International system of standards ISO (ISO) and its requirements. International system of standards ISO (ISO) and its requirements Standards iso 9001 smk

In modern market relations, the manufacturer of the product (enterprise) and the supplier is required not only to comply with certain standards of the standard that are established for goods, works, services, but also to guarantee the stability of his management system. The business must be reliable in its contractual obligations to consumers. Increasing competitiveness, rapid growth in labor productivity, ensuring High Quality goods and services - today these issues have become the most relevant.

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International Standard for Management Systems ISO quality 9001: 1994 replaced ISO 9001: 2000, which replaced ISO 9001: 2008 and finally ISO 9001: 2015. ISO is an abbreviation that stands for International Organization for Standardization, that is, ISO International Organization for Standardization. Its purpose is to support the development of standards and certification systems that aim at the development of management systems.

Quality management system iso 9001, created individually for each organization, reflects its characteristics and should help reduce management costs. This management system is focused on increasing customer satisfaction, customers, and it also allows you to take into account the requirements and expectations of other interested parties in the organization in a balanced way. In addition, the 2015 version of ISO 9001 introduced requirements for accounting for risks in business processes, which can lead to both negative consequences, and to the realization of opportunities.

With the full implementation of a quality management system based on ISO 9001, the competitiveness of the business increases, as well as the enterprise becomes more attractive for investors.

Development and implementation quality management system iso 9001- a process that takes a long period of time, which depends on such important factors how: attentiveness and preparedness of company leaders, full involvement of personnel, leadership of senior management.

In order to speed up and simplify the process of developing a quality management system, professional consultants are often involved, since without appropriate knowledge in this area, it is very difficult to understand the practical interpretation of the requirements of the standard.

The responsibilities of the consultants include training the organization's employees to correctly interpret the requirements of the standards, taking into account the activities of their organization, as well as to manage the process of developing the management system and actually develop and implement it together with the employees of the enterprise and transfer their knowledge to those who can manage all the elements of this system themselves. That is why consultations help to make sure that quality management system iso 9001 is robust and efficient, meaning it can be maintained and improved, and it meets all standard requirements. Qualified specialists often exchange experience with auditors, take part in various forums and seminars, while accumulating more and more knowledge and experience in order to transfer them later when developing the system to the employees of the enterprise.

Taking a box in hand, the consumer sees a lot of abbreviations that are not always known to him. In addition, everyone around is talking about the quality of goods and services, certifications and guarantors. Modern man, especially a business owner or manager, should be aware of what is happening. Therefore, it is worth delving into this issue and starting with the most popular international standard ISO 9001. What is it, how to get a certificate, what benefits it gives and other issues will be discussed in detail below.

Quality

The word "quality" has become firmly established in the vocabulary of every person. All standards give different, capacious definitions. The quality in the life of an ordinary consumer is the correspondence (or better yet, exceeding) what he expects to what he receives. Whether it is services, food, clothing, household items, or something else, the consumer expects them to be of benefit or pleasure.

Since this attitude is too subjective, special criteria have been developed, the compliance with which will determine the degree of quality. Various independent structures can confirm the conformity of goods or services, while issuing their opinion.

The consumer is primarily interested in the quality of goods or services, but if this issue is not one of the most important for the manufacturer, he will never be able to achieve serious and long-term success.

Quality checking

Many organizations have an internal review. When a department or certain employees assess the work and the goods produced. Of course, you can doubt the objectivity of such indicators, but you should not completely abandon them.

The second type of verification is partner verification. For example, when certain requirements are imposed on suppliers, non-compliance with which will lead to the termination of a cooperation agreement. Checks can be carried out independently or with the involvement of third parties. For example, organizations that carry out certification in accordance with GOST or ISO 9001 standards.

Certification can be mandatory or voluntary. There is no need to talk about the possible difference in the attitude to the quality of the manufacturer with these types. Many products must undergo mandatory certification: baby products, perfumes, medicines, computers, cars, etc. But compulsory certification does not prevent you from going through the voluntary and getting the ISO 9001 certificate.

