International system of standards ISO (ISO) and its requirements. ISO International Standards System (ISO) and its requirements Benefits from implementation and certification

GOST R ISO 10007-2007

Group T59

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

Organisation management

CONFIGURATION MANAGEMENT GUIDELINES

Organization management.
Guidelines for configuration management

Introduction date 2008-06-01

Foreword

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On technical regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions"

Information about the standard

1 PREPARED by the Open Joint Stock Company "Research Center for Control and Diagnostics of Technical Systems" (OJSC "NITs KD") and the Technical Committee for Standardization TC 10 "Advanced Production Technologies, Management and Risk Assessment" on the basis of its own authentic translation of the standard specified in clause 4

2 INTRODUCED by the Department of Development, Information Support and Accreditation of the Federal Agency for Technical Regulation and Metrology

3 APPROVED AND PUT INTO EFFECT by the Order of the Federal Agency for Technical Regulation and Metrology of November 14, 2007 N 302-st

4 This International Standard is identical to ISO 10007: 2003, Quality management systems - Guidelines for configuration management.

The name of this standard has been changed relative to the name of the specified international standard to bring it in line with GOST R 1.5-2004 (subsection 3.5).

In the application of this International Standard, it is recommended to use, instead of the referenced International Standards, the corresponding national standards, details of which are given in Appendix B.

5 INTRODUCED FOR THE FIRST TIME

Information about changes to this standard is published in the annually published information index "National standards", and the text of changes and amendments - in the monthly published information indexes "National standards". In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the monthly published information index "National Standards". Relevant information, notice and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet

Introduction

The purpose of this International Standard is to improve the understanding of the configuration management process.

Configuration management is an activity aimed at applying technical and administrative control to the product life cycle process, product configuration items and data associated with product configuration.

The product configuration should be documented to ensure that the physical and functional requirements for the product are identified and traceable, and accurate data are available at all stages of the life cycle.

Configuration management depends on the size of the organization and the nature and complexity of the product.

Configuration management can be used to meet the product identification and traceability requirements specified in ISO 9001: 2000, Quality management systems - Requirements.

1 area of use

This International Standard provides guidance for the application of configuration management. The standard is intended to be used at all stages of the product life cycle from concept to disposal.

Before describing configuration management processes, which include planning configuration management, configuration identification, change management, configuration status accounting, and configuration auditing, responsibilities and authorities should be assigned.

The standard is not intended for certification or contractual use.

2 Normative references

This standard uses a normative reference to the following standard:

ISO 9000: 2005 Quality management systems. Fundamentals and vocabulary

3 Terms and definitions

This International Standard uses the terms and definitions from ISO 9000, as well as the following terms with the corresponding definitions:

3.1 change management change control product control action following the formal approval of product configuration data (see 3.9)

3.2 permission to deviate(concession): Authorization to use or release products that do not meet specified requirements.

Notes (edit)

1 Permission to deviate usually extends to the supply of nonconforming products and subject to agreed time or quantity limits for that product.

[cm. definition 3.6.11 of ISO 9000: 2005].

NOTE 2 The authorization to deviate does not affect the basic configuration (see 3.4) and includes the authorization to manufacture non-conforming products.

3 Some organizations use the terms waiver or waiver instead of authorization waiver.

3.3 configuration configurationrelated functional and physical characteristics of a product specified in product configuration data (see 3.9)

3.4 basic configuration baseline configuration validated product configuration data (3.9) that establishes the interrelated functional and physical characteristics of a product at a specified point in time and used as a reference throughout the life cycle of a product

3.5 config item configuration item: A configuration object (see 3.3) that performs a complete function.

3.6 configuration management configuration managementcoordinated actions to form and control a configuration

NOTE Configuration management typically includes support for technical and administrative activities related to product control and configuration requirements at all stages of the product life cycle.

3.7 configuration status reporting configuration status accounting records and reports in the prescribed form of product configuration data (see 3.9), the status of proposed changes and the status of implementation of approved changes.

3.8 responsible executor dispositioning authorityperson or group of persons with the requisite authority and responsibility for making a configuration decision (see 3.3)

Notes (edit)

1 The executives are also referred to as the "configuration management board".

NOTE 2 Relevant stakeholders inside and outside the organization should be represented as responsible agents.

