the Russian Federation Order of CJSC "TsNIIPSK named after Melnikov"

STO QMS 07-2004 Quality management system. Organization standards. The order of development, construction and design

3.2 STO QMS: Quality Management System Organization Standard;

3.3 standardization object: Products, process or service subject to or subject to standardization (GOST R 1.4-2004, 4.2).

4 General provisions

4.1 The standard of the organization establishes a set of norms, rules, requirements for the object of standardization, is approved by the director of the institute and is mandatory for use in this organization.

4.2 Based on the main directions of the institute's production activities, the objects of standardization are:

• design standards, general principles and recommendations for the design of building steel structures and their connections, basic provisions for calculation, principles and methods for calculating structures, composition and rules for the design of working drawings, terminology requirements;
• processes for performing work at the stages of the life cycle of structures, buildings and structures, including the manufacture and installation, transportation and storage of structures, testing and acceptance of structures and structures, examination of the technical condition of structures, their repair and reconstruction, safety expertise, technical and architectural supervision;
• processes of organization and management of production, management processes in order to constantly improve the performance and improve the current quality management system (QMS).

The list of objects of standardization, according to which the Institute's standards can be developed, is given in Appendix A.

4.3 The standards of the organization can also be developed to ensure compliance with the requirements and application of technical regulations, international, regional and national Russian standards and to disseminate and use the results of scientific research.

4.4 The development of standards is carried out taking into account the national standards of general technical systems, as well as other national standards that apply to the relevant products, works or services.

4.5 The development of standards is entrusted to the relevant departments and services of the institute according to their subject, methodological guidance on the construction and execution of standards and coordination of standardization work - to the standardization department.

Highly qualified specialists of the institute of the relevant area of ​​work and third-party organizations can be involved in the development of standards as co-executors on an equal basis.

5 Organization standards development process

5.1 The development of organization standards is carried out in accordance with the annual Program for the development and revision of standards, approved by the director of the institute, which determines the responsible executors and co-executors of the work, the development timeframe, and a brief description of the content of the standards planned for development.

Responsible executors are appointed from among the leading specialists of the institute on the relevant subject.

5.2 Depending on the nature, complexity, degree of preliminary study of the issue, the development of an organization standard is carried out, in general, in the following sequence:

• development of a draft standard;
• accounting of the draft standard in the standardization department with the assignment of a designation to it in accordance with section 6 of this standard;
• public discussion of the draft standard in the interested departments of the institute, in third-party organizations;
• drawing up a summary of comments and proposals on the project and finalizing the draft standard in accordance with the summary;
• consideration of the draft standard at the Scientific and Technical Council of the Institute or its sections in accordance with the established procedure (appointment of a reviewer (expert), acquaintance with the draft of all interested parties, etc.); the decision to consider the project at the NTS is made by the leadership of the institute.

The decision of the NTS on the adoption of the standard is documented in a protocol; all comments and proposals accepted at the NTS are entered into the standard, after which it is endorsed by the reviewer on the last page of the standard.

• in agreement with the management, the standards, if necessary, can be sent for examination (including compliance with the legislation of the Russian Federation, current technical regulations and national standards, scientific and technical, legal, metrological, patent examination) to the competent organizations or the relevant technical committee (TC ) Rostekhregulirovaniya;
• approval and registration of the standard.

The final version of the project is approved by the director of the institute by order or personal signature on the first page of the standard. When approving the standard by order, it sets the date for the introduction of the standard into force and develops, if necessary, organizational and technical measures for the application of the standard.

The standard is put into effect from the date of its approval by the director or the date of introduction specified in the order; standards of organizations are approved, as a rule, without limitation of validity period.

After approval, the standard enters the standardization department for registration in the register and registration, where information about its approval is entered.

The original of the standard with accompanying documentation (summary of remarks, NTS decision, expert opinions, etc.) is stored in the department that develops the standard.

5.3 The procedure for approval, registration and storage of quality management system standards is established by STO QMS 28-2004.

5.4 Construction, presentation, design, designation and requirements for the content of standards - in accordance with the rules established by GOST R 1.5 and the requirements of section 6 of this standard.

5.5 Development of a change to the standard

5.5.1 A change to the standard is developed if it is necessary to replace, supplement or exclude individual requirements of the standard in the form of fragments of sections and paragraphs that are included in the standard on the basis of an order or Order of the institute's management.

Changes to the standard of an editorial or reference nature are made when the standard is reissued or included in the next change.

5.5.2 The development of a change is usually carried out by the developer of this standard.

The standardization department assigns a serial number to the approved change and enters it in the standards register.

Each change to the standard is also recorded in the change registration sheet, which is attached to the standard.

6 General requirements for the construction, presentation, design, content and designation of standards

6.1 The standard must contain all the data necessary and sufficient for its application in accordance with the purpose, and, if necessary, must be illustrated with visual material.

6.2 Building the standard

6.2.1 The title of the standard should normally consist of:

• a group header common to a set of system or product group standards;
• a title that briefly and accurately defines the object of standardization;
• a subheading that defines the generalized content of the provisions established by the standard.

The group heading and subheading are printed in lowercase letters with the first capital. The heading of the standard is printed in capital letters.

1 Quality management system

INTERNAL AUDITS

Planning, conducting

2 Vertical cylindrical steel tanksfor oil and oil products

RULES FOR TECHNICAL DIAGNOSIS, REPAIR AND RECONSTRUCTION

6.2.2 The standard, in general, includes the following sections:

• application area;
• Normative references;
• terms and definitions, abbreviations;
• basic regulations, requirements established by the standard;

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• applications;
• bibliography;
• bibliographic data.

6.2.3 In the section "Scope" indicate the purpose of the standard or the object of standardization and the scope of its distribution (application).

The section gives a more detailed definition of the object of standardization, given in the title of the standard, lists the names of the main requirements, characteristics, test methods, etc., included in the normative sections of the standard.

The section may contain information about limiting the scope of the standard.

6.2.4 The main regulatory provisions are drawn up in the form of sections, the composition and content of which is established depending on the object of standardization and the type of standard.

6.2.5 Standards are developed in the following types:

• fundamental standards that establish the rules for the construction, presentation and execution of documentation of various types (including project documentation), the rules for the implementation of drawings, general requirements and norms necessary to ensure various production processes, general safety requirements, terms and definitions, etc. ;
• standards for products, services that establish the general technical conditions for its production, technical requirements for a group (general) or specific types of products;
• standards for the processes of production and operation of products;
• standards for methods of control, testing, measurements.

6.2.6 The rules for constructing standards of various types, the nomenclature of indicators, requirements and characteristics included in the standard are given in section 7 of GOST R 1.5.

