Quality management systems ISO 9001. International system of ISO standards (ISO) and its requirements. Types of ISO certificates

The ISO 9001 quality management system is one of the elements of the ISO 9000 series. The latter is an international system that regulates quality management in an enterprise. It consists of many parts, each of which has its own task. For example, ISO 9000 itself can be characterized as a collection of management definitions. And ISO 9001 contains advice for practical application.

Why is an ISO 9001 quality management system needed?

Any fact must be officially confirmed, and nowadays it is customary to have a “piece of paper” for everything. So, enterprises that have passed a special test receive a certificate of compliance with ISO 9001.

What is it for? In truth, this document will give little to individual entrepreneur Vasechkin, who sells clothes on the market. This certificate is only required if your customers or suppliers are interested in it. In some areas of business, ISO certification is mandatory. This applies to economic and government spheres.

! An interesting fact is that for a large number of consumers, the entry on the packaging “compliance with the ISO 9001 standard” increases the level of trust in the company. Many people believe that this certificate is a guarantee of product quality. Although this is not true - the standard only guarantees the presence of quality work at the enterprise, and nothing more.

Many companies today use ISO certificates as a means of competition. For some this allows them to achieve the best conditions cooperation with partners, others use it as a PR tool.

What does the ISO 9001 standard say?

ISO 9001 2008 (latest version) is optional. But still, in order to obtain a document confirming compliance with these regulations, the company will need to work hard.

For example, basic principle management and ISO standard is a simple truth: plan, implement, control, analyze (PDCA). This means that all actions of your enterprise must be clearly planned and implemented. Implementation should be carried out under strict control, following which an analysis of the work done should be carried out. If something didn’t work out or better ideas appeared during the control process, then it is necessary to make changes to the plan and again the same circle: implementation, control, analysis.

Everything would be fine, but how will the commission know that you have a similar scheme in place? Of course, more paperwork. Therefore, every step and every point of this golden rule should be displayed in graphs, tables and other internal documents your company.

In addition, the ISO 9001 quality management system states that the company must have packages of documents that reflect the policy, goals and management of achieving product quality.

Also, the company must have a quality control department and, of course, the heads of this department. Of course, to work on the quality of a product, one cannot do without working with consumer opinion. Therefore there must be continuous Feedback: consumer surveys, analysis of behavioral factors, information collection.

By the way, one paper about each process will not be enough. All this must be carried out at the enterprise constantly and continuously.

Conclusion

We hope that we were able to clarify the situation. Whether to obtain a certificate of compliance with ISO standards or not is up to you. But as practice shows, any preparation for certification has a beneficial effect on the company’s working environment. At these moments, maximum attention is paid to each process, which allows you to see what was missed earlier and improve the productivity of the company.

Quality Management System (QMS)- part of the management system aimed at quality (clause 3.5.4 of ISO 9000:2015), created to develop policies and goals, as well as processes to achieve these goals.

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

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

This is not only about maintaining the quality of each service or product at the level of compliance with consumer requirements, but also about a 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 standardization organizations (ISO member committees). The goal of ISO is the development of standardization principles and the design of standards based on them that promote integration processes in different fields and areas of activity.

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

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

Currently, the ISO 9000 series 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 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 called standards, although some of them are guidelines or collections of recommendations and only ISO 9001 sets 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 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 goals, external factors, products, experience, processes of a particular enterprise. Although 9001 defines what requirements must be implemented in the quality management system, it does not define how the enterprise must fulfill them.

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

Focus on the consumer (customer). The main focus in quality management is to satisfy customer requirements and strive to exceed their expectations. Therefore, the organization must in every possible way focus its attention on researching the needs and expectations of the consumer for the subsequent implementation of the obtained information in manufactured 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 goals. Achieving unity of purpose, direction, and engagement allows an organization to coordinate its strategies, policies, processes, and resources to achieve its goals.

Staff involvement. The implementation of the goals set for the enterprise is possible only if employees at all levels of the organization behave adequately. It is important for an organization that all personnel are competent, empowered, and involved in creating value. Competent, empowered, and engaged people enhance an organization's ability to create value.

Process approach. Relevant and predictable results are achieved more effectively and efficiently when activities are represented and managed as interconnected processes that function as a complete system. The quality management system consists of interconnected processes. Understanding how the system produces results, including all its processes, resources, controls and interactions, allows an organization to optimize its performance.

Improvement. Successful organizations have a constant focus on improvement. Improvement is important to an organization in terms of maintaining current levels of performance, responding to changes in internal and external conditions, and creating new opportunities.

Evidence-based decision making. Process continuous improvement must rely on data obtained through objective measurements of the actual state of the quality system and product quality. It is important to understand cause and effect 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 produce the desired results.

