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International standards ISO 9001. International quality system: ISO standards

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 consists of models or guidelines. All of these documents are called standards, despite the fact that some of them are guidelines or collections of recommendations.

The ISO 9000 series of standards is a summary of national and international standards for quality systems. ISO 9000 standards are recognized throughout the world and have been 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 countries of the European Union. The first quality system standard was the American Mil Spec (Mil-Q-9858), published in 1959. The various quality system standards developed since then have many common properties.

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: Selection and application guidelines
ISO 9001:94 Quality systems. - Quality assurance model for design, development, production, installation and maintenance
ISO 9002:94 Quality systems. - Quality assurance model for production, installation and maintenance
ISO 9003:94 Quality systems. - Quality assurance model for final inspection and testing
ISO 9004-1:94 Total 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. was put into effect new edition 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, assessing customer satisfaction with products or services provided, resource management.

When developing the ISO 9000 standards, version 2000, one of the goals was also to simplify the structure of the standards to make them easier to use 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 Audit of quality management systems

Terminology

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

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

Term organization denotes an object to which ISO standards apply.
Term supplier now replaces the previously used term "subcontractor".
Term products used to describe the intermediate or final results of an organization's activities, can also be understood as "service".

Quality Management Concepts

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

Process and systems approach. Product quality management is carried out through the management of its production processes, interconnected into a coordinated system.

Leadership leadership. The way processes within a management system operate are determined by the overall policies and goals for the entire organization, set by senior management, who ensure that those policies and goals are achieved with the necessary resources.

Staff involvement. The implementation of the goals set for the enterprise is possible only if employees at all levels of the organization behave adequately.

Continuous improvement. Because the needs of consumers and others stakeholders continuously increase or change, the organization must keep up with these changes, ensuring continuous growth in the internal quality of its production and management processes.

Acceptance management decisions based on evidence. The continuous improvement process must be based on data obtained through 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 high-quality growth should also be based on establishing mutually beneficial partnerships with suppliers.

Process approach

This International Standard advocates the adoption of a process approach when 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 is necessary to identify and manage numerous interrelated activities. Activities that use resources and are managed in a specific order to transform "inputs" into "outputs" can be considered as processes. Often the "output" of one process is the immediate "input" to a subsequent process.

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

The advantage of the process approach is continuous management, which ensures a good relationship 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 requirements;
the need to consider processes in terms of “added value”;
obtaining results of process execution and effectiveness;
continuous process improvement based on objective measurements.

A model of a process-based quality management system is depicted in the figure illustrating interconnection of processes, presented in clauses 4 to 8 of the ISO 9001:2000 standard. This illustration shows that consumers play a significant role in determining inputs. Monitoring customer satisfaction requires assessing 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 show the processes in detail.

Fig.2. Model of a process-based quality management system

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 applies to both commercial and public organizations in 170 countries.

IN new version standard:

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

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

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

24 months after the publication of ISO 9001:2008, i.e. after 14 November 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 to 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 may be made during any scheduled recertification or periodic audit within those 24 months.

The ISO 9000 series of standards, which describe a quality management system model, are designed to help organizations consistently provide customers and other interested parties with products or services that can meet their requirements and expectations. This series of standards was created by a committee of the International Organization for Standardization - ISO; Based on these standards, national standardization organizations can develop national analogues, in particular, in Russia these are GOST R ISO standards of the 9000 series.

The ISO 9000 standard defines the basic provisions and principles of quality management, which create the basis for the development and maintenance of a quality management system, the specific requirements for which are formulated in the ISO 9001 standard.

Organizations that seek recognition of their quality management system can use this standard to independent assessment, they can also be used to demonstrate execution contract requirements.

Organizations can receive an independent external assessment from a third party, a certification body, by undergoing an appropriate audit. More than a million organizations around the world have certified quality management systems, confirming the effectiveness of the ISO 9001 standard as one of the most common tools for building a management system.

The IS0 9000 series includes:

ISO 9000 Standard – Fundamentals and Vocabulary. The standard is intended to establish a common understanding of the terms and concepts used in the ISO 9000 series of standards.

ISO 9001 Standard - Requirements. The standard defines the requirements that organizations' quality management systems must meet. Being general and universal, the ISO 9001 standard can be applied to any business and is suitable for all organizations, regardless of their field of activity, size, form of ownership, or geographic location.

