The process of creating a QMS in an organization. Development of the organization's quality management system. The role of the financial director in the implementation of the QMS

Step 2. Since the analysis of the current situation in the organization is carried out in order to build a quality system, the next step will be to train the members of the working group in quality management and the requirements of ISO 9000 series standards. analysis of the current state of affairs and the development of a quality system will be their main task.

Step 3. In order to understand how much the existing activities in the organization differ from the requirements of ISO 9001:2008, it is necessary to analyze the current situation. The collection of initial data is carried out mainly by two methods - questionnaires and interviews. It is most effective to use both methods, first to conduct a survey, and then clarify the necessary information during conversations with employees. The members of the working group are responsible for questioning and conducting interviews.

Of course, you can not do all this, but in this case, the members of the working group should, based on their knowledge of the work of the units, conduct such an analysis.

The result of the analysis may be a report or other document, in which, for each requirement of the standard, it will be indicated how it is implemented and what is the depth of implementation of this requirement in various departments of the organization.

An analysis of the current situation should reveal:

the main production processes of the organization;

support and support processes;

the most critical business processes in terms of the quality system;

availability and relevance of regulatory documentation (enterprise standards, instructions, regulations on subdivisions, job descriptions etc.);

the existing distribution of responsibilities, authorities and resources for the processes of the organization.

Development of documentation and changes in the work of employees

This stage is the most time-consuming and lengthy. During this stage, the design, development and implementation of quality system documentation, as well as the introduction of changes in the work order of employees, is carried out.

The works of the second stage consist of the following main steps:

Step 1. At this step, it is necessary to plan how the quality system will be built, what its scope will be, what processes will be included in the quality system, how it will be expanded. For example, an organization provides its customers with several types of different services. These services are provided by various departments. Then at this stage it may be decided to initially include in the scope of the quality system all the processes and departments involved in the provision of one service, and the processes and departments involved in the provision of other services can be involved later, after the quality system fully operational when managing the quality of the first service. In this case, the construction of a quality system will take place on the principle of increasing the scope of its distribution.

Step 2. The main principle of the ISO 9001:2008 standard is the process approach. In order to be able to implement process approach, the standard requires the organization's processes to be defined and documented. To fulfill this requirement, the working group must first formalize the processes that were included in the scope of the quality system as they are, and then make changes to these processes in accordance with the requirements that are specified in the standard.

When performing this step, pay attention to the following points:

The implementation of a quality system is associated with the management of changes in the activities of the organization. The implementation of any changes always affects the interests of the employees affected by these changes. As a result, people either resist change or support it, and a neutral attitude is rare. In order to be able to effectively implement process changes at the level of performers, administrative support is needed from the management of the organization (to reduce the level of resistance) and getting fast enough results from changes (to maintain support from those who accept changes). To implement this principle, it is necessary to correctly determine the order of documenting and changing processes. First of all, it is recommended to formalize and correct the most important processes.

Step 3. Documentation and implementation of quality management system procedures.

ISO 9001:2008 requires that an organization's processes be defined and documented. Documentation of processes can be carried out in the form of process maps, which indicate the sequence of process operations, the input and output data (information, resources) of each operation, and those responsible for the operation. Documenting processes in the form of maps significantly reduces the amount of documentation. In addition, when documenting processes, it is important to strike a balance in the detail of the process presentation. The process must be presented with such a level of detail that the personnel involved in the process can understand the order of the process operations and determine their “place” in this process.

In accordance with the requirements of the standard, 6 mandatory procedures and a quality manual must be developed, as well as documents necessary organizations to ensure effective planning, implementation and management of processes (process maps, regulations, instructions).

The implementation of process maps and quality system procedures is best done in parallel with their development, i.e. Having developed a process map and making changes to the process, it is necessary to put it into action.

The introduction of procedures and new process maps must be accompanied by staff training and control of work on the procedure (process map).

After all the necessary process maps and quality system procedures have been developed, it is necessary for the organization to work on these maps and procedures for some period of time. This time is necessary for “finishing” the quality system. During this period, there are usually minor changes quality system documentation.

Conducting an internal audit of the quality system

The main purpose of this stage is to check the operation of the company's quality system before the certification audit. Additional goals this stage will be - training in practice for internal auditors to conduct audits, training of the organization's personnel before a certification audit.

