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CNCA-C22-03:2014 China compulsory certification implementation rules Vehicle occupant restraint system for children

Issue Date:2021-08-24 Views:0

Number: CNCA-C22-03: 2014

 

 

 

China Compulsory Certification Implementation Rules

 

Vehicle occupant restraint system for children

 

 

 

 

 

Published on 2014-05-30; Effective on 2014-09-01

Released by China National Certification and Accreditation Administration (CNCA)

 

Contents

  1. Introduction............................................................................................................... 1
  2. Scope ....................................................................................................................... 1
  3. Standards for Certification  .................................................................................... 1
  4. Certification Mode.................................................................................................... 1
  5. Certification Unit division........................................................................................ 2
  6. Certification Application.......................................................................................... 2
    1. Proposal and Acceptance of Certification Commission.............................................. 2
    2. Application Material.................................................................................................... 3
    3. Implementation Arrangements................................................................................... 3
  7. Certification Implementation................................................................................... 3
    1. Type test................................................................................................................... 3
    2. Initial Factory Inspection............................................................................................ 5
    3. Certification Evaluation and Determination................................................................. 6
    4. Certification Time Limit.............................................................................................. 6
  8. Post-certification Supervision................................................................................. 6
    1. Follow-up Inspection after Certification..................................................................... 7
    2. Sample Test or Inspection at the Production Site...................................................... 7
    3. Market Sampling Test or Inspection ......................................................................... 7
    4. Frequency and Date of Post-certification supervision............................................... 8
    5. Records of Post-certification Supervision.................................................................. 8
    6. Evaluation of the Results of Post-certification Supervision........................................ 8
  9. Certificate.................................................................................................................. 8
    1. Maintenance of the Certificate.................................................................................. 8
    2. Contents of the Certificate......................................................................................... 8
    3. Change of the Certificate.......................................................................................... 9
    4. Cancellation, Suspension and Revocation of the Certificate...................................... 9
    5. Use of the Certificate................................................................................................. 9
  1. Certification Mark...................................................................................................... 9
    1. Mark Style Permitted................................................................................................. 9
    2. Requirements for Use............................................................................................. 10

10Charging Method.................................................................................................... 10

  1. Certification Responsibility................................................................................. 10
  2. Detailed Certification Implementation Rules..................................................... 10

Annexes.1: Product Description of the Vehicle Occupant Restraint System for Children    12

Annex 2: Requirements for Production Consistency ............................................ 13

 
  1. Introduction

Based on the safety risks and certification risks of the vehicle occupant restraint system for children, this rule stipulates the basic principles and requirements for the compulsory product certification of vehicle occupant restraint system for children.

This rule is compatible with general rules issued by the CNCA, including "Compulsory Product Certification Implementation Rules: Classification and Management of Production Enterprises, Certification Mode Selection and Determination", " Compulsory Product Certification Implementation Rules: the Use of Testing Resources and other Certification Results of Production Enterprises", " Compulsory Product Certification Implementation Rules: General Requirements for Factory Inspection".

The certification agency shall stipulate detailed certification and implementation rules based on the general implementation rules and the requirements of this rule, and implement the three together.

Production enterprises shall ensure that the production of certified products continue to meet the requirements of the certification and application standards.

 

  1. Scope

This rule applies to child occupant restraint systems on motor vehicles with three wheels or more, but not to those installed on folding seats or side-facing seats.

Any adjustment to the application scope caused by changes in laws and regulations or relevant standards, technology, industrial policy and other factors concerning the product, shall be subject to announcement issued by the CNCA.

 

  1. Standards for Certification

GB27887 Restraining devices for child occupants of power-driven vehicles

The above standards shall, in principle, implement the latest version issued by the national standardization administrative department. Other versions of the standard shall be used in accordance with the announcement issued by the CNCA on the application of relevant standard.

 

  1. Certification Mode

The basic certification mode for the compulsory certification of restraining devices for child occupants of power-driven vehicles is as follows: type test + initial factory inspection + post-certification supervision.

The post-certification supervision mentioned above refers to any of the following ways: follow-up inspection, sample test or inspection at the production site, sample test or inspection in the market.

The certification agency shall, in accordance with the requirements of the "Compulsory Product Certification Implementation Rules: Classification and Management of Production Enterprise, Certification Mode Selection and Determination", implement classification and management for production enterprises, and according to its result, add combined ways of post-certification supervision at discretion on the basis of basic certification modes, in order to determine the suitable certification mode for certification client.

