GOST R 15.301-2016

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

System for developing and launching products

PRODUCTS FOR PRODUCTION AND TECHNICAL PURPOSE

The procedure for developing and putting products into production

System of product development and launching into manufacture. Products of industrial and technical design. Procedure of product development and launching into manufacture

Text Comparison of GOST R 15.301-2016 with GOST R 15.201-2000, see the link.
- Database manufacturer's note.
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OKS 01.040.01
OKSTU 0015

Date of introduction 2017-07-01

Preface

Preface

1 DEVELOPED by the Federal State Unitary Enterprise "All-Russian Research Institute of Standardization and Certification in Mechanical Engineering" (VNIINMASH)

2 INTRODUCED by the Technical Committee for Standardization TC 051 "Design Documentation System"

3 APPROVED AND ENTERED INTO EFFECT by Order of the Federal Agency for Technical Regulation and Metrology dated October 31, 2016 N 1541-st

4 INSTEAD GOST R 15.201-2000

5 REPUBLICATION. August 2018


The rules for the application of this standard are established in Article 26 of the Federal Law of June 29, 2015 N 162-FZ "On Standardization in the Russian Federation" . Information about changes to this standard is published in the annual (as of January 1 of the current year) information index "National Standards", and the official text of changes and amendments is published in the monthly information index "National Standards". In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the next issue of the monthly information index "National Standards". Relevant information, notices and texts are also posted in information system common use- on the official site Federal agency on technical regulation and metrology on the Internet (www.gost.ru)

1 area of ​​use

This standard establishes the procedure for the development and production of products for industrial and technical purposes, including development rules terms of reference, design and technological documentation, acceptance of development results, preparation and development of production, testing of prototypes of products and products manufactured during the development of production, as well as rules for confirming their compliance with mandatory requirements.

If necessary, the rules established in this standard can be specified in the standards of organizations and/or other documents of these organizations.

The standard does not apply to aircraft and sea ​​vessels civil purpose.

The provisions of this standard are subject to application by those located in the territory Russian Federation organizations and other entities economic activity regardless of forms of ownership and subordination, as well as Federal authorities executive power of the Russian Federation, involved in the development and production of products in accordance with current legislation.

2 Normative references

This standard uses Normative references to the following standards:

GOST 2.001 Unified system of design documentation. General provisions

GOST 3.1001 Unified system of technological documentation. General provisions

GOST 2.102 Unified system of design documentation. Types and completeness of design documents

GOST 2.103 Unified system of design documentation. Development stages

GOST 2.105 Unified system of design documentation. General requirements to text documents

GOST 2.106 Unified system of design documentation. Text documents

GOST 15.016 System for developing and launching products into production. Technical task. Requirements for content and design

GOST 15.311 System for developing and launching products into production. Starting production of products according to technical documentation foreign companies

GOST 16504 System of state testing of products. Testing and quality control of products. Basic terms and definitions

GOST R 8.563 State system ensuring uniformity of measurements. Measurement techniques (methods)

GOST R 8.568 State system for ensuring the uniformity of measurements. Certification of testing equipment. Basic provisions

GOST R 15.000 System for developing and putting products into production. Basic provisions

GOST R 15.011 System for developing and launching products into production. Patent research. Contents and procedure

GOST R ISO 9001-2015 Quality management systems. Requirements

GOST R ISO 10006 Quality management systems. Design Quality Management Guide

Note - When using this standard, it is advisable to check the validity of the reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or using the annual information index "National Standards", which was published as of January 1 of the current year, and on issues of the monthly information index "National Standards" for this year. If an undated reference standard is replaced, it is recommended that the current version of that standard be used, taking into account any changes made to that version. If a dated reference standard is replaced, it is recommended to use the version of that standard with the year of approval (adoption) indicated above. If, after the approval of this standard, a change is made to the referenced standard to which a dated reference is made affecting the referenced provision, it is recommended that that provision be applied without regard to this change. If the reference standard is canceled without replacement, then the provision in which a reference to it is given is recommended to be applied in the part that does not affect this reference.

3 Terms, definitions and abbreviations

3.1 This standard uses terms in accordance with GOST 16504, as well as the following terms with corresponding definitions.

3.1.1 mandatory requirements: Requirements established by national standards and other standardization documents based on current legislation to ensure the safety of products, works and services, protection environment, life, health and property, ensuring technical and information compatibility, interchangeability of products, uniformity of control and labeling methods, as well as other mandatory requirements established by technical regulations and legislation of the Russian Federation.

3.1.2 competitive basis: The principle of distributing orders for the development (production) of products, which consists in using competitive selection based on the results of bidding (competitions).

3.1.3 product customer: Entity, which provides financing for the development (creation, modernization) of products, their production and determines the basic requirements for products.

3.1.4 product manufacturer: A legal entity that produces products.

3.1.5 product consumer: Legal and/or individual using products for their intended purpose.

3.1.6 work organization model (model): A certain combination of work organization modules that establishes a standard work scheme and rules of interaction, which are the objects of standardization in the SRPP.

3.1.7 work organization module (module): A systematically ordered set of standard elements of an organizational and technical mechanism, characterized by a specific target orientation, organizational completeness and an established procedure for planning, providing and executing its constituent elements.

3.1.8 head sample: A product manufactured according to newly developed documentation, which simultaneously acts as the first samples of non-serial and small-scale products sold to the customer at special conditions supplies.

Notes

1 Non-serial products include individual copies of products or a batch, materials and substances of limited volume, manufactured as the need arises (occasionally).

2 Small-scale products are products produced in small batches to meet the needs of a specific customer (consumer).

3.2 The following abbreviations are adopted in this standard:

KD - design documentation;

R&D - experimental design work;

TD - technological documentation;

TK - technical specifications;

TR - technical regulations;

TU - technical conditions.

4 General provisions

4.1 This standard covers the following stages and types of work life cycle products established by GOST R 15.000:

- stage "Development", type of work "R&D for product development";

- stage "Production", type of work "Putting into production".

4.2 Certain types of work on the development and launch of products into production, characterized by target orientation, organizational completeness, a certain sequential order of execution and planning, availability certain performers, are combined into work organization modules.

4.3 Depending on the availability of targeted product development programs, the presence or absence of a customer, the nature of the relationship between business entities, the development and production of products is carried out according to the following work organization models:

model 1 - creation of products under state and municipal orders, as well as other orders financed from the federal budget and budgets of constituent entities of the Russian Federation (hereinafter referred to as government orders);

model 2 - creation of products ordered by a specific consumer;

model 3 - proactive product development without a specific customer at the commercial risk of the developer and manufacturer.

The work organization model is chosen based on the status of the customer, source of financing and market conditions.

4.4 When creating products under government orders, an agreement (contract) for the work performed is concluded in the prescribed manner, and a technical specification or a replacement document (hereinafter referred to as the technical specification) for the work performed is developed. A document containing necessary and sufficient requirements for product development and mutually recognized by the customer and developer can be used as a replacement document.

General principles and requirements for contracts for state needs and regulation of the contract system in the field of state and municipal needs - according to Federal laws and.

4.5 Based on the initial requirements of the customer (if any), the product developer carries out the necessary development and technological work, paying special attention to ensuring the following requirements:

- safety, health and environmental protection, including during product operation;

- resource saving;

- establishing for the conditions of use of products the values ​​of indicators that determine its technical level;

- resistance to external influences;

- interchangeability and compatibility components and products in general;

- if necessary, recycling and/or destruction and burial of products, waste from them and disposal of hazardous waste.

4.6 The decision to develop products on an initiative basis is made taking into account marketing conditions.

4.7 The “Development” stage and the “Production” stage generally provide for:

- development of technical specifications for development work;

- carrying out design and development work, including the development of design documentation and technical documentation, production of prototypes, testing of prototypes, acceptance of the results of design and development work;

- finalization of the working design documentation for the prototype;

- putting into production, including preparation of production, mastering production (production of an installation series, qualification tests).

The stages of a specific design and development work (a component of the design and development work), as well as the procedure for their acceptance, must be defined in the terms of reference for the design and development work (a component of the design and development work) and the agreement (contract) for its implementation.

4.8 At all stages of design and development work (an integral part of design and development work) and when placing products into production, performers ensure compliance mandatory requirements standards and TR.

The achieved indicators and their compliance with the requirements of the technical specifications for R&D (an integral part of R&D) are assessed upon acceptance of the stages and are reflected in the test reports (acts) of prototypes of products and acceptance certificates for the stages of R&D and R&D as a whole.

4.9 Relationships between the developer (manufacturer) and state supervisory (control) authorities are carried out in accordance with current legislation.

4.10 Documents confirming compliance with the mandatory requirements of standards and technical regulations are submitted to state supervision (control) bodies in accordance with their rules.

The composition of the documents is established by the relevant state supervision (control) body.

4.11 Products of intellectual labor obtained in the process of creating and putting products into production and being objects of intellectual property protection are used in the manner established by the Federal Law.

5 Development of technical specifications for development work

5.1 The basis for carrying out development work according to models 1 and 2 to 4.3 is the technical specification and the agreement (contract) for its implementation.

Development of technical specifications, requirements for the construction, content and presentation of technical specifications, as well as the procedure for coordination and approval of technical specifications - in accordance with GOST 15.016.

In the case of proactive product development (model 3 to 4.3), the basis for performing R&D is the technical specification approved by the management of the developer organization (or a document replacing it), based on the results of marketing, as well as patent research in accordance with GOST R 15.011.

The specific content of the technical specification is determined by the customer and the developer, and in case of proactive development - by the developer.

TK is mandatory original document for the development of new (modernized, modified) products and design documentation for them.

When analyzing an agreement (contract), one should be guided by the provisions of GOST R ISO 9001 (clauses 8.1-8.3).

5.2 At any stage of product development, with the consent of the customer and developer, changes and additions can be made to the technical specifications or a document replacing it that do not violate the conditions for fulfilling the mandatory requirements of standards and technical regulations, in accordance with GOST 15.016.

6 Development of documents, production and testing of prototypes of products

6.1 Development of design documentation, technical documentation, and, if necessary, program documentation for products is carried out according to the rules established according to the standards Unified system design documentation (GOST 2.001), Unified System of Technological Documentation (GOST 3.1001) and Unified System of Program Documentation.

General requirements for design (development) management - in accordance with GOST R ISO 9001 (clause 8.3).

Quality requirements for design (development) - in accordance with GOST R ISO 10006.

The rules for the development of technical documentation for materials and substances are established by the developer, taking into account standardization documents, the specifics of the product and the organization of its production.

6.2 In the process of developing documentation for the selection and verification of new technical solutions, ensuring the achievement of the basic consumer properties of products, laboratory research, bench and other tests can be carried out in accordance with GOST 16504, as well as development tests of experimental and pre-production samples of products under conditions simulating real operating (consumption) conditions, while taking into account the patent and legal aspects of economic use of these technical solutions.