The work of the stage consists of the following main steps:

Step 1. To conduct an internal audit of the quality system, it must be prepared and planned.

Accordingly, at this step it is necessary:

Officially (by order of the organization) appoint a team of auditors (lead auditor and auditors). The audit team is appointed from among the employees trained to conduct internal audits;

Prepare a plan and program for the audit in the units. Since the internal audit is carried out in order to prepare for the certification audit, the plan and schedule of the internal audit should include all departments of the enterprise whose activities are subject to the quality system;

Prepare audit questionnaires;

Issue an order for the organization to conduct an audit.

Step 2. Conducting audit conversations. During audit interviews, auditors check the employees of the organization for their work in accordance with process maps and quality system procedures. The audit is carried out according to the audit program. If nonconformities are found during the audit, the auditors should draw up nonconformity records that indicate the identified nonconformities. When conducting an audit, auditors check the availability of quality system documentation at the workplace, work on this documentation, quality records required by the system.

The main provisions related to the development and implementation of the QMS are defined in the ISO 9000 series standards.

QMS is a complex organizational and technical system, the main elements of which are organizational and production structures, managerial and production functions(processes, procedures), resources, technologies, financial and information communications, methods, etc. It should be noted that the QMS should be clearly focused on a specific object (organization, subdivision) and has no practical value as an isolated, independent system.

Considering the QMS as an object of development and implementation in the enterprise, it is necessary to emphasize once again characteristics this system:

¨ focus on increasing customer satisfaction with the quality of products (services);

¨ focus on ensuring the competitiveness of the organization;

¨ a tool for implementing the organization's policy and goals in the field of quality.

Thus, the quality management system should be considered as a system of interrelated and interacting elements, the composition and content of which is determined by the organization depending on the tasks solved by the quality management system, the characteristics of activities, products (services), production (technological) processes, and the already established management system. , as well as requirements and recommendations of standards ISO 9000 series latest versions.

The creation of a quality management system requires a strategic decision by the top management of the organization. The development and implementation of an organization's quality management system is influenced by changing needs, specific goals, manufactured products, applied processes, the size and structure of the organization (GOST ISO 90001-2011, Introduction).

The process of creating a QMS that meets the requirements of current standards can be divided into several stages. The actual number and name of the stages is determined in relation to specific organization.

The composition of the tasks, the set of necessary measures and the final result of each stage will be determined by the operating conditions of the existing management system of a particular organization. The most effective tool for the development of such systems is organizational design, which has been developed from the widely used technical design in practice.

organizational design - a specific type of activity, which consists in the development and implementation of projects for the creation and improvement of management systems (elements, subsystems) in order to increase their efficiency.

At the preliminary stage necessary:

¨ to carry out a set of works to justify the need to develop a QMS with the subsequent adoption by the top management of the organization of a decision to create a quality management system in accordance with the concepts and requirements of international standards ISO 9000 series. The resulting document should be an order to develop a QMS project. Characteristic for activities in the field of civil aviation is the fact that the Federal Aviation Rules (FAR) contain requirements for the availability of a quality system in an aviation enterprise and its subsequent approval during mandatory certification;

¨ create a working group (working bodies), appoint its leader with broad administrative powers. The resulting document is a provision on working group;

¨ conduct an analysis of the current QMS in the organization, which includes the definition of the structure administration, study of activities, provision of resources, the possibility of attracting consulting organizations etc.;

¨ develop a business plan for creating a QMS (requirements, scope, resources, tools, results);

¨ organize and conduct training in the field of quality (including the study of international standards ISO series 9000) of the top and middle management of the organization;

¨ to ensure the acquisition of the regulatory and methodological documentation necessary for further work in the field of QMS (MS ISO series 9000 and the corresponding national standards GOST R, methodological and guidance materials of the international organization for standardization ISO, federal bodies executive power Russian Federation etc.) and others external documents;

¨ determine the list, volume and sources of obtaining the necessary information for the development of the QMS, ensure the preparation of forms required documents to analyze the QMS and its elements.

The final result of the stage is to develop a strategy and work plan to bring the current quality management system in the organization to the level of compliance with the requirements of MS ISO 9000 series.

