What is the iso 9001 system. The international system of standards ISO (ISO) and its requirements. What does an ISO certificate give?

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

The purpose of ISO 9001 is to promote the application of a process approach for developing, implementing and improving the effectiveness of a quality management system and increasing customer satisfaction by meeting customer requirements.

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

  • ISO 9001-2015. Quality management systems requirements.
  • ISO 9000-2015. Quality management systems. Basic provisions. Dictionary.
  • GOST R ISO 9001-2015 (date of last change: 07/30/2018). Quality management systems. Requirements.
  • GOST R ISO 9000-2015 (date of last change: 07/30/2018). Quality management systems. Fundamentals and vocabulary.

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

ISO 9001 / GOST R ISO 9001 requirements

The ISO 9001 standard is based on 7 principles:

  • consumer orientation
  • leadership
  • attraction of human resources
  • process approach
  • improvement
  • evidence-based decision making
  • relationship with clients and partners

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

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

Scope of ISO 9001 / GOST R ISO 9001

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

Which companies implement ISO 9001 / GOST R ISO 9001

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

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

Internal benefits of implementing ISO 9001

  • Efficient and efficient achievement of planned results
  • The ability to manage the interactions and relationships of processes in the system and, as a result, improve the performance of the organization as a whole
  • Ensure processes are properly resourced and managed

External benefits of implementing ISO 9001

  • Ability to consistently deliver products and services that meet customer requirements
  • Increasing customer confidence
  • Opportunities to enter new, including international, markets, expand existing sales markets
  • Additional benefits when participating in important tenders

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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 called standards, although some of them are guidelines or guidelines and only ISO 9001 specifies 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.

Today, in the context of expanding international trade, improving product quality, enterprises face the problem of implementing ISO 9000 series standards and transitioning from integrated quality management systems to international standards.

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, 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 manufacture 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. Another principle of TQM serves this process - the “supplier-customer” principle within the enterprise, which helps to eliminate losses, increase responsibility, eliminate disunity and create a normal internal climate in the team.

The ISO 9001 quality management system is one of the items in 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 described as a collection of management definitions. And ISO 9001 contains advice for practical application.

What is ISO 9001 Quality Management System for?

Any fact must be confirmed officially, and in our time 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 IP Vasechkin, who sells clothes on the market. This certificate is only required if your customers or suppliers are interested in it. In some business areas, ISO certification is mandatory. This applies to the economic and public spheres.

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

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

What does ISO 9001 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, the basic principle of management and the ISO standard is the simple truth: Plan, Implement, Control, Analyze (PDCA). This means that all actions of your enterprise must be clearly planned and implemented. Implementation should take place under strict control, as a result of which an analysis of the work done is carried out. If something did not work out or more perfect ideas appeared in the process of control, 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? Of course, again papers. Therefore, every step and every point of this golden rule should be displayed in graphs, tables and other internal documents of your company.

In addition, in the ISO 9001 quality management system there is a provision 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 should be continuous feedback: consumer surveys, analysis of behavioral factors, collection of information.

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

Conclusion

We hope that we were able to clarify the situation. It is up to you to decide whether to receive an ISO certificate of conformity or not. But as practice shows, any preparation for certification has a beneficial effect on the working environment of the company. At these moments, the maximum amount of attention is paid to each process, which allows you to see what was missed earlier and improve the productivity of the company.


You will learn:

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

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

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

What is the ISO 9001 standard?

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

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

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

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

Based on the provisions of ISO 9001, the enterprise creates a QMS documentation system that regulates all activities that are somehow related to the provision of services and the production of tangible goods. Detailed documentation depends on the needs of a particular enterprise, the only condition is that it must comply with the requirements of the standard. The developed documentation should be rotated with strict implementation of all the described procedures. The management of the enterprise should exercise leadership in all major issues. All information important for the successful functioning of the QMS must be carefully studied and analyzed.

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Features of ISO 9001

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

  1. Strict customer orientation. The main goal of the QMS implementation is the maximum satisfaction of the needs of consumers and work for the future. The organization should continually conduct research into customer needs and expectations. In the future, the information obtained is used in the production of products.
  2. Staff involvement. To achieve all the goals, it is necessary that each employee knows his place in the production of the product.
  3. Process approach. QMS includes many interrelated processes. Understanding how this system functions, with all its processes, resources and means, allows the enterprise to optimize its activities to the maximum and obtain an effective result.
  4. Improvement. Every organization strives to improve its performance at some stage. This is an inevitable consequence of the reaction to the emergence of new opportunities and changes in external and internal circumstances.
  5. Certification. If the manufactured product meets all the requirements, an independent body can provide a certificate of conformity, which will increase the recognition and prestige of the product in the market.