3.9 product configuration data * product configuration informationrequirements for the design, production, verification, operation and maintenance of a product
________________
* Refer to the product configuration documentation for data.

4 Responsibility for configuration management

4.1 Responsibility and authority

The organization shall identify and describe the responsibilities and authorities associated with the implementation and verification of the configuration management process. Consider the following:

- the complexity and nature of the product;

- requirements for products at various stages of the life cycle;

- the boundaries between the various activities directly involved in the configuration management process;

- other interested parties inside and outside the organization;

- identification of responsible executors for verification of actions for the implementation of the configuration management process;

- identification of responsible executors.

4.2 Responsible person

Prior to approving changes, the executive officer, within his or her authority, must verify the following:

- the need for the proposed change and the acceptability of its consequences;

- duly documenting and classifying the change;

- the adequacy of the planned actions to introduce changes to documents, hardware and / or software.

5 Configuration management process

5.1 General

To increase the efficiency of the process, it is important that configuration management activities are coordinated.

The configuration management process should be focused on customer requirements for the product and should take into account specific manufacturing conditions. The configuration management process should be detailed in the configuration management plan. The configuration management plan should specify all the procedures defined in the design and the extent to which they are applied at all stages of the product life cycle.

5.2 Planning configuration management

Configuration management planning is the foundation of the configuration management process. Effective planning allows you to coordinate configuration management activities in specific situations at all stages of the product life cycle. The output of the product configuration management planning process is the configuration management plan.

The product-specific configuration management plan should:

- be documented and approved;

- be controlled;

- identify the configuration management procedures used;

- include references to relevant applicable processes in the organization (if applicable);

- contain an updated description of the responsibility and authority of the responsible persons to maintain the configuration management process in working order at all stages of the product life cycle.

A configuration management plan can be a stand-alone document, part of another document, or it can be composed of multiple documents.

In some situations, an organization needs a vendor to provide its configuration management plan. The organization can save these plans as separate documents or include them in its own configuration management plan.

Appendix A provides examples of the structure and content of a configuration management plan.

5.3 Configuration identification

5.3.1 Product structure and selection of configuration items

The selected configuration items and their relationships should describe the structure of the product.

Configuration items should be identified using established criteria. Configuration items should be selected so that functional and physical characteristics can be controlled autonomously to achieve full performance of the item's ultimate function.

When choosing a criterion, it is necessary to consider:

- the criticality of configuration items in relation to risk and safety;

- the use of new or modified technologies, design or development;

- relationships with other configuration items;

- conditions for purchasing configuration items;

- maintenance and service of products.

The number of selected configuration items should be optimal for product management. The selection of configuration items should be initiated as early as possible in the product life cycle. Configuration items need to be reviewed for product improvements and upgrades.

5.3.2 Product configuration data

Product configuration data includes product descriptions and performance characteristics. Typically, product configuration data includes requirements, specifications, design documents, parts list, software documentation, models, test requirements, maintenance and operating instructions.

Product configuration data must be relevant and traceable. The product configuration data must be assigned a unique identifier (eg a numeric code). Identification should be clear and unambiguous, and should ensure that configuration items are properly managed, be based on the organization's existing data management identity, and include a document and data revision status.

5.3.3 Basic configuration

The baseline configuration consists of approved product configuration data, which is data for defining product requirements. The base configuration and approved changes to it represent the current approved configuration.

A baseline configuration should be established whenever necessary during the product life cycle when defining recommendations for further activities.

The level of detail with which a product is defined in a baseline configuration depends on the degree of control required.

5.4 Change management

5.4.1 General

After the initial establishment of product configuration data, all product configuration changes need to be managed. The potential impact of changes, customer requirements, and baseline configuration affects the degree of control required to enact a proposed change or apply a deviation permit.

The change management process should be documented and should include:

- a description of the process, supporting documents and change records;

- the classification of the change in terms of its complexity, required resources and planning for implementation;

- an assessment of the consequences of the change;

- a detailed description of how the change should be prepared;

- a detailed description of how the change should be implemented and verified.

