According to iso standards. International quality system: ISO standards. Benefits from implementation and certification

The ISO 9001 "Quality Management Systems - Requirements" standard implies the systematic management of processes and their interaction in accordance with the quality policy and strategic directions of the company's development.

The purpose of ISO 9001 is to promote the application of a process approach for the development, implementation and improvement of the effectiveness of the quality management system and the growth of customer satisfaction by fulfilling its requirements.

Normative documents of the ISO 9000 / GOST R ISO 9000 series

• ISO 9001-2015. Quality management system requirements.
• ISO 9000-2015. Quality management systems. Basic provisions. Dictionary.
• GOST R ISO 9001-2015 (date of last change: 30.07.2018). Quality management systems. Requirements.
• GOST R ISO 9000-2015 (date of last change: 30.07.2018). Quality management systems. Fundamentals and vocabulary.

Until September 2018, the previous version of the ISO 9001-2008 standard, GOST R ISO 9001-2011, is in effect.

ISO 9001 / GOST R ISO 9001 requirements

The ISO 9001 standard is based on 7 principles:

• customer focus
• leadership
• attraction of human resources
• process approach
• improvement
• evidence-based decision making
• system of relationships with clients and partners

The ISO 9001 standard uses a PDCA (Plan-Do-Check-Act - Plan-Do-Check-Improve) approach - an iterative process used by an enterprise to achieve continuous improvement), focused on risk-based thinking and includes:

• defining the purpose of the system and its processes, as well as the resources necessary to achieve results that meet customer requirements and company policy
• execution of scheduled processes
• monitoring the compliance of processes, end products and services with the company's quality management policy, generating reports on results
• continuous improvement of the performance indicators of processes in the field of quality management of the company

Scope of ISO 9001 / GOST R ISO 9001

The ISO 9001 standard applies to all organizations that seek to systematically manage their quality management processes.

Which companies are implementing the ISO 9001 / GOST R ISO 9001 standard

• Organizations that need to demonstrate their ability to consistently deliver products and services that meet customer and current legal and regulatory requirements
• Companies operating in the international market, according to customer requirements
• Organizations seeking to improve the effectiveness of other management systems already in place in the company

Internal and external benefits of implementing ISO 9001 / GOST R ISO 9001

Internal benefits of implementing ISO 9001

• Effective and effective achievement of planned results
• The ability to manage interactions and interconnections of processes in the system and, as a result, improve the activities of the organization as a whole
• Ensuring that processes are properly resourced and managed

External benefits of ISO 9001 implementation

• Ability to consistently deliver goods and services that meet customer requirements
• Increased customer confidence
• Opportunities for entering new, including international, markets, expanding existing sales markets
• Additional benefits when participating in important tenders

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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 provision are properly controlled. This refers to the control of the full 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 working without prepayment. For 7 years, 14,000 documents have been issued for 3,500 companies in Russia, Belarus and Kazakhstan.

The certification of these systems is recognized as a highly effective market instrument. The authority of ISO in the international market is beyond doubt, therefore, the certificates issued by this organization are perceived in terms of indisputable evidence of the quality of products (services).

ISO certification confirms that the products manufactured or the services provided are in full compliance with the quality standards that are taken into account throughout 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 met 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 define 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 it mandatory to carry out tests when the final product is accepted and to control 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. Their observance is charged with the responsibility of the enterprise in order to ensure the protection of the 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 the 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 stages, 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. Customer priority based on customer 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 the leadership of a leader who is able to improve the organizational structure of the company due to his qualities. It is imperative to have a development strategy and an effective management system. 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 object: an official or a department, which should be related to mandatory control.
7. Making decisions of a management nature based on evidence. Making adjustments to management activities should be justified by the real state of affairs. 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 company's divisions involved in the production process, supplemented by 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 an ISO certificate includes a 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 in accordance with ISO requirements.

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 its 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;
• efficiency of the QMS, contributing to this growth of 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 from many countries. As a result, standards have been 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 company performance 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.

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 most popular set of international standards in the world, created by the International Organization for Standardization. Despite the fact that all ISO standards are only advisory in nature, in about 100 countries around the world they are used as the main ones. Part of the ISO package is 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 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 goal of QMS implementation is to maximize customer satisfaction and work for the future. The organization should 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

Successful business development requires 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 a more efficient operation of the company, strengthening competitive advantages, searching for new markets and improving the situation in old ones, all areas of activity should be streamlined into a single management system. One of them is the quality control system.

