ISO 9000 quality management system standards. International quality system: ISO standards. Safety quality requirements

Quality Management System (QMS)- part of the management system focused on quality (clause 3.5.4 of ISO 9000:2015), created to develop 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.

With regard to the activities of 1C partners, QMS is a system of methods and technologies that ensures the 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 consumer requirements, but also about the mechanism for preventing a possible loss of the established quality level, as well as its continuous improvement.

ISO (International Organization for Standardization) - International Organization for Standardization, a worldwide federation of national standards organizations (ISO member committees). The goal of ISO is the development of the principles of standardization and the design of standards based on them that promote integration processes in various fields and activities.

The 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 core set of international standards related to quality management was adopted by ISO in March 1987 and has since been updated periodically.

The ISO 9000 series currently consists of the following standards.

  • ISO 9000:2015 “Quality management system. Fundamentals and Glossary" - is an introduction to the QMS, as well as a glossary of terms and definitions.
  • ISO 9001:2015 “Quality management system. Requirements” - establishes requirements for quality management systems and defines a process-based QMS model.
  • ISO 9004:2009 “Managing for the sustainable success of an organization. Approach based on quality management”.
  • ISO 19011:2011 "Guidelines for auditing management systems".

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

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

ISO 9001 is based on a set of quality management principles:

Orientation to the consumer (customer). The main focus of 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 the study of the needs and expectations of the consumer for the subsequent implementation of the information obtained in the products. Understanding the current and future needs of customers and other stakeholders contributes to the sustainable success of an organization.

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

Staff involvement. Realization 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 value creation. Competent, empowered and engaged people enhance an organization's ability to create value.

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

Improvement. Successful organizations focus on continuous improvement. Improvement is important to 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 process of continuous improvement should be based on data obtained in the course of objective measurements of the actual state of the quality system and product quality. It is important to understand causal relationships and potential consequences. Facts, evidence and data analysis lead to greater objectivity and confidence in decisions made. Decisions based on the analysis and evaluation of data and information are more likely to lead to 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 must also be based on establishing mutually beneficial partnerships with suppliers. Achieving sustainable success is more likely 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.

A successfully implemented quality management system is confirmed by its certification for compliance with the international standard ISO 9001. The presence of a certificate in a company indicates that the company is well organized, responsibilities and procedures are clearly distributed in it, the work technology is followed, there are operational instructions documented and known to all staff , the procedure for monitoring work performed and, of course, professional and well-trained staff. In other words, an ISO 9001 certificate indicates that a company's quality system is able to ensure and improve the quality of its products and services.

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

Firm "1C" provides voluntary certification of franchising companies according to ISO 9001:2015 and GOST R ISO 9001-2015.

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

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, and staff training. But to build a quality management system or put into operation its individual essential elements, 1C encourages all 1C: Franchisee partners seeking to make their company competitive in the information services market.

Picking up a box, 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. A modern person, especially one who owns or manages a business, must 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 it is, how to get a certificate, what benefits it gives, and other issues will be discussed in detail below.

Quality

The word "quality" has firmly entered the lexicon of every person. All standards give different, capacious definitions. The quality in the life of an ordinary consumer is the correspondence (or even better, the excess) of what he expects to what he receives. Whether it is services, food, clothing, household items or something else, the consumer expects that they will bring him benefit or pleasure.

Since such an attitude is too subjective, special criteria have been developed, 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 a product or service, but if this issue is not one of the most important for the manufacturer, he will never succeed in achieving serious and long-term success.

Quality checking

Many organizations have internal audits. When a department or certain employees evaluate the work and the product produced. Of course, one can doubt the objectivity of such indicators, but one should not completely abandon them either.

The second type of verification is partnership. For example, when certain requirements are imposed on suppliers, non-compliance with which will lead to the termination of the cooperation agreement. Inspections can be carried out independently or with the involvement of third parties. For example, organizations that certify according to GOST standards or the ISO 9001 standard.