For certain types of products or their components, tests of prototypes can be carried out under operating conditions (including in organizations that are consumers of the products).

The scope and content of tests necessary to prevent the production of unproven products that do not comply with the specifications are determined by the developer, taking into account the novelty, complexity, features of production and use of the product, and customer requirements. In this case, tests must be carried out to ensure compliance with all mandatory requirements of standards and technical regulations.

The need to develop, manufacture and test prototypes (models), experimental and pre-production samples of products, their list and quantity are determined in the technical specifications and/or agreement (contract) for R&D (an integral part of R&D). This does not exclude the possibility of such work being carried out by the developer if the need for it is revealed later, and appropriate changes are made to the technical specifications and/or agreement (contract) with the consent of the customer.

Requirements for inspection and testing procedures are established in accordance with documented inspection and test procedures to verify compliance established requirements to products, including software tests, which detail the necessary types of control, testing and registration.

6.3 For repairable products, it is recommended that the agreement (contract) and/or technical specifications for development and development work provide for the development of repair documentation intended for preparation of production, repair and control of products after repair in repair organization(repair or service organization).

6.4 To confirm compliance of the developed technical documentation with the initial requirements and selection best solution(if there are options) produce prototypes (pilot batches) of products if the products are intended for mass production (with an expected constant need). For non-serial production of products, head samples are also made.

When creating a single product, prototype product samples, as a rule, are subject to sale to the customer (unless otherwise specified in the agreement or contract and technical specifications for development work).

6.5 Testing of prototype products

6.5.1 To assess and control the quality of the results obtained at certain stages of the development work (an integral part of the development work), prototypes (pilot batch) of products (head product samples) are subjected to control tests in the following categories:

- preliminary tests carried out for the purpose of preliminary verification and assessment of the degree of compliance of the prototype product with the requirements of the technical specifications, determining the final scope of changes in the design documentation and modification of the design necessary to ensure compliance of the prototype product with the requirements of the technical specifications, as well as the volume of repeated and/or additional types tests for their inclusion in the prototype acceptance testing program;

- acceptance tests carried out for the purpose of final verification and confirmation of compliance of the prototype product with the requirements of the technical specifications and making a decision on the readiness of the results of the design and development work for presentation to the acceptance committee for their acceptance.

6.5.2 If products are subject to mandatory requirements of standards and technical regulations, which are subsequently subject to mandatory confirmation of conformity (certification), the results of product acceptance tests in terms of mandatory requirements carried out in laboratories (centers) accredited in accordance with Federal law, can be used to obtain confirmation of compliance according to established rules.

The place for testing prototypes of products is determined by the developer together with the manufacturer of the product [in the event that the functions of the developer and manufacturer are performed by different organizations and there are no specific test conditions established by state supervision (control) bodies].

6.5.3 When creating products (work organization model 1 to 4.3), state (interdepartmental, departmental) acceptance tests are carried out.

To certify the testing equipment used when testing products according to this model, measuring instruments of approved types must be used, which must be verified, and measurement techniques must be certified in accordance with GOST R 8.563 and GOST R 8.568.

When creating products according to models 2 and 3 - acceptance tests with the participation of the relevant government supervision (control) bodies and other interested organizations.

For component parts of products developed according to the technical specifications of the lead R&D contractor, acceptance tests are carried out with the participation of interested organizations. The ultimate goal These tests are to assess compliance with the requirements of the specification according to which they are developed, and to determine the possibility of installing components in a prototype product intended for its preliminary testing.

6.5.4 Lead samples of non-serial products are subjected to acceptance tests in order to decide on the admissibility of their intended use and to decide on the advisability of putting the product into non-serial production.

6.5.5 Lead product samples are tested in accordance with the requirements of this standard and taking into account the features established for it in the relevant regulatory documents.

6.5.6 Preliminary testing of products is organized by the R&D contractor.

State (interdepartmental, departmental) acceptance tests of products (model 1 to 4.3) are organized by the customer, unless otherwise specified in the agreement (contract).

Acceptance tests of products (models 2 and 3 to 4.3) with the participation of interested bodies and organizations specified in 6.5.3 are organized by the developer.

Acceptance tests of prototypes of product components (developed according to the technical specifications of the lead R&D contractor) with the participation of interested organizations are organized by the lead developer for the creation of the product. In other cases, testing of prototypes of product components is organized by their developer.

If R&D is carried out during proactive development (without a specific customer), acceptance tests are organized by the developer.

The organizer is responsible for conducting the tests.

6.5.7 Preliminary and acceptance tests are carried out according to the relevant programs and test methods developed and approved by the party responsible for conducting these tests.

Test programs and methods are developed based on the requirements of technical specifications, design documentation using, if necessary, standard programs, standard (standardized) test methods and standards regarding the organization and conduct of tests.

The test program includes:

- test object;

- purpose of testing;

- scope of tests;



- logistics support for testing;

- metrological support of tests;

- reporting on tests.

The test programs include lists of specific checks (tasks to be solved, assessments) that should be carried out during tests to confirm compliance with the requirements of the technical specifications with links to the relevant test methods.

The program and methodology for acceptance testing of prototype products must, in addition, contain verification of a set of working design documentation (including draft specifications for industrial production products) to decide on the suitability of documentation in industrial production.

The test procedure includes:

- assessed characteristics (properties, indicators) of products;

- conditions and procedure for testing;

- methods of processing, analysis and evaluation of test results;

- used testing, control and measurement tools;

- reporting.

Designation, design and content of programs and product testing methods are in accordance with GOST 2.102, GOST 2.105 and GOST 2.106.

Test methods used to determine product compliance with mandatory requirements, if they are not standard (standardized) methods, must be certified in the prescribed manner and agreed with the relevant government supervision (control) bodies.

6.5.8 Tests are carried out after checking the readiness of test sites (laboratories, test centers, etc.) to ensure technical requirements, safety requirements and after appointing responsible specialists for all work during the preparation and conduct of tests, assessing product characteristics with established measurement accuracy, as well as recording their results.

6.5.9 To conduct preliminary and acceptance tests, as a rule, a testing commission is appointed, which includes representatives of the developer, the manufacturer of the prototype (pilot batch) and specialists from the testing organization (testing center, laboratory), who control the completeness of the test program. , compliance with test deadlines, reliability, objectivity of test results and their documentation.

If necessary, the testing commission may include representatives of the customer, component suppliers and specialists from expert organizations.

As a rule, the chairman of the testing commission is a representative of the developer, who provides general management and organizes interaction between organizations whose representatives are members of the testing commission.

With the consent of the interested organizations, it is allowed to conduct tests without appointing a commission, but with the assignment of its functions and responsibilities to the relevant services of the organization conducting the tests.

6.5.10 By the start of the tests, preparation measures must be completed, including:

- availability, suitability, sufficiency and operability at the test site of logistics and metrological support, guaranteeing the creation of conditions and test regimes corresponding to those specified in the test program;

- training and, if necessary, certification of personnel admitted to testing;

- appointment of a commission or relevant organizations and their services (if a commission is not appointed);

- timely submission to the testing site of a prototype product with a set of design, regulatory and other documentation provided for by the testing program.

6.5.11 During the testing process, the progress and results of the tests are documented in the form and within the time limits provided for in the test program.

If a product sample does not comply with the requirements of the technical specifications or design documentation or if it fails, the tests may be interrupted or terminated, which is documented.

6.5.12 The specified and actual data obtained during testing are reflected in the protocol(s).

6.5.13 In test reports, texts relating to verification of mandatory requirements should be drawn up in accordance with the requirements of the rules for conformity assessment for and.

6.5.14 Positive results for all or certain types of tests and inspections obtained during preliminary tests can be counted as positive results for similar types of tests and inspections submitted for acceptance testing, subject to an appropriate decision of the testing commission.

Upon completion of preliminary tests, the developer assigns the letter “O” to the developed design documentation and technical documentation. Letters KD are assigned according to GOST 2.103.

Positive results of all tests provided for in the acceptance test program are the basis for presenting the results of the design and development work to the acceptance committee for their acceptance. The letter "O" is assigned by the acceptance committee after carrying out acceptance tests and reviewing the complete set of design documents.

Test results are considered negative if negative results are obtained for at least one item from those provided for in the test program and/or the acceptance committee negatively evaluates the technological readiness of the enterprise to be able to produce products.

Upon completion of acceptance tests, prototypes or samples of a pilot batch are considered to have fulfilled their functions. Their further use (as units of non-serial products) is determined in the acceptance test report.

Disposal or destruction of prototypes is determined by a special decision that complies with current legislation.

6.5.15 When accepting the results of work, state supervision (control) bodies determine the degree of product compliance with the mandatory requirements of standards and technical regulations and issue a final conclusion based on the test results.

7 Acceptance of product development results

7.1 To accept the development results and assess the possibility of putting the developed product into production by order of the customer (in its absence, by order of the developer), an acceptance committee is created, which includes representatives of the customer (if any), the developer, the manufacturer of the prototype (pilot batch), test organizations (centers, laboratories) that tested the prototype, representatives of organizations that approved the technical specifications and were interested in considering the results of the development work, as well as, if necessary, representatives of state supervision (control) bodies and expert organizations. Representation for participation in the acceptance committee and the timing of its holding are pre-agreed by the customer with the involved organizations and institutions.

As a rule, a representative of the customer is appointed as the chairman of the commission, and in the absence of a customer, a representative of the developer.

7.2 State supervision (control) bodies determined by the current legislation for a given product may, if necessary and at the request of the developer, participate in the acceptance committee or send the developer an opinion on the compliance of the developed product with the mandatory requirements of standards and technical regulations based on the results of the tests.

In the absence of representatives of supervisory authorities in the acceptance committee, as well as approval letters about their participation in it, as well as corresponding conclusions, it is believed that the supervisory authorities agree to accept the results of the development work or are not interested in the development.

7.3 The developer submits to the acceptance committee the terms of reference for the implementation of development work, a draft specification or standard type specification (if their development is provided), design documentation and/or technical documentation requiring joint consideration, a report on patent research, test reports signed by persons who carried out specific types of tests and inspections , an act on the results of acceptance tests, signed by members of the testing commission, if such a commission was created, or by the head of the organization that conducted the tests, and other technical documents and materials required by law, confirming the compliance of the developed products with the technical specifications and/or agreement (contract) and certifying its technical level and competitiveness.

The acceptance committee, as a rule, is also presented with prototypes of products, and if their production was not envisaged - a head sample or a single product created as part of the development work.

7.4 Based on the results of consideration of the submitted materials, the commission draws up an act in which it indicates:

- compliance of samples of developed (manufactured) products with the requirements specified in the technical specifications, admissibility of their production (delivery to the consumer);

- assessment results technical level and competitiveness of products, including in the patent and legal aspect;

- results of assessment of the developed technical documentation (including draft specifications and operational documentation);

- recommendations on the possibility of further use of prototypes of products;

- recommendations for the production of the installation series and its volume when performing work on putting products into production;

- comments and suggestions for improving products and documentation (if necessary);

- procedure and method of liquidation of products;

- recommendations for assigning the letter “O” to developed design documentation and technical documentation;

- other recommendations, comments and suggestions of the acceptance committee.