5.4.2 Initiation, identification and documents required for changes

The change can be made by an organization, a customer, or a supplier. Before submitting the change to the designated executive for evaluation (see 4.2), all change proposals shall be identified and documented. The proposed changes should include the following:

- configuration item (s) and associated information (s) that need to be changed, including a detailed description of their name and current revision status;

- a description of the proposed change;

- a detailed description of other configuration items or information that could be affected by the change;

- the interested party who submitted the proposal and the date of its preparation;

- the reason for the change;

- change category.

The status of the change procedure and related decisions should be documented. A typical method for documenting change is to use a standard form that is assigned a unique identification number for ease of identification and traceability.

5.4.3 Assessment of change

5.4.3.1 The proposed change shall be assessed and documented. The assessment should be based on the complexity of the product, the category of change, and should include:

- the technical advantages of the proposed change;

- risks associated with the change;

- potential impact on the contract, schedule and costs.

5.4.3.2 In determining the impact of a change, the following factors should also be considered:

- established legal and regulatory requirements;

- the interchangeability of configuration items and the need to re-identify them;

- the relationship between configuration items;

- test, control and manufacturing methods;

- inventory and purchases;

- activities related to supplies;

- customer service requirements.

5.4.4 Allocation of responsibilities

A process should be established for the assignment of responsibilities for the introduction and implementation of a change, which includes the appointment of a responsible executive (see 4.2) for each proposed change. However, the category of the proposed change should be taken into account.

After evaluating the proposed change, the responsible executor should review the evaluation and decide on the allocation of responsibilities for submission and implementation.

The assignment of responsibilities must be recorded. The assignment of responsibilities should be communicated to interested parties inside and outside the organization.

5.4.5 Executing and verifying the change

Making an approved change usually involves:

- changes in product configuration requirements that are in the interest of interested parties;

- actions taken by relevant interested parties (inside and outside the organization) associated with the change.

Once the necessary actions have been taken, their compliance with the approved change shall be verified. This verification should be recorded to ensure traceability.

5.5 Accounting for configuration status

5.5.1 General

Configuration status recording activities result in records and reports of product requirements and product configuration data.

The organization shall maintain configuration status records throughout all stages of the product life cycle to maintain and ensure an effective configuration management process.

5.5.2 Records

5.5.2.1 Configuration status records shall be maintained during configuration identification and change management activities. These records are essential to provide visibility, traceability, and effective management of configuration improvements. They usually include the following:

- detailed data on the product configuration (identification number, name, date of entry into force, revision status, history of changes and their inclusion in the basic configuration, etc.);

- product configuration (part number, product design or design status);

- the status of acceptance of new product configuration data;

- procedures for making changes.

5.5.2.2 Specified product configuration data shall be recorded in a manner that can be identified by cross-referencing and relationships necessary to accomplish specified reporting (see 5.5.3).

5.5.2.3 To ensure the integrity of product configuration data and the basis for change management, it is recommended that configuration items and their associated data are aligned with external influences, including:

- meet the required conditions (hardware, software, data, documents, drawings);

- provide protection against damage or unauthorized changes;

- provided disaster recovery tools;

- allowed repairs.

5.5.3 Reports

For configuration management purposes, type of change reports should be reported. These reports can cover both individual configuration items and the entire product.

Typically, reports include:

- a list of product configuration data included in the baseline configuration;

- a list of configuration items and their basic configuration;

- a detailed description of the current revision status and history of changes;

- the status of reports on changes and permissions to deviate;

- a detailed description of the status of the delivered and repaired product (or its elements) with identifiers to ensure traceability and the status of their revision.

5.6 Configuration audit

Configuration audits shall be performed in accordance with registered procedures to determine product conformity with specified requirements and product configuration data.

There are usually two types of configuration auditing:

- configuration functional audit (formal examination to verify that a configuration item has achieved the functional and performance characteristics specified for it in the product configuration data);

- physical configuration audit (formal examination to verify that a configuration item has achieved the physical characteristics specified for it in the product configuration data).

A configuration audit may be required prior to formal acceptance of a configuration item. Configuration audit is not a substitute for other forms of verification, analysis, testing, or control, but may take into account the results of these activities.

Appendix A (reference). Structure and content of a configuration management plan

Appendix A
(reference)

A.1 General

The structure of the configuration management plan should include the individual clauses discussed in A.2-A.7 of this annex. A.2 to A.7 also provide guidance on the content of the clauses.