Differences of ISO 9001:2015 from earlier versions

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

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

Why standardization is needed

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

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

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

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Implementation of ISO 9001 quality management system at the enterprise

The ISO TC 176 team that developed the ISO 9000 standards proposed the following procedure for implementing a quality management system according to the ISO 9001 standard:

  • Try to set goals. Why do you need to implement QMS? Perhaps you want to increase product credibility, reduce costs, reach a new level and a new market?
  • Try to articulate what others expect of you. Others are not only customers, but others can be stakeholders - your suppliers, the shareholders of the organization, the state, the society as a whole.
  • Find all the information you need about ISO 9001:
    • General information
    • Supporting information, which can be obtained directly from the ISO website
    • Study the world experience of using ISO 9001. In Russia and the CIS, the necessary information can be found in the magazines "Standards and Quality" and "Quality Management Methods".
  • Explore QMS guides:
    • ISO 10006 - Guidelines for quality assurance in project management
    • ISO 10007 - Configuration Management Guide
    • ISO 10014 - guidance on economic management
    • ISO 10015 - A guide to training and quality management
    • ISO/TS 16949 - studied if necessary. Particular requirements for the application of ISO 9001 in the manufacture of vehicles and auto parts
    • ISO 19011: Guidelines for the verification of a QMS.
  • Assess the compliance of your management system with the requirements of ISO 9001. This can be done by yourself or by hiring an external company for a thorough audit.
  • Review the requirements of ISO 9001 related to manufacturing activities. Make sure your quality management meets these requirements. In particular, for the following processes:
    • Production and maintenance
    • Procurement
    • Design / development
    • Communication with the consumer
    • Control of means of observation and measurement
  • If inconsistencies are found and work processes are further improved, a plan must be made to eliminate them. In the process - to allocate resources, distribute the roles and responsibilities of performers, draw up a work schedule.
  • Follow your work plan. Carry out all the developed activities and carefully record the progress according to the schedule.
  • Conduct periodic internal reviews and audits. The ISO 19011 standard can be used to create guidelines for auditing and evaluating the qualifications of auditors.
  • Decide to what extent you need official certification. There are several reasons for obtaining a certificate of conformity:
    • Satisfying the requirements of the market or consumers
    • Satisfying the requirements of various regulatory organizations
    • Satisfaction of obligations under an agreement with foreign or national partners
  • If certification is needed, contact an accredited certification body. After a thorough audit, you will be issued a certificate of conformity of the quality management system with the requirements of ISO 9001.
  • Regardless of whether you have a certificate, keep improving and growing your business.

How is ISO 9001 certified?

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

The legislation does not prohibit the involvement of third-party consulting companies that help with the creation of new control mechanisms, the development of documents and certification. Thanks to professionalism and delayed mechanisms, consulting firms significantly speed up and simplify the process.

Certification can be called an external audit. An independent party evaluates how well the product control system functions in the production. This verification takes place in two stages - a documentary and on-site assessment by an independent expert of the certifying body and a specialist from Rosaccreditation or another certification system.

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

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

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

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

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ISO 9001 Documentation

One of the main aspects of meeting the international standards ISO 9001 is documentation. The responsibilities of the organization include:

  1. Definition of the Quality Policy. It represents the main directions and goals of the enterprise in the field of quality, developed and formally formulated by the management of the organization. In the absence of a detailed policy, the firm's performance in the field of quality is uncertain. In turn, a developed policy enables employees and other stakeholders to get a clear idea of ​​​​how management relates to the quality of the product being released.
  2. Definition of Quality Objectives. This is a hierarchical structure. At the top level are the overall goals of the enterprise. Goals are revealed from top to bottom, to the level of divisions, departments, or even individual employees. At the same time, if the ISO 9001 quality system is just being developed, such a level of detail will only hurt: appropriate mechanisms will be required to obtain reliable data on the achievement of goals.
  3. Drafting of the Quality Manual- a document that discloses the quality management system. The document may contain or refer to QMS procedures established to manage activities that affect quality within the organization. Serves to facilitate the management of all procedures and activities of the enterprise in the field of quality.
  4. Document management of the quality management system. Includes the following steps:
    1. Creation of a document, from its planning to implementation and registration.
    2. Use and storage of the document
    3. Updating, including changes and approvals.
    4. Cancellation, transfer to storage, destruction of the document.
  5. Records management. A record is a document that contains the results achieved and other evidence of the work done.
  6. Internal audits, with the help of which the management of the enterprise controls the compliance of work and results in the field of quality with the requirements of ISO 9001 and the requirements of the enterprise. The results of the internal audit are carefully analyzed by the management and enable the company to declare compliance with the quality standard.
  7. Corrective actions. Includes a series of actions and procedures that are taken to eliminate the causes of non-compliance with the quality of the standard. When developing, it should be taken into account that in quality management, non-compliance with the standard is understood as any deviation from the established requirements, both for the worse and for the better. Therefore, each case is considered separately.
  8. Preventive actions.

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

 

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