In the Russian Federation, the following voluntary certificates are most common: GOST R, TR ( Technical Regulations), Fire Safety, Phytosanitary, Certificate of Origin, ISO 9001.

What is it and when to get a certificate

The company can conduct voluntary certification at any time when it feels the need and strength to implement the plan. But all the same, GOST ISO 9001 recommends certification not when the management decides to do it and lowers the directive “from top to bottom”, but when the whole company feels the importance and necessity. It can be seen from practice that if the initiative comes from the employees, then the certification process is easier, better and more efficient.

So, let's answer main question: "ISO 9001 - what is it?" This international requirements to quality management. It should be noted that these are not requirements for a specific product or service, not a guarantee of their quality, these are requirements for a management system, but the result, of course, affects the final product. This made the standard universal, suitable for both huge corporations and tiny firms.

What does the ISO certificate give

There are plenty of companies on the market today that provide similar services or products. ISO 9001 certificate gives:

If your company comes to the idea that it is time to get a kind of maturity certificate, but not all management welcomes change, it is worth introducing them to ISO 9001. What it is, what benefits it provides, and how to get certified. It is important to remember that ISO is not only a "piece of paper" for trading and image, it is primarily effective tool management. If you use it at full capacity, and not formally, the results will not be long in coming. There are organizations that "live" according to the ISO standard, but are in no hurry to get certified.

The most important thing in the ISO 9001 standard

Principles, plans, assessment, audits of ISO 9001 - what it is and how to work with them, managers are figuring out. Often, consultants from certification organizations come to their aid.

The main thing that is worth remembering and always being guided in a company where the ISO 9001 quality system is being implemented is the "Plan, Do, Check, Act" management principle. Any actions from the area of ​​certification should be coordinated and "run" through this sequence.

Many managers will chuckle because this principle has long been known. The ISO standard does not claim to be superior, it only obliges to observe this simple truth always and in everything.

ISO 9001 principles

The ISO 9001 standard consists of eight basic principles:

Certification procedure

The path to obtaining a certificate consists of 10 conditional steps:

2. Draw conclusions and make corrective decisions (remember the leadership role and staff involvement).

5. If the results of the inspection are positive, apply to the certification body.

6. Conclude an agreement with a company accredited in accordance with GOST ISO 9001.

7. Submit to the external auditor Required documents, provide access to the requested objects, processes, employees (he coordinates his requirements with you in advance in the audit program).

10. Obtain ISO 9001 certification. The quality of your company's work is now officially recognized (hang the certificate in a frame, post it on the site, congratulate colleagues, employees and inform customers and partners).

Remember that the certificate is given for 3 years, and you need to undergo control audits annually. And, of course, comply with everything that is outlined for the company, and fulfill all the obligations assumed by joining the community of certified organizations.

Disadvantages of ISO

Practice shows that, despite its popularity, the ISO certificate has its drawbacks. And although these disadvantages are easily explained, they should be known:

A lot of paperwork. Reports, protocols, questionnaires and so on, but on the other hand, without them, you cannot achieve control and an objective decision.

Too much general concepts, this makes the system universal, but at the same time deprives the specifics of those who need it.

Difficult to implement, weak, unprepared companies reduce certification to a formal event (in this case, the certificate costs them three times more than it would cost in real use).

Cost (costs of certification, re-engineering of an established system, external consultant and in-house quality specialist) is another reason why it is worth striving to actually use the quality system.

ISO certification is understood as a certain set of standards, the relevance of which is manifested in the creation and modernization of systems aimed at ensuring quality management. Such systems ensure that all stages of production or service delivery are properly controlled. This refers to the control of a complete set of components of such processes: documentation, materials, resources, etc.

Our experts will help you quickly get an ISO certificate. You provide the minimum package of documents and we start work without prepayment. For 7 years, 14,000 documents were issued for 3,500 companies in Russia, Belarus and Kazakhstan.

The certification of these systems is recognized as a highly effective market instrument. ISO's credibility international market there is no doubt, therefore, the certificates issued by this organization are perceived from the point of view of indisputable evidence of the quality of products (services).