A.2 Introduction

The configuration management plan should include an "introduction" section containing general information. The introduction usually describes:

- the purpose and scope of the configuration management plan;

- a description of the product configuration and its element (s) to which the plan applies;

- a schedule with the deadlines for the main types of configuration management activities;

- a description of the configuration management tools (eg information technology);

- documents used in conjunction with the plan (eg supplier configuration management plan);

- a list of required documents and their relationship.

A.3 Policy

The configuration management plan should contain a detailed description of the configuration management policy, which should be agreed with the customer or suppliers. The policy is the basis for the main configuration management activities within a contract, such as:

- development and communication of the policy for the management of configuration and related activities;

- organization of work, distribution of responsibilities and authorities of interested parties;

- ensuring the necessary qualifications and training of personnel;

- establishment of criteria for selection of configuration items;

- frequency of release, distribution and management of reports within the organization and at the consumer;

- establishment of terminology.

A.4 Configuration identification

The configuration management plan should contain detailed details of:

- family tree of configuration items, specifications and other documents;

- numbered symbols adapted for specifications, drawings, deviations and changes;

- the method for identifying the status of the revision;

- the baseline configuration to be established, schedule and type of product configuration requirements;

- method of use and distribution of serial numbers or other methods of identification and traceability;

- implementation of procedures for the development of requirements for product configuration.

A.5 Change management

- the relationships of the executives (see 4.2) of the organization with other interested parties;

- change management procedures prior to establishing the baseline configuration in the contract;

- the methods used in the change procedures (including procedures for customer or supplier initiated change) and when dealing with deviations.

A.6 Accounting for configuration status

The configuration management plan should contain:

- methods of collecting, registering, processing and maintaining in working order the data necessary for maintaining and recording configuration status records;

- definition of content and form (s) for complete accounting of reporting on the status of the configuration.

A.7 Configuration audit

The configuration management plan should contain:

- a list of audits to be conducted, their frequency in accordance with the project schedule;

- configuration audit procedures used;

- the credentials of relevant interested parties (inside and outside the organization);

- determination of the form of audit reports.

Appendix B (informative). Information on the compliance of national standards of the Russian Federation with reference international standards

Appendix B
(reference)

Table B.1

Electronic text of the document
prepared by JSC "Kodeks" and verified by:
official publication
M .: Standartinform, 2008

The ISO 9000 series of standards describing 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; on the basis of these standards, national standards organizations can develop national counterparts, in particular, in Russia these are GOST R ISO 9000 series standards.

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 seeking recognition of their quality management system can use this International Standard for independent assessment, or they can be used to demonstrate that contractual requirements have been met.

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

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 specifies the requirements that organizations' quality management systems must comply with. Being general and universal, the ISO 9001 standard can be applied to any business, suitable for all organizations regardless of the field of activity, size, form of ownership, geographic location.

ISO 9004 - Recommendations for performance improvement. The standard contains recommendations based on eight quality management principles that have been developed for managers to improve the organization's performance and meet the requirements of all interested parties.

ISO standards are structured in such a way that they can be easily integrated into the existing management system in the organization in order to meet and anticipate the requirements and expectations of customers. Due 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 of the most commonly used standards that define the requirements for various management systems of organizations, ISO 9001 has become much easier to comply with standards such as ISO 14001 (requirements for environmental management systems), ISO 45001 (requirements for health and safety management systems), ISO 39001 (requirements for road safety management systems), ISO 27001 (requirements for information management systems security), ISO 20000 (IT service management system requirements) 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 the transparency and clarity of the performed functional duties;
enrichment of personnel knowledge in the field of quality;
reducing costs by increasing productivity, improving the quality of products, services provided and reducing the level of defectiveness;
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 world markets

Taking a box in hand, the consumer sees a lot of abbreviations that are not always known to him. In addition, everyone around is talking about the quality of goods and services, certifications and guarantors. A modern person, especially a business owner or manager, should 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 is it, how to get a certificate, what benefits it gives and other issues will be discussed in detail below.

Quality

The word "quality" is firmly embedded in the vocabulary of every person. All standards give different, capacious definitions. The quality in the life of an ordinary consumer is the correspondence (or even better, exceeding) what he expects to what he receives. Whether it is services, food, clothing, household items, or something else, the consumer expects them to be of benefit or pleasure.