The acceptance committee report is approved by the customer.

Approval of the acceptance committee act means the completion of development, termination of the technical specifications (if it does not apply to further work), approval of the submitted design documentation (including the draft technical specifications and operational documents) and technical documentation.

7.5 Based on the results of the work of the acceptance committee, it is allowed to assign the letter “A” in the case of preparation and mastering of production in the process of manufacturing a prototype product.

8 Preparation and development of production (putting into production) products

8.1 Preparation and development of production, which are the stages of putting products into production, are carried out in order to ensure the readiness of production for the manufacture and release (delivery) of newly developed (modernized, modified) or previously produced by another organization of products in a given volume that meets the requirements of the design documentation.

8.2 The production of products is carried out by the decision of the manufacturer (supplier) in the presence of a potential customer (consumer) of the product and the prospect of concluding a supply agreement with him or, in the absence of one, at his own commercial risk.

By the time production begins, the manufacturer must resolve issues related to obtaining, updating the design documentation and the rules for owning the intellectual property contained therein, in accordance with 4.11.

8.3 By the time products are put into production for which mandatory requirements of standards and technical regulations are established, the results of acceptance tests must be recognized by state supervision (control) bodies - see 7.2.

8.4 To complete the pre-production stage, the manufacturer receives from the developer (holder of the original design documentation):

- a registered duplicate of a complete and current set of design documents with the letter no lower than “O”;

- a registered duplicate of the patent form (if patent research took place during the R&D process);

- a copy of the acceptance committee report;

- list of incoming inspection of materials and components.

8.5 At the pre-production stage, the manufacturer must perform work to ensure the technological readiness of the organization to manufacture products within the terms specified in the agreement (contract) in specified volumes, in accordance with the requirements of the design documentation, technical documentation and current legislation, as well as work on:

- concluding agreements (contracts) with suppliers of components and materials and licensing agreements with copyright holders for the use of industrial and intellectual property;

- preparation and submission of product catalog sheets to the territorial bodies of Rosstandart in the prescribed manner according to the rules;

- other jobs.

Preparation for production is considered complete when the manufacturer of the product has received all required documentation, a technical specification for the manufacture of products has been developed (tested), technological equipment and technological processes have been tested and debugged, personnel involved in the manufacture, testing and control of products have been trained (if necessary, certified), and readiness to master the production of products has been established.

8.6 At the production development stage the following is performed:

- production of the installation series (first industrial batch) of products according to the design documentation letter not lower than “O”;

- qualification tests;

- holding a qualification commission;

- further development (if necessary) of the design for manufacturability;

- adjustment of design documentation and technical documentation with assignment of the letter “A” to documents (when mastering production new organization TD can be assigned the letter "O").

8.7 During the period of launching production of products, the manufacturer (supplier) carries out all necessary work for subsequent certification of products for which mandatory requirements of standards and technical regulations are established.

8.8 Production of products according to the technical documentation of foreign companies is carried out in accordance with GOST 15.311, taking into account the requirements of this standard.

8.9 In order to assess the readiness of the organization to produce products in the volume determined by the agreement (contract), qualification tests are carried out.

8.10 Qualification tests are carried out according to the program and methodology developed and approved by the manufacturer with the participation of the product developer and agreed with the customer (consumer) of the product, if any.

The program indicates:

- the number of samples subjected to testing, which were selected from among the units of product of the installation series and passed control in the scope of checks provided for by the technical specifications for acceptance tests;

- types of tests specified in the product specifications and included in the scope of periodic tests, as well as other checks and types of tests that allow a more complete assessment of the developed product technological process and the readiness of the manufacturing organization to produce required quantity units of production;

- test methods;

- testing location.

The qualification testing program may not include verification of individual design documentation requirements that cannot change during production launch.

8.11 Qualification tests are organized and ensured by the manufacturer according to the approved program and methodology. The manufacturer conducts qualification tests on our own and means.

If it is necessary to conduct certain types of tests in third-party testing organizations (centers, laboratories) that have the necessary scope of accreditation, the manufacturer ensures that they are carried out in such organizations on contractual terms.

8.12 The tests are documented in test reports, which reflect the actual data of checks, inspections, controls, measurements and other data.

8.13 To assess the results of qualification tests and the readiness of the manufacturer’s production to produce products that comply with the specifications in the required volume, a qualification commission is created by order of the manufacturer.

The qualification commission includes representatives of the manufacturer (supplier) of the product, the customer (consumer) of the product, as well as, if necessary, representatives of bodies exercising supervision in the production of developed products, representatives of testing organizations and representatives of organizations and institutions that have approved the specifications and/or are interested in reviewing the results of putting products into production.

Representation for participation in the qualification commission and the timing of its holding are pre-agreed by the manufacturer with the organizations involved. In the absence of representatives of supervisory authorities in the qualification commission, as well as approval letters on their participation in it, it is believed that supervisory authorities positively assess the results of putting products into production or are not interested in considering them.

As a rule, a representative of the manufacturer is appointed as the chairman of the commission.

The product manufacturer must submit the following documents to the qualification commission:

- approved program and methodology for qualification tests;

- test reports and inspections of product samples from the installation series, carried out as part of qualification tests, including acceptance tests, and others accounting documents provided for by the program and methodology of qualification tests;

- a complete set of TD, developed and used for the manufacture of the installation series;

- certificate of verification/calibration of measuring instruments, certification of technological and testing equipment involved in the manufacture of products in accordance with TD;

- certificate of qualification of personnel involved in the manufacture of products in accordance with the TD.

In the course of their work, members of the commission may request other documents, the consideration of which becomes necessary.

The results of the work of the qualification commission are documented in an act signed by the members of the commission and approved by the chairman of the commission.

The act of the qualification commission reflects:

- composition of documents reviewed during the work process;

- completeness of program implementation, objectivity and reliability of the results of qualification tests;

- general assessment technological equipment and the readiness of production to produce products in the required volumes based on the documents submitted, the inspection of production and manufactured product samples, the results of random monitoring of compliance with technological discipline at the workplace (if any);

- assessment of the readiness of the design documentation for approval in the prescribed manner with the assignment of the letter “A” (if necessary);

- recommendations for assigning the next TD letter;

- recommendations for acceptance and delivery of product samples from the installation series.

Test results are considered negative if negative results are obtained for at least one item from those provided for in the program and/or test methodology.

In the event of a negative assessment by the commission of the results of launching production of products, members of the commission draw up and sign a list of deficiencies identified during the work of the commission, and recommendations for their elimination.

The manufacturer, if necessary, agrees to increase the size of the installation series, eliminates the identified deficiencies and carries out the measures provided for in this section again.

8.14 It is allowed to supply products during the period of mastering its production, if the manufacturer can confirm the compliance of these products with the mandatory requirements of standards and technical regulations.

Product units of the installation series are not classified as commercial products, as a result of which the service technical control carries out only their control, and acceptance for delivery - only at the request of the consumer.

8.15 If the results of qualification tests are positive, production development is considered completed.

Bibliography

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prepared by Kodeks JSC and verified against:
official publication
M.: Standartinform, 2018

GOST R 15.201-2000

GOST R 15.201-2000

UDC 65.012.2.002:006.354 Group T52

STATE STANDARD OF THE RUSSIAN FEDERATION

System for developing and launching products

PRODUCTS FOR PRODUCTION AND TECHNICAL PURPOSE

The procedure for developing and putting products into production

System of product development and launching into manufacture.

Products of industrial and technical design.

Procedure of product development and launching into manufacture

Date of introduction 2001-01-01

OKS 01.040.01

Preface

1 DEVELOPED by the All-Russian Scientific Research Institute of Standardization (VNIIstandart) of the State Standard of Russia

INTRODUCED by the Scientific and Technical Directorate of the State Standard of Russia

2 ADOPTED AND ENTERED INTO EFFECT by Resolution of the State Standard of Russia dated October 17, 2000 No. 263-st

3 INTRODUCED FOR THE FIRST TIME

1 area of ​​use

This standard applies to national economic products for industrial and technical purposes (hereinafter referred to as products) and establishes the procedure for their development and production.

The standard establishes the basic provisions for the development of technical specifications (TOR), design and technological documentation, acceptance of development results, preparation and development of production, testing of prototypes of products and products manufactured during the development of production, as well as confirmation of their compliance with mandatory requirements. If necessary, the requirements of this standard may be specified in other standards and methodological documents of different scopes.

The standard does not apply to civil vessels.

2 Normative references

GOST 2.124-85 Unified system of design documentation. Procedure for using purchased products

GOST 15.311-90 System for development and production of products. Launching production of products according to technical documentation of foreign companies

GOST R 15.000-94 System for developing and putting products into production. Basic provisions

GOST R 15.011-96 System for developing and putting products into production. Patent research. Contents and procedure

GOST R ISO 9001-96 Quality systems. Quality assurance model for design, development, production, installation and maintenance

3 Definitions

3.1 This standard uses terms with corresponding definitions according to, as well as those given below:

3.1.1national economic products: Products designed and manufactured to meet needs National economy, population and exports.

3.1.2products for industrial and technical purposes: Products intended for use as means of industrial and agricultural production.

3.1.3mandatory requirements: Requirements established by state standards and other regulatory documents based on the legislation of the Russian Federation to ensure the safety of products, works and services for the environment, life, health and property, technical and information compatibility, interchangeability of products, unity of control methods and unity of labeling, as well as others mandatory requirements established by the legislation of the Russian Federation.

3.1.4competitive basis: The principle of distributing orders for the development (production) of products, which consists in using competitive selection based on the results of bidding (competitions).

3.1.5work organization model: According to GOST R 15.000.

3.1.6work organization module: According to GOST R 15.000.

3.1.7state supervisory authorities: Federal executive authorities supervising the implementation of mandatory requirements.

GOST R 15.201-2000

Group T52

STATE STANDARD OF THE RUSSIAN FEDERATION

System for developing and launching products

PRODUCTS FOR PRODUCTION AND TECHNICAL PURPOSE

The procedure for developing and putting products into production

System of product development and launching into manufacture. Products of industrial and technical design. Procedure of product development and launching into manufacture

Text Comparison of GOST R 15.201-2000 with GOST R 15.301-2016, see the link.
- Database manufacturer's note.
____________________________________________________________________

OKS 01.040.01
01.110
OKSTU 0015

Date of introduction 2001-01-01

Preface

1 DEVELOPED by the All-Russian Scientific Research Institute of Standardization (VNIIstandart) of the State Standard of Russia

INTRODUCED by the Scientific and Technical Directorate of the State Standard of Russia

2 ADOPTED AND ENTERED INTO EFFECT by Resolution of the State Standard of Russia of October 17, 2000 N 263-st

3 INTRODUCED FOR THE FIRST TIME

4 REPUBLICATION. August 2010

1 area of ​​use

1 area of ​​use

This standard applies to national economic products for industrial and technical purposes (hereinafter referred to as products) and establishes the procedure for their development and production.