6.2.7 The standards should not establish requirements, parameters, characteristics and other indicators that contradict the technical regulations, international standards of ISO, IEC and other organizations, as well as current national standards.

6.2.8 Standards for products, the use of which is associated with the risk of accidents and danger, must necessarily include sections "Safety requirements" and "Environmental protection" or they must contain references to the relevant safety rules established by state oversight bodies.

6.2.9 Additional information to the main part of the standard, information is drawn up in the form of "Appendices". These can be examples of paperwork, record form, calculation methods, descriptions of equipment and instruments, large format drawings and tables, and other auxiliary material.

6.2.10 The "Bibliography" section includes a list of reference documents (rules and norms of international committees, commissions, firms; used articles, directories, catalogs and other sources) indicating their designations and titles, editions.

6.2.11 Bibliographic data are given on the last page of the standard, which is drawn up in accordance with Appendix D.

The bibliographic data includes "Keywords" that characterize the content of the standard, they are given in the order in which they are given in the titles of the standard and its sections.

6.3 Statement of the standard

6.3.1 The text of the standard should be concise, precise, not subject to various interpretations, and logically consistent.

The text of the standard is divided into sections, subsections, paragraphs, subparagraphs.

6.3.2 For clarity, reduction and convenience of presentation, tables, graphics, diagrams are used. The construction of tables, drawings must comply with the requirements of GOST R 1.5, standards for design and project documentation systems.

6.3.3 The standards, as a rule, should not repeat and duplicate the requirements and provisions established in technical regulations, documents of state supervision bodies and others that are mandatory for use. The standard provides references to this document as a whole or its individual sections, indicating the designation (number) of the document, its name and the name of the organization that approved the document.

6.3.4 The standard should use standardized units of quantities, their names and symbols.

6.3.5 If necessary, generally accepted symbols, images, signs and abbreviations can be used in the standard.

6.4 Formulation of the standard

6.4.1 Standards are performed by machine using a personal computer on A4 paper or, in justified cases, A3 format. It is allowed to complete sheets of A3 and A4 format in one standard.

6.4.2 Sheets of the standard are arranged in the following sequence:

• title page;
• foreword;
• content;
• introduction;
• first page;
• the text of the standard;

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• applications;
• bibliography;
• change registration sheet;
• the last page.

The design of the title page, preface, first and last pages of the standard is given in appendices B, C, D, E, F, respectively.

6.4.3 "Introduction" includes the basis for the development of the standard (FZ "On technical regulation", Decree of the Government of the Russian Federation, etc.) and an indication of the application of the standard by other organizations in the following wording: "The standard can be used by organizations performing work in the field of established standard, if these organizations have certificates of conformity issued by the Certification Body in the voluntary certification system created by the organizations developing the standard.

Developer organizations do not assume any responsibility for the use of this standard by organizations that do not have certificates of conformity.

The "Introduction" may also indicate the place of the standard in the set of standards, its relationship with other standards, as well as other information.

"Introduction" should not contain technical requirements. An example of the presentation of the "Introduction" is given in Appendix I.

6.4.4 The "Change Registration Sheet" is included in the standard without fail, all changes and additions are entered into it in the manner prescribed in section 5 of this standard.

6.4.5 Standards should be paginated, including annexes. Page numbering is in Arabic numerals in the lower right corner on odd pages and in the lower left corner on even pages. The title page, preface, content and introduction are numbered in Roman numerals, which are affixed in the same way.

The designation of the standard is indicated at the top of each page, on the right - on odd and on the left - on even.

6.5 Designation of the standard

6.5.1 The organization standard designation consists of:

• index "STO";
• separated from it by an interval of an eight-digit code of the organization according to the all-Russian classifier of enterprises and organizations (OK 007-93);

TsNIIPSK code according to the classifier - 02494680;

• the four-digit registration number of the standard separated from the dash code;
• separated from it by a dash of four digits of the year of approval of the standard.

Example - STO 02494680-0030-2004

6.5.2 The registration number for the standards is assigned in ascending order of numbers as they are registered in the register and registered in the standardization department.

When a standard is revised, its registration number is retained, but the number of the year of approval is changed.

6.5.3 When a standard is developed by several organizations on an equal basis, its designation indicates the codes of all developing organizations, and the registration number is assigned by the standardization department of TsNIIPSK them. Melnikov.

Example - STO 0030-2004 (02494680, 01400285, 01411411, 40427814)

When writing such a designation on the pages of the standard or when referring to it in other standards of the institute, it is allowed to indicate only its registration number and year of approval.

An example is STO 0034-2004.

6.5.4 The designation of the institute's standards for the quality management system consists of the "STO" index, the abbreviation "QMS", a two-digit registration number and the year the standard was approved.

An example is STO QMS 07-2004.

6.6 Publication and dissemination of standards

6.6.1 Standards are published in A5 format. It is allowed, in justified cases, to include separate sheets of a larger format.

6.6.2 Preparation of the standard for publication (designing the cover, determining the size of the circulation, entering output information in accordance with GOST 7.4 *) and its distribution are carried out by the development department together with the office.

* On the territory of the Russian Federation is valid GOST R 7.0.4-2006. - Database manufacturer's note.

When a standard is published, only its bibliographic data, specified in clause 6.2.9 of this standard, is given on the last page.

An example of the design of the cover of the standard when it is published is given in Appendix G.

6.6.3 Two printed copies of the standard are sent to the OOIF to form the institute's standards fund.

6.6.4 Distribution of standards is carried out in the prescribed manner to the departments of the Institute and at the request of organizations. When changes are made to the standards, organizations that have a certificate of conformity are notified, followed by provision of them with these changes.

7 Responsibility

7.1 Responsibility for the implementation of the established procedure for the development of standards rests with the work manager. The provision of methodological assistance, coordination and organization of work, accounting and registration of standards is entrusted to the standardization department.

7.2 The Standard Development Lead is responsible for:

• for the content of the standard, the reliability and sufficiency of the requirements, parameters and characteristics established by the standard;
• for the presentation and design of the standard.

Annex A
(reference)

Objects of standardization of metal structures

1 General principles for the design of building steel structures:

• loads and impacts;
• steels and alloys;
• rolled and bent profiles, decking, enclosing structures;
• welded joints;
• bolted connections;
• protection of steel structures against corrosion;
• fire protection of steel structures;
• thermal diffusion coatings of steel structures;
• basic principles of calculations of steel structures for ductile and brittle strength, stability;
• basic principles of steel structures for seismic effects;
• basic requirements for CM design documentation;
• standard designs, elements and nodes;
• basic requirements for software in the design of steel structures;
• basic requirements for the examination of the technical condition of structures;
• basic requirements for the manufacture and installation of structures;
• basic requirements for architectural supervision;
• basic requirements for technical supervision;
• composite steel concrete structures.