 

  1. Certification Unit division

In principle, restraining devices for child occupants of power-driven vehicles from the same producer (manufacturer)and production enterprise (site) are a certification unit if no significant difference in following aspects:

  1. Quality groups and types.
  2. The location and orientation of the installation on the vehicle.
  3. Geometry.
  4. The size, quality, material and color of the seats, padding and crash guards.
  5. The material, weaving method, size and color of the webbing.
  6. Rigid parts (including buckles, connecting devices, etc.)

In principle, the certification client shall put forth certification commission based on the principles for unit division. Products with multiple "type (or specification)" can be included in the same unit. The same type refers to products that are designed to have no effect on their conformity to the standard.

Type test can be done in one unit for same products produced by same producers, but different production enterprises, or products with the same type produced by different producers, but same production enterprises. Production from other production enterprises / producers shall provide materials for conformity verification.

 

  1. Certification Application
    1. Proposal and Acceptance of  Certification Application

The certification client shall propose certification commission to the certification agency in an appropriate way. The certification agency shall handle the commission, and notify the client of acceptance or non-acceptance within the time limit required by the certification implementation rules.

The certification client shall be able to assume the relevant quality and legal responsibility. The certification agency shall not accept the relevant certification commission if the commission does not meet national laws and regulations or related industrial policy requirements.

    1. Application Material

Certification agencies shall specify the application data list in the certification implementation rules in accordance with laws and regulations, standards and the requirements of the implement certification, which should include at least the certification application or contract, registration certificate from the certification client / producer / production enterprise, "Product Description of Restraining Devices for Child Occupants of Power-driven Vehicles " (Annex 1),

“Production Conformity Control Plan" (made according to Annex 2), the Chinese instructions for restraining devices for child occupants of power-driven vehicles, the declaration of the content of transferable elements in restraining devices for child occupants of power-driven vehicles, etc.

The certification client shall provide the required materials in accordance with the requirements of the application data list in the certification implementation rules. The certification agency is responsible for the audit, management, preservation and confidentiality of relevant information, and shall inform the certification client of the result.

    1. Implementation Arrangements

The certification agency shall reach an agreement with the certification client upon related responsibilities and arrangements during each process of implementing the certification, and determine the specific plan for implementing the certification according to the actual condition of production enterprises and classification management, and the requirements of this rule and certification implementation rules, as well as keep the client informed.

 

  1. Certification Implementation
    1. Type test
      1. Type Test Program

The certification agency shall develop a type test program after reviewing the materials, and inform the certification client. The certification client may choose their own designated laboratory.

A type test program includes all sample test requirements and quantity, testing standard items, and laboratory information of the type test.

      1. Sample Requirements for Type Test

Samples for the type test in principle shall be obtained through an on-site sampling / sample sealing by the certification agency, but may also be delivered according to the requirements of the type test program, by the certification client after the approval of the certification agency.

The certification client shall ensure that the sample he or she provides is consistent with the actual product produced. Certification agency and / or laboratories shall verify the authenticity of the samples provided by the client. If the laboratory has doubts about the authenticity of the sample, it shall explain the situation to the certification agency, and make corresponding treatment.

Quantity

Restraining devices for child occupants of power-driven vehicles assembly: static test 2 sets, dynamic test and flip test shall be determined according to the product specification.

Webbing: at least 15m.

Skeleton, fabric, padding, impact devices and other organic materials: it shall be ensured that samples/delivered samples whose material have the same design burning rate, can be removed off at least 5 pieces of samples in accordance with GB8410.

For materials that can only be tested using specifically manufactured standard specimens with the same material (sampling methods of c and f in Article 4.3. GB841), test shall not be conducted according to this rule.

Certification bodies shall specify the list of key components and raw materials, compulsory and voluntary products certificate that can be accepted or conditions and specific requirements of type test report in the certification implementation rule, according to relevant documents issued by the CNCA.

      1. Type Test Inspection Items

Type test items are mandatory items applicable in "GB27887 Restraining Devices for Child Occupants of Power-driven Vehicles". Among them, the combustion characteristics shall be in line with the requirements of "GB8410 Flammability of Automotive Interior Materials".

      1. Implementation of the Type Test

Type test shall be completed in the laboratory designated by the CNCA. Laboratories shall conduct the sample type test and make a complete record of the entire process and archive to ensure the traceability of the testing process and the results.

If a test item fails, it is allowed to rectify after the analysis of the causes, and the test shall be conducted again after the completion of the rectification. Where it is needed to re-test, the laboratory shall inform the certification agency, and the certification agency shall reconfirm the test program.

      1. Type Test Report

The certification agency shall provide a uniform type test report format.

After the completion of the type test, the laboratory shall timely inform the certification agency and the certification client of the type test report. The test report shall contain a description of the product and certification-related information in the application unit.

