evgeny Shilov, the former financial director of the Konfi confectionery factory, and now the integration director of the SladKo Confectionery Association (Yekaterinburg).

Reference. Confectionery Association "SladKo" is one of the largest manufacturers of confectionery products in Russia and supplies to the market all types of confectionery products: chocolate, cookies, waffles, caramel, etc. "(Yekaterinburg) and" Volzhanka "(Ulyanovsk). Currently, the association controls about 9% of the total confectionery market in Russia. The establishment of the QMS at SladCo began in the late 90s, when the company was not yet a single legal entity. The ISO 9000 Certificate of Conformity was issued by a Russian certification body.

— What prompted the company to establish and certify a quality management system?

- Some of the processes and procedures necessary for effective business growth should be implemented at the stage of its development, otherwise it will be too late. For example, many companies doubt the need for accounting in accordance with international standards, believing that if they work in Russia and do business with Russian enterprises, then the transition to IFRS is just a waste of time and money. But as soon as a business reaches a certain level, fundamentally new goals appear: to attract reliable investors, improve its own image, and become a market leader. You have to rebuild reporting, invite consultants, implement an ERP system - all this can take many years. Among such key processes that need to be implemented from the very beginning, in my opinion, is the implementation of ISO.

There is one more important aspect. Rarely when companies initially build their business processes professionally, therefore setting up a QMS helps to streamline the work of the company and direct it in the right direction. In order to reach a new organizational level, we started this project.

— In your opinion, is the participation of the financial director necessary in the process of setting up the QMS?

- The majority of Russian enterprises have existed for quite a long time and operate according to historically established rules. In order to change these rules in accordance with the QMS, a strong administrative resource is required: the CEO and CFO must not only show interest in such changes, but also manage them. That is why in 1998, while working as the financial director of Confi, I acted as a coordinator of the process of building the QMS and was directly involved in the description and systematization of procedures within the framework of this work.

— Have you dealt with the description and systematization of the processes of work exclusively of the financial service?

- No, the coordinating council, which I was a member of, made decisions on the feasibility and efficiency of all enterprise processes. For example, we discussed the actions of personnel and the workflow associated with the processing of raw materials: the receipt of raw materials at the warehouse, moving it from warehouse to production, etc., not to mention the financial procedures that were directly in my jurisdiction. In addition, I analyzed the cost structure and looked for ways to reduce them. This helped, for example, to optimize the operation of the scales at the entrance to the enterprise. The scales for weighing flour, the consumption of which is significant in the factory, gave a margin of error. However, we calculated the losses arising from this error, and realized that it was more profitable to buy a new scale.

— And what changes have occurred in the work of the financial service in connection with the setting of the QMS?

- The setting of the QMS prompted the financial service of SladCo to draw up accounting and management reporting in accordance with international standards. After all, accounting in accordance with IFRS and financial management in accordance with ISO are very close in concept. So, one of the basic principles of ISO is that all data should be collected only once and for a specific purpose: for the next user or for the end use in any process. The application of this principle to the work of the financial service allowed us to solve the issues of duplication of financial information, to determine the feasibility of collecting certain data, that is, to solve the same problems as when setting up accounting in accordance with IFRS. By eliminating the identified shortcomings and introducing uniform reporting standards, we were able to create a transparent system of both management accounting and accounting intended for external users.

- The use of the QMS leads not only to the restructuring of existing processes, but also to the emergence of new ones. Have these new processes influenced the work of financiers?

- The main output and product of the finance department is a pivot table with budget and actual data. At the same time, the financier must clearly understand why the actual data differ from the budget. The QMS helps to determine the causes of these deviations and learn how to influence them.

Interviewed by Anna Netesova

1. The approximate (estimated) cost of consulting companies services, see the table. - Note. edition.

2. For more details about the process approach, see the article "How to describe and optimize business processes", "CFO", 2003, No. 7-8. - Note. edition.

3. As a rule, this service is created at the initial stages of preparation for the implementation of the QMS. The tasks of the service are to organize the work of the QMS, control its functioning, make the necessary changes to the QMS, etc. - Note. edition.

"We want to implement the QMS!" - more and more often, such a statement comes from customers. This request is a balm for the soul of a quality expert, despite the chronic: "We need a certificate - the customer requires - how much it costs - what is the time?"

There are two fundamentally different approaches to the "implementation" of a management system. At the same time, everyone has one goal - development, profit.

