Stages of smk. Creation of a quality management system at the enterprise. Certification of the QMS

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

Documents confirming the stability, reliability and prospects of the company, such as reporting under IFRS or, have been supplemented with a certificate of compliance of the QMS with the requirements of ISO 9001. Proper implementation of the quality management system will allow the company to receive a number of advantages:

• improve manageability, competitiveness, quality of products and services;
• reduce costs;
• make the company customer-oriented.

See also Effective Internal Control: How to Deal with Risks and Key Issues in Setting Up an Internal Control System.

SMC is...

The quality management system is a system that ensures the effective operation of the company, including in the field of product quality management. The most effective when creating a QMS are the requirements fixed in the international QMS standards ISO 9000 series.

Note that an effective system can be created without focusing on the ISO 9000 series standards. However, in order to certify it, that is, to obtain a document indicating that the company's processes are effective and aimed at constantly improving the quality of products or services, the QMS must comply with the requirements ISO 9001-2000 standard. Therefore, we will consider its creation from the point of view of the requirements of ISO 9001.

In order to build a QMS in accordance with ISO 9001 standards, it is necessary:

• develop a document that formulates the goals and objectives of the QMS, as well as the principles for achieving them (“quality policy”);
• develop regulations, describing and regulating business processes ();
• think over an effective mechanism for implementing the requirements regulated by the regulatory framework;
• prepare staff.

When forming all these elements, the basic principles of quality management should be taken into account. Consider the implementation of the QMS in stages.

Principles of building a quality management system

When building a QMS, one should be guided by the principles formulated in the ISO 9000 QMS standard:

1. consumer orientation,
2. leader leadership,
3. employee involvement,
4. process approach,
5. continuous improvement,
6. fact-based decision making
7. mutually beneficial relationships with suppliers.

The model of a quality management system based on a process approach looks like this:

Stages of QMS implementation in the company

Let us consider in detail all the stages of the implementation of the QMS in the enterprise.

Stage 1. Management decision

The manager must decide on the start of the project, notify the company's employees, and also create the prerequisites for the rapid implementation of all other stages. At this stage, it is necessary to formulate the goals of building the system, highlight the processes that need to be controlled at the top level, and the criteria for assessing their quality. Subsequently, the goals must be recorded in a document called "Quality Policy", which also describes the principles for achieving them.

Stage 2. Personnel training

Personnel must understand the theory of quality management, ISO 9000 series standards, master the theory of the process approach, as well as the basic requirements for the implementation of the QMS. Training in the use of 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 it up.

Stage 3. Formation of the QMS implementation program

Implementation of the QMS is a complex and lengthy project for up to one and a half to two years. Therefore, it is necessary to draw up a program that should include:

• description of implementation stages;
• a list of people 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;
• implementation budget. It includes both the costs of certification and the payment of consultants, if they are involved, as well as the cost of further staff training and the cost of diverting management from the main work for the project. When setting up, you can do it on your own, however, distracting top management from the main work, as well as training your own specialists of the required level, can cost more than the services of a consulting company;
• procedure for evaluating the implementation of the QMS. The criteria by which management will be able to determine whether it was possible to achieve the goals set at the beginning of the project are indicated.

After compiling the program, you can proceed to the direct formulation of the QMS.

Stage 4. Description and optimization of business processes

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

Stage 5. Development of regulatory documentation

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

First, based on the "Quality Policy", a document called "Quality Manual" is prepared. It contains the main provisions governing activities: the delineation of areas of responsibility, requirements for the quality service, a description of the procedures for ensuring it, the procedure for maintaining the QMS document flow, a description of the complaint handling procedure, etc.

The next level of documents is called "System-Wide Documented Procedures". According to the ISO 9001 standard, six procedures should be carried out:

1. document management,
2. data management (records),
3. audit management,
4. management of products that do not meet standards (the process of identifying defects and the procedure for their disposal),
5. management of actions that correct nonconformities,
6. management of measures to prevent the occurrence of nonconformities.

Documents of the next level describe the rules for effective planning, implementation and management of processes. These documents include working procedures, job descriptions workers, flow charts.

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

When preparing regulatory documentation, it is necessary to take into account the requirement of the ISO 9001 standard on the competence of the personnel performing the work. This means that the regulatory documents should describe the process of employees' access to regulatory documentation, as well as the requirements for personnel competence (level of knowledge, work experience), a program to improve the level of employees if necessary, an employee motivation system, etc.