ISO 9004 - Guidelines for improving performance. The standard contains recommendations based on eight principles of quality management that were developed for managers to improve the organization's performance and meet the requirements of all stakeholders.

ISO standards are structured to be easily integrated into an organization's existing management system to meet and exceed customer requirements and expectations. Thanks to the fact that the latest version of the standard, which came into force in 2015, was developed taking into account the so-called high-level structure that underlies all the most commonly used standards defining the requirements for various management systems of organizations, ISO 9001 has become much more compatible with such, for example, standards as ISO 14001 (requirements for environmental management systems), ISO 45001 (requirements for occupational health and safety management systems), ISO 39001 (requirements for safety management systems traffic), ISO 27001 (requirements for management systems information security), ISO 20000 (requirements for an IT service management system) and others

Benefits from implementation and certification

increasing customer satisfaction by fulfilling their requirements;
increasing the efficiency of the organization’s internal processes;
continuous improvement of the organization's processes by identifying and eliminating losses in the implementation of activities;
improvement of internal communications, planning and distribution mechanism material resources;
increasing staff motivation due to transparency and clarity of work performed functional responsibilities;
enriching staff knowledge in the field of quality;
cost reduction by increasing productivity, improving the quality of manufactured products, services provided and reducing the level of defects;
continuous improvement of the organization’s activities through the use of modern quality management tools;
increasing the competitiveness of the organization in the Russian and global markets

Relatively recently, domestic businessmen did not even think about what ISO is and why this system is needed. Naturally, no one could even think that receiving such a certificate would in one way or another affect the success of the organization itself.

In fact, this system of standards was created almost 70 years ago, and Russia is one of the members of its council, and most successful global organizations necessarily think about how to meet the established requirements for conducting their business.

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This is why any company that intends to operate internationally and at the same time wants to successful business, should learn about what the ISO standard is and what its requirements are.

The essence and necessity of international standardization

The main task of this organization is to create uniform global standards in various industries and ensure maximum control over their compliance, which should have a positive impact on the general state of world trade. On at the moment ISO committees have already released thousands of documents that establish quality parameters in almost any industry and area, and the only exception today is the field of electronics, which is currently not yet burdened with any restrictions.

In the process of development of domestic companies and with attempts to enter international markets many have understood why an ISO certificate is needed, since its absence significantly reduces the possibilities of interaction with foreign organizations or makes it completely impossible.

Thus, for modern business compliance with established international standards is the optimal tool for reducing costs, including minimizing production waste, personnel or management errors, as well as restrictions on productivity growth.

What is The International Organization for Standardization?

The International Organization for Standardization is an international standardization organization that was founded in 1947.

Today, 164 countries and more than three thousand technical bodies are members of this organization. ISO has its central secretariat in Switzerland and is a completely independent and non-governmental body governed solely by its members.

From Russia to this organization includes FATRIM or Rosstandart.

There are several types of ISO membership:

The development of standards for this organization is carried out by highly qualified groups of experts who unite in specialized technical committees, of which more than 250 are registered today.

Types of ISO standards

The ISO standard is specialized document, which contains information about what quality characteristics this or that product should have, how management processes should be conducted in the organization, what needs to be taken into account in the production process, performance of work or services, and so on. They themselves are extremely diverse, since together they cover almost any economic activity.

Series 9000

There are several main types of ISO 9000 series:

It is worth noting the fact that the standards from this series do not relate to the standardization of any products, and include only various methodological or methodological standards with the help of which a company can create for itself the most optimal quality management system, ensuring the European quality of its work and continuous improvement of competitiveness at the international level.

Other series

As already mentioned, to date more than 20,000 international standards have already been adopted, so it is almost impossible to consider all of them. Nowadays, with the help of ISO, it is possible to standardize almost any area, from standard file systems in the form of CDs to the technologies used to support management and management decision-making.

Thus, for example, the 12800 standard allows you to regulate the production procedure nuclear fuel, while ISO 14000 includes a series of standards by which an environmental management system should operate.

