The process of creating a QMS in the 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 existing situation in the organization is performed on the subject of building a quality system, the next step will be the training of participants in the quality management of the quality management and the requirements of the ISO series 9000 standards. The head of the working group and its participants must be trained necessarily, because An analysis of the existing state of affairs and the development of a quality system will be their main task.

Step 3. In order to understand how much existing activities in the organization differs from the requirements of the ISO 9001: 2008 standard, it is necessary to analyze the current situation. The collection of source data is carried out mainly by two methods - questioning and interviewing. Most effectively use both methods, first spend the survey, and then clarify the necessary information during conversations with employees. Responsible for the survey and interviews are the participants of the Working Group.

Of course, it is possible to do this, but in this case, the participants of the Working Group should, on the basis of their knowledge of the work of the divisions, to conduct such an analysis.

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

Analysis of the current situation should reveal:

the main production processes of the organization;

auxiliary processes and process processes;

the most critical business processes in terms of quality system;

the presence and relevance of regulatory documentation (enterprise standards, instructions, regulations on divisions, job descriptions, etc.);

the existing distribution of responsibility, powers and resources for the organization's processes.

Development of documentation and changing employees

This stage is the most time consuming and long. During this stage, the design, development and implementation of quality system documentation, as well as the introduction of changes in the order of employees, is being implemented.

The operation of the second stage consists of the following fixed steps:

Step 1. At this step, it is necessary to plan how the quality system will be built, what will the area of \u200b\u200bits application, which processes will be included in the quality system as it will expand. For example, an organization provides its consumers several types of various services. These services are provided by various departments. Then, at this stage, it may be decided to initially include in the area of \u200b\u200bquality system all processes and units involved in providing some one service, and processes and units involved in the provision of other services can be involved later after the quality system Fully earn when managing the quality of the first service. In this case, the construction of the quality system will occur on the principle of increasing its distribution.

Step 2. The basic principle of ISO 9001: 2008 is the process approach. In order to be able to implement the process approach, the standard requires to determine and document the organization's processes. To fulfill this requirement, the Working Group must first formalize the processes that have been included in the quality system area as they are, and then make changes to these processes in accordance with the requirements specified in the standard.

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

The implementation of the quality system is associated with the management of changes in the organization's activities. Conducting any changes always affects the interests of employees who concern these changes. As a result, people either resist changes, or support them, is rarely neutral. In order to be able to effectively carry out changes in the processes at the level of the performers, administrative support is necessary for the management of the organization (to reduce resistance levels) and receiving fairly quick results from the changes (to maintain support, from those who make changes). To implement this principle, it is necessary to correctly determine the procedure for documenting and changing processes. First of all, it is recommended to formalize and adjust the most important processes.

Step 3. Documenting and implementing quality management procedures.

Standard ISO 9001: 2008 requires that the organization's processes have been identified and documented. Documentation of processes can be performed in the form of cards of processes, which indicates the sequence of process operations, input and output (information, resources) of each operation and responsible for performing the operation. Documentation of processes in the form of cards significantly reduces the amount of documentation. In addition, when documenting processes, it is important to comply with the balance in the detail of the process presentation. The process should be submitted to such a degree of detail so that the personnel involved in the process can understand the order of the process operations and determine its "place" in this process.

In accordance with the requirements of the Standard, 6 mandatory procedures and quality management should be developed, as well as documents, the necessary organizations to ensure effective planning, the implementation of processes and management of them (processes, regulations, instructions).

The introduction of process cards and quality procedures is better to exercise in parallel with their development, i.e. After developing a process card and making a change in the process, it is necessary to put it into action.

The introduction of procedures and new cards of processes must be accompanied by the training of personnel and the work control of the procedure (process map).

After all the necessary process cards and quality procedures are developed, it is necessary to organize a certain period of time on these cards and procedures. This time is necessary for the "refinement" of the quality system. During this period, minor changes in the quality system documentation are usually carried out.

Conducting an internal audit of the quality system

The main purpose of this stage is to check the operation of the enterprise quality system before the certification audit. Additional objectives of this stage will be - training in the practice of internal auditors to conduct audits, training personnel training before certification audit.

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

Step 1. To carry out the internal audit of the quality system, it must be prepared and plan.

Accordingly, at this step it is necessary:

Officially (by order on the organization), assign auditors command (leading auditor and auditors). The audit team is appointed from among employees of trained internal audits;

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

Prepare questionnaires for audit;

Create an order for the organization of audit.