Certification

The certification client shall ensure that a complete and valid type test report can be provided to certification agency and law enforcement agencies during post-certification supervision.

    1. Initial Factory Inspection

The initial factory inspection is an evaluation conducted by the certification agency of whether the factory’s production conformity control system can meet the certification requirements. It shall be conducted by review of the production conformity control plan + factory site inspection for production conformity.

      1. Basic Principle

Producers and production enterprises shall establish, implement and maintain the production conformity control system in accordance with the requirements of Annex 2 of this rule to ensure that certified products continue to meet the certification requirements.

The certification agency shall conduct inspection on company's production conformity control system for compliance checks. Initial factory inspection in principle shall be completed within one year after the type test, otherwise products should be re-type tested.

      1. Production Consistency Control Plan Review

The producer or production enterprise shall develop a production conformity control plan in accordance with the requirements of Annex 2, and submit it to the certification agency for review. The certification agency shall inform the certification client of the results.

If the production conformity control plan can meet the requirements of Annex 2 of this rule, the review of the production conformity control plan is passed. If the certification agency considers that the production conformity control plan does not meet the requirements, the producer or production enterprise shall rectify and resubmit it. The certification agency shall inform the certification client of results of the review to the certification client after re-examination.

After the production conformity control plan developed by the producer or the production enterprise has been passed, the certification agency shall prepare program for production conformity factory site inspection based on the plan. The program shall include inspection of products, sites and scope.

The review date for production conformity control program shall be determined according to the number of units applying for certification, and the production scale of the production enterprise shall be given due consideration to. Generally, each production enterprise will cost 1 to 2 person days.

      1. Factory Site Inspection for Production Consistency

In general, the inspection will be conducted after the type test and production conformity control plan review are passed.

The certification agency shall assign an inspection team formed by inspectors with compulsory product certification qualifications registered by the state to conduct on-site inspections in the production enterprises. During the process of inspection, the production company shall have the products to be certified producing.

If necessary, the certification agency may go outside the production enterprise to implement extended inspection. The date for factory site inspection is determined by the number of units to be certified, with due consideration

given to the production scale of the plant. Generally, it costs 2 to 4 man-days per plant.

For factory site inspection, the factory inspection team shall randomly select certified products from products at the end of the production line or warehouse for inspection, including but not limited to the following.

a. The structure and parameters of the certified product;

b. The logo and instructions of the certified product.

c. On-site designation test for certified product (selecting from the production conformity control program)

If no non-conformity is found in the factory inspection, the inspection result is qualified.

Otherwise, the factory is allowed to rectify. The certification agency shall take appropriate ways to confirm the result of the rectification. The rectification period shall not exceed 3 months. If the rectification cannot be completed within the time limit or the rectification results are not qualified, the inspection results will be unqualified.

If the factory inspection finds that there are serious deviations between the implementation of the production conformity control plan and the plan itself, or there are significant differences between the actual production of the structure and parameters of products and the type test samples, the inspection result is unqualified and the inspection is terminated.

    1. Certification Evaluation and Determination

The certification agency shall make comprehensive evaluation on the result of type test, initial factory inspection and related materials / information. If the evaluation is passed, certificates will be issued by unit; if the evaluation fails, the certification is terminated.

    1. Certification Time Limit

The certification agency shall make clear the time limit for each link of the certification, and ensure that the relevant work is completed in accordance with the time frame requirements. The certification client must actively cooperate with certification activities. In general, the certificate will be issued to the certification client within 90 days from the acceptance of the certification commission.

 

  1. Post-certification Supervision

Post-certification supervision refers to the supervision implemented by the certification agency for certified products and their production enterprises.

The certification agency shall clarify the specific requirements for the selection of post-certification supervision mode in the detailed certification and implementation rules, according to the classification management of the production enterprise and its actual situation.

    1. Follow-up Inspection after Certification
      1. Principles for Follow-up Inspection after Certification

The certification agency shall carry out effective tracking checks on certified products and their production enterprises based on the classification and management of production enterprises, to verify that the quality assurance capabilities of production enterprises continue to meet the certification requirements, and to ensure that certified products continue to meet the standard requirements and maintain consistent with the type test samples.

The follow-up inspection after the certification shall be carried out when the production enterprise is in normal production, with the prior method being not notifying the inspected party in advance. For non-continuous production of products, the certification client shall submit to the certification agency of the relevant production plans to facilitate the effective implementation of post-certification tracking checks.

      1. Content of Follow-up Inspection after Certification

The certification agency shall, ensuring that the certification risks are controllable, formulate the specific content of post-certification tracking and inspection requirements in accordance with Annex 2, and make it clear in the detailed implementation rules for certification.