Quality Management System 9001

The ISO 9001 standard includes several important principles:

Customer focus	In this case, not only end buyers are considered, but also internal employees organization, since all departments in any case must cooperate with each other, conducting a kind of production chain.
Leadership	It's always good when employees can show their initiative, but management should always participate in all processes, control them and make important decisions.
Employee Engagement	Regardless of their position, each employee must perfectly understand their own contribution to the quality of manufactured products and understand exactly why their actions influence its achievement.
Process approach	The ISO 9001 system includes several units, taking into account the needs, capabilities and problems of each of them.
Systematic approach	If all departments in the company work only for themselves and to achieve their own success, it will be necessary to find a compromise and ultimately achieve a solution that will fully satisfy the needs of all employees, thus increasing the quality of manufactured products and the image of the organization.
Continuous improvement	The company should not stop growing and constantly think about how to improve its work and take it to the next level.
Actual solutions	The management team of the company must make certain decisions based on audits, reports, assessments, analysis of indicators, complaints from various companies and other documents.
Mutually beneficial relationships with suppliers	Suppliers any commercial products are an integral participant in the business, so the fruitfulness of the work of any company will also depend on their interest.

Features of the new version 2020

For a long time, businessmen from all over the world regularly contacted ISO, asking about the development of a standard for integrated management systems. In this regard, in 2020, it was decided to revise the ISO directives, which established the basic rules by which standards were developed, adopted and revised. Thus, a separate SL annex to the directives appeared, which set fairly stringent requirements for the structure, requirements and main part of the text of standards related to management systems.

Thus, 9001, 14001 and other standards receive a certain similarity, and in the future they will differ from each other only in name and certain additions. Thus, the new SL application has become a full-fledged template for the work of standards creators, who will now be able to fully concentrate their efforts on making requirements for certain disciplines, reflecting their specifics mainly only in Chapter 8 of all standards.

Companies will now be able to much more easily select standards in accordance with their specifics, without thinking too much about how best to integrate them into a single system.

In addition, it will be easier for auditors to work, who will now only be able to increase their competence in certain sectors of the economy, as well as applicable legal requirements.

How to obtain a 9001 certificate of conformity?

The presence of a certificate indicates that the company operates in accordance with a quality management system, basing it on a process approach to business activities.

The presence of this certificate opens doors to the field public procurement, providing access to various industry tenders, as well as providing additional benefits in case of joining self-regulatory organizations.

But the most important thing in this case is that the management system, which meets international requirements, is classified as highly adaptive, due to which the company’s resistance to any negative impacts from the economic environment significantly increases, as well as to achieve survival in crisis conditions and achieve competitive positions on the market.

In order to obtain this certificate, you will need to contact any bodies that have passed the appropriate accreditation and go through several stages:

Submit an application for certification along with a package of all necessary documents.
Conduct a preliminary assessment of the QMS.
Complete the training procedure by specialists and managers who are directly related to the company’s QMS.
Conduct a QMS audit.
If the organization's activities comply with ISO 9001, obtain a certificate.

The package of documents that accompany the application may also include a number of constituent documents, all kinds of permits and licenses, previously received awards, a list of completed objects and many other papers.

Safety quality requirements

To date, security assessment information systems is a rather complex procedure, but, as is known, it is possible, and a whole series has been developed for this qualitative methods assessments of the level of security, with the help of which it is possible to obtain at the output not a quantitative, but a qualitative assessment, that is, determine the compliance of the protection system with a certain class or level. Quantitative assessment methods have not yet begun to be used in practice.

The use of qualitative assessment methods at the moment can be called the only way to get an idea of what the real level of security is information resources companies.

The international information systems security standard is called BS 7799 and sets out the rules by which a company's entire information security management process should be carried out, regardless of the industry in which it operates.

The security service and management of the organization work in accordance with general regulations, and there is no difference in whether protection is provided paper document or electronic information.

In conditions of fairly fierce competition, the introduction of certain quality guarantees is fundamental and decisive in the choice of services and products by the buyer or consumer specific company. In this case, the best and main guarantee is the certification of quality management systems and the receipt of the ISO 9001 series standard.

ISO standards in Russia, including the most famous standard ISO 9001, combine many years of experience in most countries of the world in the field of quality system management and are the latest versions of assessing criteria for managing all work and production processes in enterprises.

ISO 9001 Certificate is an official document confirming full compliance the current quality management system to the requirements specified in the international standard ISO 9001.

Today, having gone through a whole range of various additions and modifications, the international standard ISO 9001 has become fully adapted and harmonized in accordance with current European standards and is aimed at maximizing the quality of products (services provided).

The ISO 9001 standard has a clear structure consisting of 8 sections:

scope and purpose;
normative references;
basic definitions and terms;
quality management system;
level of management responsibility;
resource management;
release of products (services);
analysis, measurement and improvement.