It should be noted that the effective use of a large number of regulatory elements requires the presence in the organization.

Stage 6. Testing and internal audit of the quality management system

After the development of all regulatory documents, trial operation begins. You can start processes gradually, for example, first implement control over the procurement process, then production, etc. Pilot operation is accompanied by internal audit, special procedures for verification of work. At the beginning of operation, they are carried out frequently (perhaps once a week), then less frequently (once a month or even a quarter).

For internal audit purposes it is necessary to fix quantitative indicators of quality, for example, rejection rate, customer satisfaction rate, return rate, etc., to which it is necessary to strive. To determine the value of such indicators, similar indicators of industry leaders are usually used. Internal audits should identify inconsistencies between current work and the requirements of the standard. These deviations must be recorded. Then, based on the results of the audit, adjust the work of employees, as well as regulatory documentation, in order to avoid deviations in the future. All this work should also be documented.

Stage 7. Certification

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

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

Specialists of the certification body conduct an examination of the submitted documents within a month. The examination may include a visit by representatives of the certification body to the enterprise to check the QMS in operation. Based on the results of the audit, a protocol is drawn up in which all inconsistencies between the system and the requirements of the ISO 9001 standard 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 of the QMS is carried out. If all significant discrepancies are eliminated, the company is issued a certificate, it is issued for about a month. Repeated (surveillance) audits of the QMS are carried out by the certification body at regular intervals. They confirm that the company has not only implemented the system, but is constantly improving it. The cost of such an audit is approximately one third of the cost of primary certification.

The role of the financial director in the implementation of the QMS

Majority Russian enterprises have existed for a long time and work according to historically established rules. In order to change these rules in accordance with the QMS, a strong administrative resource is needed: the CEO and CFO must not only take an interest in such changes, but also manage them. Often financial directors act as a coordinator of the process of building a system and are directly involved in the description and systematization of procedures within the framework of this work.

QMS staging sometimes pushes financial service to the preparation of financial and management reports for international standards. After all, accounting under IFRS and financial management in accordance with ISO are very close in their idea.

To develop a quality management system in the new edition of the standard, a single quality system model is used for organizations of all types. In accordance with the requirements of ISO 9001:2000, the creation of a QMS in any enterprise should include several stages:

Establishing the needs and expectations of buyers and other interested parties;

Development of the organization's policy and goals in the field of quality;

Establishment of processes and responsibilities necessary to achieve quality objectives;

Determining the necessary resources and providing them;

Development of methods to measure the effectiveness and efficiency of each process;

Determining the means necessary to prevent nonconformities and eliminate their causes;

Development and application of processes for continuous improvement of the QMS.

Under the quality policy, the standard means the goals and obligations of the enterprise to ensure quality. Besides, he wants her documentation, compliance with the organizational goals of the enterprise or firm, the requirements and demands of consumers. The manager, in turn, must ensure that this policy is understood, implemented and supported at all levels.

The quality policy is an integral part of the company's philosophy, its long-term strategy in the market and is a priority in relation to commercial, technical and social policies (see Appendix). It enables employees of the enterprise, suppliers and consumers to get a clear idea of ​​the official attitude of the company's managers to quality.

When establishing a quality policy, an organization should:

Assess the expected level of customer satisfaction, taking into account competition in its market share;

Take into account the balance between the needs of the stakeholders being met and the contribution of each of the parties

in achieving the goals of the organization;

Assess the risks in solving organizational problems;

Identify opportunities and needs

for continuous improvement;

Identify required resources and capabilities

suppliers and partners.

Entered into force formulated and disseminated

the quality policy should:

Conform to the vision of the future of the organization;

Clearly define organizational objectives and stakeholder needs, giving direction to the organization as a whole;

Support the development of more competitive business plans by integrating continuous improvement with strategic and business planning;

Ensure the creation of comprehensive and competitive plans that functionally link the input elements of the processes;

Demonstrate top management's commitment to quality;

To ensure the pursuit of high quality at all levels of the organization;

Provide a basis for setting and reviewing quality objectives;

Lead to visible and expected results that must be effective and productive.

When creating a quality management system, the most important role belongs to the management structure of the organization.