Since this attitude is too subjective, special criteria have been developed, the compliance with which will determine the degree of quality. Various independent structures can confirm the conformity of goods or services, while issuing their opinion.

The consumer is primarily interested in the quality of goods or services, 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 an internal review. When a department or certain employees assess the work and the goods produced. Of course, you can doubt the objectivity of such indicators, but you should not completely abandon them.

The second type of verification is partner verification. For example, when certain requirements are imposed on suppliers, non-compliance with which will entail termination of the cooperation agreement. Checks can be carried out independently or with the involvement of third parties. For example, organizations that carry out certification in accordance with GOST or ISO 9001 standards.

Certification can be mandatory or voluntary. There is no need to talk about the possible difference in the attitude to the quality of the manufacturer with these types. Many products must undergo mandatory certification: baby products, perfumes, medicines, computers, cars, etc. But compulsory certification does not prevent you from going through the voluntary and getting the ISO 9001 certificate.

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

What is it and when to get a certificate

The company can conduct voluntary certification at any time when it feels the need and strength to implement the plan. But all the same, GOST ISO 9001 recommends certification not when the management decides to do it and lowers the directive “from top to bottom”, but when the whole company feels the importance and necessity. It can be seen from practice that if the initiative comes from employees, then the certification process is easier, better and more efficient.

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

What does the ISO certificate give

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

If your company comes to the conclusion that it is time to receive a kind of maturity certificate, but not all management welcomes change, it is 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 of all, an effective management tool. If you use it at full capacity, and not formally, the results will not be long in coming. There are organizations that "live" according to the ISO standard, but are in no hurry to get certified.

The most important thing in the ISO 9001 standard

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

The main thing to remember and always be guided by in a company where the ISO 9001 quality system is being implemented is the management principle "Plan, Do, Check, Act". Any actions from the area of certification should be coordinated and "run" through this sequence.

Many managers will chuckle because this principle has long been known. The ISO standard does not claim to be superior, it only obliges to observe this simple truth always and in everything.

ISO 9001 principles

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 about nonconformities (do not forget about the role of leadership and staff involvement).

5. If the results of the verification are positive, apply to the certification body.

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

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

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

Remember that the certificate is given for 3 years, and you need to undergo control audits annually. And, of course, comply with everything that is outlined for the company, and fulfill all the obligations assumed by joining the community of certified organizations.

Disadvantages of ISO

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

A lot of paperwork. Reports, protocols, questionnaires and so on, but on the other hand, without them, you cannot achieve control and an objective decision.

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

Difficult to implement, weak, unprepared companies reduce certification to a formal event (in this case, the certificate costs them three times more than it would cost in real use).

Cost (costs of certification, “redesigning” an established system, external consultant and in-house quality specialist services) is another reason why it is worth striving to actually use the quality system.

You will learn:

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

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

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

What is ISO 9001 standard?

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

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

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

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

Based on the provisions of ISO 9001, the company creates a QMS documentation system that regulates all actions that have something to do with the provision of services and the production of material goods. The detail of the documentation depends on the needs of a particular enterprise, the only condition is that it must comply with the requirements of the standard. The developed documentation should be rotated with strict adherence to all the described procedures. The management of the enterprise must exercise leadership in all major issues. All information important for the successful functioning of the QMS must be carefully studied and analyzed.

Product certification: mandatory and voluntary, schemes

Features of ISO 9001

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

Strict customer focus... The main goal of QMS implementation is to maximize customer satisfaction and work for the future. The organization should conduct ongoing research into the needs and expectations of customers. In the future, the information obtained is used in the production of products.
Involvement of personnel... To achieve all the goals set, it is necessary that each employee knows his place in the production of the product.
Process approach... QMS includes many interrelated processes. Understanding how this system functions, with all its processes, resources and means, allows an enterprise to optimize its activities as much as possible and get an effective result.
Improvement... Each organization at a certain stage seeks to improve its activities. This is an inevitable consequence of the reaction to the emergence of new opportunities and changes in external and internal circumstances.
Certification... If the manufactured product meets all the requirements, an independent body can provide a certificate of conformity, which will increase the recognition and prestige of the product on the market.