2 Basic requirements for steel structures of buildings and structures, including industrial and civil structures, tanks, blast furnace complexes, bridges, high-rise structures (towers, masts, chimneys), fixed offshore platforms, special structures, large-span and spatial structures for:

• examination, assessment of the technical condition, repair;
• strengthening, reconstruction;
• design;
• standard designs;
• manufacturing and installation;
• test;
• architectural supervision;
• technical supervision;
• operation and monitoring.

3 Processes of organization and management of production (management processes).

Annex B
(mandatory)

Form of the title page of the organization standard

a) when developing a standard by the institute

b) when developing a standard with co-executors

CJSC "TsNIIPSK named after Melnikov",
	Name
development organizations
ORGANIZATION STANDARD
	name of the standard
	standard designation
	(codes of developer organizations)
Moscow 2004

Annex B
(mandatory)

Preparation of the "Preface" to the standard

The preface is placed on the next page after the title page (or on its back) and contains information about the development of the standard in the following sequence:

	standard designation
Foreword
1 DESIGNED
	full name of the organization (starting with the parent)
and initials, surnames of the developers of the standard
2 INTRODUCED by organizations developing the standard
	date and number of the NTS protocol on the consideration of the draft standard
4 INTRODUCED for the first time
	or indicate "INSTITUTE" and the designation of the standard, instead
which developed an accepted standard
5 AGREED
	position, name of the organization, initials, surname,
number and date of the letter
6 Development, approval, approval, publication (replication), updating (change or revision) and cancellation of this standard is carried out by developing organizations
	names of organizations of right holders, year of publication

Annex D
(mandatory)

Form of the first page of the organization standard

	standard designation
ORGANIZATION STANDARD
	name of the standard
Approved and put into effect by the Order of CJSC "TsNIIPSK named after Melnikov" dated _______200 N_______
information about the approval of the standard by developer organizations
Introduction date
	year, month, day
1 area of ​​use
Note - When approving the standard with the personal signature of the head of the organization, instead of the words "approved and put into effect ...", the stamp of approval is introduced:
	APPROVE Director of CJSC "TsNIIPSK" them. Melnikov"
	personal signature		initials, surname

Annex D
(mandatory)

Form of the last page of the organization standard

	standard designation
			OK code 001-2000		product code according to OK 005-93
Keywords
Institute management
position		personal signature		initials, surname
Head of standardization department
		personal signature		initials, surname
Supervisor development
	position
name of the development department		personal signature		initials, surname
Performers
position, department		personal signature		initials, surname
position, department		personal signature		initials, surname
CO-PERFORMERS
Head of the co-executing organization (co-executing department)		personal signature		initials, surname
Supervisor development
	position		personal signature		initials, surname
Executor
	position		personal signature		initials, surname
Reviewer Visa
signature (signature decryption)

Annex E
(mandatory)

Change registration sheet form

An example of the design of the cover of the standard of the organization CJSC "TsNIIPSK named after Melnikov" when publishing

An example of the presentation of the "Introduction"

Introduction

This Standard was developed in accordance with the Federal Law "On Technical Regulation" N 184-FZ, the Federal Law of July 21, 1997 N 116-FZ "On the Industrial Safety of Hazardous Production Facilities" as amended on January 10, 2003, the Regulations on the Procedure for Conducting examination of industrial safety in the chemical, petrochemical and oil refining industries, by Decree of the Gosgortekhnadzor of the Russian Federation N 8 dated March 18, 2003 and is intended for the developers of the Standard, as well as organizations operating tanks or being customers for their diagnosis, repair or reconstruction.

The Standard can be applied by organizations that carry out technical diagnostics of tanks and develop design documentation for their repair and reconstruction, if these organizations have certificates of conformity issued by the Certification Body in the voluntary certification system created by the organizations developing the Standard.

Development organizations do not assume any responsibility for the use of this Standard by organizations that do not have certificates of conformity.

The need to develop the Standard is dictated by the fact that the experience gained by organizations developing the Standard, as well as domestic enterprises and organizations in diagnosing, repairing, reconstructing, calculating, monitoring methods and testing tanks, bases and foundations, is contained in several dozen disparate regulatory documents (SNiP, TU , RD, VSN, departmental rules, etc.), partially obsolete and not covering the problem of safe operation of tanks as a whole.

The main goal of the Standard is to create a modern regulatory framework for technical diagnostics, within which the technical condition of tanks is determined and predicted and issues are resolved about the need for repair and (or) reconstruction to maintain their working condition.

When developing the Standard, the following were analyzed and taken into account:

• legislative, legal and normative-technical documentation on the issues of ensuring industrial safety;
• experience in the design, repair, installation and operation of tanks;
• results of surveys of industrial facilities;
• some foreign standards;
• new aspects of the work of Gosgortekhnadzor of Russia related to the adoption of the Federal Law "On Industrial Safety of Hazardous Production Facilities";
• proposals of enterprises, organizations, associations and specialists.

Please send comments and suggestions on additions and changes to this Standard to the address: 117393 Moscow, Architect Vlasov str., 49, CJSC "TsNIIPSK named after Melnikov", fax: 960-22-77, E-mail: , telephone for inquiries.

APPROVE
CEO
PJSC "Company"
____________ P.P. Petrov

"___"___________ G.

METHODOLOGICAL INSTRUCTION

Quality Management System

ORDER OF DEVELOPMENT AND IMPLEMENTATION,
REQUIREMENTS FOR THE CONSTRUCTION, STATEMENT, CONTENT AND FORMULATION OF ENTERPRISE STANDARDS

Instance No. ____________

PJSC "Company"

METHODOLOGICAL INSTRUCTION

Quality Management System
ORDER OF DEVELOPMENT AND IMPLEMENTATION, REQUIREMENTS FOR CONSTRUCTION, STATEMENT, CONTENT AND FORMULATION OF ENTERPRISE STANDARDS

Foreword

1. DEVELOPED AND INTRODUCED
Department of technical control

2.PUT INTO OPERATION
By order of PJSC "Company" dated "__" _____, No. ___

3. The requirements of MI QMS comply with the requirements of the ISO standard
Content

1 Scope and scope
2 Normative references
3 Definitions and abbreviations
4 General provisions
5 The procedure for the development, approval, approval and implementation of the enterprise standard
6 The order of construction, presentation and execution of the enterprise standard
7 Accounting, modification and use of STP
8 Responsibility for implementing and monitoring compliance with the requirements of the standard
Appendix A Order form for the development of STP
Annex B Form of the order on the introduction of the STP
Annex B Form of the registration log STP
Annex D Form of the first page of the title page of the enterprise standard
Annex D Form of the second page of the enterprise standard
Annex E Form of the change registration sheet
Appendix G Enterprise Standard Page Form
Annex I Form of the last page of the enterprise standard
Annex K Form of the journal of familiarization with orders and instructions
Annex L Notice of change

CHANGES REGISTRATION SHEET

1 Scope and scope

1.1. This instruction establishes general requirements for the construction, presentation, content, design, procedure for the development and implementation of enterprise standards.
1.2. The instruction is obligatory for all departments of PJSC "Company", within the framework of the quality management system.