The standard establishes the basic provisions for the development of technical specifications (TOR), design and technological documentation, acceptance of development results, preparation and development of production, testing of prototypes of products and products manufactured during the development of production, as well as confirmation of their compliance with mandatory requirements. If necessary, the requirements of this standard may be specified in other standards and methodological documents of different scopes.

The standard does not apply to civil vessels.

2 Normative references

This standard uses references to the following standards:

GOST 2.124-85 Unified system of design documentation. Procedure for using purchased products

GOST 15.311-90 System for development and production of products. Launching production of products according to technical documentation of foreign companies

GOST R 15.000-94 System for developing and putting products into production. Basic provisions

GOST R 15.011-96 System for developing and putting products into production. Patent research. Contents and procedure

GOST R ISO 9001-96 * Quality systems. Quality assurance model for design, development, production, installation and maintenance
_________________
* Valid until December 15, 2003.
GOST ISO 9001-2011

GOST R ISO 9001-2001 * Quality management systems. Requirements
________________
* Since November 13, 2009, GOST R ISO 9001-2008 has been in force.
GOST ISO 9001-2011 is in force on the territory of the Russian Federation, hereinafter in the text

3 Definitions

3.1 This standard uses terms with corresponding definitions according to, as well as those given below:

3.1.1 national economic products: Products developed and manufactured to meet the needs of the national economy, population and export.

3.1.2 products for industrial and technical purposes: Products intended for use as means of industrial and agricultural production.

3.1.3 mandatory requirements: Requirements established by state standards and other regulatory documents based on the legislation of the Russian Federation to ensure the safety of products, works and services for the environment, life, health and property, technical and information compatibility, interchangeability of products, unity of control methods and unity of labeling, as well as others mandatory requirements established by the legislation of the Russian Federation.

3.1.4 competitive basis: The principle of distributing orders for the development (production) of products, which consists in using competitive selection based on the results of bidding (competitions).

3.1.5 work organization model: According to GOST R 15.000.

3.1.6 work organization module: According to GOST R 15.000.

3.1.7 state supervisory authorities: Federal executive authorities supervising the implementation of mandatory requirements.

4 General provisions

4.1 This standard considers the following stages and types of work in the product life cycle, established by GOST R 15.000:

- stage "Development", type of work "Experimental design work (R&D) for product development";

- part of the “Production” stage, type of work “Putting into production”.

4.2 Certain types of work on the development and production of products, characterized by target orientation, organizational completeness, a certain sequential order of execution and planning, the presence of certain performers, are combined into work organization modules that meet the requirements of GOST R 15.000 in composition and content.

4.3 Depending on the availability of targeted product development programs, the presence or absence of a customer, the nature of the relationship between business entities, the development and production of products is carried out according to the following work organization models:

1 - creation of products under state and municipal orders, as well as other orders financed from the federal budget and budgets of constituent entities of the Russian Federation (hereinafter referred to as government orders);

2 - creation of products ordered by a specific consumer (interested organizations, societies, commercial structures);

3 - proactive product development without a specific customer at the commercial risk of the developer and manufacturer.

The work organization model is chosen based on the ability to ensure required quality products, compliance with mandatory requirements and competitiveness of products.

4.4 Government orders are placed on a competitive basis, taking into account data on the qualifications of the contractor, in accordance with the current procedure for organizing the procurement of goods, works and services for government needs.

4.5 When creating products under government orders and orders of a specific consumer, an agreement (contract) for the work performed is concluded in the prescribed manner, and technical specifications for the work performed are developed.

If necessary, the contract and (or) technical specifications indicate regulatory documents regulating the procedure for performing work, and documents defining mandatory rules and requirements for products.

If necessary, the agreement (contract) specifies a set of work organization modules that ensure the fulfillment and confirmation of mandatory requirements, as well as requirements established by laws and regulatory documents of state supervisory authorities.

4.6 Based on the initial requirements of the customer (if any), the product developer carries out the necessary research, development and technological work, paying special attention to ensuring the following requirements:

- safety, health and environmental protection (including their preservation during product operation);

- resource saving;

- values ​​of indicators established for the conditions of use of the product that determine its technical level;

- resistance to external influences;

- interchangeability and compatibility of components and products as a whole.

4.7 The decision to develop products on an initiative basis is made taking into account the conditions of the sales market.

4.8 Development and production of products generally provides for:

1) development of technical specifications for development work (R&D);

2) carrying out development work, including:

- development of technical documentation [design (CD) and technological (TD)],

- production of prototypes,

- testing of prototypes,

- acceptance of R&D results;

3) production launch, including:

- production preparation,

- development of production:

production of installation series,

qualification tests.

The stages of a specific design and development work (a component of the design and development work), as well as the procedure for their acceptance, must be defined in the terms of reference for the design and development work (a component of the design and development work) and the agreement (contract) for its implementation.

4.9 At all stages of R&D (an integral part of R&D) and when placing products into production, performers ensure compliance with mandatory requirements.

The achieved indicators and their compliance with the requirements of the technical specifications for R&D (an integral part of R&D) are assessed upon acceptance of the stages and are reflected in the test reports (acts) of prototypes of products and acceptance certificates for the stages of R&D and R&D as a whole.

4.10 The relationship between the developer (manufacturer) and state supervisory authorities is determined by the current legislation.

4.11 Documents confirming compliance with mandatory requirements are submitted to state supervisory authorities in accordance with their rules.

The composition of these documents is established by the relevant state supervision body.

4.12 Products of intellectual labor obtained in the process of creating and putting products into production and being objects of intellectual property protection are used in the manner established by the legislation of the Russian Federation.

5 Development of technical specifications for R&D

5.1 The basis for performing the design and development work is the technical specifications approved by the customer and the agreement (contract) with him. Another document containing necessary and sufficient requirements for product development and mutually recognized by the customer and developer can be used as technical specifications.

Requirements for the analysis of an agreement (contract) are given in 4.3 GOST R ISO 9001.

In the case of proactive product development, the basis for performing R&D is the technical specification approved by the management of the developer enterprise (or a document replacing it), based on the results of product market research, as well as patent research in accordance with GOST R 15.011.

When developing technical specifications, the developer takes into account information about similar products contained in databases (all-Russian and regional) created in the State Standard of Russia on the basis of product catalog sheets.

5.2 It is recommended that the technical specifications indicate technical and economic requirements for products that determine their consumer properties and effectiveness of use, a list of documents requiring joint consideration, and the procedure for delivery and acceptance of development results.

The technical specifications provide for the implementation of all mandatory requirements that apply to these products.

The technical specifications indicate the form of confirmation of product compliance with mandatory requirements provided for by law.

It is recommended that the technical specifications take into account the interests of all possible consumers.

The specific content of the technical specification is determined by the customer and the developer, and in case of proactive development - by the developer.

It is not allowed to include in the technical specifications requirements that contradict the laws of the Russian Federation and mandatory requirements.

5.3 It is recommended that the TOR include the following provisions:

- forecast of the development of requirements for this product for the expected period of its release;

- recommended stages of product modernization taking into account the forecast for the development of requirements;

- compliance with the requirements of the countries of intended export, taking into account the forecast for the development of these requirements;

- maintainability characteristics;

Possibility of replacing spare parts without the use of industrial technology;

- accessibility and safety effective use products by disabled people and elderly citizens (for the corresponding products provided for by the legislation of the Russian Federation).

5.4 Technical specifications are developed and approved in the manner established by the customer and developer.

Other interested organizations (enterprises) may be involved in the development of technical specifications: manufacturer, trade (intermediary) organization, insurance organization, design organization, installation organization and etc.

5.5 To confirm individual requirements for products, including safety, health and environmental requirements, as well as assessing the technical level of products, the technical specifications can be sent by the developer or customer for examination (conclusion) to third-party organizations. The decision on the conclusions received is made by the developer and the customer before approval of the technical specifications.

5.6 At any stage of product development, with the consent of the customer and developer, changes and additions may be made to the technical specifications or a document replacing it that do not violate the conditions for fulfilling the mandatory requirements.

6 Development of documentation, production and testing of prototypes of products

6.1 The development of design and technological, and, if necessary, program documentation for products is carried out according to the rules established respectively by the standards of the Unified System of Design Documentation (USD), the Unified System of Technological Documentation (ESTD) and the Unified System of Program Documentation (USPD).

General requirements for design management - according to 4.4 GOST R ISO 9001.

The rules for the development of technical documentation for materials and substances are established by the developer, taking into account current state standards, the specifics of the product and the organization of its production.

6.2 In the process of developing documentation for the selection and testing of new technical solutions that ensure the achievement of the basic consumer properties of products, laboratory research, bench and other tests, as well as development tests of experimental and pre-production samples of products can be carried out under conditions simulating real operating (consumption) conditions. , while taking into account the patent and legal aspects of the economic use of these technical solutions.

For certain types of products or their components, tests of prototypes can be carried out under operating conditions (including at enterprises that are consumers of the products).

The scope and content of tests necessary to prevent the production of unproven products that do not comply with the specifications are determined by the developer, taking into account the novelty, complexity, features of production and use of the product, and customer requirements. In this case, tests must be carried out to ensure compliance with all mandatory requirements.

The need to develop, manufacture and test mock-ups (models), experimental and pre-production samples of products, their list and quantity are determined in the technical specifications and the agreement (contract) for R&D (an integral part of R&D). This does not exclude the possibility of such work being carried out by the developer if their need is revealed later, while appropriate changes are made to the technical specifications and the agreement (contract), with the consent of the customer.

Requirements for control and testing procedures are established in accordance with 4.10-4.12 GOST R ISO 9001.

6.3 For repairable products, it is advisable in the agreement (contract) and technical specifications for development work to provide for the development of repair documentation intended for preparation of production, repair and control of products after repair.

6.4 To confirm the compliance of the developed technical documentation with the initial requirements and to select the best solution (if options are available), prototypes (pilot batches) of products are produced if the products are intended for serial production (with an expected constant need). For non-serial production of products, head samples are also made.

When creating a single product, prototype product samples, as a rule, are subject to sale to the customer (unless otherwise specified in the contract and technical specifications for development work).