The second way, conditionally formal: "I need a certificate." How to do it: open a search, find the cheapest certification offer, call. The certificate will be issued in an hour. Let us warn you right away - such a technique will not work.

Therefore, below we will talk about implementation according to such a plan:

1. How to start implementing the QMS
2. Implementation steps:
   1. Analysis
   2. Development
   3. Adaptation
   4. Training
   5. Certification
   6. Development
3. Conclusion, conclusions

How to start implementing the QMS

If the customer says that he wants to "first implement" and then get certified, this will not work. Because "implementation of a quality management system" is not one-time, but a long-term step-by-step process of building and improving the quality management system linked to the results. It is aimed at the development of the organization as a whole.

Let's consider in stages how the process takes place.

Steps to implement the QMS

1. Analysis the existing quality management system.

It cannot be that the enterprise was working and there was no QMS in it. Most likely, what we have is not called “QMS”.

An ideal situation for implementation is when the development of the QMS "matures" from the inside, when the driving force is the desire of the participants in the process to increase the efficiency and quality of work. It remains to plow this fertile soil with the right tools and sow with the right crops - to systematize processes, apply experience, knowledge of already approved management systems.

An imperfect situation is when there is nothing. When there are three on the staff, three hundred under GPC contracts, the customer requires a certificate, the military representative threatens to come with an inspection, and you need to resolve urgent production issues.

Here, in the context of implementation, there are two options for analyzing the quality management system:

• - checking the current management system for the presence, compliance with the requirements of the required standard: "pass - will not pass".
  If there is no QMS at all, the resume will be: "There is no system, you need to develop it."
  If it exists, but is not formulated or worded incorrectly: “Yes: according to the standard it will pass / will not pass because ... .; you need to do this: 1)…; 2) ...; 3) ... ".
  As a rule, such an audit is cheaper, or even free. For example, we practice this type of cooperation - preliminary diagnostics of the customer's quality management system before the conclusion of development contracts. You can learn more about this.

• An external audit is the same as a diagnostic one, but in the end it is a whole system of audit reports with detailed comments on the identified inconsistencies. This option is usually ordered by companies that have a working quality management system, but need a third-party opinion about its quality and compliance.

We analyzed it, got conclusions: what is, what is not, what is needed, what is superfluous, we go further.

2. Development based on the current situation of the actual QMS that meets the requirements of the standard. If you don't have your own competent specialist in-house, it's up to consulting.

Let's clarify right away! When there is your (and) expert (s) are the best option! See point 4 below for training.

The main task of a competent specialist (own or hired) is translate requirements from the language of the standard, written at a high level of abstraction, to the understandable language of a specific enterprise.

Let us allow ourselves an allegory. Imagine that you came to New Zealand with the legendary James Cook to establish trade relations with the aborigines, but, due to a misunderstanding of the traditional cultural way of life of the counterparty, you were uncompromisingly eaten out of the best intentions.

Who is Cook here and who are the natives - we will decipher later. Let's say that New Zealand is a lucrative contract, and the best intentions are the requirements of the standards. According to legend, Cook had no intelligent translators.

Let's go back to the QMS. The next tasks of developer experts are to reverse engineer, optimize, refine, and document. It is important to understand that the customer's desire: "We pay you, and you develop everything for us" is impossible. The maximum that is possible - templates of reporting forms, recommendations can be provided, but this will still need to be adapted. A quality management system is not needed by experts. You need it, so development means collaborative with labor.

3. Adaptation recommendations of experts at the enterprise. This means that the responsible persons will not just put a signature in the act of acceptance and transfer of the package of developed documents, but subtract them for reality and reliability.

4. Training employees.

In our activity there was a case when a teacher came to study, drew a management system developed jointly with the management staff on the board with a marker, and the next day the head of the quality department quit. Why? Because it is no longer good to “do nothing”. The quality management system is what is supposed to work. Even if there is an impression that this is just a "tuning" of the company's image, the time will come when the QMS will become a support, a vital pillar of the organization, and not a "keychain" on the keys to profitable contracts.

And right there about motivation - any manager understands that this is “our everything”. This is how the Great Patriotic War was won: on the right motivation and in spite of the powerfully paid for but campaigns of the enemy. Returning to the QMS: it can be built by the commander's decision of the head, but maintain and develop- only on the basis of personal interest of employees. Starting from the head, ending with the cleaner. Otherwise, it turns out that the quality management system is in itself, and the enterprise is in itself.