2 Normative references

2.1. The instructions refer to the following documents:
ISO 9000:2005 “Quality management systems. Fundamentals and vocabulary"
ISO 9001:2008 “Quality management systems. Requirements"
ISO/TR 10013:2001 Guidelines for documenting quality management systems

3 Definitions and abbreviations

3.1. Definitions:
Enterprise standard - a regulatory document on standardization, containing rules, general principles, characteristics of standardization objects related to certain types of activities or their results, approved by the head of the organization;
A procedure is an established way of carrying out an activity or process.
Interested subdivision is a structural unit of the enterprise, the activities of which are reflected in the framework of this documented.
3.2. Abbreviations:
QMS - quality management system;
STP - enterprise standard;
MI - methodical instructions;
PAO - public joint stock company;
QCD - department of technical control.

4 General provisions

4.1. Standards for organization procedures establish basic requirements for methods, methods, techniques, modes, norms for performing various types of work and technological processes for manufacturing, storage, transportation, taking into account safety for the environment, life and health of personnel.
QMS standards provide a common understanding of quality objectives and procedures for ensuring, managing and improving quality, allow you to clearly allocate responsibilities, rights and obligations in the QMS, establish the procedure for interaction between departments and performers in the performance of their quality functions.
4.2. The main tasks associated with the development and implementation of the enterprise standard:
— development, coordination, approval and implementation of standards;
- accounting, storage and access to the text of standards.
4.3. Enterprise standards are developed by enterprise specialists responsible for organizing work in their field of activity.
4.4. The organization, coordination and methodological management of work on the development and implementation of enterprise QMS standards is carried out by the technical control department.

5 The procedure for the development, approval, approval and implementation of the enterprise standard

5.1. The need to develop STP for the QMS procedure is determined by the heads of departments, services, departments together with the departments authorized for quality.
5.2. The authorized representative for the quality of the unit draws up a memo of any form, signed by the head of the unit, about the need to develop STP and transfers it to the Quality Control Department.
5.3. The QCD, on the basis of a memo, determines the development unit and draws up an order for the development of STP (Appendix A).
5.4. Development of the STP project.
Enterprise Standard Development Unit:
- develops a draft STP, submits it for familiarization to interested departments (TCD, to the departments participating in the procedure described in this STP);
– corrects the draft STP taking into account the received comments and suggestions and makes the final version;
– coordinates the final version of the STP with the interested departments and the lead QMS engineer of the technical control department;
Submits the document to the CEO for approval.
5.5. Implementation of the STP.
5.5.1 After the approval of the STP, the development unit transfers the agreed and approved document to the QCD along with an electronic copy for accounting and storage.
5.5.2 The draft document (STP) is kept by the development unit responsible for maintaining the QMS documentation for 3 years.
5.5.3 The Technical Control Department prepares an order (Appendix B) on the introduction of the STP QMS (the same order sets the date of the entry into force of the STP) and, if necessary, an action plan for its implementation (together with the development departments).

6 The order of construction, presentation and execution of the enterprise standard

6.1. Structure of STP QMS.
The enterprise standard includes the following structural elements:
- title page;
- name (title);
- foreword;
- content;
— scope and scope;
- Normative references;

— general provisions;
— description of the procedure;

- related documents;
- the procedure for making changes;
- applications;

6.2. The first page of the title page of the enterprise standard is drawn up in accordance with Appendix D;
On the second page is placed "Foreword" (Appendix E).
6.3. "Name" (title).
6.3.1 The "title" of the standard should be concise and clearly indicate the documented procedure.
6.3.2 It is not allowed to use abbreviations, Roman numerals, mathematical signs, Greek letters in the "Name" of the standard.
6.3.3 The title of the standard is printed in capital letters without a dot at the end, without underlining.
6.3.4 The heading of the standard should contain the necessary and sufficient features that distinguish this object from other objects of standardization.
6.4. "Foreword".
6.4.1 The word "Foreword" is written in capital letters in the middle of the page;
6.4.2 The information given in the "Foreword" is numbered in Arabic numerals and placed in the sequence indicated in Appendix E.
6.5. "Content".
6.5.1 "Contents" includes serial numbers and titles of sections:
- application area;
- Normative references;
— definitions, designations and abbreviations;
— general provisions;
— description of the procedure;
- responsibility and authority;
- related documents;
- applications;
- change registration sheet.
Applications and the change registration sheet are not numbered.