Relationship management. To achieve sustainable 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 high-quality growth should also be based on establishing mutually beneficial partnerships with suppliers. Achieving sustainable success is more likely when an organization manages its relationships with all 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. The use of ISO 9001 standards ensures that customers receive consistent products and services good quality, i.e. according to their requirements and expectations.

Confirmation of a successfully implemented quality management system is 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 assigned, work technology is followed, and there are operational instructions that are documented and known to all personnel , the procedure for monitoring the work performed and, of course, professional and well-trained personnel. In other words, an ISO 9001 certificate indicates that a company's quality system is capable of ensuring and improving the quality of its products and services.

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

The 1C company provides voluntary certification of franchise companies according to the ISO 9001:2015 standard and GOST R ISO 9001-2015.

1C:Franchisee certification is carried out by ISO accredited certification bodies. 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.

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

Building a quality management system is a rather labor-intensive process. Obviously, not all franchisee firms can approach certification at the same time, due to objective circumstances, such as company structure, regional characteristics, personnel training. But the 1C company encourages all 1C:Franchisee partners seeking to make their company competitive in the information services market to build a quality management system or put into operation its individual essential elements.

Having picked 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. Modern man, especially those who own or manage a business, need to 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 obtain a certificate, what advantages it provides and other issues will be discussed in detail below.

Quality

The word “quality” has firmly entered the vocabulary of every person. All standards provide different, comprehensive definitions. Quality in the life of an ordinary consumer is matching (or better yet exceeding) what he expects with what he receives. Whether it is services, food, clothing, household items or something else, the consumer expects them to bring him benefit or pleasure.

Since this 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 conclusions.

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

Quality checking

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

The second type of verification is affiliate verification. For example, when certain requirements are imposed on suppliers, failure to comply with which will result in termination of the cooperation agreement. Inspections can be carried out independently or with the involvement of third parties. For example, organizations conducting certification according to GOST standards or ISO 9001 standard.

Certification may be mandatory or voluntary. There is no need to talk about the possible difference in attitude towards the quality of the manufacturer in these types. Many products must undergo mandatory certification: children's products, perfumes, medicines, Computer Engineering, cars, etc. But mandatory certification does not interfere with completing the voluntary process and obtaining an ISO 9001 certificate.

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

What is it and when should you get a certificate?

A company can conduct voluntary certification at any time when it feels the need and strength to implement its plans. But still, GOST ISO 9001 recommends certification not when management decides to do it and issues a top-down directive, but when the entire company feels the importance and necessity. From practice it is clear that if the initiative comes from employees, then the certification process is easier, better and more effective.

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

What does an ISO certificate provide?

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’s time to get a kind of certificate of maturity, but not all management welcomes the changes, it’s worth introducing them to ISO 9001. What it is, what benefits it provides and how to get certified. It is important to remember that ISO is not only a “piece of paper” for trading and image, it is first and foremost effective tool management. If you use it to its full potential, and not formally, the results will not keep you waiting. There are organizations that “live” according to the ISO standard, but are in no hurry to get certified.

The most important thing in the ISO 9001 standard

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

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

Many managers will grin, since this principle has long been known. The ISO standard does not claim primacy, it only obliges us to comply with this simple truth at all times and in everything.

Principles of ISO 9001

The ISO 9001 standard consists of eight basic principles:

Certification procedure

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

2. Draw conclusions and make decisions to eliminate inconsistencies (don't forget about the role of management and staff involvement).

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

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

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

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

Remember that the certificate is valid for 3 years, and you must undergo surveillance audits annually. And, of course, comply with everything that has been outlined for the company, and fulfill all the obligations assumed upon joining 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:

A lot of paperwork. Reports, protocols, questionnaires and so on, but on the other hand, without them it is impossible to achieve control and an objective decision.

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

Not easy 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, “reshaping” the established system, services external consultant and a full-time quality specialist) is another reason to strive for real use of the quality system.

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

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The international standard for quality management systems ISO 9001:1994 replaced ISO 9001:2000, which was replaced by ISO 9001:2008 and, finally, ISO 9001:2015. ISO is an acronym that stands for International Organization for Standardization, that is, the International Organization for Standardization ISO. Its purpose is to support the development of standards and certification systems that are aimed at the development of management systems.

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

With the full implementation of a quality management system based on ISO 9001, the competitiveness of a business increases, and the enterprise also becomes more attractive to investors.

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

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

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

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

Adoption 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 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 requirements;
the need to consider processes in terms of “added value”;
obtaining results of process execution and effectiveness;
continuous improvement processes based on objective measurements.

A model of a process-based quality management system is depicted in the figure, which illustrates the interrelationship of the 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

November 15, 2008 International Organization ISO has published a new version of the international standard ISO 9001. ISO 9001:2008 replaces ISO 9001:2000, which applies to both commercial and public organizations in 170 countries.

In the new version of the 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 new version will not require major changes in the management system from organizations.

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 following 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.