    1. Sample Test or Inspection at the Production Site
      1. Principles for Sampling Tests or Inspections at the Production Site

The certification client, producer, production enterprises shall be cooperative if the post-supervision inspection is carried out by means of sampling at the production site for testing or inspection.

      1. Contents for Sampling Tests or Inspections at the Production Site

The certification agency shall clarify contents and requirements for sampling tests or inspections at the production site in the detailed implementation rules for certification. The certification agency shall make sampling test programs based on the principles of enterprise classification and product characteristics, and designate personnel to take samples from qualified products (including production lines, warehouses or ports, etc.) according to the sampling test program.

If the production enterprises meet the testing requirements of the "Compulsory Product Certification Implementation Rules: Requirements for the Use of Testing Resources and Other Certification Results" and certification standards, the certification agency may use the testing resources of the production enterprises to implement sampling tests (or witnessed inspection), and the test report will be issued by designated laboratories; if the production enterprise does not meet the above testing conditions, the sample shall be sent to the designated laboratory for testing. The certification agency shall specify the specific requirements and procedures in the detailed implementation rules for certification.

    1. Market Sampling Test or Inspection
      1. Principles for Market Sampling or Inspection

If supervision is carried out by taking market sampling or inspection, the certification client, the producer, the production enterprises shall cooperate and confirm the samples taken from the market.

      1. Content for Market Sampling Test or Inspection

The certification agency shall clarify the content and requirements for market sampling test or inspection in the detailed certification and implementation rules .The certification agency shall stipulate sampling test programs based on product characteristics, and designate personnel to take samples from

certified products being sold in the market (including those in vehicle manufactures or at the customers’, etc.) in accordance with the sampling test programs.

    1. Frequency and Date of Post-certification supervision

On the basis of classification and management of production enterprises, the certification agency shall adopt different supervision frequency of post-certification supervision for different categories of production enterprises and reasonably determine the date. The specific principles shall be clear in the detailed certification and implementation rules.

    1. Records of Post-certification Supervision

The certification agency shall monitor the whole process in a proper way and archive to ensure the traceability of the certification process and results.

    1. Evaluation of the Results of Post-certification Supervision

The certification agency shall carry out comprehensive evaluation on the result of follow-up inspection and sampling test or inspection, and related materials/ information. Those who passed the evaluation may continue to keep the certificate and use the certification mark; for those who failed, the certification agency shall suspend or revoke the certificate according to the corresponding circumstances, and make the decision known to the public.

 

  1. Certificate
    1. Maintenance of the Certificate

The term of validity of the product certification covered by this rule is 5 years. During the validity period, the maintenance of the validity of the certificate relies on the post-certification supervision by the certification agency.

If extension of the certificate is needed after expiration of its validity period, the certification client shall, within 90 days prior to the expiration of the validity of the certificate, submit a certification commission. If the supervision result is qualified for the last post-certification supervision in the validity period, the certification agency shall directly issue a new certificate upon receiving the certification commission.

    1. Contents of the Certificate

Certified products and their sales packaging marked with the contents contained in the certificate shall be consistent with the contents of the certificate. For the change of the certificate, the change of information shall be indicated to clearly show the number of the change.

    1. Change of the Certificate

After being certified, if the content of the certificate has changed; or if the certified product undergoes technological changes (design, structural parameters, key components / raw materials, etc.) that affect the conformity of the relevant standards; or if factory changes production conformity control plan or production conditions, which may affect production conformity; or if other matters specified in the detailed certification and implementation rules issued by the certification agency changes, the certification client  shall propose commission for change to the certification agency, which will be implemented after approved by the certification agency.

The certification agency shall clarify the specific requirements for certification changes in the detailed implementation rules for certification, including the scope and procedures of certification changes. The certification agency shall appraise the material committed based on the content of the change, to determine whether the change can be approved. If sample test and/or factory inspection is required, the change shall not be approved until the test and/or inspection is qualified. Requirements for testing resources of the production enterprise that can be used for sample test, are in accordance with Article 7.2.2 of this rule.

For those that meet the requirements, change shall be approved. For the issuance of a new certificate, the number, approval date of validity of the new certificate shall in principle remain unchanged, and the date of the approval of the change shall be indicated. For those do not need a new certificate, change confirmation form shall be submitted and the content of the change and the date of approval of the change shall be indicated.

    1. Cancellation, Suspension and Revocation of the Certificate

The cancellation, suspension and revocation of the certificate shall be conducted in accordance with the "Compulsory Product Certification Management Regulations" and "Implementation Rules for the Cancellation, Suspension, and Revocation of the Compulsory Product Certificate " and relevant provisions issued by the certification agency. The certification agency shall determine the type and scope of products that do not meet the certification requirements, and take appropriate ways to publicize the cancellation, suspension, and revocation of the certificate.