6.5.2 The "Content" in the standard is placed after the "Foreword", starting on a new page.
6.5.3 The word "Contents" is written in the middle of the page with a capital letter, highlighted in bold.
6.6. "Scope and Scope".
6.6.1 The structural element "Scope and scope" is given to determine the scope and, if necessary, to clarify the object of standardization, placed on the first page of the standard and numbered by one (1);
6.6.2 When clarifying the object of standardization, the following wording is used: “This standard applies to ...”;
6.6.3 When clarifying the content of the standard, the following wording is used: "This standard establishes ...";
6.6.4 When clarifying the scope, the following wording applies: "This standard is mandatory for ...".
6.7. "Normative references".
6.7.1 The structural element "Normative references" contains the designations of documents that are referenced in the text of the QMS standard, and their full name;
6.7.2 The list of reference documents begins with the words: “This enterprise standard uses references to the following documents: ...”.
6.8. "Definitions, notations and abbreviations".
The structural element "Definitions, symbols and abbreviations" contains the definitions necessary to clarify and decipher the terms and a list of symbols and abbreviations used in this standard.
6.9. "General Provisions".
The structural element "General Provisions" includes:
— the purpose of the documented object;
- tasks, the solution of which ensures the achievement of the goal;
- other information that is of a general informational nature.
6.10. "Procedure Description".
6.10.1 This element should clearly define and address the following questions:
— a description of the activities related to the object of documentation;
— requirements for the object of documentation:
a) what should be done and by whom, in what time frame;
b) when, where and how it should be done;
c) how the implementation is controlled;
6.10.2 When regulating each work, the frequency of its implementation is established:
- the unit or official to whom the result of the work is transferred;
- order and term of transfer;
- requirements for initial information or materials, its composition, frequency or timing of receipt;
- the unit or official transmitting information and the procedure for its transfer;
- rules for monitoring the work performed;
— Procedure for actions in case of non-compliance with the established requirements.
6.10.3 The "Procedure Description" element must consistently indicate all links to the quality record forms given in the "Appendices" element, as well as links to the quality record forms in the Annexes of the accompanying STPs, the requirements for filling out these forms are stipulated ( how and by whom they are filled in, to whom they are transferred). If possible, the forms of quality records should not be duplicated in different standards, it is enough to present a specific form in one STP for a certain type of activity and subsequently refer to the Appendix of the corresponding standard in the text.
6.11. "Responsibility and Authority".
In the structural element "Responsibility and authority", the following should be defined:
- officials of the organization responsible for the final results of the activities regulated in the document;
— officials responsible for the main types of regulated activities;
- powers of officials.
6.12. "Related Documents".
This element contains:
- a list of internal documents (MI, STP QMS, work instructions, etc.), quality records, to which references were made in the text of the corresponding STP.
- the terms and places of storage of records, the element "Appendices" of this STP.
6.13. "Applications".
6.13.1 In the "Appendices" element, original forms of record keeping are given that are necessary for the functioning of each specific standard, as well as specific texts explaining the order in which the elements of the procedures are performed. Each "Application" is assigned a name and a letter designation.
6.13.2 "Appendices" are denoted by capital letters of the Russian alphabet, starting with A (with the exception of Ё, Z, O, Ch, b, Y and Ъ). The word "Appendices" is followed by a letter denoting its sequence. If there is one application in the enterprise standard, then it is designated "Appendix A".
6.13.3 The status "Application" shall be defined. Application status can be:
- compulsory;
- recommended;
- reference.
6.14. Change registration sheet.
The change registration sheet is mandatory for all standards and is the last page of the enterprise standard, drawn up in accordance with Appendix E.
6.15. Requirements for the presentation of the standard.
6.15.1 The text of the standard is divided into sections. Sections can be divided into paragraphs. Items, if necessary, can be divided into sub-items. After the number of the section, paragraph, subparagraph, do not put a dot;
6.15.2 Sections, subsections, paragraphs and subparagraphs should be numbered with Arabic numerals.
6.15.3 Sections should have headings that are capitalized without a trailing dot and are not underlined. Headings are in bold. Headings should lag behind the previous section by one line, after the heading the line is not skipped.
6.15.4 There may be enumerations within clauses and subclauses. Each position is preceded by a hyphen or a lowercase letter followed by a parenthesis;
6.15.5 Formulas, with the exception of formulas placed in the "Appendix", must be numbered consecutively with Arabic numerals, which are written at the formula level on the right in brackets. One formula is denoted by (1). References in the text to the ordinal numbers of formulas are given in brackets;
6.15.6 Notes are given in the standard when explanatory or reference data are needed and are placed immediately after the text to which they refer. If there is one note, then after the word “Note” they put a dash and it is not numbered, if there are several, then they are numbered with Arabic numerals;
6.15.7 Footnotes are used when it is necessary to explain individual data and they are indicated by a subscript;
6.15.8 The text of the document should be concise, precise, not subject to various interpretations and logically consistent;
6.15.9 Initially, the activity is formulated, then by whom it is performed and the deadlines;
6.15.10 The document does not allow:
- the use of turns of colloquial speech;
- the use of synonyms;
- the use of indefinite verbs.
6.16. Page design requirements.
6.16.1 When one-sided printing, page numbering is put down in the lower right corner in Arabic numerals. Page numbering is continuous throughout the STP.
6.16.2 The pages on which the "Preface", "Contents" are placed are numbered in Roman numerals, starting from the title page. On the title page, the page number "I" is not affixed;
6.16.3 The general form of the pages of the standard is presented in Appendix G. For the text part of the STP, Times New Roman font is used, font size 14, line spacing is one and a half.
6.16.4 The text part of the enterprise standard is completed by a list of signatures, which is drawn up in accordance with Appendix I.
6.17. Requirements for the designation of the enterprise standard.
The designation of the enterprise standard consists of the STP QMK index - the enterprise standard, quality management system, then the number corresponding to the ISO 9001:2000 section and, through a dash, the registration number of the STP assigned by the Quality Control Department, then after a dash, the year the STP was put into effect.
Example: STP QMS 4-001-2006 (4 is the number corresponding to the ISO 9001-2008 section; 001 is the registration number of the STP, 2006 is the year of entry into force).
6.18. Header formatting requirements.
The header contains three cells: in the left cell there is the trademark of PJSC "Company", in the middle cell in two lines "Standard of the enterprise of PJSC "Company", in the right cell in two lines the designation of the standard and the version number of the document from the beginning of the existence of the QMS.
The footer contains the page number (6.16.1, 6.16.2).

7 Accounting, modification and use of STP

7.1. The Lead QMS Engineer of the QCD registers the STP in the "STP Registration Log" (Appendix B).

7.2. The control copy of the STP is stored in the Quality Control Department during the entire period of validity of the document. Current working copies of the current QMS documents are stored electronically on the organization's server at ________ and are available for reading for general use. Only the leading QMS engineer has the right to make changes to the texts of the working STP.
7.3. After production copies are printed from the server, they automatically become "Untracked Copies". At the time of use, the relevance of the unaccounted copy must be established. The relevance is evidenced by the absence of records or the presence of identical records in the Change Registration Sheets of the working version of the STP and an unaccounted copy.
7.4. Revision and amendments to the STP may be caused by production needs, significant changes in the production technology, organizational structure, or as a result of audits. Changes to the STP, their updating are carried out by the development department at the initiative of the enterprise management, interested departments or the Quality Control Department, with the obligatory agreement with the development department, or at the initiative of the development department, with the obligatory agreement with the head of the enterprise, interested departments, Quality Control Department.
7.5. Changes are made by the development unit compiling a Change Notice in the form from Appendix L. Change notices are registered by the lead QMS engineer in the "Change Notice Registration Log" and stored along with the original standard.
7.6. Changes to the STP are made by replacing the sheets or by introducing new additional sheets with a designation on it that this sheet has been replaced or is new. Information about the change in the STP is indicated on the change registration sheet, i.e. the date of the last change, the serial number of the change, the signature of the person who made the change and the registration number of the change are affixed.