6.5 Testing of prototype products

6.5.1 To assess and control the quality of the results obtained at certain stages of the development work (an integral part of the development work), prototypes (pilot batch) of products (head samples* of products) are subjected to control tests in the following categories:

- preliminary tests carried out for the purpose of preliminary assessment of the compliance of a prototype product with the requirements of the technical specifications, as well as to determine the readiness of the prototype for acceptance testing;

- acceptance tests carried out with the aim of assessing all product characteristics determined by the technical specifications, checking and confirming the compliance of a prototype product with the requirements of the technical specifications in conditions as close as possible to the conditions of actual operation (application, use) of the product, as well as for making decisions on the possibility of industrial production and sale products.

* Lead product samples are development objects that simultaneously act as the first samples of non-serial and small-scale products sold to the customer on special delivery terms.

6.5.2 If products are subject to mandatory requirements that are subsequently subject to mandatory confirmation of conformity (certification), the results of product acceptance tests in terms of mandatory requirements, carried out in laboratories (centers) accredited in the prescribed manner, can be used to obtain confirmation of conformity according to the established requirements. rules.

The place for testing prototypes of products is determined by the developer together with the manufacturer of serial products (if the functions of the developer and manufacturer are performed by different enterprises and there are no specific test conditions established by state supervisory authorities).

6.5.3 When creating products according to work organization model 1 (4.3), state acceptance tests are carried out; for models 2 and 3 - acceptance tests are carried out with the participation of the relevant state supervisory authorities and other interested organizations.

For component parts of products developed according to the technical specifications of the lead R&D contractor, independent acceptance tests are carried out with the participation of interested organizations. The ultimate goal of these tests is to assess compliance with the requirements of the technical specifications for which they are developed, and to determine the possibility of installing components in a prototype product intended for its preliminary testing.

6.5.4 Lead samples of non-serial products are subjected to acceptance tests in order to resolve the issue of the admissibility of their use for their intended purpose, and for repeating non-serial products - and to resolve the issue of the advisability of putting the product into non-serial production.

6.5.5 Lead product samples are tested according to the rules of this standard, taking into account the features established for it in the relevant regulatory documents.

6.5.6 Preliminary testing of products is organized by the R&D contractor.

State acceptance tests of products (model 1 to 4.3) are organized by the state customer, unless otherwise specified in the agreement (contract).

Acceptance tests of products according to work organization models 2 and 3 to 4.3 with the participation of interested bodies and organizations specified in 6.5.3 are organized by the developer.

Acceptance tests of prototypes of product components (developed according to the technical specifications of the lead R&D contractor) with the participation of interested organizations are organized by the lead developer for the creation of the product. In other cases, testing of prototypes of product components is organized by their developer.

If R&D is carried out during proactive development (without a specific customer), acceptance tests are organized by the developer.

The organizer is responsible for conducting the tests.

6.5.7 Preliminary and acceptance tests are carried out according to the relevant programs and test methods (hereinafter referred to as test programs), developed and approved by the party responsible for conducting these tests.

Test programs are developed based on the requirements of technical specifications, design documentation using, if necessary, standard programs, standard (standardized) test methods and others. regulatory documents in terms of organizing and conducting tests.

The test program includes:

test object,

purpose of testing,

scope of tests

conditions and procedure for testing,

logistics support for testing,

metrological testing support,

test reporting.

The test programs include lists of specific checks (tasks to be solved, assessments) that should be carried out during tests to confirm compliance with the requirements of the technical specifications with links to the relevant test methods. The program and methodology for acceptance testing of prototype products must, in addition, contain a quality check of the working design and operational documentation (including the design technical specifications for industrial production of products) to decide on the suitability of documentation in industrial production.

The test procedure includes:

assessed characteristics (properties, indicators) of products;

conditions and procedure for testing;

methods of processing, analysis and evaluation of test results;

the testing, control and measurement equipment used;

reporting.

Test methods used to determine product compliance with mandatory requirements, if they are not standard standardized methods, must be certified in the prescribed manner and agreed upon with the relevant state supervisory authorities.

6.5.8 Tests are carried out after checking the readiness of testing sites (laboratories, testing centers, etc.) to meet technical requirements, safety requirements and after appointing responsible specialists for all work during the preparation and conduct of tests, assessing product characteristics with established measurement accuracy , as well as recording their results.

6.5.9 To conduct acceptance tests, as a rule, a commission is appointed, which monitors the completeness, reliability and objectivity of the test results, as well as the completeness of information, compliance with test deadlines and documenting their results. With the consent of the interested organizations, it is allowed to conduct tests without appointing a commission, but with the assignment of its functions and responsibilities to the relevant services of the organization conducting the tests, which must be reflected in the technical specifications and (or) agreement (contract) for the implementation of the development work.

6.5.10 By the start of the tests, preparation measures must be completed, including:

- availability, suitability and readiness at the test site of logistics and metrological support facilities that guarantee the creation of conditions and test regimes corresponding to those specified in the test program;

- training and, if necessary, certification of personnel admitted to testing;

- appointment of a commission or relevant organizations (enterprises) and their services (if a commission is not appointed);

- timely submission to the testing site of a prototype product with a set of design, regulatory, reference and other documentation provided for by the test program.

6.5.11 During the testing process, the progress and results of the tests are documented in the form and within the time limits provided for in the test program.

In justified cases, tests may be interrupted or terminated, which is documented.

6.5.12 The specified and actual data obtained during testing are reflected in the protocol(s).

6.5.13 In test reports, texts relating to verification of mandatory requirements should be formatted in accordance with the requirements of the conformity assessment rules.

6.5.14 Tests are considered completed if their results are documented in an act confirming the implementation of the test program and containing an assessment of the test results with specific, precise wording reflecting the compliance of the tested prototype product with the requirements of the technical specifications.

Upon completion of acceptance tests, prototypes or samples of a pilot batch are considered to have fulfilled their functions. Their further use (as units of non-serial products), recycling or destruction is determined by a special decision that complies with current legislation.

6.5.15 During acceptance tests, state supervisory authorities determine the degree of product compliance with mandatory requirements and issue a final conclusion based on the test results, which is reflected in the act or in a separate documented conclusion.

7 Acceptance of product development results

7.1 The results of product development are assessed by an acceptance committee, which includes representatives of the customer, developer and manufacturer. Experts can participate in the work of the commission third party organizations, and for products for which mandatory requirements have been established - state supervisory authorities (or the conclusion of these authorities has been submitted).

If there is a customer, his representative is appointed chairman of the commission. The composition of the commission is formed and approved by the customer or, with the customer’s consent, by the developer.

7.2 The acceptance committee conducts acceptance tests of prototypes (pilot batches) of products in accordance with 6.5.

At the request of the customer or in accordance with the rules for assessing compliance with mandatory requirements, testing can be entrusted to a specialized testing organization (testing center) or to the manufacturer, if this is stipulated in the terms of reference for the implementation of R&D (agreement, contract).

The manufacturer and state supervisory authorities have the right to take part in acceptance tests, regardless of the place where they are carried out, who must be informed about the upcoming tests one month before their start.

All state supervisory authorities determined by current legislation for this product either participate in acceptance tests or issue conclusions based on test results.

In the absence of a representative of the state supervisory authority or its conclusion, it is considered that the state supervisory authority agrees to accept the development or is not interested in it.

7.3 The developer submits to the acceptance committee the technical specifications for the implementation of the development work, draft technical conditions (TS) or standard technical conditions (if their development is envisaged), design and (or) technological documents requiring joint consideration, a report on patent research, other technical documents and materials, required by law, confirming the compliance of the developed product with the specifications and the agreement (contract) and certifying its technical level and competitiveness. The acceptance committee, as a rule, is also presented with prototypes of products, and if their production was not envisaged - a head sample or a single product created as part of the development work.

7.4 Based on the results of acceptance tests and consideration of submitted materials, the commission draws up a report in which it indicates:

1) compliance of samples of developed (manufactured) products with the requirements specified in the technical specifications, admissibility of their production (delivery to the consumer);

2) the results of assessing the technical level and competitiveness of products, including in the patent and legal aspect;

3) results of assessment of the developed technical documentation (including draft technical specifications);

6) comments and suggestions for improving products and documentation (if necessary);

7) other recommendations, comments and suggestions of the acceptance committee.

The acceptance committee report is approved by the customer.

Approval of the acceptance committee act means the end of development, termination of the technical specifications (if it does not apply to further work), approval of the submitted specifications and technical documentation.

7.5 The acceptance committee’s act, with the consent of the relevant state supervisory authorities, may reflect the requirements of 4.9, 4.10, 5.2, 6.5.15, 7.2, 8.3.

8 Preparation and development of production (putting into production) products

8.1 Preparation and development of production, which are the stages of putting products into production, are carried out in order to ensure the readiness of production for the manufacture and release (delivery) of newly developed (modernized) or previously produced by another enterprise products in a given volume that meets the requirements of design documentation.

8.2 The basis for putting into production is an agreement (contract) concluded with the customer for the purchase from the supplier (manufacturer) of products manufactured within a specified period.

In the absence of a specific customer, the basis is the decision of the supplier’s management at its own commercial risk.

8.3 By the time the product is put into production, the results of acceptance tests must be recognized by state supervisory authorities (6.5.15, 7.2).

8.4 The manufacturer accepts from the product developer:

set of CD and TD letter O or higher;

special means of control and testing;

a prototype product (if necessary) in accordance with the conditions for the use of scientific and technical products specified in the agreement (contract) for development work;

documents on approval of the use of components in accordance with GOST 2.124;

conclusions on the examinations carried out (including metrological, environmental, etc.);

a copy of the acceptance test report;

documents confirming compliance of the developed products with mandatory requirements.

8.5 At the pre-production stage, the manufacturer must carry out work to ensure the technological readiness of the enterprise for the manufacture of products within the terms specified in the contract (agreement) in specified volumes, in accordance with the requirements of the design documentation and the legislation of the Russian Federation, as well as the following main works:

- development of technical documentation (or adjustment of the received technical documentation) for the manufacture of products for delivery, control and testing;

- development of the design for manufacturability taking into account ESTD standards;

- concluding agreements (contracts) with suppliers of components and materials and licensing agreements with copyright holders for the use of industrial and intellectual property;

- preparation and submission of product catalog sheets to the territorial bodies of Gosstandart of Russia in the prescribed manner;

- other jobs.

Preparation of production is considered complete when the manufacturer of the product has received all the necessary documentation, developed (worked out) TD for the manufacture of products, tested and adjusted technological equipment and technological processes, trained personnel involved in the manufacture, testing and control of products, and established readiness for mastering production products.

8.6 At the production development stage the following is performed:

- production of the number of units of product of the installation series (first industrial batch) established by the agreement (contract) or other document in accordance with the requirements of the design documentation (letter O or higher), finalization of the developed technological process for the production of products according to the design documentation (letter O or higher);

- qualification tests;

- further development (if necessary) of the design for manufacturability;

- approval of the design documentation and technical documentation with the assignment of the letter A.

8.7 During the period of launching production of products, the manufacturer (supplier) carries out all the necessary work for subsequent certification of products required by law.