Certification can be mandatory or voluntary. It is not worth talking about the possible difference in attitudes towards the quality of the manufacturer in these types. Many products must undergo mandatory certification: children's products, perfumes, medicines, computers, cars, etc. But mandatory certification does not prevent you from passing a voluntary one and obtaining an 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 should I get a certificate

A company can conduct voluntary certification at any time when it feels the need and strength to implement its plans. But nevertheless, GOST ISO 9001 recommends certification not when the management decides to do this and lowers the directive “from top to bottom”, but when the whole company feels the importance and necessity. Practice shows that if the initiative comes from employees, then the certification process is easier, better and more efficient.

So, let's answer the main question: "ISO 9001 - what is it?" These are international requirements for quality management. It is worth noting that these are not requirements for a particular product or service, they are 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 an ISO certificate give?

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


If your company comes to the conclusion that it is time to receive a kind of maturity certificate, but not all management welcomes the changes, it is worth introducing them to ISO 9001. What it is, what it provides and how to get certified. It is important to remember that ISO is not only a piece of paper for bidding and image, it is primarily an effective management tool. 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, evaluation, audits ISO 9001 - what is it and how to work with them, managers find out. Often they come to the aid of consultants from certification organizations.

The main thing to remember and always be guided by in a company that implements the ISO 9001 quality system is the management principle "Plan, Execute, Check, Act". Any actions from the field of certification should be coordinated and “driven” 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 us to observe this simple truth at all times and in everything.

ISO 9001 principles

The ISO 9001 standard consists of eight core principles:


Certification procedure

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

2. Draw conclusions and make decisions to eliminate nonconformities (do not forget the role of management and the involvement of personnel).

5. If the test results are positive, submit an application to the certification body.

6. Conclude an agreement with a company accredited in the direction of GOST ISO 9001.

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

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

Remember that the certificate is given for 3 years, and you need to pass surveillance audits every year. And, of course, to comply with everything that is planned for the company, and fulfill all the obligations assumed with the entry into the community of certified organizations.

Disadvantages of ISO

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

    Lots of paperwork. Reports, protocols, questionnaires, and so on, but on the other hand, without them, control and an objective decision cannot be achieved.

    Too 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 (expenses for certification, "re-engineering" of an established system, the services of an external consultant and a full-time quality specialist) is another reason why it is worth striving for the actual use of a quality system.

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. The ISO 9000 series of standards are models or guidelines. All of these documents are called standards, even though 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 practically 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 United States, 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 that time have many common features.

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: Guidelines for selection and use
  • ISO 9001:94 Quality systems. - Quality assurance model for design, development, production, installation and maintenance
  • ISO 9002:94 Quality systems. - Quality assurance model in production, installation and service
  • ISO 9003:94 Quality systems. - Quality assurance model for final inspection and testing
  • ISO 9004-1:94 General quality management and quality system elements - 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 has been put into effect, which has undergone significant changes. The new version is based on the concept of business processes and includes some new areas - the process of continuous improvement, evaluation of customer satisfaction with products or services provided, resource management.

In developing the ISO 9000 version 2000 standards, one of the goals pursued was also to simplify the structure of the standards to make them easier to apply in organizations. As a result of this restructuring, instead of the 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 Auditing of quality management systems

Terminology

The standards use the following basic terminology, which defines 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 object to which ISO standards apply.
  • Term the supplier now replaces the previously used term "subcontractor".
  • Term products used to describe the intermediate or final results of an organization's activities, may also be understood as a "service".

Quality management concepts

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

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

leadership leadership. The way in which the processes within the management system operate 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.

Staff involvement. Realization 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 up with these changes by ensuring that the internal quality of its production and management processes continues to grow.

Making managerial decisions based on actual data. The process of continuous improvement should be based on data obtained in the course of objective measurements of the actual state of the quality system and product quality.

Mutually beneficial relationships with suppliers. Since product quality is largely determined by the quality of raw materials, materials and information, achieving quality growth must also be based on establishing 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 the effective functioning of the organization, it is necessary to identify and manage numerous interrelated activities. Activities that use resources and are managed in a specific order that allows the transformation of "inputs" into "outputs" can be considered as processes. Often the "output" of one process is the direct "input" to a subsequent process.