Therefore, the dialogue between the quality management department and the management often does not work. The manager delegates quality management, not allowing him to grow out of his area of ​​competence - from the centralized system management of the enterprise as a whole. It turns out that internal auditors demand something from the heads of departments, but they are ignored until certification is urgently required.

5. Certification of the QMS for compliance with the required standard.

Simply put, this is how to pass an exam on knowledge of a subject in two stages: to tell a theory (documentary audit) and to confirm it in practice (on-site). If you have passed it, you will receive a certificate, if not, you will receive a retake. And an adequate examiner will always help and prompt: it is in his interests so that the graduate has knowledge, and not standard forms on hand. As the Hippocratic oath "... Whatever house I enter, I will enter there for the benefit of the patient ..."

Standard certification scheme:

1. Documentary audit:

• provision of the necessary documentation to the certification body;
• analysis of documentation by the certification body, drawing up comments, recommendations for their elimination;
• correction of documentation, the quality management system itself by the customer.

1. Onsite audit:

• the auditor assesses the QMS "on the spot", draws up comments on inconsistencies, recommendations for their elimination. Transfers them to the customer;
• fixing problems;
• issuance of a certificate.

By submitting an application for certification, the company receives not a "piece of paper" - a certificate, but ready-made plan for the improvement and development of the QMS.

6. Development of the QMS.

It has already been said that implementation is package of measures according to the quality management system within the company. Let us repeat: practice stubbornly confirms that the theory does not work. Our article, which calls for building a QMS from the inside, is likely to evoke a noble response in the soul of every quality specialist. But all the difficulties, problems will begin at the stage of "doing". The so-called "psychological factor" of implementation comes into force.

The challenge for leadership is to get this issue moving. Engaging third-party experts for implementation is one of the tools.

They will help in:
a) “translation” for legislative updates, adaptation of new requirements of the QMS standards;
b) training of employees (sometimes this implies a high-quality formatting of the way of thinking, attitude to quality management in general);
c) optimization, systematization to free up resources and get rid of ballast;
c) planned inspection controls, recertification, involving constant diagnostics of compliance, control of improvements.

Conclusion
(or where is Cook and the Great Patriotic War)

Today, there are as many myths and legends about the QMS as there are about the eaten Englishman Cook (eaten, or maybe not, by the way, not in New Zealand, but in Hawaii).

For example, that “QMS is coming to us from the West as an advanced experience of efficient production”. Few people know that in the early eighties, executive positions in ISO were held by officials from the State Standard, and when developing the ISO 9000 standard, its developers relied heavily on quality management standards in our defense industry (especially in documenting processes, making decisions, developing process metrics, managing changes).

“The reality is that ISO 9000 grew out of the depths of the Soviet military-industrial complex. It was the SMK that allowed us to launch a satellite, forge both a missile sword and a nuclear shield ". (with) And earlier - to win the Great Victory.

Who, if not us, will introduce, develop, and enrich domestic management systems with methods and technologies for the rational use of resources?

In the story of James Cook, we are the natives who will digest any ISO standard with its fashionable Anglicisms and produce an inevitably effective result.

With respect to you and all domestic standardization,
ISU experts

Difficult to get. Companies-holders of certificates that have already implemented the QMS exhibit corporate secrecy, which is usual for our market. Consulting companies are all the more not interested in publishing such information. Why replicate something in the public domain if it can be sold. And the methods of implementation consultants are different. The reference experience of working with both from the Paris Chamber of Weights and Measures simply cannot exist, just as there cannot be a wrench for any size. Everything is measured by the specifics of a particular organization. In countries where management systems have been involved for a long time, certain formats have been developed for exchanging the practical details of the implementation of ISO 9001. For example, experienced users of ISO 9001 talk about methods to newcomers at the ASQ (American Society for Quality - Ed.) Site. They even initiate excursions for employees of one enterprise on the QMS of another company. It works in a similar way in other countries. Unfortunately, such a system has not yet developed in Russia. There is even a reverse process, when quality associations that have gained popularity due to an unfavorable business environment are scrapping their work. ? First, the Russian branch of the Deming Association was opened and then closed. What is happening is associated with many chronic problems of the Russian economy. God grant that competent people were entrusted with solving them.