8.8 Production of products according to the technical documentation of foreign companies is carried out in accordance with GOST 15.311, taking into account the requirements of this standard.

8.9 In order to demonstrate the readiness of the enterprise to produce products that meet the requirements of the design documentation, to verify the developed technological process that ensures the stability of product characteristics, as well as to assess the readiness of the enterprise to produce products in the quantity determined by the agreement (contract), qualification tests are carried out.

8.10 Qualification tests are carried out according to a program developed by the manufacturer with the participation of the product developer and agreed with the customer (if any). The program indicates:

- the number of product units subjected to testing and inspection based on their complexity, cost, reliability and other factors necessary for reliable assessments;

- all types of tests corresponding to the periodic tests specified in the technical specifications, as well as other tests and inspections that allow achieving the purpose of qualification tests;

- testing location.

The qualification testing program may not include verification of individual design documentation requirements that cannot change during production launch.

8.11 Qualification tests are organized and carried out by the manufacturer (supplier) of the product. Qualification tests are carried out by a commission consisting of representatives of the manufacturer, product developer, developers and suppliers of components and, if necessary, government supervisory authorities and other interested parties (for example, insurance organizations, public organizations on consumer rights protection, etc.).

8.12 The tests are documented in test reports, which reflect the actual data of checks, inspections, controls, measurements and other data, which must be signed by members of the commission and persons participating in a specific type of test.

8.13 The results of qualification tests are considered positive if the product (installation series) has passed the tests on all points of the qualification test program, the technological equipment of production and the stability of the manufacturing process are positively assessed for the possibility of producing in specified volumes of products that comply with design documentation, as well as technical specifications.

Positive results are documented in a document indicating:

- product compliance with mandatory requirements and design documentation, results of consideration of materials submitted to the commission, results of selective control of the technological process of manufacturing (assembly) of products (parts, assembly units) in the workplace;

- recommendations for establishing standards for established industrial production (if necessary);

- assessment of the manufacturer’s readiness to produce serial products for the implementation of the agreement (contract) and the readiness of the design documentation, technical documentation for approval in the prescribed manner with the assignment of the letter A;

- recommendations on the possibility of supplying products from those manufactured during the development of production (with mandatory notification of consumers about this and the sale of such products only with their consent and after carrying out acceptance tests in the prescribed manner).

8.14 Delivery of products during the period of mastering its production is allowed if the manufacturer can confirm the compliance of these products with mandatory requirements.

Product units of the installation series are not classified as commercial products, as a result of which the Quality Control Department only carries out their control, and accepts them for delivery only at the request of the consumer.

8.15 If the results of qualification tests are positive, production development is considered completed.

APPENDIX A (for reference). Bibliography

APPENDIX A
(informative)

R 50-605-80-93* System for developing and launching products into production. Terms and Definitions
________________
* The document is the author's work. For more information please follow the link. - Database manufacturer's note.

PR 50-718-94* Rules for filling out and submitting product catalog sheets
________________
* The document is not valid on the territory of the Russian Federation. PR 50-718-99 is valid. - Database manufacturer's note.


Electronic document text
prepared by Kodeks JSC and verified against:

official publication
Development and staging system
products for production:
Collection of national standards. -

M.: Standartinform, 2010

GOST R 15.301-2016

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

System for developing and launching products

PRODUCTS FOR PRODUCTION AND TECHNICAL PURPOSE

The procedure for developing and putting products into production

System of product development and launching into manufacture. Products of industrial and technical design. Procedure of product development and launching into manufacture

Text Comparison of GOST R 15.301-2016 with GOST R 15.201-2000, see the link.
- .
____________________________________________________________________

OKS 01.040.01
OKSTU 0015

Date of introduction 2017-07-01

Preface

Preface

1 DEVELOPED by the Federal State Unitary Enterprise "All-Russian Research Institute of Standardization and Certification in Mechanical Engineering" (VNIINMASH)

2 INTRODUCED by the Technical Committee for Standardization TC 051 "Design Documentation System"

3 APPROVED AND ENTERED INTO EFFECT by Order of the Federal Agency for Technical Regulation and Metrology dated October 31, 2016 N 1541-st

4 INSTEAD GOST R 15.201-2000

5 REPUBLICATION. August 2018

The rules for the application of this standard are established in Article 26 of the Federal Law of June 29, 2015 N 162-FZ "On Standardization in the Russian Federation" . Information about changes to this standard is published in the annual (as of January 1 of the current year) information index "National Standards", and the official text of changes and amendments is published in the monthly information index "National Standards". In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the next issue of the monthly information index "National Standards". Relevant information, notices 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 (www.gost.ru)

1 area of ​​use

This standard establishes the procedure for the development and production of products for industrial and technical purposes, including the rules for the development of technical specifications, design and technological documentation, acceptance of development results, preparation and development of production, testing of prototypes of products and products manufactured during the development of production, as well as rules for confirming their compliance with mandatory requirements.

If necessary, the rules established in this standard can be specified in the standards of organizations and/or other documents of these organizations.

The standard does not apply to civil aircraft and maritime vessels.

The provisions of this standard are subject to application by organizations and other business entities located on the territory of the Russian Federation, regardless of their form of ownership and subordination, as well as by the Federal executive authorities of the Russian Federation involved in the development and launch of production of products in accordance with current legislation.

2 Normative references

This standard uses normative references to the following standards:

GOST 2.001 Unified system of design documentation. General provisions

GOST 3.1001 Unified system of technological documentation. General provisions

GOST 2.102 Unified system of design documentation. Types and completeness of design documents

GOST 2.103 Unified system of design documentation. Development stages

GOST 2.105 Unified system of design documentation. General requirements for text documents

GOST 2.106 Unified system of design documentation. Text documents

GOST 15.016 System for developing and launching products into production. Technical task. Requirements for content and design

GOST 15.311 System for developing and launching products into production. Launching production of products according to technical documentation of foreign companies

GOST 16504 System of state testing of products. Testing and quality control of products. Basic terms and definitions

GOST R 8.563 State system for ensuring the uniformity of measurements. Measurement techniques (methods)

GOST R 8.568 State system for ensuring the uniformity of measurements. Certification of testing equipment. Basic provisions

GOST R 15.000 System for developing and putting products into production. Basic provisions

GOST R 15.011 System for developing and launching products into production. Patent research. Contents and procedure

GOST R ISO 9001-2015 Quality management systems. Requirements

GOST R ISO 10006 Quality management systems. Design Quality Management Guide

Note - When using this standard, it is advisable to check the validity of the reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or using the annual information index "National Standards", which was published as of January 1 of the current year, and on issues of the monthly information index "National Standards" for the current year. If an undated reference standard is replaced, it is recommended that the current version of that standard be used, taking into account any changes made to that version. If a dated reference standard is replaced, it is recommended to use the version of that standard with the year of approval (adoption) indicated above. If, after the approval of this standard, a change is made to the referenced standard to which a dated reference is made that affects the provision referred to, it is recommended that that provision be applied without regard to that change. If the reference standard is canceled without replacement, then the provision in which a reference to it is given is recommended to be applied in the part that does not affect this reference.

3 Terms, definitions and abbreviations

3.1 This standard uses terms in accordance with GOST 16504, as well as the following terms with corresponding definitions.

3.1.1 mandatory requirements: Requirements established by national standards and other standardization documents based on current legislation to ensure the safety of products, works and services, protection of the environment, life, health and property, ensuring technical and information compatibility, interchangeability of products, uniformity of control and labeling methods, as well as other mandatory requirements established by technical regulations and legislation of the Russian Federation.

3.1.2 competitive basis: The principle of distributing orders for the development (production) of products, which consists in using competitive selection based on the results of bidding (competitions).

3.1.3 product customer: A legal entity that provides financing for the development (creation, modernization) of products, their production and determines the basic requirements for products.

3.1.4 product manufacturer: A legal entity that produces products.

3.1.5 product consumer: Legal and/or individual using the product for its intended purpose.

3.1.6 work organization model (model): A certain combination of work organization modules that establishes a standard work scheme and rules of interaction, which are the objects of standardization in the SRPP.

3.1.7 work organization module (module): A systematically ordered set of standard elements of an organizational and technical mechanism, characterized by a specific target orientation, organizational completeness and an established procedure for planning, providing and executing its constituent elements.

3.1.8 head sample: A product manufactured according to newly developed documentation, which simultaneously acts as the first samples of non-serial and small-scale products sold to the customer on special delivery terms.

Notes

1 Non-serial products include individual copies of products or a batch, materials and substances of limited volume, manufactured as the need arises (occasionally).

2 Small-scale products are products produced in small batches to meet the needs of a specific customer (consumer).

3.2 The following abbreviations are adopted in this standard:

KD - design documentation;

R&D - experimental design work;

TD - technological documentation;

TK - technical specifications;

TR - technical regulations;

TU - technical conditions.

4 General provisions

4.1 This standard considers the following stages and types of work in the product life cycle established by GOST R 15.000:

Stage "Development", type of work "R&D for product development";

Stage "Production", type of work "Putting into production".

4.2 Certain types of work on the development and production of products, characterized by target orientation, organizational completeness, a certain sequential order of execution and planning, and the presence of certain performers, are combined into work organization modules.

4.3 Depending on the availability of targeted product development programs, the presence or absence of a customer, the nature of the relationship between business entities, the development and production of products is carried out according to the following work organization models:

model 1 - creation of products under state and municipal orders, as well as other orders financed from the federal budget and budgets of constituent entities of the Russian Federation (hereinafter referred to as government orders);

model 2 - creation of products ordered by a specific consumer;

model 3 - proactive product development without a specific customer at the commercial risk of the developer and manufacturer.

The work organization model is chosen based on the status of the customer, source of financing and market conditions.

4.4 When creating products under government orders, an agreement (contract) for the work performed is concluded in the prescribed manner, and a technical specification or a replacement document (hereinafter referred to as the technical specification) for the work performed is developed. A document containing necessary and sufficient requirements for product development and mutually recognized by the customer and developer can be used as a replacement document.

General principles and requirements for contracts for state needs and regulation of the contract system in the field of state and municipal needs - according to Federal laws and.

4.5 Based on the initial requirements of the customer (if any), the product developer carries out the necessary development and technological work, paying special attention to ensuring the following requirements:

Safety, health and environmental protection, including during product operation;

Resource saving;

Establishing for the conditions of use of products the values ​​of indicators that determine its technical level;

Resistance to external influences;

Interchangeability and compatibility of components and products as a whole;

If necessary, recycling and/or destruction and burial of products, waste from them and disposal of hazardous waste.

4.6 The decision to develop products on an initiative basis is made taking into account marketing conditions.

4.7 The “Development” stage and the “Production” stage generally provide for:

Development of technical specifications for design and development;

Carrying out design and development work, including the development of design documentation and technical specifications, production of prototypes, testing of prototypes, acceptance of the results of design and development work;

Finalization of the working design documentation for the prototype;

Putting into production, including preparation of production, mastering production (production of an installation series, qualification tests).