    1. Use of the Certificate

The use of the certificate shall conform to the requirements of the "Compulsory Product Certification Management Regulations".

 

9. Certification Mark

The management and use of the certification mark shall conform to the provisions of the " Compulsory Product Certification Mark Management Measures".

    1. Mark Style Permitted

Certified child restraint systems shall use certification mark (S) of the safety category as bellow:

    1. Requirements for Use

The certification mark shall be able to be permanently preserved and clearly visible without damaging the vehicle and the certified product. Compulsory product certification marks printed/molded to non-standard specifications shall be used.

Depending on the product and process characteristics, printed/molded marks can be completed at various stages of product formation. The mark shall be printed/molded on the appropriate location on the body of the certified product.

 

  1. Charging Method

The certification agency and laboratory shall charge fees in accordance with national regulations on compulsory product certification fees.

The certification agency shall determine properly the specific date in accordance with the provisions of charging fees during initial factory review, post-certification supervision in the compulsory product certification issued by the state.

 

  1. Certification Responsibility

The certification agency shall be responsible for the certification result.

The laboratory shall be responsible for the test results and test reports.

The certification agency and its appointed factory inspectors shall be responsible for the results of the factory inspection.

The certification client shall be responsible for the authenticity and legality of the commission information and samples submitted.

 

  1. Detailed Certification Implementation Rules

The certification agency shall, based on the principles and requirements of this implementation rule, make detailed rules that are scientific, reasonable and operational for the implementation of certification. Detailed certification and implementation rules shall be recorded to the CNCA before its implementation. Detailed certification implementation rules shall include at least the following.

  1. Certification process and time limit,
  2. The selection of certification mode and related requirements,
  3. The requirements for production enterprise classification and management;
  4. Materials for certification commission and related requirements,
  5. Sample testing requirements,
  6. Initial factory inspection requirements,
  7. Post-certification supervision requirements (including requirements for inspections implemented by using production resources),
  8. Requirements for certification of changes (including standards change),
  9. The list of key components and raw materials and related requirements,
  10. The basis of fees and related requirements,
  11. The requirements for process and time limit related to technical disputes and complaints.
 

Annex 1: Product description of the restraining devices for child occupants of power-driven vehicles

 

  1. Product description (to be filled in electronically, the certification agency shall ensure that its system should contain at least the following).

1.1 Quality group of certified products: □0 group □0+ group □Ⅰ group □Ⅱ group □Ⅲ group

1.2 Type of restraint system: □ General-purpose □ Semi-general-purpose □ Restricted □ Special vehicle type (installation location.                                                                                                    )

1.3 Position and direction: □ forward-facing seat □ backward-facing seat □ portable bed □ booster cushion

1.4 Fixing mode of child restraint system: □ seat belt (□ two-point type □ three-point type) □ ISOFIX

Anti-flip mode: □ upper pull belt □ support legs □ dashboard support

1.5 ISOFIX size category: □A □B □B1 □C □D □E □F □G

1.6 Child restraint mode (seat belt form):

□ adult three-point seat belt □ adult lap belt □ special type of seat belt □ self-prepared belt □ retractor □ collision protection device

1.7 Description of seat assembly features (if applicable, including fastening method, adjustment/locking method, energy absorption device, etc.).

1.8 Description of the features of collision protection device (if applicable).

1.9 Vehicle models for which the certified products are applicable (list may be attached).

1.10 Other issues needing to be explained

2. Photographs:

Photographs sufficient to identify the main features of the child restraint system, vehicle structure and/or vehicle seat structure.

3. Product drawings:

3.1 A general assembly drawing of the child restraint system, which should be sufficient to identify the main features of all retractors, seat assemblies and collision protection devices.

3.2 Drawings of vehicle structures and vehicle seating structures involved in certified products, such as adjusting devices and connecting devices (Note: All energy absorbing devices should be included).

  1. Product manual

Chinese version of the installation and operation manual is required.

  1. Declaration of transferable element

Declaration of compliance with the content of specific toxic elements in the seat materials and related test reports

  1. List of key components and raw materials

The list of at least the following parts (if available) shall be provided: seat belt, fabric, seat (skeleton and padding), portable bed (skeleton and padding), collision protection devices, webbing, buckles, adjusters, connectors, support legs, energy absorbers, retractors, fixers, ISOFIX fixers, anti-reversal devices, ISOFIX connectors (upper and lower), ISOFIX upper fixing hooks and upper pulling straps, tension release devices, etc.

The list should include at least the name, type, specifications, supply units and incoming inspection items of key components (materials).