Due to the fact that obtaining the ISO-9001 certificate of conformity is on a voluntary basis, the overwhelming majority of firms resort to this in order to solve certain business problems. Among other things, the availability 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 a 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 as a whole.
• Find all the information you need about ISO 9001:
  • General information
  • Supporting 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 on 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
  • Procurement
  • Design / development
  • Consumer communication
  • Monitoring of observation and measurement instruments
• If inconsistencies are discovered 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 a certificate, continue to improve and develop your business.

How is certification for compliance with the ISO 9001 standard

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 bodies can be viewed on the website of the Russian Accreditation Agency. 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 legislation does not prohibit the involvement of third-party consulting companies to help with the creation of new control mechanisms, the development of documents 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 of 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 the 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, following 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, the paperwork may require from 15 to 250 thousand rubles.

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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 well-developed policy, the 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 is a hierarchical structure. At the top level, the overall goals of the enterprise. 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 hurt: to obtain reliable data on the achievement of the goals set, 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. The results of the internal audit are carefully analyzed by management and enable the company to declare compliance with the quality standard.
7. Corrective action... It includes 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 is understood as any deviation from the established requirements, both for the worse and for the better. 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.

Quality Management System (QMS)- the part of the management system focused on quality (clause 3.5.4 of ISO 9000: 2015), established to establish policies and objectives, as well as processes to achieve these objectives.

The external environment of business organizations is constantly changing, therefore, to ensure the quality of their services, companies must regularly analyze customer requirements, identify processes that contribute to the creation of products that meet customer needs, and also maintain these processes in a manageable state.

As applied to the activities of the partners of the company, 1C, QMS is a system of methods and technologies that ensures quality management of implementations and further support of 1C: Enterprise in accordance with the requirements of the international standard ISO 9001: 2015.

It is not only about maintaining the quality of each service or product at the level of compliance with the requirements of consumers, but also about the mechanism for preventing possible loss of the established level of quality, as well as its constant improvement.

ISO (International Organization for Standardization) - International Organization for Standardization, a worldwide federation of national standards organizations (ISO member bodies). The goal of ISO is to develop the principles of standardization and design standards based on them that facilitate integration processes in different areas and areas of activity.

Standards developed by ISO are grouped into families (series). ISO 9000 is a series of quality management standards designed to help organizations of all types and sizes develop, implement and maintain effective QMS.

A major set of international standards related to quality management was adopted by ISO in March 1987 and then updated periodically.

The ISO 9000 series currently consists of the following standards.

• ISO 9000: 2015 Quality Management System. Fundamentals and Dictionary "- is an introduction to the QMS, as well as a dictionary of terms and definitions.
• ISO 9001: 2015 Quality Management System. Requirements "- establishes requirements for quality management systems and defines a QMS model based on processes.
• ISO 9004: 2009 “Management for sustainable organizational success. Quality Management Approach ”.
• ISO 19011: 2011 Guidelines for auditing management systems.

All of these documents are called standards, although some of them are guidelines or collections of recommendations and only ISO 9001 specifies the requirements for quality management systems and is the only standard against which external certification can be carried out.

The ISO 9001 standard can be used by any organization, large or small, regardless of the field of activity. However, it is a mistake to believe that this international standard has the goal of unifying the management systems of all enterprises. The creation, construction and implementation of a system is always influenced by the goals, external factors, products, experience, and processes of a particular enterprise. Although 9001 define what requirements should be implemented in a quality management system, it does not define how an enterprise should fulfill them.

The basis of the ISO 9001 standard is a number of quality management principles:

Consumer (customer) orientation. The main focus in quality management is on meeting customer requirements and striving to exceed their expectations. Therefore, the organization should in every possible way focus its attention on researching the needs and expectations of the consumer for the subsequent implementation of the information obtained in the manufactured product. Understanding the current and future needs of customers and other interested parties contributes to the sustained success of an organization.

Leadership. Leaders at all levels establish unity of purpose and direction and create an environment in which people are involved in achieving the organization's quality objectives. Achieving unity of purpose, direction, and engagement enables an organization to coordinate its strategies, policies, processes and resources to achieve its goals.

Involvement of personnel. The implementation of the goals set for the enterprise is possible only in the case of adequate behavior of employees at all levels of the organization. It is important for an organization that all personnel are competent, empowered and involved in creating value. Competent, empowered, and engaged people increase the organization's ability to create value.