The ISO 9001 standard requires the management of an enterprise to have and control the following basic elements in the field of quality:

Politicians;

Distribution of staff powers;

Providing the necessary resources;

Ensuring customer satisfaction;

Appointment of a representative;

Carrying out internal checks (audits);

Continuous improvement of the quality system;

Analysis of the functioning and effectiveness of this system.

The practical part of creating a quality system in an enterprise may include several main technical steps:

1) organization;

2) the actual development and implementation;

3) conducting internal audits of the quality system (actually monitoring the correctness of the work done).

For their successful implementation, it is necessary to provide the necessary organizational, resource, methodological and socio-psychological conditions in the organization. It is important to keep in mind that mistakes or shortcomings made at the first stage, as a rule, lead to time-consuming adjustments and alterations at subsequent ones.

Organization of work on the creation of the QMS includes:

Appointment of responsible officials;

Provision of work participants with standards and other documents;

Involvement of external consultants;

Diagnosis of the current QMS;

Holding special education participants in the work and explanatory work with the personnel of the organization;

Allocation of resources necessary to perform work within the established calendar timeframes.

Persons responsible for the organization and implementation of activities to create a QMS should be representatives of the top and middle management. It is best when the quality officer responsible for general organization work, a representative of the top management with a rank not lower than a deputy is appointed Director General, and the manager of the work on the QMS project is the middle manager.

Proper performance of these activities requires that the organization have both base and supporting ISO 9000 series standards. The use of unofficial versions of these documents is unacceptable. Attention should also be paid to the fact that the official Russian translation of the provisions does not always correspond to the wording of these provisions in the original language. Documents developed by ISO/TC 176, in particular the Guide to documentation requirements according to ISO 9001:2000, the Guide to the terminology used in ISO 9001:2000 and ISO 9004:2000, and the brochure ISO 9000 Standards: 2000. Choice and Application.

For methodological validity and minimum probability of erroneous decisions during the creation of the QMS, it is advisable to involve qualified external consultants. Their advantages over the specialists of the organization are: independence and impartiality of views; a higher level of qualification in the field of quality management; focus on the successful experience of other organizations; high intensity of work due to tight time frames.

An examination of the QMS operating in the organization (and such a system exists in any enterprise, even if it is not properly documented) is a preliminary analysis of the system and an assessment of the degree of its compliance with the requirements of MS ISO 9001:2001. It is carried out most often by external consultants and is aimed at determining the need for specific changes to the current system. Of particular importance in this case are changes in the organizational structure, which it is desirable to include in initial stages developed on the basis of the survey plan for the implementation of the QMS. Meanwhile, in practice, quite often one has to deal with a situation where the management of the organization begins to carry out a serious restructuring after the documentation of the QMS has been completed, which has secured the responsibility and authority of the main officials and departments. And this inevitably entails processing

many documents in the system.

For the development of the QMS, as well as for its effective and efficient functioning, the management of the organization must provide the necessary training of personnel. Since this process must be continuous, at the initial stage of work it is advisable to conduct basic (in the amount not exceeding 20 hours) training for the heads of organizations, starting with their top management, and the so-called working group (project team), including quality service employees and specialists from other departments. At the same time, it is extremely important to pay close attention to the updated terminological apparatus in the ISO 9000:2000 series standards. As experience shows, the QMS involves almost all employees of the enterprise.

Along with training, when creating a QMS, it is necessary to familiarize with the goals, objectives of the organization, the basic principles of quality management and certain provisions of the standards. Explanatory conversations that are assigned to the quality service are designed to involve staff in the work, prevent the emergence of socio-psychological barriers associated with the implementation of ISO 9000 series standards, and prevent individual employees from misunderstanding the importance of focusing on standards, nullifying the effect of implementation.

The actual implementation of the plan for the implementation of the QMS is carried out by the project team. It typically includes consultants, the project manager, and the organization's managers. The number of participants depends on the size of the enterprise and the time allotted for the project. Implementation works are expected to take approximately 1-1.5 years and include:

Establishing the scope of the SC;

Development of a quality policy;

Distribution of tasks between working groups;

Analysis of the actual state of normative and technical documentation;

Coordination and definition of processes and operations and measures of their quality;

Transferring the description of processes to the quality manual and its distribution;

Quality management training for participating employees;

Development of IC documentation;

Training in evaluating the implementation of procedures according to established quality criteria;

Implementation of SC;

Internal audits;

SC adjustment;

Preparation of SC for certification;

Submitting an application for certification.