 

Annex 2: Requirements for Production Consistency

 

The producer (hereinafter also referred to as the manufacturer) or production enterprise (hereinafter also referred to as the factory) shall ensure that the mass production of certified products continue to meet the requirements of this rule and relevant laws and regulations.

    1. Production conformity inspection is done through production conformity control plan review and factory site inspection (initial and supervisory) to confirm the conformance of mass-produced certified products and type test samples, as well as their conformity with the certification standards.
    2. The production conformity control plan is a documented regulation formed by the manufacturer or factory to ensure the production conformity of the mass-produced certified products. It shall include:
  1. The manufacturer or factory shall establish documented provisions to ensure the conformity between mass-produced certified products and type test samples; and ensure the proper storage and use of the certification mark.
  2. The manufacturer or factory shall make documented provisions of necessary tests or related inspections to clarify product certification, or the content, methods, frequency, deviation range, analysis of results, records and preservation of relevant inspections in accordance with the implementation rules. As well as identifying critical components, raw materials and key manufacturing processes, assembly processes, inspection processes and determining their control requirements in accordance with certification standards. Necessary tests or related inspections that are not performed at the factory site, as well as critical components, raw materials, key manufacturing processes, assembly processes, and inspection processes of the control shall be specifically listed in the plan, with an indication of the actual department and location of the control. If production conformity control for projects is clarified in the certification standard, the factory's control provisions shall not be lower than the requirements of the standard. Among them, the frequency of dynamic tests for each quality group and type of child seat shall not be less than once a year.
  3. Regulations and requirements of manufacturer or factory for the equipment and personnel involved in 2.2 product testing or related inspections.
  4. Relevant provisions of manufacturer or factory for production conformity control plan changes, reporting and implementation.
  5. Relevant provisions of how the manufacturers or factories shall implement all necessary measures to restore the conformity of production as soon as possible in the event of a product inconformity.
  6. The provisions of the traceability and handling measures taken by the manufacturer or factory when non-conformities are found in the product.
  7. The factory quality assurance system shall make standards according to the actual situation of the factory and with reference to the requirements of Appendix 1 of this Annex.

The manufacturer's certificate (the scope of which shall cover the products entrusted to the certification) conform to ISO 9001, ISO/TS16949 and other standards or other equivalent evaluation criteria that meet the requirements of Appendix 1 of this Annex are acceptable. The certification client must provide the following information in accordance with the relevant content of Appendix 1, submit the information as a quality assurance capacity control plan, and the client shall commit to notifying the certification agency in the event of changes that affect its effectiveness or scope of application. Factories not obtaining ISO 9001, ISO/TS16949 or other equivalent evaluation certificate, may establish a quality assurance system according to the provisions of the appendix, while the production enterprise should accept the certification agency to check the conformity of its quality system.

  1. Production conformity site inspection

The initial factory inspection is a review by the certification agency of the implementation of the production conformance control plan proposed by the manufacturer or factory.

  1. Implementation Report on Production Conformance Control Plan

The Implementation Report on Production Conformance Control Plan is a documented description of the manufacturer's or factory's annual implementation of its Production Conformance Control Plan. The report shall, against the plan, itemize the work performed and important changes in production conformity control, and shall focus on the causes, treatment and traceability results, and corrective and preventive measures taken for production inconsistencies that occur.

  1. Production conformity supervision and inspection

Factory inspection team shall, in accordance with the requirements of the certification agency, inspect the implementation of production conformity control plan and its implementation report at the site.

In the process of supervision and inspection, factories should ensure that

      1. at each supervision and inspection, the inspector should have access to test or inspection records and production records.
      2. If the test conditions are appropriate, the inspector may randomly select samples and test in the manufacturer's or factory's laboratory. The experimental items and the minimum number of samples can be determined according to the manufacturer or factory self-inspection requirements.
      3. If the inspection reveals production inconsistencies, the certification agency shall take all necessary steps to urge the manufacturer to restore production conformity as soon as possible.
  1. If Manufacturer or factory production conformity control plan changes, a declaration for changes of production conformity control plan shall be submitted to the certification agency. The certification agency shall, based on the impact of the change on production conformity, determine whether immediate on-site inspection is needed.

 

 

 

Appendix 1:

 

Requirements for factory quality assurance capability

 

The factory is responsible for the quality of the product, and its quality assurance capabilities shall continue to meet the certification requirements. The products produced shall meet the standard requirements, and the factory shall ensure that certified products and type test samples are consistent. The factory shall cooperate with the certification agency in implementing various types of factory site inspection, market inspection, and sample test in accordance with the implementation rules and related product certification implementation rules / detailed rules.