The first three sections of the standard are official and do not contain requirements or standards.

The main purpose of the ISO 9001 standard is to actively encourage proper organization various production processes and the operation of the company as a whole to comply with specific legal requirements and most fully satisfy the desires and requests of consumers and partners.

The implementation of a QMS based on the receipt of ISO 9001 standards confirms that:

the company’s personnel are well acquainted with their duties, rights, powers and responsibilities, and also have the necessary competence to perform their work more efficiently, effectively and correctly;
the company has predetermined processes that affect the quality of products;
all production processes are regulated and provided with all necessary resources;
conditions have been created for the competent implementation of the production infrastructure and environment, as well as the high-quality work of the enterprise’s employees;
system for preliminary collection and further analysis of information about production processes, customer and product satisfaction, is optimally adjusted and provides objective information for timely making the necessary decisions to improve the work of personnel and the enterprise itself;
a motivated system focused on quality has been created;
work processes were organized with subsequent focus on the expectations of the end user, including implementation latest technologies, improving consumer properties, parameters and characteristics of manufactured products;
internal audits are carried out to ensure continuous improvement of processes and activities;
The company has established records management and document flow;
the organization pays special attention to competent work with suppliers and partners;
the top management of the organization is familiar with the level of quality and bears full responsibility for it;
the enterprise sets and develops quality goals and regularly plans to achieve them;
the company has a well-functioning system of responding to claims and complaints made by customers and clients (developing effective measures to eliminate shortcomings and failures);
There is a continuous improvement process in place to ensure sustainable development of the company.

For each organization, the project for developing quality systems in accordance with the ISO 9001 standard is unique and is determined based on its size, types of activities, presence of a branch network, features organizational structure, the level of development of the existing and current management system, etc.

Stages of standardization in accordance with ISO 9001

The process of standardization according to ISO 9001 itself is not a complete guarantee of the quality of a service or product, but provides only a set of norms and rules for the implementation of civilized activities of an organization in compliance with standard and universal step-by-step steps.

The stages of the project for the implementation and development of ISO 9001 series standards consist of the following main activities:

preparatory stage - creation technical assignments, calendar plans, administrative registration of work, project management plan;
assessment of the current quality management system (QMS) of the organization;
conducting training and special training for employees and responsible officials in the company;
regulation of processes and determination of the QMS process model;
development of QMS documentation and organizational management structure;
creating a process for improving the QMS;
performing a cycle of internal audits;
implementation of ISO 9001 certification.

A competently and correctly developed and implemented quality management system, as well as its subsequent certification in the ISO system, provides a number of economic and strategic advantages for business owners.

Key benefits of being ISO 9001 certified

The high level of competitiveness of an enterprise and its products or services on the market is directly influenced by regular and continuous improvement of the company’s activities as a whole. This ensures a uniform improvement in the quality of products and services offered. The basic norms and rules in this area are determined by the well-known international standard ISO 9001, which is evidence of the company’s production of high-quality goods and the compliance of its technologies and activities with international standards.

A company that owns this certificate has a number of undeniable advantages over other enterprises that do not have a similar standard, namely:

achieving a high level of quality allows you to reduce the overall cost of production, as well as reduce the costs of defective products;
significant improvement and optimization of current business processes;
increasing the level of cooperation;
actively improving the quality of staff work;
opportunity to streamline activities structural divisions enterprises;
the possibility of obtaining government orders and the company’s entry into the international external consumer market;
increasing trust on the part of financial and insurance organizations, which influences the investment of large investments in the development of the enterprise.

Based on this, an organization or company that adheres to the conditions and requirements of this certificate receives many useful opportunities, ranging from effective competition with other manufacturers and ending with a significant increase in the quality of the manufactured goods or services provided. Even these two basic parameters can maximize and increase the company's profits. The ISO 9001 standard in this regard is a worthy guarantee of the success, longevity and prosperity of the manufacturer.

Standardization according to ISO 9001 does not eliminate the need to issue separate certificates for certain types of goods, products and services included in the list of categories requiring mandatory certification.

ISO 9001 standard

ISO 9001 standards are international standards that describe the requirements for the quality management system of organizations and enterprises. ISO 9000 standards include ISO 9001 standards, the demand for which is increasing every day. This is the current version of ISO9001:2008 “Quality management systems. Requirements." This is the only standard to which certification can be achieved. This procedure is not mandatory certification and is carried out at the request of the applicant.