Step 2. Conduct audit conversations. During the audit conversations, auditors check the organization's employees for their work in accordance with the process cards and quality system procedures. Audit is carried out under the audit program. If inconsistencies are detected during the audit, the auditors must issue the discrepancy record protocols that indicate the discrepancies identified. When conducting an audit, auditors check the availability of quality system documentation in the workplace, work on this documentation, the quality record required by the system.

The main provisions related to the development and implementation of the SMC are defined in the 9000 ISO Standards.

The 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 connections, methods, etc. It should be noted that the QMS should be clearly focused on a particular object (organization, division) and does not have practical value as isolated, independent system.

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

¨ Orientation to increase customer satisfaction with product quality (services);

¨ focus on ensuring the competitiveness of the organization;

¨ Instrument for the implementation of the organization's policy and objectives 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 features of activities, products (services), production (technological) processes already undergoing management system as well as requirements and recommendations of standards ISO. Series 9000 last versions.

To create a quality management system, a strategic solution of the highest management of the organization is required. The development and implementation of the organization's quality management system is influenced by changing needs, specific goals, manufactured products applied processes, size and structure of the organization (GOST ISO 90001-2011, Introduction).

The process of creating a QMS satisfying the requirements of existing standards can be divided into several stages. The actual number and name of the stages are determined in relation to a particular organization.

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

Organizational design - a specific type of activity, which consists in the development and implementation of projects for creating and improving systems (elements, subsystems) of management in order to increase their effectiveness.

At the preliminary stage Need:

¨ Conduct a set of works to substantiate the need to develop a QMS with subsequent adoption by the top management of the organization of the decision to establish a quality management system in accordance with the concepts and requirements of international standards ISO. Series 9000. The resulting document must be an order to develop a QMS project. Characteristic of civil aviation activities is that federal aviation rules (FAP) contain requirements for the availability of the quality system in the aviation enterprise and its subsequent approval during compulsory certification;

¨ Create a working group (workers), appoint its head with broad administrative powers. Resulting document - Regulations on the Working Group;

¨ conduct an analysis of the current QMS in an organization that includes the definition of the administrative management structure, the study of activities, the provision of resources, the ability to attract consulting organizations, etc.;

¨ Develop a business plan for creating a QMS (requirements, distribution area, resources, funds, results);

¨ Organize and conduct training in the field of quality (including the study of international standards ISO. 9000 series) of the highest and middle links of the organization of the organization;

¨ Ensure the acquisition necessary for the further work of the regulatory and methodological documentation in the field of the QMS (MS ISO. 9000 series and the corresponding National Standards GOST R, Methodological and Guidelines of the International Organization for the Standardization of ISO, federal executive authorities of the Russian Federation, etc.) and other external documents;

¨ Determine the list, scope and sources of obtaining the necessary information for the development of the SMC will provide preparation of the forms of the necessary documents for analyzing the SMC and its elements.

The final result of the stage is to develop a strategy and work plan for bringing the quality management system to the organization to the level of compliance with the requirements of MS ISO Series 9000.

E. the TAP of Development and Implementation of the Quality Management System involves:

¨ Organization of work on improving the quality management system in the enterprise: the formation of the working bodies for the project, providing resources, the development of the organization's policy and the establishment of quality goals. The resulting documents - an order about the start and timing of work, development and approval of the calendar work plan;

¨ Implementation of the state of production: determination of the processes of the organization, E of the organizational structure, distribution of powers and responsibility for the quality between divisions, organization services and officials, the definition of the resources required for production activities and, etc.;

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

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

Development, implementation and improvement of the QMS is a complex, long-term, costly and time consuming process. The tasks set can only be solved with the participation of the entire staff of the enterprise and at the targeted activities of the Supreme Guide. As a result, an organization that introduced an effective QMS should be able to quickly and adequately respond to market changes, solve external and internal problems associated with the necessary level of product quality or service.

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

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

The hierarchy of documents relating 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, formulated by management.

Quality Guide - the main document defining the quality policy and objectives, the organizational structure of the quality management system and the structure of its documentation, the distribution of powers and


personnel responsibility, basic workflows, necessary resources, as well as providing quality management system.

Procedures and Standards - Documents that establish requirements for the implementation of processes. STP - standard enterprise.

Regulations on the departments - establish tasks and functions, rights and obligations, responsibility, interaction.

Official instructions establish tasks and functions, types of work performed, powers, rights, responsibility and procedure for the interaction of employees.

Entries - Documents used to register data indicating compliance with the requirements.