  1. Responsibilities and Resources
    1. Responsibilities

The factory shall specify responsibilities, authority and interrelationships for various types of personnel related to certification requirements, and designate the quality director from the management layer of the organization. Regardless of his or her responsibilities in other areas, he or she shall be entitled to the following responsibilities and authority.

(a) Ensure that the requirements of this document are effectively established, implemented and maintained in the factory;

(b) Ensure product conformity and product conformity to standards.

(c) Ensure the correct use of CCC certificate and mark, and the validity of the certificate of products with CCC mark.

The quality manager shall have sufficient ability to perform his or her job, and can meanwhile serve as the certification technical director.

Production operations for all shifts shall be assigned with personnel to ensure product quality.

Personnel responsible for product quality shall have the right to stop production in order to correct quality problems.

    1. Resources

The factory shall be equipped with the necessary production equipment, inspection and testing instruments and equipment to ensure stable production of products that meet the requirements of the certification rules; shall be equipped with corresponding human resources and ensure that the staff engaged in the quality of product certification has the necessary capacity; shall establish and maintain a suitable environment and facilities necessary for product production, inspection and testing, and storage, etc.

For external resources that are to be used on a rental basis, the factory shall ensure the continued availability and proper use of the external resources; the factory shall keep records related to the external resources, such as contractual agreements, usage records, etc.

  1. Documents and Records
    1. The factory shall establish and maintain documented procedures to ensure effective control of the documents required by this document, necessary external documents and records. Product design standards or specifications shall not be lower than the requirements of the certification rules of this product. For the main content that may affect the conformity of the product, the factory shall have the necessary drawings, samples, key parts list, process documents, work instructions and other design documents, and ensure the continuous validity of the documents.
    2. The factory shall ensure the adequacy and appropriateness of the document, and the use of valid versions of the documents.
    3. The factory shall ensure that the records are clear, complete and traceable, to prove that the product meets the specified requirements. Quality-related record retention period shall meet the requirements of laws and regulations to ensure that the records of the previous inspection are available in the current inspection, and shall be no less than 24 months.
    4. Factories shall identify and keep important documents and quality information related to product certification, such as type test reports, factory inspection results, CCC certificate status (valid, suspended, revoked, canceled, etc.), certification change approval, supervision and sampling test reports, product quality complaints and processing results, etc.
  2. Purchasing and Critical Parts Control
    1. Purchasing control

For the procurement of critical parts, the factory shall identify and specify its technical requirements in the procurement documents. The technical requirement shall ensure that the final product meets the certification requirements. The procurement documents shall also include requirements for product and manufacturing process approval for suppliers of critical components or materials

The factory shall establish and maintain a list of qualified producers/production enterprises of critical parts and purchase critical parts from them. The factory shall keep records of procurement and use of critical parts, such as purchase orders, inlet and outlet orders, ledgers, etc.

    1. Quality control for critical parts

3.2.1    The factory shall establish and maintain documented procedures, which should include inspection items, methods, frequency and determination guidelines, and complete verification and/or inspection of the technical requirements of the purchased critical parts at the time of purchase (into the factory) and keep relevant records.

3.2.2    For the quality characteristics of the procured critical parts, the factory shall select appropriate control methods to ensure that the technical requirements of the critical parts are continuously met, and that the final product meets the certification requirements, and keep relevant records. Appropriate control methods may include:

(a) For critical parts with CCC certificate or voluntary product certification results that can be recognized as compulsory certification for final products, the factory shall ensure their valid status.

(b) For critical parts without relevant certificate, its periodic confirmation inspection shall be in line with the requirements of the product certification implementation rules / detailed rules.

(c) For control program made by the factory itself, its effectiveness shall be no lower than the requirements of (a) or (b).

3.2.3  When procuring critical parts from distributors and traders, the factory shall take appropriate measures to ensure the conformity of the procured critical parts and continuously meet their technical requirements.

For key parts, components, sub-assemblies, assemblies and semi-finished products entrusted to subcontractors, the factory shall conduct control according to the procurement of key parts to ensure that the subcontracted products continuously meet the specified requirements.

For the key parts of self-production, control is carried out according to 4.