7.7. When reviewing and abolishing the STP, the new STP indicates in place of which ones they are being introduced.
7.8. Printed copies of the canceled (annulled) STP are withdrawn and disposed of by the person responsible for maintaining the QMS documentation in the subdivisions. The canceled (annulled) originals of the STP, left as information material, are stored in the QCD and have a mark of cancellation (cancellation). Canceled STPs are kept for 2 years.
7.9. When the STP is revised or changed, those responsible for maintaining the QMS documentation in the units covered by the scope of the STP are notified of this by a memo, after which they are obliged to notify the staff of the introduction of a new STP or change the version and help familiarize the staff with the enterprise standard and order to put it into effect. Conduct training (if necessary, which is determined by the heads of departments) for its implementation at the workplace with an entry in the "Journal of Familiarization with Orders and Instructions for the Department" (Appendix K).

8 Responsibility for implementing and monitoring compliance with the requirements of the standard

8.1. Responsibility for the implementation and compliance with the requirements of this standard rests with the heads of services, departments and subdivisions of PJSC "Company".
8.2. The lead QMS engineer is responsible for the availability of the current version of the STP on the organization's server.
8.3. Control over compliance with the requirements of this standard is assigned to the deputy director for quality - the head of the Quality Control Department, the lead engineer for the QMS of the Quality Control Department and the departments of the enterprise authorized for quality.

Chief OK

Agreed:

Head of the legal department

Lead QMS Engineer

Organization Standard (STO) is a regulatory document that establishes the technical requirements that products must meet

Organizational standards in Russia can be developed for the products, processes and services used in this organization, as well as for products created and supplied by this organization to the domestic and foreign markets, for work performed by this organization on the side and provided by it on the side services in accordance with the concluded agreements (contracts).

In particular, SRT can be developed for:

— component parts (parts and assembly units) of products being developed or manufactured;
— processes of organization and management of production;
— management processes;
– technological equipment and tools;
- technological processes, as well as general technological norms and requirements, taking into account the safety for the life and health of citizens, the environment and property;
— methods; design, test, measurement and/or analysis procedures;
- services provided within the organization, including social ones;
- nomenclature of raw materials, materials, components used in the organization;
— processes for performing work at the stages of the product life cycle, etc.

Organizational standards should not conflict requirements of technical regulations, as well as national standards developed to facilitate compliance with the requirements of technical regulations.

The organization's standards are approved by the head (deputy head) of the organization by order and (or) personal signature on the title page of the standard in the manner prescribed by the organization.

If the organization's standard is approved by order, the date the standard is put into effect is set in the order. When the standard of the organization is approved by the personal signature of the head (deputy head) of the organization, the date the standard is put into effect is given on its first page.

The standards of the organization approve, as a rule, without limitation of validity.

How to assign a service station number?

The designation of the organization's approved standard for products supplied to the domestic or foreign market, for work performed on the side, or services provided by it on the side should include:

- an abbreviation of the words "organization standard" (STO)
- code according to the All-Russian classifier of enterprises and organizations OKPO, which allows you to identify the organization that developed the standard
- registration number assigned by the organization that developed and approved the standard
— year of approval of the standard.

The classification code of the organization standard (OKS) is set according to the All-Russian classifier of OK standards (MK (ISO / INFCO MKS) 001-96) 001, the classification code of the product (OKP) or service (OKUN) covered by the standard of the organization - according to the all-Russian OK classifiers 005 or OK 002, respectively, and are given on the last page of the organization's standard.

Example - Classification codes of the organization standard "Fire light annunciators. Specifications” and the products to which it applies:

"OKS 13.320" "OKP 43 7135".

The organization standard contains the following sections:

- Terms and Definitions
- application area
— general technical requirements
- Normative references
— requirements for specific processes (transportation, dismantling, etc.)
- methods of control and some other, directly dependent on the type of product, sections.

The list of necessary data for the development of an organization standard in NormoProject:

- OKPO code of the manufacturer;
— full name of the head, developer;
- name, appearance of the product, list of modifications;
— technical description of the technological process;
— table of technical parameters (as complete as possible);
— list of components;
- the procedure and conditions for the presentation and acceptance of products by the technical control bodies of the manufacturer;
— methods and means of test control;
- methods of packaging and packaging material, a list of documents included in the packaging;
— transportation (modes of transport and vehicle, transportation parameters);
- storage conditions;
- terms of Use;
- warranty period.

Our Development Center "NormoProject" will help you quickly, efficiently and inexpensively develop an organization standard in a short time with minimal effort on your part.

Organization standards. Development of organization standards. Implementation of organization standards.

Organization standards

Organizational standards are not the most important document in the Standardization Documentation System, however, these standards are significant and have great practical value. For an organization, they (standards) are the main internal governing document, where local norms, requirements for employees and management are legally fixed, that is, everything necessary for the technical regulation of all issues of the company.

Types of organization standards:

Organizational standards can be created in the following areas:

• for their products - service delivery processes
• for work performed by the company

Objects of standardization within the organization:

Management and organization of processes in production; Management and its processes; Working tool and technological equipment; Production technology - its processes, norms corresponding to ensuring safety for the life and health of citizens, the environment and property; Design - its methods and techniques, tests, measurements and (or) analysis; Intraorganizational services (for example, social); Nomenclature (raw materials, products); The whole process at the stages of the life cycle (life cycle) of products / goods / services.

Also, when creating organization standards, it is possible to reflect national, international and interstate standards of technical regulations in them.

You can also reflect the issues of standards of other organizations.

The subjects for SRT (organization standards) are:

Organizations (legal entities) that have separate property in their ownership or economic management or operational management and are liable for their obligations with this property, capable of acquiring and exercising property and personal non-property rights on their own behalf, incurring obligations, being plaintiffs and defendants in court , as well as having an independent balance sheet or estimate and duly registered as such.

Such organizations include: commercial, public, scientific, self-regulatory organizations, associations of legal entities (associations, unions).

The goals of developing organization standards:

• Improving the quality of services/works/products.

improvement of production, all its processes.

The goals of the development of SRT similar to the goals of creating national standards.

Important! The standards of the organization cannot contradict the technical requirements and national standards that ensure the application of such international standards as: ISO, IEC, as well as other international organizations to which the state has joined.

Service station requirements

These requirements must be observed in the organization that approved the standard, as well as in its structural divisions (in the case of corporate or departmental subordination) from the moment (date) the standard is put into effect. The requirements of STOs for products, processes, works and services are subject to compliance by other business entities and purchasers, but only if these STOs are indicated in the accompanying technical documentation of the manufacturer (supplier) of products, performer of works and services in the agreement (contract). An organization standard developed and approved by one organization can be used by another organization in its own interests only under an agreement with the organization that approved it, which, if necessary, provides for the provision of information on subsequent changes to the standard.

The company "Business Expert Group KZ" offers its **standards development services organizations in Almaty , development of standards of the organization Astana , implementation of organization standards**.