The stages of a specific design and development work (a component of the design and development work), as well as the procedure for their acceptance, must be defined in the terms of reference for the design and development work (a component of the design and development work) and the agreement (contract) for its implementation.

4.8 At all stages of R&D (an integral part of R&D) and when placing products into production, performers ensure compliance with the mandatory requirements of standards and technical regulations.

The achieved indicators and their compliance with the requirements of the technical specifications for R&D (an integral part of R&D) are assessed upon acceptance of the stages and are reflected in the test reports (acts) of prototypes of products and acceptance certificates for the stages of R&D and R&D as a whole.

4.9 Relationships between the developer (manufacturer) and state supervisory (control) authorities are carried out in accordance with current legislation.

4.10 Documents confirming compliance with the mandatory requirements of standards and technical regulations are submitted to state supervision (control) bodies in accordance with their rules.

The composition of the documents is established by the relevant state supervision (control) body.

4.11 Products of intellectual labor obtained in the process of creating and putting products into production and being objects of intellectual property protection are used in the manner established by the Federal Law.

5 Development of technical specifications for development work

5.1 The basis for carrying out development work according to models 1 and 2 to 4.3 is the technical specification and the agreement (contract) for its implementation.

Development of technical specifications, requirements for the construction, content and presentation of technical specifications, as well as the procedure for coordination and approval of technical specifications - in accordance with GOST 15.016.

In the case of proactive product development (model 3 to 4.3), the basis for performing R&D is the technical specification approved by the management of the developer organization (or a document replacing it), based on the results of marketing, as well as patent research in accordance with GOST R 15.011.

The specific content of the technical specification is determined by the customer and the developer, and in case of proactive development - by the developer.

Technical specification is a mandatory source document for the development of new (modernized, modified) products and design documentation for it.

When analyzing an agreement (contract), one should be guided by the provisions of GOST R ISO 9001 (clauses 8.1-8.3).

5.2 At any stage of product development, with the consent of the customer and developer, changes and additions can be made to the technical specifications or a document replacing it that do not violate the conditions for fulfilling the mandatory requirements of standards and technical regulations, in accordance with GOST 15.016.

6 Development of documents, production and testing of prototypes of products

6.1 The development of design documentation, technical documentation, and, if necessary, program documentation for products is carried out according to the rules established according to the standards of the Unified System of Design Documentation (GOST 2.001), the Unified System of Technological Documentation (GOST 3.1001) and the Unified System of Program Documentation.

General requirements for design (development) management - in accordance with GOST R ISO 9001 (clause 8.3).

Quality requirements for design (development) - in accordance with GOST R ISO 10006.

The rules for the development of technical documentation for materials and substances are established by the developer, taking into account standardization documents, the specifics of the product and the organization of its production.

6.2 In the process of developing documentation for the selection and testing of new technical solutions that ensure the achievement of the basic consumer properties of products, laboratory research, bench and other tests can be carried out in accordance with GOST 16504, as well as development tests of experimental and pre-production samples of products under conditions simulating real operating conditions (consumption), while taking into account the patent and legal aspects of the economic use of these technical solutions.

For certain types of products or their components, tests of prototypes can be carried out under operating conditions (including in organizations that are consumers of the products).

The scope and content of tests necessary to prevent the production of unproven products that do not comply with the specifications are determined by the developer, taking into account the novelty, complexity, features of production and use of the product, and customer requirements. In this case, tests must be carried out to ensure compliance with all mandatory requirements of standards and technical regulations.

The need to develop, manufacture and test prototypes (models), experimental and pre-production samples of products, their list and quantity are determined in the technical specifications and/or agreement (contract) for R&D (an integral part of R&D). This does not exclude the possibility of such work being carried out by the developer if the need for it is revealed later, and appropriate changes are made to the technical specifications and/or agreement (contract) with the consent of the customer.

Requirements for inspection and testing procedures are established in accordance with documented inspection and test procedures to verify compliance with specified product requirements, including test software, which detail the required inspection, testing and recording.

6.3 For repairable products, it is recommended that the agreement (contract) and/or technical specifications for design and development work provide for the development of repair documentation intended for the preparation of production, repair and control of products after repair in a repair organization (repair or service organization).

6.4 To confirm the compliance of the developed technical documentation with the initial requirements and to select the best solution (if options are available), prototypes (pilot batches) of products are produced if the products are intended for serial production (with an expected constant need). For non-serial production of products, head samples are also made.

When creating a single product, prototype product samples, as a rule, are subject to sale to the customer (unless otherwise specified in the agreement or contract and technical specifications for development work).

6.5 Testing of prototype products

6.5.1 To assess and control the quality of the results obtained at certain stages of the development work (an integral part of the development work), prototypes (pilot batch) of products (head product samples) are subjected to control tests in the following categories:

Preliminary tests carried out for the purpose of preliminary verification and assessment of the degree of compliance of a prototype product with the requirements of the technical specifications, determination of the final scope of changes in the design documentation and modification of the design necessary to ensure compliance of the prototype product with the requirements of the technical specifications, as well as the scope of repeated and/or additional types of tests for their inclusion to the prototype acceptance testing program;

Acceptance tests carried out for the purpose of final verification and confirmation of compliance of the prototype product with the requirements of the technical specifications and making a decision on the readiness of the results of the development work for presentation to the acceptance committee for their acceptance.

6.5.2 If products are subject to mandatory requirements of standards and technical regulations, which are subsequently subject to mandatory confirmation of conformity (certification), the results of product acceptance tests in terms of mandatory requirements, carried out in laboratories (centers) accredited in accordance with the Federal Law, can be used for obtaining confirmation of compliance according to established rules.

The place for testing prototypes of products is determined by the developer together with the manufacturer of the product [in the event that the functions of the developer and manufacturer are performed by different organizations and there are no specific test conditions established by state supervision (control) bodies].

6.5.3 When creating products (work organization model 1 to 4.3), state (interdepartmental, departmental) acceptance tests are carried out.

To certify the testing equipment used when testing products according to this model, measuring instruments of approved types must be used, which must be verified, and measurement techniques must be certified in accordance with GOST R 8.563 and GOST R 8.568.

When creating products according to models 2 and 3 - acceptance tests with the participation of the relevant government supervision (control) bodies and other interested organizations.

For component parts of products developed according to the technical specifications of the lead R&D contractor, acceptance tests are carried out with the participation of interested organizations. The ultimate goal of these tests is to assess compliance with the requirements of the technical specifications for which they are developed, and to determine the possibility of installing components in a prototype product intended for its preliminary testing.

6.5.4 Lead samples of non-serial products are subjected to acceptance tests in order to decide on the admissibility of their intended use and to decide on the advisability of putting the product into non-serial production.

6.5.5 Lead product samples are tested in accordance with the requirements of this standard and taking into account the features established for it in the relevant regulatory documents.

6.5.6 Preliminary testing of products is organized by the R&D contractor.

State (interdepartmental, departmental) acceptance tests of products (model 1 to 4.3) are organized by the customer, unless otherwise specified in the agreement (contract).

Acceptance tests of products (models 2 and 3 to 4.3) with the participation of interested bodies and organizations specified in 6.5.3 are organized by the developer.

Acceptance tests of prototypes of product components (developed according to the technical specifications of the lead R&D contractor) with the participation of interested organizations are organized by the lead developer for the creation of the product. In other cases, testing of prototypes of product components is organized by their developer.

If R&D is carried out during proactive development (without a specific customer), acceptance tests are organized by the developer.

The organizer is responsible for conducting the tests.

6.5.7 Preliminary and acceptance tests are carried out according to the relevant programs and test methods developed and approved by the party responsible for conducting these tests.

Test programs and methods are developed based on the requirements of technical specifications, design documentation using, if necessary, standard programs, standard (standardized) test methods and standards for organizing and conducting tests.

The test program includes:

Test object;

Purpose of testing;

Scope of testing;

Logistics support for testing;

Metrological support of tests;

Test reporting.

The test programs include lists of specific checks (tasks to be solved, assessments) that should be carried out during tests to confirm compliance with the requirements of the technical specifications with links to the relevant test methods.

The program and methodology for acceptance testing of prototypes of products must, in addition, contain a check of the set of working design documentation (including the draft technical specifications for industrial production of products) to make a decision on the suitability of the documentation for industrial production.

The test procedure includes:

Evaluated characteristics (properties, indicators) of products;

Conditions and procedure for testing;

Methods for processing, analyzing and evaluating test results;

Testing, monitoring and measurement tools used;

Reporting.

Designation, design and content of programs and product testing methods are in accordance with GOST 2.102, GOST 2.105 and GOST 2.106.

Test methods used to determine product compliance with mandatory requirements, if they are not standard (standardized) methods, must be certified in the prescribed manner and agreed with the relevant government supervision (control) bodies.

6.5.8 Tests are carried out after checking the readiness of testing sites (laboratories, testing centers, etc.) to meet technical requirements, safety requirements and after appointing responsible specialists for all work during the preparation and conduct of tests, assessing product characteristics with established measurement accuracy , as well as recording their results.

6.5.9 To conduct preliminary and acceptance tests, as a rule, a testing commission is appointed, which includes representatives of the developer, the manufacturer of the prototype (pilot batch) and specialists from the testing organization (testing center, laboratory), who control the completeness of the test program. , compliance with test deadlines, reliability, objectivity of test results and their documentation.

If necessary, the testing commission may include representatives of the customer, component suppliers and specialists from expert organizations.

As a rule, the chairman of the testing commission is a representative of the developer, who provides general management and organizes interaction between organizations whose representatives are members of the testing commission.

With the consent of the interested organizations, it is allowed to conduct tests without appointing a commission, but with the assignment of its functions and responsibilities to the relevant services of the organization conducting the tests.

6.5.10 By the start of the tests, preparation measures must be completed, including:

Availability, suitability, sufficiency and operability at the test site of logistics and metrological support facilities that guarantee the creation of conditions and test regimes corresponding to those specified in the test program;

Training and, if necessary, certification of personnel admitted to testing;

Appointment of a commission or relevant organizations and their services (if a commission is not appointed);

Timely submission to the testing site of a prototype product with a set of design, regulatory and other documentation provided for by the test program.

6.5.11 During the testing process, the progress and results of the tests are documented in the form and within the time limits provided for in the test program.

If a product sample does not comply with the requirements of the technical specifications or design documentation or if it fails, the tests may be interrupted or terminated, which is documented.

6.5.12 The specified and actual data obtained during testing are reflected in the protocol(s).

6.5.13 In test reports, texts relating to verification of mandatory requirements should be drawn up in accordance with the requirements of the rules for conformity assessment for and.

6.5.14 Positive results for all or certain types of tests and inspections obtained during preliminary tests can be counted as positive results for similar types of tests and inspections submitted for acceptance testing, subject to an appropriate decision of the testing commission.