  1. Production Process Control
    1. Process Preparation
  1. The factory shall identify and confirm the key production process; the operators of the key process shall be equipped with appropriate competence; if the process cannot guarantee the quality of the product without documentation, the corresponding process work instructions shall be formulated to make the production process controlled.
  2. Conduct process studies of critical production processes to validate process capability and provide input for process control.
  3. Operational readiness verification shall be proceeded in an appropriate manner.
    1. If production process has requirements for environment conditions, the factory shall ensure the working environment meets the requirements.
    2. If necessary, the factory shall monitor and measure the appropriate process parameters.
    3. The factory shall establish and implement a production tooling management system and a preventive maintenance system for critical equipment to ensure that the capacity of the equipment continues to meet production requirements.
    4. If necessary, the factory shall inspect, monitor and measure the product and its characteristics at the appropriate stage of production to ensure product conformity to the standards, and product consistency according to the rule.
    5. The factory shall establish and implement a traceability system for its products. When it is appropriate, identify and apply statistical techniques.
  4. Instruments and equipment for inspection and testing
    1. Basic requirements

The factory shall be equipped with sufficient inspection and testing equipment to ensure that the capability of instrument and equipment used during procurement, manufacturing, final inspection and testing meets the inspection and testing requirements of the certified products in mass production.

Inspection and testing personnel shall be able to use the instruments and equipment correctly, master the inspection and testing requirements and implement them effectively.

    1. Calibration and verification

Inspection and testing equipment used to determine the certified products produced meet the standard shall be calibrated or tested in accordance with the prescribed cycle. Calibration or calibration period can be set according to the frequency of the use of equipment, and the previous calibration; for internal calibration, the factory shall specify the calibration method, acceptance guidelines and calibration cycle; calibration or calibration shall meet national or international benchmarks. The calibration or verification status of the instrument and equipment shall remain qualified and shall be easily identified by management personnel. The factory shall keep records of calibration or verification of instruments and equipment.

For calibration or verification activities entrusted to external agencies, the factory shall ensure that the external agencies' capabilities meet the calibration or verification requirements and keep the relevant capability evaluation results.

Note: For critical monitoring and measuring devices controlled in the process of production, the factory shall conduct management in accordance with the requirements of the product certification implementation rules / regulations.

    1. Laboratory management

The factory shall define the scope of in-house laboratory experiments, including the ability to perform inspection, testing or calibration services.

External/commercial/independent laboratories providing inspection, testing or calibration services to the factory shall have a defined scope that includes inspection, testing or calibration services that they are capable of.

  1. Control of non-conforming products
    1. For non-conforming products found in procurement, manufacturing and inspection, the factory shall take measures such as marking, isolation and disposal to avoid unintended use or delivery of non-conforming products.

The factory shall make instructions for rework and repair, which should include that products after rework and repair shall be retested. Rework of important parts or components shall be documented accordingly.

Undetermined or suspicious products shall be classified as non-conforming.

Scrap products must be controlled in a similar manner to non-conforming products.

Records of the disposal of non-conforming products shall be kept.

    1. For failure of certified products, including recalls, national and provincial supervision and sampling, product recalls, customer complaints and grievances that comes from the external, the factory shall analyze the reasons for the failure and take appropriate corrective measures. The factory shall keep records of certified product failure, cause analysis, disposal and corrective measures.
    2. When factories are informed of major quality problems with their certified products (such as recalls, national and provincial supervision and sampling failure, etc.), they shall promptly notify the certification agency.
  1. Internal Quality Audit

The factory shall establish documented internal quality audit procedures to ensure continuous compliance of the factory's quality assurance capabilities, product conformity, and products compliance to standards.

Complaints against the factory, especially complaints about products not meeting the requirements of the certification rules and standards, shall be kept as records and shall be input to internal quality management system audits.

The factory shall audit each manufacturing process with appropriate frequency to determine its effectiveness.

The factory shall audit its products at appropriate stages of production with appropriate frequency to verify compliance with all specified requirements. For problems found in the audit, the factory shall take appropriate corrective measures and preventive measures. The factory shall preserve the result of internal quality audits.

  1. Product Protection and Delivery

Product protection proceeded by the factory in the procurement, manufacturing, inspection and other aspects, such as marking, handling, packaging, storage, protection, etc. shall meet the requirements of the regulations. If necessary, the factory shall control the process of product delivery according to specified requirements.

The factory shall check the condition of the inventory at appropriately planned intervals to detect deterioration in a timely manner.

  1. CCC certificate and mark

Factory management and use of CCC certificates and marks shall comply with the "Management of Compulsory Product Certification Regulations", "Compulsory Product Certification Mark Management" and other provisions. For standard specifications CCC mark printed unified or applied by printing, molding and other ways, the factory shall keep records of their use. For the following products, the CCC mark shall not be applied or approved.

(a) uncertified products that are in the compulsory product certification catalog,

(b)products whose change of certificate need to be confirmed by the certification agency, but not confirmed,

(c) products exceeding the period validity of certification,

(d) products whose certificate has been suspended, revoked, canceled,

(e) non-conformity products.

Note: The content expressed in italics is quoted from GB/T18305-2003.