ISO certification confirms that the products or services provided are in full compliance with the quality standards that are taken into account all over the world. The certification itself is provided by an independent expert. Its successful implementation, if compliance with the standards is confirmed, ends with the issuance of an ISO certificate.

The implemented type of certification has repeatedly confirmed its effectiveness, which has led to its widest distribution throughout the world. ISO certificates are also valid in Russia. They are recognized at the level of national standards used for the assessment of management systems.

Enterprises that receive ISO certificates create a certain set of advantages for themselves, which increases their competitiveness in the market:

• raising the efficiency of almost all business processes while reducing production costs. The latter is achieved by reducing the number of intersections of activities when there is duplication of processes;
• changing the approach to management itself by giving the management system the necessary motivation;
• changing products (services) from the standpoint of increasing its quality;
• optimization of production processes, leading to a decrease in losses due to poor product quality or outright rejects;
• increasing the discipline of employees and their responsibility for the work process;
• transfer of the enterprise to a mode of operation based on world standards;
• improving the positive perception of the organization by investment companies;
• growing consumer acceptance and expansion into sales markets;
• the possibility of bringing products (services) to the Western European market;
• reaching the level of world prices.

Quality management is a guarantee that the requirements, norms and standards will be observed to ensure the necessary management of the company. This is where ISO certificates can help, with their versatility.

Types of ISO certificates

Among the ISO standards adopted in Russia, the following are most common:

• ISO 9000 is a guideline for the use and selection of a specific quality management system (QMS) based on the parameters that determine the functioning of the company. The series certificate includes the main provisions, an introduction to the system and a glossary of terms used in the standard of this type;
• - clearly defined and stringent requirements, the observance of which is imposed on the suppliers of products (services). Standards are established for all stages of product release: development, design, production, delivery, installation and maintenance. Compliance with the standard is confirmed by control checks and product certification;
• ISO 9002 - specifies requirements for suppliers. They must provide a certain degree of efficiency in the production process. The release of quality products (services) requires appropriate confirmation;
• ISO 9003 is a system related to the minimum requirements for a supplier, which are presented at the stage of final tests, during control and following certification. This certificate makes testing mandatory when acceptance is carried out. final product, and control of the production process;
• ISO 9004 - standardization of QMS, where norms and requirements for the implementation and development of such systems come to the fore;
• ISO 10012 is a standard that defines the standards, compliance with which guarantees the release of high-quality equipment in the form of various measuring instruments;
• - requirements for environmental management systems. Compliance with them is the responsibility of the enterprise in order to ensure protection environment from negative factors arising during production processes or as a result of the provision of services. With the help of this certificate, the parameters of the system are set, on the basis of which responsibility is redistributed, planning and management of the entire volume of available resources required for the implementation of the environmental program at the proper level is carried out;
• ISO 19011 - Recommendations describing the effective functioning of the QMS and defining the norms for conducting audit programs in relation to environmental management;
• ISO 13485 - Requirements for medical products and related services. This includes the design, installation, production and service phases;
• - assessment of management systems that ensure occupational safety and health. The presence of such a certificate confirms that the company conducts a wide range of measures aimed at ensuring that the life and health of employees are not endangered. This significantly strengthens the company's reputation;
• - a management system in the field of food products, which regulates safety standards, and also forms a model for the management and control of risks that may arise in Food Industry.
• - an objective indicator of the assessment of a number of factors that directly characterize the level of trust in a particular company.

Specific ISOs include either all production steps, or only any one. Regardless of this, norms are set with the help of which the characteristics of the quality of products (services) are established.

The main provisions of ISO determine the development of relevant standards, characterized in that they have an effective impact on the QMS. This is achieved by adhering to 8 principles that guarantee the success of any enterprise:

1. Consideration of the priority of the client, based on his satisfaction. The company must show interest in cooperation with the end consumer. It requires constant analysis of how satisfied he is with the purchased products (services).
2. Understanding the importance of leader leadership, who is able to improve the organizational structure of the company due to his qualities. A development strategy and an effective management system are required. At the same time, the activities of employees should be stimulated by creating an appropriate business environment.
3. Fostering employee activity through incentives in order to increase the return on their work for the benefit of the company.
4. Management of the company within a single system, where there is full interaction between management and production.
5. A systematic approach to the functioning of a company, when clearly defined links are established between production processes and structural divisions.
6. Continuous activities to modernize business processes, involving the use of performance assessments regardless of the facility: executive or a subdivision that should be related to mandatory control.
7. Making decisions of a managerial nature, based on evidence. Making adjustments to management activities should justify real situation cases. Only this allows you to make the only correct decisions.
8. Continuous maintenance of relationships with suppliers on a mutually beneficial basis.