For the developed measures for the creation of the SC, a plan is drawn up for putting them into effect (Fig. 3), containing information:

About the time sequence of their implementation, the time of each event and the time of manifestation of the planned effect;

The person responsible for the implementation of each of these activities, and the specific performer;

Structural unit of the organization in which they should be implemented;

Technologies used (for example, software products);

A result that can be controlled;

The person who controls the result and determines its compliance with the planned one;

The cost of the event, including control of the result; the source of funding for the event (for example, an item in the enterprise's budget).

Figure 3 - Matrix-plan for creating a QMS at the enterprise

The progress of the implementation of the QMS can be tracked through regular scheduled reviews of the project, while checking whether the project brings the desired results. If necessary, changes are allowed in the project related to both its depth (degree of detail) and the breadth of coverage of the QMS (the number of processes that fall under the scope of the QMS). In addition, it may be necessary to modify the plan or

project budget.

The final stage of the implementation of the quality management system is the conduct of internal audits. It is necessary to plan these checks, according to MS ISO 9001, taking into account the status and significance of the processes, as well as the results of previous Checks. The status can be determined by the following options:

The process was audited during the reporting period, meets the established requirements and is effective;

The process was audited during the reporting period, meets the established requirements, but is not effective;

The process was audited during the reporting period and found to be non-compliant

(critical);

The process was not audited during the reporting period (process with an undetermined level of performance compliance).

The significance of the process is established based on the degree of its influence on the achievement of the organization's goals in the field of quality in the period under review.

In cases where the organization does not have a documented procedure for any QMS process, internal auditors should conduct an audit according to the requirements of the relevant section of ISO 9001 MS. At the same time, various types of records containing objective evidence of the actions performed or the results achieved can serve as evidence of compliance with the requirements of the standard. .

Thus, the created system is a means that ensures the implementation of a certain policy and the achievement of the goal in the field of quality. The quality management system provides for comprehensive quality management by combining the activities of various departments responsible for the development of quality indicators, their achievement, maintaining the achieved level of quality, ensuring the production and operation of products at the most economical level with full satisfaction of customer requirements. Integrated quality management involves the participation of all departments of the enterprise, including production, design, supply, sales, technical control quality, standardization, etc.

If you are going to implement a QMS in an enterprise, strictly adhere to the following sequence:

1. Familiarize all staff with upcoming changes. Awareness always breeds trust.
2. Justify the need for the implementation of the QMS.
3. Try to have all personnel involved in the implementation of the QMS. Joint decision-making will create collective responsibility in the enterprise.

• Stage 1 Distribution of responsibility. Formation of the Coordinating Council.
  • 1.1 Top management pre-assesses the needs and desires of customers.
  • 1.2 Top management determines the scope of the QMS, appoints a person who leads the work on the implementation of the QMS.
  • 1.3 Top management preliminarily formulates the Quality Policy and objectives at the organization level.
  • 1.4 Top management identifies the processes required for the quality system.
  • 1.5 Top management appoints process owners and employees responsible for the development of procedures required by the requirements of STB ISO 9001.
  • 1.6 Top management allocates the required resources for the development of the QMS.
• Stage 2 Formation of the structure of the quality management system. Creation of working groups of processes.
  • 2.1 The Coordinating Council forms working groups.
  • 2.2 The project manager organizes the analysis of the enterprise's activities for compliance with the requirements STB ISO 9001-2009.
  • 2.3 The CC determines the number and types of documents that are required, the time for development, appointing those responsible for development, incl. to organize activities according to the process approach.
  • 2.4 The SC highlights the processes required for the QMS, their sequence and interaction.
  • 2.5 The project manager organizes the setting of goals by levels and departments, as a result of the deployment of goals over high level and directions of the Policy, taking into account the requirements STB ISO 9001-2009.
• Stage 3 Coordination and testing of documents.
  • 3.1 Working groups develop, agree and check in practice all developed documents, including those that are needed for effective process management.
  • 3.2 Working groups collect proposals for finalizing the developed documentation.
• Stage 4 Implementation of QMS documents.
  • 4.1 Conduct a study of the developed documents.
  • 4.2 Organize work on the application of the developed documents.
  • 4.3 The staff informs the working groups on the necessary revisions of the developed documents.
  • 4.4 Working groups clarify goals before processes and departments.
  • 4.5 The working groups finalize the documents of the QMS.