E The stage of development and implementation of a quality management system involves:

¨ organization of work to improve the existing quality management system at the enterprise: formation of working bodies for the project, provision of resources, development of the Organization's Policy and setting quality goals. Resulting documents - an order on the start and timing of work, development and approval calendar plan works;

¨ examination of the state of production: determination of the organization's processes, organizational structure, distribution of powers and responsibilities for quality between departments, services of the organization and officials, determination of the resources required for production activities, etc.;

¨ development of elements of the quality management system, their documentation: analysis of existing internal documentation and its revision within the framework of established activities, development of internal documents (guides, procedures, organization standards, etc.), their coordination and approval;

¨ QMS implementation: implementation of activities in accordance with the developed documents, their analysis, testing, adjustment; methodological assistance to the personnel and its training, ensuring the proper fulfillment of requirements, internal audit.

The development, implementation and improvement of the QMS is complex, time-consuming, costly and laborious process. The tasks set can be solved only with the participation of all the personnel of the enterprise and with the purposeful activity of top management. As a result, an organization that has implemented an effective QMS should be able to quickly and adequately respond to market changes, solve external and internal problems related to ensuring the required level of product or service quality.

One of the most effective methods quality assurance is currently the development and implementation of a quality management system at the enterprise based on the international standards ISO 9000 series.

The quality management system (QMS) is one of the quality assurance institutions, which is a set of processes operating in an enterprise, the functioning of which ensures the stability of the quality of products (works or services).

The hierarchy of documents related to quality is shown in Figure 2.

Figure 2 - QMS documentation

Quality policy - the general intentions and aspirations of the organization in the field of quality, formally formulated by management.

The quality manual is the main document that defines the policy and objectives in the field of quality, organizational structure quality management system and the structure of its documentation, distribution of powers and

personnel responsibilities, basic work processes, required resources, and providing a description of the quality management system.

Procedures and standards are documents that establish requirements for the implementation of processes. STP is the standard of the enterprise.

Regulations on departments - establish tasks and functions, rights and obligations, responsibilities, interactions.

Job descriptions establish tasks and functions, types of work performed, powers, rights, responsibilities and procedures for the interaction of employees.

Records are documents used to record data that indicates compliance with requirements.

The whole complex of works on the creation, implementation and successful formation of the QMS can be divided into 6 stages:

1) Preparation for the creation of the QMS. At this stage, the following tasks are solved:

The policy and goals of the enterprise in the field of quality are determined;

The organizational structure of the QMS is being formed - a responsible person is appointed from the side of the management (deputy director for quality), a quality management department is created (at initial stage it can be a lead specialist or a quality manager), a project team is created;

Training of personnel (staff of the quality department and the project team) is carried out;

A work plan for the creation of the QMS is being developed, the types, terms, cost of work and responsible executors are determined.

2) Holding complex analysis the current system of the Criminal Code and the definition of existing processes in the enterprise. At this stage:

An analysis of the organizational structure of the enterprise is carried out;

The analysis of the existing system of the Criminal Code is carried out, the identification of strong and weaknesses quality organizations.

3) Development of QMS documents. At this stage, the following are developed:

Quality quide;

Documented procedures;

Quality records.

After that, all regulatory documents of the enterprise are brought into line, such as: structural divisions, job descriptions and work instructions. All these documents are coordinated with the performers and approved by the management of the enterprise.

4) Implementation of the QMS. At this stage, the following is carried out:

Familiarization of all personnel of the enterprise with the QMS documentation, which must be duplicated in the required number of copies and transferred to the workplaces of all performers;

Training of all personnel of the organization to work in the conditions of the functioning of the QMS;

Preparation and publication of the order of the enterprise management on the beginning of the implementation of the QMS;

Development of an action plan for the implementation of the QMS, indicating the types of work, deadlines and responsible executors.

All plant personnel during this period must work according to documented procedures and keep quality records. The implementation of these activities is controlled by the department of the Criminal Code.

5) The functioning of the QMS. At this stage, there are:

Internal audits of the QMS; for this purpose, the MC department develops and draws up annual plans for internal audits, forms a commission (audit team), draws up and provides management with the results of internal audits;

Analysis of the functioning of the QMS by the management of the enterprise; for analysis, they use the results of audits, feedback from the consumer, the results of product testing, etc.;

Continuous improvement of the QMS. it required condition its functioning. Here, based on the results of internal audits and analysis by the management, measures are developed to improve the QMS and their implementation is carried out.