The whole complex of works on the creation, implementation and successful formation of the SMC 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 objectives of the enterprise in the field of quality are determined;

The organizational structure of the QMS is formed - the responsible is assigned by the leadership (deputy. Director for quality), the quality management department is created (at the initial stage it may be a leading specialist or quality manager), a project team is created;



Personnel training is being conducted (staff of the quality department and team of the project);

The plan for the creation of the SMC is being developed, species, deadlines, cost of work and responsible performers are determined.

2) carrying out a comprehensive analysis of 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;

An analysis of the existing system of the Criminal Code is carried out, identifying the strengths and weaknesses of the organization in the field of quality.

3) Development of documents of the SMC. At this stage are designed:

Quality quide;

Documented procedures;

Quality records.

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

4) the introduction of the QMS. At this stage is carried out:

Familiarization of the entire staff of the enterprise with the QMS documentation, which should be multiplied in the required number of copies transferred to the workplaces of all performers;

Training in the entire staff of the organization in the functioning of the SMC;

The preparation and publication of the order of the enterprise leadership on the start of the introduction of the SMC;

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

All staff of the enterprise during this period should work on documented procedures and record quality records. The progress of these events controls the Criminal Code department.

5) Functioning of the QMS. At this stage are held:

Internal audits of the QMS; To do this, the Criminal Code is developing and amounts to the annual plans for conducting internal audits, forms the Commission (Audit Group), issues and provides the leadership results of internal audits;

Analysis of the operation of the SMK by the management of the enterprise; For analysis, the results of audits, feedback with the consumer, product test results, etc.;

Continuous improvement of the QMS. This is a prerequisite for its operation. Here, according to the results of internal audits and analysis by the leadership, measures are being developed to improve the QMS and implement them.

6) Certification of the SMC (if the QMS according to GOST R ISO 9001). Here is held:

Selection of the certification authority;

Preparation and submission of the application for certification and package of documents;

Work on the elimination of inconsistencies.

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

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

Preparatory stage. The management of the enterprise must define policies, objectives, commitments in the field of quality, adhering to the following principles:

Quality policy is part of the general policies and strategy of the enterprise;

Politics serves as the basis for establishing goals aimed at improving product quality.

To fulfill work on the creation of the SMC, the head of the enterprise appoints a representative of the management management team responsible for quality, organizes the quality service, forms a team to develop a QMS (Group, Coordination Council) and appoints its leader. The head of the enterprise carries out general management of work and the adoption of strategic decisions on the development and implementation of ISO standards and is personally responsible for the final results of this work. Prior to work, the team is a program (plan) of 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 execution.

The second stage is to carry out a comprehensive analysis of the current quality management system and the definition of existing processes in the enterprise. The execution of the stage begins with the analysis of the existing management system, the strengths and weaknesses of the activity of the enterprise in the field of quality, as well as the organizational structure and the methods of product quality control methods. An assessment of the actual status of quality management in the company's quality policy and the requirements of the ISO 9001: 2011 standard is carried out in the following areas:

Identification of the level of qualifications and professionalism of staff;

Evaluation of the availability of appropriate equipment for the production of high-quality products (services);

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

Organization of quality control in the process of production and final control of the quality of finished products (services).

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

Documents of the enterprise that can be used in the SMC created;

Activities of quality assurance units;

Organizational structure of the enterprise and quality service;

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

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

Business processes;

Requirements for the organization of jobs;

Forms, checklists;

Route technology, operating cards, methodological, workers,

Control instructions; - EDO programs (electronic data processing);

Metrological documentation;

Control maps, test programs, instructions for use and service, tags, stamps, types of accompanying documentation;

GOST, OSET, enterprise standards (STP);

Specifications (TU, SPECIFICATIONS) PA products, sales directories;

Classifiers of defects;

Records of quality on paper and other media information.

After analyzing the existing quality management system, the conceptual model of the SMC enterprise is developed. First of all, it is necessary to identify 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 introduction, if necessary, changes to the production process and in the organizational structure in accordance with the requirements of ISO 9001: 2011. According to the results of the analysis, the development schedule is drawn up, adjusting the QMS documents.

The third stage is the development of quality management documents.