  Procedure for implementing documents:

  1. Implementation order
  2. Specialist training
  3. Development of registration forms
  4. Execution control
  5. Internal audit
• Stage 5 Approval of QMS documents. Implementation of the QMS.
  • 5.1 The CC approves the documents of the JMC.
  • 5.2 The SC approves the final versions of the Policy and quality objectives. The director of the enterprise approves the Policy and objectives in the field of quality in the organization.
  • 5.3 Development of the Quality Manual.
  • 5.4 Preliminary analysis of the QMS.
  • 5.5 Planning for the implementation of internal audit.
  • 5.6 The CC approves plans (measures) for the implementation of the established goals.
• Stage 6 Measurement, analysis, monitoring and improvement of the QMS.
  • 6.1 Conducting internal audits.
  • 6.2 Monitoring, assessment of the constancy of the QMS processes.
  • 6.3 Amendments to the QMS documents.
  • 6.4 Review and approval of the Quality Manual.
  • 6.5 Implementation of corrective actions based on the results of internal audit.
  • 6.6 Implementation of the analysis of the quality system according to the prepared methodology.

The implementation of all the above works preliminarily requires the following set of measures:

• - Draw up and issue an order on the implementation of work on the formation of the QMS;
• - Determine the governing (coordinating council) and working bodies (working group) for the implementation of work on the development of the QMS. Issue by orders the composition and powers of these bodies and provide them with office equipment, communications and working conditions;
• - Organize and conduct general training of employees of the organization on quality management issues.

It should be noted that the ISO 9000 series of standards describe the elements that should include a quality management system, but not ways to implement it. They do not impose the uniformity of the QMS, since the management system depends on the tasks of the enterprise, the type of products it produces. As a result, the QMS of one enterprise will differ from the QMS of another enterprise. These standards describe only the minimum requirements that an enterprise must fulfill when creating a QMS.

It is advisable to create a QMS in the following sequence.

First step- substantiation of the project. At this stage, a draft QMS should be prepared and submitted to management for consideration. The decision of the head of the enterprise is an important step in the creation of the system. The project is planned in detail, including information from all staff using various media.

Second phase- decoding, detailing of the project. Here it is important to achieve a clear idea of ​​the form and content of all elements of the QMS, streamline the components of the project, and bring stability to the process. At this stage, the layout of the Quality Manual should also be prepared.

Third stage- implementation. At this stage, the main work is performed by separate working groups that create a Quality Manual for the entire enterprise and all its departments. This stage is the most important and difficult.

Fourth stage - internal control. It provides for internal control of the results of the development of the QMS and the effectiveness of its work.

Since the ISO 9000 series of standards only provide guidance on the choice of a QMS model, it is important to choose the model that best suits the production process option. Then, taking into account the recommendations of the selected standard, a list of functions and elements of the QMS is determined. This list may include additional elements or only a subset of the elements recommended by the selected standard. The absence of this or that element in the QMS must be justified so that it can be convincingly explained to the customer or the organization that checks the QMS.

After that, you need to define structural units enterprises that will individual tasks (elements) QMS. To do this, it is necessary to analyze the functions of existing units and compare them with the list of functions adopted for the created QMS, taking into account the recommendations of the selected standard. As a result of such a comparison, the performers of each element of the QMS are established. After determining the performers and their functions, the QMS takes on a very specific shape, which can be represented structural And functional schemes.

The block diagram of the QMS is built on the basis block diagram enterprise and makes it possible to show the relationship of all structural units in the QMS.

In contrast to the block diagram showing the "device" of the QMS, the functional diagram allows you to visualize the "work" of the QMS, i.e. quality management process. Such a scheme is built in the form of a quality loop, similar to how it is done in relation to the manufacture of products. When developing a functional diagram, it is necessary to take into account all stages of production and all management functions given on the quality loop. At the same time, for each function in the diagram, it is advisable to indicate the main structural units that will perform them at all stages of production.