It is worth noting that the ISO 9001:2008 standard is successfully used by organizations of any size; it has been successfully implemented by more than 1 million companies in 170 countries. The use of the ISO 9001:2008 standard ensures that the buyer receives high quality products and services, which leads to increased sales growth and business success. In addition, the implementation of the ISO 9001:2008 standard can help check the performance of the entire system as a whole, improve its effectiveness, motivate, involve senior management and reduce losses.

An important feature of the ISO 9001:2008 standard

An important feature of the ISO 9001:2008 standard is that it does not imply uniform quality management systems and accompanying documentation describing them. Therefore, by implementing a quality management system based on the ISO 9001:2008 standard, you can be sure of exceptional individuality and see for yourself how flexible this system is. After all, the development and implementation of an organization’s quality management system is influenced by: the size of the organization, the products manufactured, the structure of the organization, applicable processes, changing needs, specific goals, external environment, changes or risks associated with this environment.

The ISO 9001:2008 standard is safely used by organizations of all sizes and has been successfully implemented by more than 1 million companies in 170 countries.

The ISO 9001:2008 standard aims to apply a process approach in the development, implementation, and subsequently improvement of the effectiveness of a quality management system in order to increase end-customer satisfaction by predicting and meeting its requirements. The benefits of a process approach are countless. First of all, this is the continuity of control, which is achieved through combinations and interactions at the junction of individual processes.

This approach helps to better understand and fulfill requirements, achieve planned results, ensure their effectiveness, and improve the process by objectively assessing and measuring it. Also, in addition to the process approach, the implementation of a quality management system based on the ISO 9001:2008 standard to all processes in the organization can allow the application of the “Plan – Do – Check – Act” cycle. This cycle can be briefly described as:

planning (plan) - development of goals and processes necessary to achieve results in accordance with customer requirements and organizational policies;
implementation (do) – implementation of processes;
check - continuous monitoring and measurement of processes and products in comparison with policies, goals and product requirements and reporting of results;
action (act) – taking action to continuously improve process performance.

The timing and cost of implementing the ISO 9001:2008 standard depend on individual characteristics Your type of organization and degree of functioning of the system's actions. In most cases it does not take more than 2 weeks. If you are still in doubt, you can order free consultation our specialists ( There should be some kind of “click” button here). With their help, you can choose the certification system that best suits your organization.

And don’t let the lack of standard prices scare you, this only means that we approach each case separately, weigh the uniqueness of the situation and take all possible measures to optimize the implementation of the ISO 9001:2008 standard. By contacting us you are guaranteed to receive a unique offer that will improve your existing processes and establish careful control, and most importantly, increase the position of your organization/company in the market.

Upon completion of the work you receive from us:

ISO 9001:2008 certificate in Russian and English;
permission to use the quality mark;
quality manual for your organization;
organizational standards for your organization.

Remember that working with us will help you reach new heights!

Organizations seeking recognition of their quality management system can use this standard for independent assessment, and it can also be used to demonstrate compliance with contractual requirements.

The IS0 9000 series includes:

ISO 9000 Standard – Fundamentals and Vocabulary. The standard is intended to establish a common understanding of the terms and concepts used in the ISO 9000 series of standards.

ISO standards are structured to be easily integrated into an organization's existing management system to meet and exceed customer requirements and expectations. Thanks to the fact that the latest version of the standard, which came into force in 2015, was developed taking into account the so-called high-level structure that underlies all the most commonly used standards defining the requirements for various management systems of organizations, ISO 9001 has become much more compatible with such as, for example, standards such as ISO 14001 (requirements for environmental management systems), ISO 45001 (requirements for occupational health and safety management systems), ISO 39001 (requirements for road safety management systems), ISO 27001 (requirements for information management systems security), ISO 20000 (requirements for an IT service management system) and others

Benefits from implementation and certification

increasing customer satisfaction by fulfilling their requirements;
increasing the efficiency of the organization’s internal processes;
continuous improvement of the organization's processes by identifying and eliminating losses in the implementation of activities;
improvement of internal communications, planning mechanism and distribution of material resources;
increasing staff motivation due to transparency and clarity of functional responsibilities;
enriching staff knowledge in the field of quality;
cost reduction by increasing productivity, improving the quality of manufactured products, services provided and reducing the level of defects;
continuous improvement of the organization’s activities through the use of modern quality management tools;
increasing the competitiveness of the organization in the Russian and global markets