Process approach. Appropriate and predictable results are more effective and efficient when activities are presented and managed as interrelated processes that function as a whole system. The quality management system consists of interrelated processes. Understanding how the system generates results, including all of its processes, resources, controls and interactions, enables an organization to optimize its performance.

Improvement. Successful organizations place constant emphasis on improvement. Improvement is important for the organization in terms of maintaining the current level of performance, responding to changes in internal and external conditions and creating new opportunities.

Evidence-based decision making. The continuous improvement process should be based on data obtained from objective measurements of the actual state of the quality and product quality system. It is important to understand causal relationships and potential consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions. Decisions based on the analysis and evaluation of data and information are more likely to produce the desired results.

Relationship management. To achieve sustained success, organizations manage their relationships with stakeholders, such as suppliers. Since product quality is largely determined by the quality of raw materials, materials and information, achieving quality growth should also be based on the establishment of mutually beneficial partnerships with suppliers. Sustained success is more likely to be achieved when an organization manages relationships with all of its stakeholders to optimize their impact on its operations.

The requirements of ISO 9001 standards have been implemented in more than one million companies in more than 170 countries around the world. The use of ISO 9001 standards ensures that consumers consistently receive good quality products and services, i.e. according to their requirements and expectations.

Confirmation of the successfully implemented quality management system is its certification for compliance with the international standard ISO 9001. The presence of the certificate indicates that the company is well organized, it has clearly defined responsibilities, procedures, the work technology is observed, there are operational instructions, documented and known to all personnel , the procedure for monitoring the work performed and, of course, professional and well-trained staff. In other words, the ISO 9001 certificate demonstrates that a company's quality system is capable of providing and improving the quality of its goods and services.

Certification- provision by an independent body of written confirmation (certificate of conformity) that the product, service or system meets the established requirements.

1C provides voluntary certification of franchising firms in accordance with ISO 9001: 2015 and GOST R ISO 9001-2015.

Certification 1C: Franchisee is carried out by certification bodies with ISO accreditation. Accreditation- official recognition by an independent body (accreditation body) that the certification organization has the right to certification activities. Accreditation is optional but adds another layer of credibility.

The most authoritative and largest international certification organizations - Det Norske Veritas (DNV GL) and Bureau Veritas Certification - have been approved by 1C as QMS certification bodies.

Building a quality management system is a rather laborious process. Obviously, not all franchisee firms can approach certification at the same time, due to objective circumstances, such as the structure of the firm, regional characteristics, staff training. But 1C invites all partners of 1C: Franchisees who want to make their company competitive in the information services market to build a quality management system or put into operation its individual essential elements.

The ISO 9000 series of standards includes several quality assurance system standards. These standards are developed by the International Organization for Standardization (ISO) and have the same content as the corresponding European standards (EN), as well as national standards in a number of countries. Models or guidelines constitute the ISO 9000 series of standards. All of these documents are referred to as standards, although some of them are guidelines or collections of recommendations.

The ISO 9000 series of standards is a compilation of national and international standards for quality systems. ISO 9000 standards are recognized in practice all over the world and adopted as national standards in more than 70 countries. These standards are very popular in countries with active international trade such as the USA, Canada and Japan, as well as in the European Union. The first quality system standard was the US Mil Spec (Mil-Q-9858), published in 1959. The various quality system standards developed since then have many properties in common.

ISO 9000: 1994 standards

The ISO 9000: 1994 series contained five main standards:

• ISO 9000-1: 94 General quality management and quality assurance standards - Part 1: Guidance for selection and use
• ISO 9001: 94 Quality systems. - Model for quality assurance in design, development, production, installation and service
• ISO 9002: 94 Quality systems. - Model for quality assurance in production, installation and service
• ISO 9003: 94 Quality systems. - Model for quality assurance in final inspection and testing
• ISO 9004-1: 94 General quality management and elements of a quality system - Part 1: Guidelines
• ISO 8402: 1994 Quality management and quality assurance - Vocabulary

ISO 9000: 2000 standards

As a result of the next revision of the ISO 9000 series standards, December 25, 2000. a new edition was put into effect, which underwent significant changes. The new version is based on the concept of business processes and includes some new areas - the process of continuous improvement, assessment of customer satisfaction with released products or services provided, resource management.