Obtaining ISO certificates

The first stage of ISO certification involves the formation of a certain package of documents, including:

• an application, the preparation of which must be carried out in accordance with the established form;
• the statutory documents of the applicant company and the necessary details;
• a schematic representation of the divisions of the company involved in production process supplemented with information regarding their functional responsibilities;
• the composition of the company in terms of the qualifications of employees with an indication of the person responsible for product quality;
• licenses (copies) confirming the company's right to carry out certain types of activities;
• a list of NTDs regulating the work of the company.

Obtaining ISO certification includes preparatory stage... An audit of the company's management system is required. Such a check of management reveals the magnitude of non-compliance with European standards. In the future, measures are taken to reorganize management taking into account the requirements of ISO.

After completing the preparation, you can proceed to the direct receipt of the ISO certificate, which is based on the following algorithm:

• submission of an application supplemented with the required package of documents to the certification body;
• examination of the provided documentation by experts to understand how exactly the company's management system functions;
• making a decision by the certification body regarding the compliance of the company's QMS with the ISO criteria;
• issuance of an international certificate if all conditions are met.

ISO certification brings positive aspects to a company that strengthens its position in the market. The quality of products is improving, which is ensured through the development of the qualifications of employees and the optimization of the management system.

International Organization for Standardization ISO

The activities of the international organization ISO are conditioned by the release of standards. It was founded in 1946. The core of the new project is two companies: ISA and UNSCC. Although the total number of its participants was 25 national companies. the Russian Federation took her place on the ISO Council in 2005.

ISO develops and produces standards that are recognized throughout the world. Also, this organization solves certification problems. ISO standardizes almost all areas with the exception of electrical engineering and electronics. The latter is the prerogative of the International Electrotechnical Commission.

Confirmation of compliance with ISO requirements applies to products and services, but to a greater extent it concerns the QMS. Such certification is carried out exclusively by accredited bodies holding a valid certificate, which serves as proof of the legitimacy of their actions. In addition to the certification itself, tests and inspections can be carried out. The positive completion of this process leads to the issuance of a certificate of conformity. In Russia ISO certification is a purely voluntary matter.

In any case, ISO guarantees:

• confidence that the consumer will have access to a quality service or purchase a product that will not cause any complaints;
• the effectiveness of the QMS, contributing to this growth competitive advantages;
• safety of the environment and preservation of human health.

The ISO logo is a registered trademark. This fact suggests that its use is impossible by third-party companies and any persons. ISO does not authorize this. The ISO organization itself does not carry out direct certification activities, so it would be inappropriate for its logo to be used in this way.

Compliance with ISO requirements is confirmed by authorized certification bodies, acting on the basis of a proper attestation. It is their logo that can be used by certified companies. A written ISO notification to the purchaser is also available. For example, this is done using a product counter-label.

ISO certification for management systems is more popular. Standards in this area have been developed for a long time by experts in many countries. As a result, standards were developed, the adherence to which significantly increases the efficiency of any company. Obtaining such an ISO certificate not only changes the status of the company, but also contributes to the benefits from the application in practice of global developments in relation to the QMS. Regardless of size, companies learn to use resources more appropriately, improve risk management and improve product (service) quality, which increases customer satisfaction.

Why get ISO certified

ISO certifications have a positive impact on a company's efficiency and profitability. Obtaining them involves bringing management to a certain standard, adherence to which leads to good performance, which has been tested many times in practice in different countries Oh.