Despite serious problems, detailed examples of QMS implementation at domestic enterprises can be obtained. You just need to know where to look. , shows greater openness than business. Management dissertations are available to everyone, and they are also written by those. Doctor of Medical Sciences Tarasenko O.A. She defended her thesis at the Federal Medical Biophysical Center "Quality Management System of a Clinical Diagnostic Laboratory". The scientist took part in the implementation of ISO 9001 at the Blood Transfusion Station of the Department of Health. The dissertation contains a lot of interesting things for any leader who himself begins the large-scale task of implementing the QMS. First, the author analyzed all the documents that regulate the operation of blood transfusion stations at the state level. In total, it turned out to be necessary to study and take into account a little more than ten documents. After that, the standards were determined according to which the system will be created. The group of specialists responsible for solving the problem settled on ISO 15189 “Medical laboratories. Particular requirements for quality and competence ”. Directly "deployment and implementation" started with the "formulation of the basic philosophy of the organization and quality policy." began an active search for "philosophy". The condition was one, to be accepted, the philosophy formulated had to meet the needs of both the personnel and the clients of the blood transfusion station. The plant manager was made a Quality Management Representative. Recall that the presence of such an employee was required by the standard before the release of the version. With the participation of senior management, a Responsibility Allocation Matrix document was prepared. It should also be noted here that the delineation of roles in the organization -. To work with personnel who had to restructure their activities in accordance with the changed rules, we prepared a test questionnaire with questions that make it possible to better understand the personal characteristics of professionals employed at the blood transfusion station. Many documents that were already in force were somewhat rethought and were correlated with certain types of documents that are required by ISO 9001. reserve of personnel, their transfer and appointment, received the status. For conducting internal audits, which are a mandatory element of the system according to the model (International Organization for Standardization, - ed. ) the implementing organization appointed internal auditors who underwent two training cycles: "Quality system in accordance with ISO 9000 standards" and "Corporate communication training". To encourage employees to work with the QMS, the management of the Moscow blood transfusion station provided for employees with 10-20 percent salary increments for additional responsibilities that they assumed in connection with the implementation of the ISO 9001 standard.

The group of specialists who were responsible for the implementation of the quality management system project devoted a lot of effort to the formation of the document management system. If the documents that go "top-down", that is, from managers to employees have been circulating regularly and regularly () for a long time, then there were problems with feedback. In this regard, it was decided to develop the format of the memoranda to the management, so that the information flow also goes from bottom to top. But this measure was far from the only one that was taken in the working group. The organization began to hold frequent general meetings of the collective, not to mention even more frequent operational meetings with the management of the transfusion station.

Many dissertations have been defended in Russia on the complex procedure for creating a quality management system in accordance with the ISO 9001 standard. Rodionov V.S. defended himself on the implementation of the standard in 2003. The work was prepared on the basis of the QMS project of the company OJSC Mostochlegmash. Basically, the organization produces needle products.

In his scientific work, Rodionov V.S. like Tarasenko O.A. dwells on how it happens ...

Quote:‘At the first stage, a general collection of information is carried out both about the enterprise as a whole, and about the technology of manufacturing products. General information about the enterprise is data on the organizational structure of the plant, the structure and functions of the quality control department, instructions and standards for quality assurance ''

After these preparatory measures, it is necessary to analyze: how the inconsistencies are recorded, whether there are statistical methods for processing the results of data collection. Then you need to create a database with information about all non-compliance with quality standards and process the information using statistical methods. The algorithm is optimized for specific processes. In parallel, work is underway with personnel, using various methods adopted in such cases, it is required to achieve their involvement and interest in the project for the implementation of ISO 9001. Especially carefully you need to work with middle managers, since the success of all work with the standard depends on them even more than on ordinary performers.

Tarasenko O.A. in his work so characterizes from the quality management system according to ISO 9001 ...

Quote:“A feature of the work of clinical diagnostic laboratories of the blood service is the need not only to determine the health status of the donor, but also to ensure the quality of the harvested blood components and blood products. For the effective operation of the blood service, algorithms for laboratory diagnostics and algorithms based on their results for culling hematoproduction and admitting donors to donation are required ''

To create a system requires the organization of work and the establishment of relationships between employees, including the distribution of responsibilities and the exchange of information. Documenting the interaction of individual officials in the implementation of certain processes allows you to resolve any communication problems of personnel. With a detailed description of the processes, on the one hand, the documents turn out to be weighted and redundant, but on the other hand, the performers understand the essence of the requirements and are well oriented in their work. But still, how much to detail the processes depends on the type of activity of the enterprise and its size, the complexity of the processes and the qualifications of personnel.