6) QMS certification (if the QMS is in accordance with GOST R ISO 9001). It takes place here:

Choice of certifying body;

Preparation and submission of an application for certification and a package of documents;

Work to eliminate inconsistencies.

The creation and implementation of the QMS should be considered as an innovative approach to management activities and the desire to improve the performance of each employee, thereby improving the quality of services provided.

All work on the creation and implementation of the QMS can be divided into 6 stages.

Preparatory stage. The management of the enterprise should determine the policy, goals, obligations in the field of quality, adhering to the following principles:

The quality policy is part of the overall policy and strategy of the enterprise;

The policy serves as the basis for setting goals aimed at improving product quality.

To carry out work on the creation of a QMS, the head of the enterprise by order appoints a management representative responsible for quality, organizes a quality service, forms a team for the development of a QMS (group, coordinating council) and appoints its head. The head of the enterprise carries out general management of the work and makes strategic decisions on the development and implementation of ISO standards and is personally responsible for the final results of this work. Prior to the start of work, the team draws up a program (plan) for the work, which is approved by the head of the enterprise. The program defines the stages and types of work, performers, deadlines and, if necessary, the cost of implementation.

The second stage is a comprehensive analysis of the current quality management system and the definition of existing processes at the enterprise. The implementation of the stage begins with an analysis of the existing management system, the strengths and weaknesses of the enterprise's activities in the field of quality, as well as the organizational structure and methods used to control product quality. Assessment of compliance of the actual state of quality management at the enterprise with the Quality Policy and the requirements of ISO 9001:2011 is carried out in the following areas:

Identification of the level of qualification and professionalism of the personnel;

Assessment of the availability of appropriate equipment for the production of quality products (services);

Determination (clarification) of methods for checking the quality of supplied raw materials and materials;

Organization of quality control during production and final quality control finished products(services).

All divisions and services of the enterprise are involved in the analysis, which, in accordance with the established forms and terms, provide the quality service with the necessary information. The main objects of analysis are:

Enterprise documents that can be used in the created QMS;

Activities of quality assurance units;

Organizational structure of the enterprise and quality service;

Regulations on divisions, job descriptions that determine the distribution of responsibility and authority in the enterprise;

Information about the quality of the provision of services, products;

Business processes;

Requirements for the organization of jobs;

Forms, checklists;

Route technology, operational maps, methodological, working,

control instructions; - EDI programs (electronic data processing);

Documentation of metrological support;

Checklists, test programs, operating instructions and after-sales service, tags, stamps, types of accompanying documentation;

GOSTs, OSTs, enterprise standards (STP);

Specifications (TU, specifications) for products, sales catalogs;

Defect classifiers;

Quality records on paper and other media.

After analyzing the existing quality management system, a conceptual model is developed Enterprise QMS. First of all, it is necessary to define business processes and develop their organizational and technological schemes. The development of organizational and technological schemes is accompanied by an analysis of the existing management system and, if necessary, changes to manufacturing process and organizational structure in accordance with ISO requirements 9001:2011. Based on the results of the analysis, a schedule for the development and adjustment of QMS documents is drawn up.

The third stage is the development of quality management system documents.

The QMS documentation is one of the main elements of the functioning of the QMS. By defining the forms and types of interactions and establishing the order of input and output of information, it ensures the performance of the functions of the QMS. QMS documentation includes:

Quality Manual - the main document of the system, which provides the policy and goals of the enterprise in the field of quality, the composition of the system and describes the implementation of all the requirements for the QMS of the enterprise ISO standard 9001:2011;

Documented procedures for coordination various kinds activities that ensure the effective functioning of the QMS;

Quality records - documentation on the proof of the quality of products, works, services, which contains the registered values of controlled features and parameters.

When organizing work on the development of QMS documentation, it is recommended to provide for the following activities:

Coordination of work, ensuring full mutual coordination of the developed and corrected documented procedures with the Quality Manual;

Systematic control of the progress of work by the management of the enterprise and periodic review of the progress of work at meetings coordinating council, quality days, etc.;

Training of auditors for internal audit of the QMS before completion of work on its creation and implementation.

Based on the developed documented procedures, the quality service prepares the final version of the Quality Manual, which includes:

Scope of QMS;

Documented procedures developed for the QMS or reference to them;

Description of the interaction of processes included in the QMS.