Information about standardization documents and technical regulations

The procedure for changing, canceling the standard

Standard changes are carried out to maintain its compliance with quality assurance and usability needs. The development of changes to the standard consists in adding or deleting individual requirements of the standard. This is done to introduce more progressive requirements into the standard, which at the same time ensure the interchangeability of manufactured products with products according to the current standard.

The revision of the standards provides for the abolition of the current and the introduction of a new standard that ensures the progress of quality or production.

Change, cancellation of standards is carried out by the national standardization body on the proposal of the technical committee.

The technical committee analyzes proposals from organizations, engineering societies, entrepreneurs and other interested parties to revise the standard. Taking into account the proposals received, the TC develops and sends to the national standardization body a draft amendment to the standard or a proposal to cancel the standard.

Official information about national standards and their development is given in the Federal Information Fund of Technical Regulations and Standards of the Unified Information System for Technical Regulation, the regulation of which was approved by Decree of the Government of the Russian Federation No. 500 of August 15, 2003.

This fund contains over 235 thousand normative documents, which are approved technical regulations, national standards, classifiers, as well as international standards ISO and IEC, standards of over 40 countries of the world.

The unified information system for technical regulation was created to provide interested parties with information about documents that are part of the Federal Information Fund, with the exception of documents that are state or commercial secrets.

The information system provides the following types of products and services:

1) information about documents, in paper or electronic-digital form;

2) information about the developers;

3) organizations that have approved regulatory documents.

Since the exclusive right to publish GOSTs, classifiers, belongs to the agency or body that accepts these documents, unauthorized copying and distribution is prohibited and is considered a copyright infringement.

Information about the current national standards, their validity periods, changes can be obtained in the monthly information indexes "National standards of the Russian Federation".

The requirements established by the standard of the organization (enterprise) should not contradict the requirements of national standards and technical regulations for similar standardization objects. Organizational standards are developed based on their need.

The procedure for developing standards, making changes and canceling is established by the organization independently, taking into account the principles of standardization and the provisions of national standards.

According to GOST 1.4. the standard of the organization is approved by the head of the organization by order or personal signature on the title page of the standard. A draft standard for products or services intended for use outside the organization may be submitted to a technical standards committee, which will arrange for the review of the draft. Based on the results of the examination, the technical committee prepares an opinion and sends it to the developer of the standard.

Previously, enterprise standards had the abbreviation "STP". According to GOST R 1.4, organization standards must have the abbreviation "STO", contain the organization code according to the all-Russian classifier, registration number and year of approval of the standard.

The federal law on amendments and additions to the law on technical regulation limits the scope of the organization's standards only to the organization itself. For other subjects, SRT has legal force only when it is mentioned in contracts for the supply of products or in other similar cases.

Read also:

Enterprise standards are being developed for culinary products made using non-traditional methods of cold and thermal culinary processing of food products, as well as for new trade and technological processes. The construction, presentation and design of enterprise standards must comply with GOST 1.5-92.

The enterprise standard (STP) establishes the basic requirements for products, recipes, production process, acceptance rules and methods of analysis, packaging, labeling, transportation and storage. STP is developed for a specific public catering enterprise, taking into account the production conditions.

STP projects are coordinated with the sanitary and epidemiological service, on the territory of which the developer is located. The STP is approved by the head of the enterprise, the standard is put into effect by his order or order. The validity period of the STP is determined by the enterprise approving the standard.

The technological process set out in the STP must ensure compliance with the safety indicators and requirements established by the current state regulations. Enterprise standards should not violate the mandatory requirements of GOSTs or conflict with them. Business entities are liable for such violations.

Changes to the standards of enterprises are developed in case of replacement, exclusion or introduction of additional requirements for the mode of preparation of products or the trade and technological process for the provision of public catering services.

The designation of the enterprise standard consists of an index (STP), a registration number assigned in the prescribed manner, and separated by the last two digits of the year the document was approved. For example: STP 1-97, STP 2-97, etc. STP must be printed on one side of the sheet. The first and last page are designed in accordance with annex 25 this manual. When developing a document, the terms defined by GOST R 50617-94 “Public catering. Terms and Definitions".

The sequence and content of the sections of the enterprise standard:

1. Product name (trading process) and scope. This section indicates the exact name of the product, service process, which cannot be changed without approval. The same section specifies the list of enterprises that are given the right to use this standard.

2. List of raw materials used to make the dish. All types of food products necessary for the preparation of a given dish (product) and regulatory documentation for each type of raw material (product) are indicated.

3. Requirements for the quality of raw materials (for dishes and products). In this section, it is mandatory to record that food raw materials, food products and semi-finished products used to prepare this dish (product) comply with the requirements of regulatory documents (GOST, OST, TU), biomedical requirements and sanitary standards and have certificates of conformity and certificates of quality.

4. Bookmark rates. Indicate the mass of gross and net raw materials, the output of the semi-finished product and the finished product.

Technological process of product preparation and trade service. The section should contain a detailed description of the technological process of preparing the product or providing catering services, while the cold and heat treatment modes that ensure the safety of the product are highlighted for the products. Specifies the specifics of the use of non-traditional methods of preparation or the use of food additives, dyes. Trade and technological processes (services) of enterprises of various types and classes must comply with the requirements of safety and environmental friendliness, intended purpose and be provided to consumers in conditions that meet the requirements of current regulatory documents. Requirements may be established for specific technological and commercial operations that guarantee security.

6. Requirements for registration, submission, sale and storage, transportation of public catering products. The section reflects the design features and rules for serving products, the requirements and procedure for the sale of each batch of culinary products, the conditions, terms of sale and storage, and, if necessary, the conditions of transportation in accordance with GOST R 50763-95 “Public catering. Culinary products sold to the public. General technical conditions”, sanitary rules. It can also reflect: the established sales procedure, batch sizes, control standards (the number and procedure for seizing products for a control check), paperwork, transportation parameters and conditions for protection from external factors.

7. Packaging and labeling (for dishes and products). Indicate the type of container, packaging material permitted by the Ministry of Health of Russia for contact with food products, and the data included in the label in accordance with GOST R 50763-95.

8. Quality and safety indicators. They describe the organoleptic characteristics of products: taste, color, smell, consistency and the main physical, chemical and microbiological indicators that affect the safety of products, in accordance with the annexes to GOST R 50763-95 “Public catering. Culinary products sold to the public. General specifications” and SanPiN 2.3.2.1078-01 “Hygienic requirements for the safety and nutritional value of food products”. For trade and technological processes (services), the ergonomics requirement should be taken into account, which characterizes the compliance of service conditions with hygienic, anthropometric, physiological consumption criteria. Compliance with the requirements of ergonomics ensures the comfort of service and contributes to the preservation of the health and performance of the consumer.