A clear and complete description of all processes allows you to prevent errors that are possible during oral communication with personnel, and also helps to identify duplicate operations and weaknesses in the interaction of structural units within the same process. Therefore, when developing documents, it should be borne in mind that direct executors can better describe the processes and work that they perform. The basic rule is that the text of the document must be unambiguous, accurate, understandable for performers and supervising personnel, while the document must follow a logical sequence, use standardized terminology.

But, in addition to this, the documents must ensure the collection of data on the conduct of processes for their subsequent analysis and, if necessary, contain instructions for the development of measures to eliminate inconsistencies. A simple principle: "Do what is documented, document what you do." If it is violated, then the system loses its adaptability to audits: auditors check the documents and the compliance of the procedures performed. If not written, then not done! By documenting the actions taken, the result of meeting the requirements of the documents is recorded and the fulfillment is confirmed. Thus, it is possible to trace each stage of production of a specific product and analyze all production operations, to minimize their incorrect performance.

QMS implementation

Implementation of the system allows maintaining order within the enterprise. To do this, at the initial stage, it is necessary to get the staff to understand the requirements of ISO 9001 and to convince employees of the need for cohesive work. After all, a mistake or negligence of one performer can develop into a problem for subsequent performers. Strict adherence to the approved QMS procedures is mandatory for all personnel of the enterprise.

Competent implementation of the QMS allows enterprises to gain advantages:

Increase the manageability of the enterprise;

Improve the quality of products;

Reduce costs;

Maintaining the QMS performance and improving

It is necessary to confirm compliance with the established requirements and adherence to the priority of quality by the daily work of the personnel of all divisions of the enterprise. But, in the conditions of changing market realities, just maintaining the system is not enough. New production technologies are being developed, modern equipment is being purchased, new types of raw materials and packaging materials are emerging. All this entails a change in production technology, a change in the requirements for the qualifications of personnel, etc. Therefore, continuous analysis and improvement of the QMS is required.

QMS LLC "KorolevFarm"

KorolevFarm LLC, being a contract manufacturer of biologically active food supplements and cosmetic products, considers the QMS as a complex of organizational structure, documentation, processes and resources that are necessary at each stage of the product life cycle. Preparations for the implementation of QMS in accordance with ISO 9001 at KorolevFarm LLC began back in 2007. The development of the system and its implementation was carried out by the company's specialists and took about a year. Documenting the processes helped to streamline the work and activities of the company as a whole. The implemented system made it possible to make the company's processes transparent, which made it possible to make strategic and tactical decisions based on facts, and not on assumptions and opinions of employees. But the main goal of the implementation of the QMS was to stimulate the activities of the enterprise in order to increase the degree of satisfaction of customers and consumers of products.

At any modern enterprise, it is not enough just to control the finished product. After all, if we consider the concept of "quality" as the ability of products to meet the needs of the consumer, then such moments as the selection and training of personnel, the purchase of raw materials and materials only from "approved" suppliers, the preparation of production facilities and equipment, the availability of documents at workplaces at all stages production, customer satisfaction analysis.

Quality management at KorolevFarm LLC is a concept of organization management.

Stage 1. Management decision.

The manager must decide to start the project, notify the employees of the company, and also create the prerequisites for the rapid implementation of all other stages. You should also formulate the goals of building the QMS, highlight at the top level the QMS processes that need to be monitored, and the criteria for assessing their quality. Subsequently, the objectives of the QMS must be recorded in a document called "Quality Policy", which also describes the principles of their achievement. This document is fundamental in the company's QMS regulatory documentation system.

Stage 2. Personnel training.

For the further successful work of the QMS, the company's personnel must study the theory of quality management, the ISO 9000 series standards, master the theory of the process approach, as well as the basic requirements for the implementation of the QMS. Training in using the system can be carried out both with the help of consultants and independently, if the company has an employee who has experience in setting up the QMS.

Stage 3. Formation of the QMS implementation program.

The implementation of the QMS should be considered as a complex and lengthy project (up to one and a half to two years).

Therefore, it is necessary to draw up a QMS implementation program, which should include:

• - description of the stages of implementation;
• - a list of those responsible for each stage of the project. As a rule, they are chosen from among top managers, as well as specialists who know best the specifics of the work of their departments;
• - budget for the implementation of the QMS. It includes both the cost 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 diverting management from the main work for the project. When setting up a QMS, you can do it on your own, however, the distraction of top management from the main work, as well as the training of your own specialists of the required level, can cost more than the services of a consulting company;
• - the procedure for assessing the implementation of the QMS. Indicates the criteria by which management will be able to determine whether the goals set at the beginning of the project have been achieved.