Upon completion of the construction of structural and functional schemes, the next task is to determine the composition of the normative and technical documents of the QMS. As a rule, the largest number of documents is required for operational control in manufacturing process. This composition may include both documents that need to be developed additionally, and documents that are already available at the enterprise, but require some refinement.

The most common QMS documents are the standards of the organization, but, in addition to them, instructions, prescriptions and other regulatory documents can be used. For the final formation of the QMS documentation, it is necessary to develop another, generalizing document, which provides a general description of the system. Such a description is provided by the ISO 9000 standard in the form of a “Quality Manual”. This Manual is not only for internal use, but also for presentation to customers when awarding contracts and to independent experts during quality system reviews. Specific guidance on the development of this document is given in ISO 10013, Guidelines for the development of quality manuals.

The guide usually includes:

the scope and status of the Quality Manual itself;

· brief description enterprises and products;

the company's policy in the field of quality;

· a brief description of the top management structure, indicating the main functions, powers, and responsibilities for quality;

description of the structure and functions of the quality service;

description of the elements of the quality system, indicating the performers and brief description methods for their implementation.

As an illustrative material in this document, we can cite the structural and functional diagrams of the QMS.

The development of the QMS should allow to streamline the elements available at the enterprise into a clearly structured system that fully meets the requirements of GOST R ISO 9001:2001 (ISO 9001:2000) for the quality model.

It should be noted that in practice one often has to deal with the creation of a QMS from scratch, and with the refinement of an existing QMS to the requirements of GOST R ISO 9001:2001 (ISO 9001:2000). In this case, the scope of work will depend on how the existing QMS meets the requirements of the standard.

After the development of a new or improvement of an existing QMS, it is necessary to check its functioning and, if necessary, make adjustments. To do this, internal checks of the system are carried out, in particular:

Are all stages of production covered by the impact of the QMS;

Are there enough elements (functions) provided in the system to ensure product quality;

Whether the performers of all functions of the QMS have been identified;

Whether functions are performed at the workplace;

Whether the structure, functions and documentation of the QMS need to be adjusted.

Based on the results of the inspections, the QMS is adjusted to eliminate the identified shortcomings and ensure the smooth functioning of the QMS.

The tasks that need to be solved to create a QMS are presented in Table 3.1.

Table 3.1

PROGRAM

development, implementation and certification of the Quality Management System

for compliance with the requirements of GOST R ISO 9001-2001 (ISO 9001:2000)

No. p / p	Job Title	The result of the work
1.	Making a decision on the development, implementation of the QMS and bringing it to the attention of the heads of departments	Relevant company directives
2.	Analysis of the structure and activities of the enterprise and current documentation; analysis of the existing system and methods of enterprise management
3.	Development of the "Quality Policy"	Document "Quality Policy"
4.	Development of "Quality Objectives"	Document "Quality Objectives"
5.	Allocation of financial and other resources necessary for the development and implementation of the QMS	Director General's Order
6.	Determination of the responsible representative of the management for the QMS; creation of a quality service	Order of appointment
7.	Training of managers of all departments of the enterprise to the requirements of GOST R ISO 9001-2001 (ISO 9001:2000)	Protocol, order
8.	Distribution of powers and responsibilities in the QMS	Responsibility matrix
9.	Restructuring of the organizational structure of the enterprise	Designed and approved organizational structure
10.	Determination of the main processes and activities of the QMS, their sequence and interaction.	Process maps
11.	Determination of the structure and composition of the QMS documentation. Planning the development of QMS documents	Hierarchy of QMS documentation
12.	Development of the Quality Manual	Quality quide
13.	Development of documented procedures (methodological instructions)	Documents - MI
14.	Development of procedures and methods for monitoring, measuring, analyzing and quality control of all departments covered by the QMS, recording control results, evaluating the effectiveness and efficiency of the QMS	Development of enterprise standards
15.	Training of internal auditors
16.	Conducting an internal audit	Report
17.	Elimination of inconsistencies identified during the internal audit	Issued sheets of discrepancies and notifications
18.	Carrying out a pre-certification audit	Report
19.	Preparation for QMS certification. Elimination of inconsistencies identified during the pre-certification audit	Corrected documentation
20.	Applying for QMS certification	Application
21.	QMS certification
22.	Obtaining a certificate of conformity of the QMS to the requirements of GOST R ISO 9001-2001 (ISO 9001:2000)	Certificate of conformity