ISO contributes to facilitating global trade. Following the proposed standards breaks down existing barriers. Imported products are mostly ISO certified. Foreign companies are actively using this method of recognizing the quality of goods (services). If you are interested in new markets abroad or if you want to gain a foothold in where you are now, then following international standards will help you with this. As a result, the company is able to obtain both internal and external benefits.

You will learn:

• What is ISO 9001 standard and what are its features.
• How much does it cost and how long does it take to prepare a certificate for a quality management system.

ISO 9001 is the world's most popular suite of international standards created by An international organization on standardization. Despite the fact that all ISO standards are only advisory in nature, they are used as the main ones in about 100 countries around the world. Part of the ISO package was also approved in Russia, within the framework of official state standards(GOST). The State Committee of the Russian Federation for Standardization, Metrology and Certification (Gosstandart) is a national member of ISO and participates in the work of this organization.

ISO 9001 specifies a minimum set of requirements for quality systems and is used for certification... One of the main features of this standard is its versatility - it can be applied to any kind of activity.

What is ISO 9001 standard?

ISO 9001, the first version of which appeared back in 1987, is the world's largest standard dedicated to the creation of a quality management system (QMS). It is based on attention to the needs of the client. The requirements and standards have been repeatedly revised and updated, but the main provisions remain unchanged today.

The main task of the QMS is not control the quality of each individual operation or unit of production, but to develop conditions to minimize errors in work. This approach appeared in the 2008 version of the standard and was developed in the ISO 9001: 2015 version.

Formally, the implementation of ISO 9001 is considered voluntary. There are areas of industry, such as the military-industrial complex or aircraft construction, where the implementation of its individual elements, reflected in industry standards, is mandatory.

The standard is based on many concepts and methodologies developed by leading experts in quality management. In particular, the sequence of actions that must be performed during the implementation and operation of the QMS, or the RDCA cycle, was created by the famous American scientist Walter Schuhart.

Based on the provisions of ISO 9001, the company creates a QMS documentation system that regulates all actions that have something to do with the provision of services and the production of material goods. The detail of the documentation depends on the needs of a particular enterprise, the only condition is that it must comply with the requirements of the standard. The developed documentation should be rotated with strict adherence to all the described procedures. The management of the enterprise must exercise leadership in all major issues. All information important for the successful functioning of the QMS must be carefully studied and analyzed.

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Features of ISO 9001

The international standard ISO 9001 is based on several fundamental principles:

1. Strict customer focus. the main objective QMS implementation - maximum satisfaction of consumers' needs and work for the future. The organization shall conduct ongoing research into the needs and expectations of customers. In the future, the information obtained is used in the production of products.
2. Involvement of personnel... To achieve all the goals set, it is necessary that each employee knows his place in the production of the product.
3. Process approach... QMS includes many interrelated processes. Understanding how this system functions, with all its processes, resources and means, allows an enterprise to optimize its activities as much as possible and get an effective result.
4. Improvement... Each organization at a certain stage seeks to improve its activities. This is an inevitable consequence of the reaction to the emergence of new opportunities and changes in external and internal circumstances.
5. Certification... If the manufactured product meets all the requirements, an independent body can provide a certificate of conformity, which will increase the recognition and prestige of the product on the market.

Differences between ISO 9001: 2015 and earlier versions

The 9001 standard has been revised several times. After the first version, released in 1987, there were updates in 1994, 2000 and 2008. At the moment, version 9001: 2015 is relevant. It differs from the previous ones in a number of points:

1. Development of QMS and setting goals, taking into account external and internal factors, determined for each organization separately.
2. The requirements that all interested parties put forward to the QMS are taken into account
3. The QMS has implemented a risk-oriented approach. The use of formal risk management in identifying opportunities and risks is optional. The method is chosen by the organization itself, in accordance with its own needs.
4. Emphasis on the management of measurements in the QMS as a whole, including in products and in the organization's processes.

Why standardization is needed

For successful business development, you need produce competitive products... Competitiveness is based on continuous development. The competitive struggle is even more aggravated with the advent of globalization: with the expansion of the market, the consumer can purchase products from most of the world's manufacturers. As a result, the manufacturer who can offer a quality product at the lowest price survives on the market.