After that, all regulatory documents, such as provisions on functional and production departments, job descriptions, must be brought into line with the developed documented procedures and the Quality Manual. The nature and depth of the documentation must meet the requirements established in contracts, legislative and regulations; the needs and expectations of consumers and other interested parties. The QMS documentation is agreed with all performers and approved by the management of the enterprise.

The fourth stage is the introduction of a quality management system. All personnel of the enterprise must be familiar with the QMS documentation and trained to work in the conditions of the functioning of the QMS.

Since the introduction of the QMS, all departments have been working according to documented procedures and keeping quality records without fail. Nonconformities identified during the implementation of the QMS should be analyzed by the quality service in order to establish the causes of their occurrence and correct, if necessary, the relevant documentation. To establish the operability of the created QMS, the quality service conducts internal audits. They show how the QMS, represented by the Quality Manual, documented procedures, process descriptions and work instructions, meets the requirements of the standard (adequacy check), and what is the degree of understanding, implementation and compliance by the employees of the enterprise with the planned activities (conformity check). Verification of compliance is carried out by comparing the actual performance of procedures with their requirements.

The fifth stage is the functioning of the quality management system. Analysis of the functioning of the QMS is carried out at all levels in certain areas in order to establish cause-and-effect relationships and evaluate alternative proposals for preventive and corrective actions that may relate to various aspects of the enterprise. According to the results of the analysis, appropriate changes are made to the QMS documentation.

The sixth stage is the certification of the quality management system. Certification of existing QMS is carried out by various international and national bodies, the enterprise needs to make a choice of a certification body, taking into account the wishes of the customer. A contract is concluded with the selected certifying body and an application is submitted in the prescribed form. The enterprise submits the required package of QMS documents to the certification body for preliminary verification. After receiving comments on the documentation, the quality service makes appropriate changes to it and agrees on the date for the external audit at the enterprise. After elimination of inconsistencies, a certificate of conformity is issued for a period of three years.

As defined by GOST R ISO9000-2008 Quality Management System- this is " a management system to direct and control an organization with regard to quality».

It is a set of organizational structure, distribution of powers and responsibilities, methods, procedures and resources necessary to establish, maintain and improve product quality.

Objectives of the quality management system

All quality management systems (QMS), despite the characteristics of organizations, are aimed at achieving the following fundamental goals:

Increasing customer satisfaction;

Improving quality and: productivity;

Cost reduction;

Increasing competitiveness;

Improving the working climate;

Meeting the requirements of environmental safety.

Stages of development and implementation of QMS

The approach to developing and implementing a quality system includes several stages:

1. setting needs and expectations consumers and other interested parties;

2. development of policies and goals organizations in the field of quality;

3. establishing processes and responsibilities required to achieve quality objectives;

4. determining the necessary resources and providing them to achieve quality objectives;

5. development of methods to measure the effectiveness and efficiency of each process;

6. data application these measurements to determine the effectiveness and efficiency of each process;

7. identification of funds necessary to prevent nonconformities and eliminate their causes;

8. process development and application continuous improvement of the quality system.

General provisions for the development of QMS

Regardless of the conditions in which the QMS is created, this process, as a rule, includes:

Development of a system of general MC;

- "product systems" of the Criminal Code;

Systems for non-contractual conditions.

« Product system» QM is a subsystem of the overall QMS of an organization that ensures the quality of a specific (homogeneous) type of product supplied under contracts (according to ISO 9000). For products manufactured by the organization, regardless of any terms of the contract, it is sufficient to carry out quality management within the framework of the general QMS subsystem.

Development and implementation of the QMS requires certain costs, but world practice shows that all resource investments in the quality management system should be considered not as costs, but as investments. This is due to the fact that activities to improve and ensure the quality of products within the framework of the quality management system are entrepreneurial and innovative, therefore it is necessary to more deeply substantiate (for example, business planning) the feasibility of such investments and their effectiveness.

The development of the QMS should involve almost all divisions and services of the enterprise, as well as consulting, research and other specialized external organizations. At the same time, it is important to clearly define their tasks, functions, rights and obligations.

General leadership all work related to the creation of the QMS is carried out by top managers, and first of all by the head (general director) of the organization.

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