After drawing up the program, you can proceed to the direct setting of the QMS.

Principles of building a QMS.

When building a QMS, one should be guided by the following principles of quality management, formulated in the ISO 9000 standard. Customer orientation.

Organizations depend on their customers, so they must understand their current and future needs, fulfill their requirements and strive to exceed their expectations.

Leadership of the leader. Leaders ensure the unity of purpose and direction of the organization. They should create and maintain an internal environment in which people can be fully involved in the tasks of the organization.

Involvement of workers. Workers at all levels are the backbone of the organization, and their full involvement in the work of the company enables it to capitalize on their capabilities.

Process approach. The desired result is achieved more efficiently when activities and associated resources are managed as a process. A systematic approach to management. Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.

Continuous improvement. Continuous improvement of the organization as a whole should be seen as its permanent goal.

Making decisions based on facts. Effective decisions are based on the analysis of data and information.

Mutually beneficial supplier relationships. An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both parties to create value.

Stage 4. Description and optimization of business processes.

The basis of the quality management system is the process approach. First of all, it is necessary to describe those business processes, the management of which the management considers the most important for the QMS. The description is carried out using specialized computer tools based on information obtained during interviews with performers, etc.

The described business processes need to be optimized, that is, to eliminate all inconsistencies with the requirements of the standard and duplicate processes, as well as to develop new processes in accordance with the rules of the standard.

Most often, companies do not have a “Customer Satisfaction Assessment” process, which is required by the standard.

Therefore, it is necessary to develop a system of indicators, as well as the procedures necessary for the implementation and monitoring of this process.

Stage 5. Development of the QMS normative documentation.

At this stage, normative documents, regulations and procedures are formed to ensure the operation of the quality management system. 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, on the basis of the Quality Policy, a document is prepared called the Quality Manual. It contains the main provisions governing activities within the QMS: delineation of areas of responsibility, requirements for the quality service, a description of quality assurance procedures, the procedure for maintaining the QMS document flow, a description of the complaints procedure, etc.

The next level of documents is called "System-wide documented procedures". According to ISO 9001, six procedures should be followed:

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

The next level documents describe the rules for the effective planning, implementation and management of processes. Such documents include working methods, job descriptions of employees, process flow charts.

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

When drawing up regulatory documents, it is necessary to take into account the requirement of ISO 9001 on the competence of personnel performing work within the framework of the QMS. This means that regulatory documents should describe the process of employees' access to regulatory documents, as well as requirements for the competence of personnel (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 of the QMS requires the presence of electronic document management systems in the organization.

Stage 6. Testing of the QMS and internal audit.

After the development of all regulatory documents, the trial operation of the quality management system begins. It is possible to launch processes within the new system gradually, for example, first introduce control over the procurement process, then production, etc.

The trial operation is accompanied by an internal audit, special procedures for checking the work of the QMS. At the beginning of operation, they are carried out often (perhaps once a week), then less often (once a month or even a quarter).

For internal audit purposes, it is necessary to record quantitative indicators of quality, for example, scrap rate, customer satisfaction rate, return rate, etc., which should be aimed at. To determine the value of such indicators, similar indicators of industry leaders are usually used.

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, the work of employees, as well as regulatory documentation, is adjusted in order to avoid deviations in the future. All this work should also be documented in the appropriate QMS procedures.

Stage 7. Obtaining a certificate.

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

• - application for certification;
• - all documents on the QMS ("Quality Policy", "Quality Manual";
• - a diagram of the organizational structure of the company, documented procedures and other developed QMS documents);
• - a 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 quality system in operation. Based on the results of the audit, a protocol is drawn up, in which all inconsistencies between the QMS and the requirements of ISO 9001 are recorded. Usually, according to the results of the first stage of the audit, more than a hundred inconsistencies are found, and the task of the enterprise is to eliminate them as soon as possible and prove it to the certification body. As a rule, these operations take 1-4 months.

After that, the actual certification is carried out. If all significant inconsistencies are eliminated, the company is issued a certificate (it is drawn up for about a month). The certification body conducts repeated (supervisory) audits of the QMS with a certain frequency. They confirm that the company has not only implemented a quality management system, but is also constantly improving it. The cost of such an audit is about a third of the cost of the initial certification.