Test methods. Indicate the methods of control and the frequency of each study to verify the safety of products. In the section, you can specify the control standards and volumes of the controlled lot. The conditions for the provision of the service (trade and technological process) must comply with the requirements of the current regulatory documentation for the level of noise, vibration, degree of illumination and the state of the microclimate in accordance with the requirements of SanPiN No. producing soft ice cream", architectural and planning and design solutions, indicators of electrical, fire and explosion safety in accordance with the requirements of SNiP 2.08.02.-89 "Public buildings and structures" and SNiP 21-01-97 "Fire safety of buildings and structures".

10. Requirements for environmental protection. Environmental requirements are established to prevent harm to the environment and human health in the course of production.

11. Information data on the nutritional and energy value of products. The section contains information about the content of proteins, fats, carbohydrates and the energy value of the product.

The holder of the original STP is a person appointed by the head of the enterprise. STP are not subject to state registration. The head of the enterprise issues an order or order to put the STP into effect.

Today, a document that confirms the stability and prospects of an enterprise is not only a business plan and reporting. The most important is the enterprise standard, which determines the compliance of quality management with the established ISO 9001 standard. A competent approach to such a system allows you to get a number of advantages (this increases the manageability of the company, the quality and competitiveness of products, and reduces production costs). at the enterprise (QMS) - a system designed to ensure efficient operation, especially in the field of commercial products. To build such a system, the following elements are needed:

A document that sets out the tasks and objectives of the QMS;

Regulatory documents that describe and regulate the entire business process of an enterprise in the field of QMS;

Appropriate system of complementary processes;

The mechanism for implementing the established requirements regulated by the regulatory framework;

Trained company staff.

The quality system of the enterprise implies various Any manufacturer in its work provides that all incoming materials, components, semi-finished products are not used and processed until they pass the check (control) corresponding to the quality plan and other registration and identification. Then, in case of detection of its non-compliance with the standards, it can be immediately replaced or returned. the company provides for:

Continuous monitoring of all technological processes and their regulation;

Inspection, identification and testing of products in accordance with the established quality plan and other regulatory documents;

Delaying the release of products until the completion of all required control and testing processes with the receipt of reports on their results;

Identification of all non-conforming products.

The enterprise standard (abbreviated as STP) establishes the requirements for each specific type of service, work. It is developed by a certain legal or natural person and is applied by him, from the moment of enactment until the date of replacement or cancellation. An enterprise standard is created in order to develop, update and maintain organizational, methodological, regulatory and other types of documentation that comply with international standards.

The STP specifies the powers, responsibilities and relationships of the management personnel who perform, review and review the organization's activities. An enterprise standard is developed both for individual elements of the QMS, and for the entire sequence of actions that applies to several such elements at once. This function is performed by the heads of existing structural units with all specialists directly involved in this type of activity. Often, the enterprise standard is developed again with changes in the emergence of new divisions in the enterprise.

The enterprise standard includes the following sections: title and approval sheets; content; appointment; scope (area) of application; definitions, abbreviations, designations; Normative references; description of the procedure; responsibility; Appendix; sheets of approval and registration of changes.

The procedure for developing an enterprise standard:

1. Drawing up a preliminary project.

2. Coordination, decision-making on finalization of the preliminary draft.

3. Preparation, adoption and approval of the final draft.

4. Approval of the STP.

In 1987, a number of international standards were adopted by the international organization for standardization ISO. ISO-9000 – ISO-9004 who installed requirements for the QMS of enterprises. In 1994, these standards were revised and supplemented by standards ISO10000 and others. All these standards are called series of standardsISO 9000 . The current version is 2008. These standards should be considered as the world's best achievements in the field of quality management. Compliance of the QMS of the enterprise with the requirements set forth in the ISO 9000 series of standards is an argument in favor of the fact that the manufacturer is able to provide a high level of quality in real production conditions.

As part of the standards seriesISO9000 distinguish basic:

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

ISO 9001 “Quality system. Quality assurance model for design, development, production, installation and maintenance”

ISO 9002 “Quality system. Model of quality assurance in production, installation and service”

ISO 9003 “Quality system. Quality Assurance Model for Final Inspection and Testing”

ISO 9004 “Quality management and quality system elements. Guidelines"

ISO 8402 “Quality management and quality assurance. Vocabulary"

These standards in one form or another are accepted as state standards in almost all countries of the world.

In Russia:

GOST R ISO 9000-2001 “QMS. Basic provisions. Vocabulary"

GOST R ISO 9001-2001 “QMS. Requirements"

Basic standards are divided into 2 groups:

1) for contract situations,

2) for non-contract situations.

1) for contract situations(standards ISO 9001, 9002,9003, in Russia GOST 9001). These standards are normative in nature and serve as models against which actual quality controls in enterprises are compared. There can be four contract situations:

a) when concluding a contract for the development and production of products,

b) if it is necessary to confirm the effectiveness of the QMS in the process of implementing the contract,

c) when certifying products,

d) during QMS certification.

ISO 9001,9002,9003 standards are distinguished by the completeness of coverage of product life cycle stages. For example, the ISO 9001 standard is used when it is required to ensure high quality of a product at all stages of its life cycle. This standard is the most prestigious.

2) for non-contract situations(all other standards). These standards are in the nature of guidelines and can be used by the enterprise in the formation and improvement of its QMS. For example, the ISO 9000 standard contains recommendations for the selection and application of ISO 9000 standards, depending on a number of factors:

b) the complexity and novelty of the project,

c) the complexity and novelty of the technological process,

d) consequences of possible failures,

e) reputation of the supplier.

The ISO 10000 standards contain guidelines for QMS audits, quality assurance of measuring and control equipment, economic aspects of quality, and others.

Structure of GOST R ISO 9001-2001:

1) Application area. This International Standard specifies requirements for a QMS when an organization:

a) needs to demonstrate its ability to supply products that meet customer and regulatory requirements,

b) aims to improve customer satisfaction through the effective application of the system, including processes for continual improvement and compliance with customer and regulatory requirements;

3) Definitions;

4) QMS:

4.1) general requirements,

4.2) documentation requirements;

5) Management Responsibility:

5.1) management commitments,

5.2) quality policy,

5.3) responsibility, authority and information exchange;

6) Resource management:

6.1) provision of resources,

6.2) human resources, etc.;

7) Product Life Cycle Processes:

7.1) planning of product life cycle processes,

7.2) customer related processes,

7.3) design and development,

7.4) purchases,

7.5) production and service;

8) Measurements, analysis and improvements.