For more effective performance companies, strengthening competitive advantages, searching for new markets and improving the situation in old ones, all areas of activity should be streamlined in unified system management. One of them is the quality control system.

Due to the fact that obtaining the ISO-9001 certificate of conformity is voluntary, the overwhelming majority of firms resort to this in order to solve certain business problems. Among other things, the presence of a certificate of conformity allows the company to apply the appropriate certification mark on its product, which affects consumer confidence. Also, the presence of a certificate can become one of the conditions for winning a tender or concluding a contract with foreign firms.

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Implementation of the ISO 9001 quality management system at the enterprise

The TC 176 ISO team, which developed the ISO 9000 standards, proposed the following procedure for the implementation of a quality management system according to ISO 9001:

• Try to define goals. Why do you need to implement the QMS? Perhaps you want to increase product confidence, cut costs, reach a new level and a new market?
• Try to articulate what others expect of you. Others are not just consumers, there may be others as stakeholders - your suppliers, your organization's shareholders, your state, society at large.
• Find all the information you need to know about ISO 9001:
  • General information
  • Accompanying information that can be consulted directly on the ISO website
  • Study the world experience of using ISO 9001. In Russia and the CIS, the necessary information can be found in the magazines "Standards and Quality" and "Methods of Quality Management".
• Explore the QMS guides:
  • ISO 10006 - Guidelines for quality assurance in project management
  • ISO 10007 - Guidance for configuration management
  • ISO 10014 - Guidance for economic management
  • ISO 10015 - Guidelines for training and quality management
  • ISO / TS 16949 - studied as needed. Particular requirements for the application of ISO 9001 in the production of cars and auto parts
  • ISO 19011. Guidelines for auditing a QMS.
• Assess your management system's compliance with ISO 9001. This can be done on your own or by outsourcing a thorough audit.
• Explore the ISO 9001 requirements for your business. Make sure your quality management meets these requirements. In particular, for the following processes:
  • Manufacturing and maintenance
  • Purchases
  • Design / development
  • Consumer communication
  • Monitoring of observation and measurement instruments
• If inconsistencies are found and workflows are further improved, a plan should be drawn up to eliminate them. In the process - allocate resources, assign roles and responsibilities of performers, draw up a work schedule.
• Follow your work plan. Follow all the developed activities and carefully record the progress according to the schedule.
• Conduct periodic internal reviews and audits. ISO 19011 can be used to create guidelines for auditing and assessing the qualifications of auditors.
• Decide to what extent you need formal certification. There may be several reasons for obtaining a certificate of conformity:
  • Meeting the requirements of the market or consumers
  • Meeting the requirements of various regulatory organizations
  • Satisfaction of obligations under a contract with foreign or national partners
• If certification is needed, contact an accredited certification body. After a thorough audit, you will be issued a certificate of compliance of the quality management system with the requirements of ISO 9001.
• Regardless of the availability of the certificate, continue to improve and develop your business.

How is certification for compliance with ISO 9001 carried out?

The final stage of QMS implementation is obtaining an official certificate of conformity ISO 9001. Certification takes place with the participation of bodies accredited within the framework of a unified national system, voluntary systems or an international system. The list of national authorities can be viewed on the Rosaccreditation website. The list of voluntary certification systems is on the Rosstandart website. If it is planned to be carried out in one of the voluntary systems, the parent body itself determines one of the accredited certification organizations for the applicant.

The law does not prohibit the involvement of third-party consulting companies to help with the creation of new controls, document development and certification. Thanks to professionalism and deferred mechanisms, consulting firms significantly speed up and simplify the process.

Certification can be called an external audit. An independent party assesses how successfully the production control system is functioning. This check takes place in two stages - documentary and field assessment by an independent expert of the certification body and a specialist from Rosaccreditation or another certification system.

If the submitted documents and activities of the applicant firm fully and fully comply with all existing requirements, a certificate is issued that the company has created and implemented a QMS.

Terms and cost of obtaining a certificate for a quality management system

The time required for the full implementation of the quality management system 9001 at the enterprise is calculated individually. In most cases, this can take from several months to several years. After implementation, the QMS is assessed for compliance with existing standards, based on the results of which a certificate is issued. This stage takes up to two weeks, the exact time depends on the size of the company and the number of employees.