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

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

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

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

The model of a process-based quality management system is depicted in the 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 determining the input. Monitoring customer satisfaction requires the evaluation of information related to the customer's perception of whether the organization has met its requirements. The model shown in the figure covers all the requirements of this International Standard, although it does not represent the processes in detail.

Fig.2. Model of a quality management system based on processes

ISO 9001:2008 standard

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 applies 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 editorial;
  • Several changes have been made to improve compatibility with ISO14001:2004.

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

ISO and IAF have jointly issued migration 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 ISO 9001:2008;
  • Certificates of conformity to ISO 9001:2008 and/or national equivalents may only be issued after a scheduled periodic audit or recertification to ISO 9001:2008;
  • The transition can be made during any scheduled recertification or periodic audit within these 24 months.

Today, in the context of expanding international trade, improving the quality of products, the problem of introducing ISO 9000 series standards and the transition from integrated quality management systems to international standards is very acute for enterprises.

There are the following differences between quality systems (according to ISO 9000) and a comprehensive product quality management system:

Focus on customer satisfaction;

Assigning responsibility for product quality to specific performers;

Verification by the consumer 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;

Solving the issues of disposal of products after operation.

The following 5 ISO 9000 series standards:

1. ISO 9000 General quality management and quality assurance standards. Guidelines for selection and application.

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".

There are the following main goals for issuing ISO 9000 series standards:

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

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

¨ assistance and methodological assistance to organizations of various sizes from various fields of activity in the creation of effectively 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 that have developed in the enterprise, the production structure, technology and organization of production, specific features of products, economic factors, etc. . P.

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, the 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 used in the system. The standard considers the economic aspects of quality, various types of costs and cost items for quality, provides guidance on conducting internal quality audits that allow the management of organizations to assess the degree of readiness of their departments for a stable supply of products that meet the requirements of standards and consumer expectations. ISO 9004 is primarily applicable to internal quality assurance tasks and should not be used in contract situations or for certification purposes.


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

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

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

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

The ISO 9000 series of standards require that a quality system be interrelated with all activities of an enterprise and its application extends to all stages of the product life cycle and processes from the initial identification of market needs to the final satisfaction of established needs.

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

These include the following provisions:

¨ the management of the enterprise initiates, develops, implements and maintains the quality system;

¨ within the framework of the general organizational structure, the functions related to the quality system are clearly established;

¨ the management of the enterprise allocates all the resources necessary for the implementation of the quality policy and the achievement of the set goals;

¨ all activities performed in the quality system are documented;

¨ the quality system should be subject to regular analysis and evaluation 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 application of complex management methods, in providing competitive advantages, characteristics, or the need to determine them is indicated;

2) when the consumer is sure that the supplied products meet the established requirements. The supplier must provide evidence of its ability to design, develop, manufacture, install and service.

The supplier of a product shall establish and maintain a documented quality system as a means of ensuring product conformity with 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 of a systematic approach to product quality management;

♦ consumer 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);

♦ Documentation (preferably quantitative) of specific requirements;

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

The process model reflected in ISO 9000:2000 in clauses five through eight shows that customers play a significant role in defining requirements as inputs. Here the principle of TQM is implemented - focus on the Customer, the main meaning of which is to form such a 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 principle of TQM - the principle of "supplier-customer" within the enterprise, which helps to eliminate losses, increase responsibility, eliminate disunity and create a normal internal climate in the team.

Today, an international certification organization issues various certificates and certificates. One of the most requested services is ISO(ISO) 9001 QMS certification. This is a series of standards related to the management system in organizations. The issued certificate confirms the compliance of the quality of management in the company with all the declared standards.

What gives a certificate in Russia?

In fact, the ISO 9001 certification brings many benefits to a company. Among them are the following:

  • Participation in international and state tenders;
  • Increasing personal competitiveness;
  • Increasing overall efficiency in the company;
  • Simplification of interaction with government agencies.

Speaking about the cost of a certificate, it is worth noting that it depends on whether it is issued only for Russia or will have an international format. It is very important to receive such a certificate in an accredited company, then it will have legal force. "Unified Certification Center of the Customs Union" offers to obtain GOST 9001 2015 certificates that meet all requirements. It will take us no more than two days to issue a certificate.

 

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