Differences between ISO 9001: 2015 and earlier versions

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

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

Why standardization is needed

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

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

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

Blue ocean strategy: how to enter the market with a new product and occupy your niche

Implementation of the ISO 9001 quality management system at the enterprise

The TC 176 ISO team, which developed the ISO 9000 standards, proposed the following procedure for the implementation of a quality management system according to ISO 9001:

Try to define goals. Why do you need to implement a QMS? Perhaps you want to increase product confidence, cut costs, reach a new level and a new market?
Try to articulate what others expect of you. Others are not just consumers, there may be others as stakeholders - your suppliers, your organization's shareholders, your state, your community as a whole.
Find all the information you need about ISO 9001:
- General information
- Supporting information that can be consulted directly on the ISO website
- Study the world experience of using ISO 9001. In Russia and the CIS, the necessary information can be found in the magazines "Standards and Quality" and "Methods of Quality Management".
Explore the QMS guides:
- ISO 10006 - Guidelines for quality assurance in project management
- ISO 10007 - Guidance on configuration management
- ISO 10014 - Guidance for economic management
- ISO 10015 - Guidelines for training and quality management
- ISO / TS 16949 - studied as needed. Particular requirements for the application of ISO 9001 in the production of cars and auto parts
- ISO 19011. Guidelines for auditing a QMS.
Assess whether your management system complies with ISO 9001. This can be done on your own or by contacting a third party company for a thorough audit.
Explore the ISO 9001 requirements for your business. Make sure your quality management meets these requirements. In particular, for the following processes:
- Manufacturing and maintenance
- Procurement
- Design / development
- Consumer communication
- Monitoring of observation and measurement instruments
If inconsistencies are found and workflows are further improved, a plan should be drawn up to eliminate them. In the process - allocate resources, assign roles and responsibilities of performers, draw up a work schedule.
Follow your work plan. Follow all the developed activities and carefully record the progress according to the schedule.
Conduct periodic internal reviews and audits. ISO 19011 can be used to create guidelines for auditing and assessing the qualifications of auditors.
Decide to what extent you need formal certification. There may be several reasons for obtaining a certificate of conformity:
- Meeting the requirements of the market or consumers
- Meeting the requirements of various regulatory organizations
- Satisfaction of obligations under a contract with foreign or national partners
If certification is needed, contact an accredited certification body. After a thorough audit, you will be issued a certificate of compliance of the quality management system with the requirements of ISO 9001.
Regardless of the availability of a certificate, continue to improve and develop your business.

How is certification for compliance with the ISO 9001 standard

The final stage of QMS implementation is obtaining an official certificate of conformity ISO 9001. Certification takes place with the participation of bodies accredited within the framework of a 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 on the Rosstandart website. If it is planned to be carried out in one of the voluntary systems, the parent body itself determines one of the accredited certification organizations for the applicant.

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

Certification can be called an external audit. An independent party assesses how successfully the production control system is functioning. This check takes place in two stages - documentary and field assessment by an independent expert of the certification body and a specialist of Rosaccreditation or another certification system.

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

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

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

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

5 rules for building a successful business that others don't know about

Documentation according to ISO 9001

Documentation is considered one of the main aspects of meeting ISO 9001 international standards. The responsibilities of the organization include:

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

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

In conditions of rather tough competition, the introduction of certain guarantees of quality is fundamental and decisive in making the choice by the buyer or consumer of the services and products of a particular company. At the same time, 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 ISO 9001 standard, have combined many years of experience in most countries in the world in the field of quality systems management and are the latest versions of assessing the criteria for managing all work and production processes at enterprises.

ISO 9001 certificate Is an official document confirming the full compliance of the current quality management system with 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 the 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;
management (management) of resources;
release of products (services);
analysis, measurement and improvement.

The first three sections of the standard are service ones and do not contain requirements and norms.

The main goal of the ISO 9001 standard is to actively stimulate the correct organization of various production processes and the work of the company as a whole in order to comply with specific legislative requirements and to the fullest satisfaction of the wishes and needs of consumers and partners.