ISO 9001 certificate is issued either according to international rules or national ones. In the first case, it is issued by an international certification body - for example, TÜV Thuringen or Afnor. In the second, accredited certification bodies or voluntary systems. If the company operates exclusively in the domestic market, it is enough to issue a national document. If the plans include cooperation with foreign partners or attracting investments from abroad, the international certificate ISO 9001 is more preferable. Depending on the number of employees of the enterprise, it may take from 15 to 250 thousand rubles to complete the document.

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Documentation in accordance with ISO 9001

Documentation is considered one of the main aspects of meeting ISO 9001 international standards. The responsibilities of the organization include:

1. Definition of the Quality Policy... It represents the main directions and goals of the enterprise in the field of quality, developed and formally formulated by the management of the organization. In the absence of a detailed policy, a firm's performance in the field of quality is uncertain. In turn, a well-developed policy allows employees and other involved persons to get a clear idea of ​​how management relates to the quality of the product being produced.
2. Setting Quality Objectives... This hierarchical structure... On the upper level – common goals enterprises. Goals are expanded from top to bottom, down to the level of departments, departments, or even individual employees. At the same time, if the ISO 9001 quality system is just being developed, such a level of detail will only harm: to obtain reliable data on the achievement of the set goals, appropriate mechanisms will be required.
3. Drawing up a quality manual- a document that discloses the quality management system. The document may contain or refer to the QMS procedures established to manage activities that affect quality within the organization. Serves to facilitate the management of all procedures and activities of the enterprise in the field of quality.
4. Quality management system document management... Includes the following steps:
   1. Document creation from planning to commissioning and registration.
   2. Document use and storage
   3. Updating, including changes and approvals.
   4. Cancellation, transfer to storage, destruction of a document.
5. Records management... A record is a document that contains the results achieved and other evidence of the work done.
6. Internal audits, with the help of which the management of the enterprise controls the compliance of work and results in the field of quality with the requirements of ISO 9001 and the requirements of the enterprise. Outcomes internal audit are carefully analyzed by management and enable the company to declare compliance with the quality standard.
7. Corrective action... They include a number of actions and procedures that are taken to eliminate the causes of non-compliance with the quality standard. When developing, it should be borne in mind that in quality management, nonconformity to a standard means any deviation from the established requirements, both for the worse and for better side... Therefore, each case is considered separately.
8. Preventive action.

The form and medium of storage of documents do not matter. The degree of documentation of each stage directly depends on the size of the enterprise, the competence of the personnel, and the complexity of production processes.

Today in the face of expansion international trade In order to improve product quality, enterprises face a very acute problem of introducing ISO 9000 series standards and the transition from integrated quality management systems to international standards.

There are the following differences between quality systems (according to ISO 9000) from an integrated product quality management system:

Focus on customer satisfaction;

Assignment of responsibility for product quality to specific contractors;

Customer verification of the supplier's production;

Selection of a supplier of components and materials;

End-to-end product quality control, from materials to product disposal:

Marketing;

Organization of accounting and analysis of quality costs;

Traceability of materials and components throughout the entire production cycle;

Resolving issues of disposal of products after use.

The following 5 ISO 9000 series standards:

1. ISO 9000 “General quality management and quality assurance standards. Guidelines for selection and use ".

2. ISO 9001 “Quality systems. A model for quality assurance in design and / or development, installation and maintenance. "

3. ISO 9002 “Quality systems. A model for quality assurance in production and installation. "

4. ISO 9003 “Quality systems. Model for Quality Assurance in Final Inspection and Testing ”.

5. ISO 9004 “General quality management and quality system elements. Guidelines".

The main objectives of the ISO 9000 series standards are as follows:

¨ strengthening mutual understanding and trust between suppliers and consumers of products from different countries of the world when concluding contracts;

¨ Achievement of mutual recognition of certificates for quality systems issued by accredited certification bodies from different countries of the world on the basis of their use of uniform approaches and uniform standards when conducting certification checks (audits);

¨ providing assistance and methodological assistance to organizations of various sizes from various fields of activity in the creation of efficiently functioning quality systems.