Upon completion of preliminary tests, the developer assigns the letter “O” to the developed design documentation and technical documentation. Letters KD are assigned according to GOST 2.103.

Positive results of all tests provided for in the acceptance test program are the basis for presenting the results of the design and development work to the acceptance committee for their acceptance. The letter "O" is assigned by the acceptance committee after carrying out acceptance tests and reviewing the complete set of design documents.

Test results are considered negative if negative results are obtained for at least one item from those provided for in the test program and/or the acceptance committee negatively evaluates the technological readiness of the enterprise to be able to produce products.

Upon completion of acceptance tests, prototypes or samples of a pilot batch are considered to have fulfilled their functions. Their further use (as units of non-serial products) is determined in the acceptance test report.

Disposal or destruction of prototypes is determined by a special decision that complies with current legislation.

6.5.15 When accepting the results of work, state supervision (control) bodies determine the degree of product compliance with the mandatory requirements of standards and technical regulations and issue a final conclusion based on the test results.

7 Acceptance of product development results

7.1 To accept the development results and assess the possibility of putting the developed product into production by order of the customer (in its absence, by order of the developer), an acceptance committee is created, which includes representatives of the customer (if any), the developer, the manufacturer of the prototype (pilot batch), test organizations (centers, laboratories) that tested the prototype, representatives of organizations that approved the technical specifications and were interested in considering the results of the development work, as well as, if necessary, representatives of state supervision (control) bodies and expert organizations. Representation for participation in the acceptance committee and the timing of its holding are pre-agreed by the customer with the involved organizations and institutions.

As a rule, a representative of the customer is appointed as the chairman of the commission, and in the absence of a customer, a representative of the developer.

7.2 State supervision (control) bodies determined by the current legislation for a given product may, if necessary and at the request of the developer, participate in the acceptance committee or send the developer an opinion on the compliance of the developed product with the mandatory requirements of standards and technical regulations based on the results of the tests.

In the absence of representatives of supervisory authorities in the acceptance committee, as well as approval letters about their participation in it, as well as corresponding conclusions, it is believed that the supervisory authorities agree to accept the results of the development work or are not interested in the development.

7.3 The developer submits to the acceptance committee the terms of reference for the implementation of development work, a draft specification or standard type specification (if their development is provided), design documentation and/or technical documentation requiring joint consideration, a report on patent research, test reports signed by persons who carried out specific types of tests and inspections , an act on the results of acceptance tests, signed by members of the testing commission, if such a commission was created, or by the head of the organization that conducted the tests, and other technical documents and materials required by law, confirming the compliance of the developed products with the technical specifications and/or agreement (contract) and certifying its technical level and competitiveness.

The acceptance committee, as a rule, is also presented with prototypes of products, and if their production was not envisaged - a head sample or a single product created as part of the development work.

7.4 Based on the results of consideration of the submitted materials, the commission draws up an act in which it indicates:

Compliance of samples of developed (manufactured) products with the requirements specified in the technical specifications, admissibility of their production (delivery to the consumer);

Results of assessing the technical level and competitiveness of products, including in the patent and legal aspect;

Results of assessment of the developed technical documentation (including draft specifications and operational documentation);

Comments and suggestions for improving products and documentation (if necessary);

The procedure and method of liquidation of products;

The acceptance committee report is approved by the customer.

Approval of the acceptance committee act means the completion of development, termination of the technical specifications (if it does not apply to further work), approval of the submitted design documentation (including the draft technical specifications and operational documents) and technical documentation.

7.5 Based on the results of the work of the acceptance committee, it is allowed to assign the letter “A” in the case of preparation and mastering of production in the process of manufacturing a prototype product.

8 Preparation and development of production (putting into production) products

8.1 Preparation and development of production, which are the stages of putting products into production, are carried out in order to ensure the readiness of production for the manufacture and release (delivery) of newly developed (modernized, modified) or previously produced by another organization of products in a given volume that meets the requirements of the design documentation.

8.2 The production of products is carried out by the decision of the manufacturer (supplier) in the presence of a potential customer (consumer) of the product and the prospect of concluding a supply agreement with him or, in the absence of one, at his own commercial risk.

By the time production begins, the manufacturer must resolve issues related to obtaining, updating the design documentation and the rules for owning the intellectual property contained therein, in accordance with 4.11.

8.3 By the time products are put into production for which mandatory requirements of standards and technical regulations are established, the results of acceptance tests must be recognized by state supervision (control) bodies - see 7.2.

8.4 To complete the pre-production stage, the manufacturer receives from the developer (holder of the original design documentation):

A registered duplicate of a complete and current set of design documents with a letter not lower than “O”;

A registered duplicate of the patent form (if patent research took place during the R&D process);

A copy of the acceptance committee report;

List of incoming inspection of materials and components.

8.5 At the pre-production stage, the manufacturer must perform work to ensure the technological readiness of the organization to manufacture products within the terms specified in the agreement (contract) in specified volumes, in accordance with the requirements of the design documentation, technical documentation and current legislation, as well as work on:

Concluding agreements (contracts) with suppliers of components and materials and licensing agreements with copyright holders for the use of industrial and intellectual property;

Preparation and submission to the territorial bodies of Rosstandart of a product catalog sheet in the prescribed manner according to the rules;

Other jobs.

Preparation of production is considered complete when the manufacturer of the product has received all the necessary documentation, developed (worked out) technical documentation for the manufacture of products, tested and adjusted technological equipment and technological processes, trained (if necessary, certified) personnel involved in the manufacture, testing and control of products, and readiness to master the production of products has been established.

8.6 At the production development stage the following is performed:

Manufacturing of the installation series (first industrial batch) of products according to the design documentation letter not lower than “O”;

Qualification tests;

Conducting a qualification commission;

Further development (if necessary) of the design for manufacturability;

Adjustment of design documentation and technical documentation with the assignment of the letter “A” to the documents (when mastering production by a new organization, the technical document may be assigned the letter “O”).

8.7 During the period of launching production of products, the manufacturer (supplier) carries out all necessary work for subsequent certification of products for which mandatory requirements of standards and technical regulations have been established.

8.8 Production of products according to the technical documentation of foreign companies is carried out in accordance with GOST 15.311, taking into account the requirements of this standard.

8.9 In order to assess the readiness of the organization to produce products in the volume determined by the agreement (contract), qualification tests are carried out.

8.10 Qualification tests are carried out according to the program and methodology developed and approved by the manufacturer with the participation of the product developer and agreed with the customer (consumer) of the product, if any.

The program indicates:

The number of samples subjected to testing, which were selected from among the product units of the installation series and passed control in the scope of checks provided for in the technical specifications for acceptance tests;

Types of tests specified in the product specifications and included in the scope of periodic tests, as well as other checks and types of tests that allow a more complete assessment of the developed technological process and the readiness of the manufacturing organization to produce the required number of units of product;

Test methods;

Test location.

The qualification testing program may not include verification of individual design documentation requirements that cannot change during production launch.

8.11 Qualification tests are organized and ensured by the manufacturer according to the approved program and methodology. The manufacturer conducts qualification tests using its own resources and resources.

If it is necessary to conduct certain types of tests in third-party testing organizations (centers, laboratories) that have the necessary scope of accreditation, the manufacturer ensures that they are carried out in such organizations on contractual terms.

8.12 The tests are documented in test reports, which reflect the actual data of checks, inspections, controls, measurements and other data.

8.13 To assess the results of qualification tests and the readiness of the manufacturer’s production to produce products that comply with the specifications in the required volume, a qualification commission is created by order of the manufacturer.

The qualification commission includes representatives of the manufacturer (supplier) of the product, the customer (consumer) of the product, as well as, if necessary, representatives of bodies exercising supervision in the production of developed products, representatives of testing organizations and representatives of organizations and institutions that have approved the specifications and/or are interested in reviewing the results of putting products into production.

Representation for participation in the qualification commission and the timing of its holding are pre-agreed by the manufacturer with the organizations involved. In the absence of representatives of supervisory authorities in the qualification commission, as well as approval letters on their participation in it, it is believed that supervisory authorities positively assess the results of putting products into production or are not interested in considering them.

As a rule, a representative of the manufacturer is appointed as the chairman of the commission.

The product manufacturer must submit the following documents to the qualification commission:

Approved program and methodology for qualification tests;

Protocols of tests and inspections of product samples from the installation series, carried out as part of qualification tests, including acceptance tests, and other reporting documents provided for by the program and methodology of qualification tests;

A complete set of TD, developed and used for the manufacture of the installation series;

Certificate of verification/calibration of measuring instruments, certification of technological and testing equipment involved in the manufacture of products in accordance with TD;

Certificate of qualification of personnel involved in the manufacture of products in accordance with the TD.

In the course of their work, members of the commission may request other documents, the consideration of which becomes necessary.

The results of the work of the qualification commission are documented in an act signed by the members of the commission and approved by the chairman of the commission.

The act of the qualification commission reflects:

The composition of the documents reviewed during the work;

Completeness of program implementation, objectivity and reliability of the results of qualification tests;

A general assessment of the technological equipment and readiness of production to produce products in the required volumes based on the submitted documents, the inspection of production and manufactured product samples, the results of random monitoring of compliance with technological discipline at the workplace (if any);

Assessment of the readiness of the design documentation for approval in the prescribed manner with the assignment of the letter “A” (if necessary);

Test results are considered negative if negative results are obtained for at least one item from those provided for in the program and/or test methodology.

In the event of a negative assessment by the commission of the results of launching production of products, members of the commission draw up and sign a list of deficiencies identified during the work of the commission, and recommendations for their elimination.

The manufacturer, if necessary, agrees to increase the size of the installation series, eliminates the identified deficiencies and carries out the measures provided for in this section again.

8.14 It is allowed to supply products during the period of mastering its production, if the manufacturer can confirm the compliance of these products with the mandatory requirements of standards and technical regulations.

Product units of the installation series are not classified as commercial products, as a result of which the technical control service only controls them, and accepts them for delivery only at the request of the consumer.

8.15 If the results of qualification tests are positive, production development is considered completed.

Bibliography

Federal Law of July 18, 2011 N 223-FZ

On procurement of goods, works, services certain types legal entities

Federal Law of 04/05/2013 N 44-FZ

On the contract system in the field of procurement of goods, works, services to meet state and municipal needs

Federal Law of December 18, 2006 N 231-FZ

On the entry into force of part four of the Civil Code of the Russian Federation

Federal Law of December 28, 2013 N 412-FZ

About accreditation in the national accreditation system

State supervision of compliance with mandatory requirements of state standards at the stages of development, preparation for production and operation of industrial products

Methodology for conducting state supervision of compliance with mandatory requirements of state standards, rules of mandatory certification and certified products at the stage of implementation (sale)

Rules for filling out and submitting product catalog sheets

Electronic document text
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M.: Standartinform, 2018

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