The implementation of the QMS on the basis of obtaining 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 for better, efficient and correct performance of work;
the company has predetermined processes that affect the quality of products;
all production processes are regulated and provided with all the necessary resources;
conditions have been created for the competent implementation of the production infrastructure and environment, as well as high-quality work of the company's employees;
the system of preliminary collection and further analysis of information about production processes, customer and product satisfaction, is optimally adjusted and provides objective information for the timely adoption of the necessary decisions to improve the work of personnel and the enterprise itself;
a motivated system focused on quality has been created;
work processes have been organized with a subsequent focus on the expectations of the end consumer, including the introduction of the latest technologies that improve 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 workflow;
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 is fully responsible for it;
the company sets and develops quality goals and regularly plans to achieve them;
the company has a well-functioning system of responses to claims and complaints made by buyers and customers (development of effective measures to eliminate shortcomings and failures);
a continuous improvement process is in place to ensure sustainable development of the company.

For each organization, the project for the development of quality systems in accordance with the ISO 9001 standard is unique and is determined based on its size, types of activities, the presence of a branch network, features of the organizational structure, the level of development of the existing and operating 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 services or products, but gives only a set of rules and regulations 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 of technical specifications, schedules, administrative registration of work, project management plan;
assessment of the current quality management system (QMS) of the organization;
conducting training and special trainings for employees and responsible officials in the company;
regulation of processes and determination of the process model of the QMS;
development of QMS documentation and organizational management structure;
creation of 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, bring a number of economic and strategic advantages for business owners.

Key Benefits of Owning an ISO 9001 Certificate

The high level of competitiveness of an enterprise and its products or services in the market is directly influenced by regular and continuous improvement of the company's activities as a whole. This ensures an even improvement in the quality of products and services offered. The main 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.

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

achieving a high level of quality allows you to reduce the total cost of production, as well as reduce the cost of defective products;
significant improvement and optimization of current business processes;
increasing the level of cooperation;
active improvement of the quality of staff work;
the ability to streamline the activities of structural divisions of enterprises;
the possibility of obtaining government orders and the company's entry into the international external consumer market;
increasing confidence on the part of financial and insurance organizations, which affects 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 product or service provided. Even these two basic parameters can maximize and increase the company's profits. In this regard, the ISO 9001 standard is a worthy guarantee of the manufacturer's success, longevity and prosperity.

Standardization in accordance with ISO 9001 does not replace 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 current version of ISO9001: 2008 Quality Management Systems. Requirements." This is the only conformance standard that can be certified. This procedure is not mandatory certification and is carried out at the request of the applicant.

It should be noted 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 of the world. The use of ISO 9001: 2008 guarantees the buyer a high quality product and service, which leads to increased sales growth and business success. In addition, the implementation of the ISO 9001: 2008 standard can help to check the operability of the entire system as a whole, to establish its greater effective effectiveness, motivate, involve top management and reduce losses.

An important feature of ISO 9001: 2008

An important feature of the ISO 9001: 2008 standard is that it does not imply uniform quality management systems and related documentation describing them. Therefore, having implemented a quality management system based on the ISO 9001: 2008 standard, you can be sure of an exceptional individuality and see for yourself how flexible this system is. Indeed, 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, the external environment, changes or risks associated with this environment.

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 of the world

The ISO 9001: 2008 standard is aimed at applying a process approach in the development, implementation, and subsequently improving the effectiveness of the quality management system in order to increase the satisfaction of the end user through forecasting and meeting its requirements. The benefits of a process approach are countless. First of all, it 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, improve the process by objectively evaluating 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 an organization can allow the application of the “Plan - Do - Check - Act” cycle. This cycle can be briefly described as:

planning (plan) - the development of goals and processes necessary to achieve results in accordance with customer requirements and the organization's policy;
implementation (do) - implementation of processes;
check - the ongoing monitoring and measurement of processes and products against the policy, objectives and requirements for the product and reporting the results;
action (act) - taking action to continually improve the performance of processes.

The timing and cost of implementing the ISO 9001: 2008 standard depends on the individual characteristics of your type of organization and the degree of functioning of the system's actions. In most cases, this does not take more than 2 weeks. If you are still in doubt, you can order a free consultation of our specialists ( there should be some kind of "press" button). With their help, you can choose a certification system that is best suited for your organization.

And let the absence of standard prices not scare you, it only means that we approach each case separately, weigh the exclusivity of the situation and take all possible measures to optimize the processes of implementing the ISO 9001: 2008 standard. By contacting us, you are guaranteed to receive a unique offer that allows you to improve existing processes and establish thorough control, and most importantly, increase the position of your organization / company in the market.

Upon completion of the work, you will receive from us:

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

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