The choice of a quality system model should be based on the recommendations of the ISO 9000 standard. The selection criteria are, for example, the presence and level of complexity of product design (development) processes prevailing at the enterprise, production structure, technology and organization of production, specific features of products, economic factors, etc.

ISO 9004 standard is for organizations a kind of methodological guide for the development and application of quality systems. The standard contains the recommended structure of the quality system, characteristics of the main functional elements of the system, certain requirements for the organizational structure, composition and content of data that should or can be applied in the system. The standard considers economic aspects quality, different kinds expenses and cost items for quality, guidelines are provided for conducting internal quality checks, which allow the management of organizations to assess the degree of readiness of their divisions for a stable supply of products that meet the requirements of standards and consumer expectations. ISO 9004 is primarily applicable for internal quality assurance purposes and should not be used in contractual situations or for certification purposes.

For contractual situations, as well as for certification purposes, the ISO 9000 series provides for the use of three basic models of quality systems, the requirements for which are regulated in the ISO 9001, 9002 and 9003 standards. ISO 9001 is the most complete of the three standards and covers all company activities, considering product quality assurance processes from product development to operation. It is important to note that the standard does not specifically mention the company's activities in the field of marketing. ISO 9001 provides a basic model of a system for quality assurance in design (or product improvement), production, installation (installation) of products, service maintenance during operation at the consumer.

ISO 9002 considers only the processes of production and testing of products and presents the quality system as a model for quality assurance in the manufacture of products and their subsequent installation at the consumer.

ISO 9003 only deals with testing finished products and presents the quality system as a model for quality assurance of final inspection and testing of finished products.

Thus, ISO 9001, as the most comprehensive, includes ISO 9002, which in turn includes ISO 9003.

ISO 9000 series standards require that the quality system be interlinked with all activities of the enterprise and its effect extends to all stages. life cycle products and processes from the initial identification of market needs to the final satisfaction of identified needs.

In addition, the ISO 9000 series contains a number of provisions on the quality system, without which its implementation and successful operation is impossible.

These include the following provisions:

¨ the company's management initiates, develops, implements and maintains a quality system;

¨ within the general organizational structure the functions related to the quality system are clearly defined;

¨ the management of the enterprise allocates all the resources necessary to implement the quality policy and achieve the set goals;

¨ all activities carried out in the quality system are documented;

¨ the quality system should be regularly reviewed and assessed by the top management of the enterprise.

The implementation of these provisions will ensure the creation of an effective quality system at almost any enterprise.

International standards apply in the following situations:

1) when the contract specifically stipulates that the requirements for design work and products are formulated in the form of the use of complex management methods, in ensuring competitive advantages, characteristics, or the need for their determination is indicated;

2) when the consumer is sure that the supplied products meet the established requirements. The supplier must provide evidence of its design, development, manufacturing, installation and service capabilities.

The supplier of the goods shall establish and maintain a documented quality system as a means of ensuring that the product meets the specified requirements. This includes:

♦ preparation of documented procedures and instructions related to the quality system in accordance with the requirements of the standard;

♦ effective application of documented procedures and quality system instructions.

Features of international standards ISO 9000: 2000 are as follows:

♦ application to product quality management systems approach;

♦ customer orientation;

♦ regulation of requirements for all stages of the product life cycle;

♦ product quality management is carried out for all main functions (except for motivation and regulation);

♦ documentary (preferably quantitative) registration of specific requirements;

From sound approaches to the management system in international standards ISO quality systems have been applied in only five (system, integration, process, quantitative, dynamic).

The process model reflected in ISO 9000: 2000 in clauses five through eighth shows that consumers play a significant role in defining requirements as inputs. Here the TQM principle is implemented - focus on the Customer, the main meaning of which is to form such corporate culture, in which the staff is aware of the fact that the Customer pays the salary, and not the head of the enterprise. This process is served by another TQM principle - the “supplier-customer” principle within the enterprise, which helps to eliminate losses, increase responsibility, eliminate disunity and create a normal internal climate in the team.