The QMS documentation is one of the main elements of the operation of the SMC. Defining the shapes and types of interactions and establishing the order of entering and displaying information, it ensures the execution of the functions of the SMC. The QMS documentation includes:

Quality Guide - the main document of the system, which provides the policy and objectives of the enterprise in the field of quality, the composition of the system and is given a description of the implementation of all the requirements for the SMC of the enterprise ISO 9001: 2011;

Documented procedures designed to coordinate various types of activities ensuring the effective operation of the SMC;

Quality records - documentation for the evidence of product quality, works, services contained by registered values \u200b\u200bof controlled signs and parameters.

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

Coordination of work that ensures complete mutual linkage of the developed and corrected documented procedures with the quality guide;

Systematic control of the course of work by the management of the enterprise and periodic consideration of the course of work at the meetings of the Coordination Council, the days of quality, and the so-called;

Preparation of auditors on the internal verification of the SMC before the completion of work on its creation and implementation.

Based on the developed documented procedures, the quality service prepares the final editorial board of quality management, which includes:

Scope of the QMS;

Documented procedures developed for the SMC or references to them;

Description of the interaction of the processes included in the QMS.

After that, all regulatory documents, such as provisions, functional and production units, job descriptions should be aligned with the developed documented procedures and guidance on quality. The nature and depth of the documentation must meet the requirements established in contracts, legislative and regulatory acts; The needs and expectations of consumers and other stakeholders. The QMS documentation is agreed with all the executors and is approved by the management of the enterprise.

The fourth stage is the introduction of a quality management system. All staff of the enterprise must be familiar with the QMS documentation and trained in the operation of the operation of the SMC.

Since the introduction of the SMC, all units work on documented procedures and are committed to recording on quality. The inconsistencies identified in the process of implementing the SMC should be analyzed by the quality service in order to establish the reasons for their appearance and adjustment, if necessary, appropriate documentation. To establish the performance of the created QMS, the quality service conducts internal checks. They show how much the QMS, presented by the quality guidelines, documented procedures, descriptions of the processes and working instructions, meets the requirements of the standard (adequacy check), and what is the degree of understanding, fulfillment and compliance with the employees of the planned activities (verification of compliance). Compliance check is carried out by comparing the actual implementation of procedures with their requirements.

Fifth stage - the functioning of the quality management system. An analysis of the operation of the SMC is carried out at all levels in certain areas in order to establish causal relations and assessment of alternative proposals for preventing 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. The certification of the current QMS is carried out by various international and national authorities, the enterprise needs to make the choice of the certifying body, taking into account the wishes of the customer. The selected certifying authority consists of a contract and applies to the established form. The company transfers to the certificate authority the required package of QMS documents for preliminary check. After receiving comments on the documentation, the quality service makes appropriate changes and coordinates the date of external audit in the enterprise. After eliminating inconsistencies, a certificate of conformity is issued for a period of three years.

By definition GOST R ISO9000-2008 quality Management System - this is " management system for manual and organization management in relation to quality».

It is a set of organizational structure, distribution of powers and responsibilities, methods, procedures and resources necessary to establish, maintain and improving the quality of 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:

Consumer satisfaction growth;

Improving quality and: performance;

Cost reduction;

Increasing competitiveness;

Improving the production climate;

Satisfying environmental safety requirements.

Stages of development and introduction of the QMS

The approach to the development and implementation of the quality system includes several stages:

1. establishing needs and expectations consumers and other stakeholders;

2. policy and goals quality organizations;

3. establishment of processes and responsibilitynecessary to achieve quality goals;

4. determining the necessary resources and ensuring them to achieve quality goals;

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

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

7. definition of fundsnecessary to prevent inconsistencies and eliminate their causes;

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

General Code of Development of the QMS

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

Development of the system of general MK;

- "grocery systems" of the Criminal Code;

Systems for non-varying conditions.

« Product System"The Criminal Code is a subsystem of a common SMD organization, which ensures the quality of a specific (homogeneous) type of products supplied under contracts (according to ISO 9000). For products manufactured by the organization regardless of any condition conditions, quality management is sufficiently carried out within the framework of the subsystem of the general QMS.

Development and implementation of the QMS requires certain costsHowever, global practice shows that all resource investments in the quality management system should be considered not as costs, but as an investment. This is due to the fact that activities to improve and ensure the quality of products within the framework of quality management system wears entrepreneurial and innovative character, so it is necessary to more deeply justify (for example, business planning) the expediency of this kind of investment and their effectiveness.

To develop the SMC should attract Almost all enterprise units and services, as well as consulting, research and other specialized external organizations. It is important to clearly define their tasks, functions, rights and obligations.

General leadership All works related to the creation of the SMC are carried out by top managers, and first of all the leader (Director-General) of the Organization.

 

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