When developing the ISO 9000 2000 version of the standards, one of the goals pursued was also a simplified structure of the standards to facilitate their application in organizations. As a result of this restructuring, instead of 20 previously used standards, the ISO 9000: 2000 series contains only 4 new standards:

• ISO 9000: 2000 Quality Management Systems. Basics and Vocabulary
• ISO 9001: 2000 Quality Management Systems. Requirements
• ISO 9004: 2000 Quality Management Systems. Guidelines
• ISO 10011: 1991 Audit of quality management systems

Terminology

The standards use the following basic terminology, defining the subjects in the quality system with reference to which requirements or guidelines are established.

These terms differ from those previously used in ISO 9000: 2000.

• Term organization denotes an entity for which ISO standards apply.
• Term provider now replaces the previously used term "subcontractor".
• Term production used to describe the intermediate or final results of an organization's activities, can also be understood as a "service".

Quality management concepts

Focus on the consumer (customer). The quality level is set by the consumer, therefore, the organization should in every possible way focus its attention on the study of problems, needs, needs and expectations of the consumer for the subsequent implementation of the information obtained in the manufactured product.

Process and systems approach. Product quality management is carried out through the management of its production processes, interconnected in an agreed system.

Leadership leadership. The way the processes operate within the management system is determined by the overall policy and objectives for the entire organization, set by top management, which ensures that these policies and objectives can be implemented with the necessary resources.

Involvement of personnel. The implementation of the goals set for the enterprise is possible only in the case of adequate behavior of employees at all levels of the organization.

Continuous improvement. As the needs of customers and other interested parties continually increase or change, the organization must keep pace with these changes, ensuring the continuous growth of the internal quality of its production and management processes.

Making management decisions based on evidence. The continuous improvement process should be based on data obtained from objective measurements of the actual state of the quality and product quality system.

Mutually beneficial supplier relationships. Since product quality is largely determined by the quality of raw materials, materials and information, achieving quality growth should also be based on the establishment of mutually beneficial partnerships with suppliers.

Process approach

This International Standard proposes the adoption of a process approach in developing, implementing and improving the effectiveness of a quality management system to increase customer satisfaction by meeting customer requirements. The process diagram is shown in the figure:

Fig. 1. Process approach diagram

For an organization to function effectively, it needs to identify and manage numerous interrelated activities. Activities that use resources and are managed in a specific order that transforms "inputs" into "outputs" can be thought of as processes. Often, the “exit” of one process is the direct “input” of a subsequent process.

The application of a system of processes within an organization, together with the identification and interaction of these processes, and their management, can be thought of as a “process approach”.

The advantage of the process approach is continuous management, which ensures good interconnection both between individual processes within the organization, and their combination and interaction.

When used within a quality management system, the process approach emphasizes the importance of:

• understanding and meeting requirements;
• the need to consider processes in terms of "added value";
• obtaining the results of the execution of processes and effectiveness;
• continuous process improvement based on objective measurements.

A model of a process-based quality management system is depicted in a figure illustrating the relationship of the processes presented in clauses 4 to 8 of ISO 9001: 2000. This illustration shows that consumers play an essential role in defining inputs. Customer satisfaction monitoring requires an assessment of information related to the customer's perception of whether the organization has met its requirements. The model depicted in the figure covers all the requirements of this International Standard, although it does not depict processes in detail.

Fig. 2. Process-based quality management system model

ISO 9001: 2008 standard

On November 15, 2008, the International Organization for Standardization (ISO) published a new version of the international standard ISO 9001. ISO 9001: 2008 replaces the ISO 9001: 2000 standard, which is applied to both commercial and public organizations in 170 countries.

In the new version of the standard:

• does not contain new requirements;
• added clarifications to existing requirements;
• the changes are mainly of an editorial nature;
• Several changes have been made to improve compatibility with ISO14001: 2004.

In general, the changes in the standard are insignificant, so the transition to the new version will not require major changes in the management system from organizations.

ISO and IAF have jointly released transition rules for the new version of the standard:

• 24 months after the publication of ISO 9001: 2008, i.e. after November 14, 2010, any existing ISO 9001: 2000 certification will not be valid;
• One year after the publication of ISO 9001: 2008 i.e. after November 14, 2009, all new accredited certifications and recertifications must be in accordance with ISO 9001: 2008;
• Certificates of conformity to ISO 9001: 2008 and / or national equivalents can only be issued after a scheduled periodic audit or recertification for compliance with ISO 9001: 2008;
• The transition can be made during any scheduled recertification or periodic audit within these 24 months.