0. Introduction

In order to shorten the cycle of compulsory certification and testing, reduce certification and testing costs, lessen the burden on production enterprises and avoid repeated evaluation, and on the premise that certification risks are controllable and certification quality is assured, where specific requirements are met and the testing resources (such as personnel and facilities) of the laboratory of the production enterprise(hereinafter referred to as the factory) provide the necessary testing competence for corresponding products and specific items, and where products applying for compulsory certification may have obtained other certifications or the factory may have obtained management system certification, compulsory certification may use the factory’s own testing resources to replace all or part of the sample testing items normally conducted at CCC designated laboratories, or may recognize evaluation results of the same content in other certifications (including testing, inspection or audit results). These Implementation Rules are formulated to regulate the above two types of activities.

Factory testing resources referred to in these Rules are resources wholly owned by the manufacturer or production enterprise applying for compulsory certification, which are  located in the same city as the factory or nearby, and are hereinafter referred to as the factory laboratory.

Other certification results referred to in these Rules are product certification certificates and management system certification certificates issued by certification bodies approved by CNCA, provided that such certificates are within their validity period.

1. Terms and Definitions

1.1 TMP Method

A testing method in which the designated laboratory directly uses the testing equipment of the factory laboratory to conduct testing, hereinafter referred to as TMP.

1.2 WMT Method

A witnessed testing method in which the designated laboratory uses the testing equipment of the factory laboratory, hereinafter referred to as WMT.

2. Utilization of Factory Testing Resources

2.1 Scope

2.1.1 Type testing: limited to the following CCC certified products:

(a) the samples are large in size or easily damaged, resulting in high transportation costs  or transportation difficulties; or

(b) the product is highly seasonal and has a short life cycle; or

(c) the product is produced only in one batch and will not be produced again thereafter; or

(d) other special circumstances.

2.1.2 Post-certification surveillance sample testing: all types of CCC certified products.

2.1.3 Supplementary difference testing during certificate extension and modification: all types of CCC certified products.

2.1.4 Where the same factory has used its own testing resources for the same item for five consecutive years, samples shall, in principle, be sent to a designated laboratory for testing to avoid systemic risks.

2.2 Implementation Methods

According to the overall situation of equipment resources, human resources and soft resources of the factory laboratory, and in combination with product characteristics, sample testing using factory testing resources is divided into two methods: TMP and WMT.

2.2.1 TMP Method

Qualified engineers from the designated laboratory dispatched by the designated certification body, shall use the testing equipment of the factory laboratory to conduct testing, and the factory shall assign testing personnel to assist. The relevant designated laboratory reviews, approves and issues the test report.

2.2.2 WMT Method

Qualified engineers from the designated laboratory, dispatched by the designated certification body, shall witness the testing conditions of the factory laboratory and the completion of all testing carried out by the factory laboratory using its own equipment, or, with respect of the testing plan submitted by the factory to the certification body, witness part of the testing conditions and testing items. Testing personnel of the factory laboratory shall be responsible for issuing original records and, together with the witnessing engineers from designated laboratory, draft the test report in the specified format. The relevant designated laboratory reviews, approves and issues the test report.

2.3 Conditions and Requirements

These Rules specify the basic conditions for the utilization of factory testing resources. Designated certification bodies shall formulate specific conditions and requirements according to specific products and management needs. Only factory laboratories that have been reviewed and assessed by the certification body, with participation organized from the designated laboratory, and found to meet the following conditions may use factory testing resources for sample testing.

2.3.1 TMP Method

(a) the factory shall be an enterprise at a relatively high level in the classification management of the certification body, and its design, manufacturing, risk control and quality management shall be at a relatively advanced level in the industry;

(b) the factory quality manual shall contain provisions related to procedures for utilizing factory testing resources and shall conform to the requirements of CCC certification procedures;

(c) the factory laboratory shall meet the technical competence requirements of Clause 5 of GB/T 27025 (ISO/IEC 17025);

(d) the factory laboratory shall have instruments and equipment meeting the accuracy requirements specified in the relevant testing standards, and such instruments and equipment shall be properly controlled, in conformity with all requirements for testing equipment in the technical requirements section of GB/T 27025 (ISO/IEC 17025).

2.3.2 WMT Method

(a) The factory shall be an enterprise at a relatively high level in the classification management of the certification body, and its design, manufacturing, risk control and quality management shall be at a relatively advanced level in the industry;

(b) The factory quality manual shall contain provisions related to procedures for utilizing factory testing resources and shall conform to the requirements of CCC certification procedures;

(c) The factory laboratory shall meet the technical competence requirements of Clause 5 of GB/T 27025 (ISO/IEC 17025);

(d) The factory laboratory shall have instruments and equipment meeting the accuracy requirements specified in the relevant testing standards, and such instruments and equipment shall be properly controlled, in conformity with all requirements for testing equipment set out in the technical requirements section of GB/T 27025 (ISO/IEC 17025);

(e) Testing personnel of the factory laboratory shall be familiar with the product structure and testing standards and have adequate testing experience;

(f) The format of testing records of the factory laboratory shall meet the requirements of the designated laboratory working on site for testing information.

2.4 Acquisition and Maintenance of Qualification

2.4.1 The factory shall apply to the certification body and conduct a self-assessment in according with the above conditions, and submit the self-assessment results and relevant documents to the certification body together with the application for review. The certification body shall organize technical experts from the designated laboratory to conduct on-site assessment and retain corresponding assessment records. Only facilities that pass the assessment may be used as factory laboratory resources for testing.

2.4.2 The certification body shall conduct regular surveillance of approved factory laboratories, for example once a year, with the frequency determined according the usage rate, which may be combined with the annual factory inspection and shall organize the factory laboratories to participate in proficiency testing, so as to ensure the accuracy and validity of test results and maintain their qualification.

2.4.3 The certification body shall retain records of approved factory laboratories and shall report to the CNCA annually the list of approved factory laboratories and their usage as part of the annual work summary.

2.5 Obligations and Responsibilities

2.5.1 Obligations

2.5.1.1 Obligations of Designated Certification Body

(a) Manage and organize the activities for utilizing factory testing resources in compulsory certification, including at least formulating implementation measures or procedures, determining specific conditions and requirements, selecting assessment experts and organizing assessment of factory laboratories;

(b) Ensure that all implementing personnel have technical competence and are familiar with relevant procedural requirements;

(c) Ensure that an appropriate tripartite agreement is in place among the certification body, the designated laboratory and the factory laboratory to ensure that the testing process conforms to requirements;

(d) Regularly report relevant work to CNCA;

2.5.1.2 Obligations of Designated Laboratory

(a) Participate in the assessment of the factory laboratory;

(b) Where necessary, assess the competence of factory laboratory personnel;

(c) As a party to the tripartite agreement, ensure that the testing process conforms to requirements;

(d) Issue the test report and include in the test report information such as the name and address of the factory laboratory used, the method adopted, and test items.

2.5.1.3 Obligations of Applicant Factory

(a) Ensure that the factory laboratory conforms to the relevant requirements of GB/T 27025 (ISO/IEC 17025);

(b) Designate appropriate personnel to be responsible for the management of the factory laboratory and to support the operation of the above testing;

(c) Ensure that factory laboratory personnel follow the testing arrangements made by personnel from the designated certification body and designated laboratory;

(d) As a party to the tripartite agreement, ensure that the testing process conforms to the requirements;

(e) Keep the scope of its corresponding accreditation updated and valid.

2.5.2 Responsibilites

The use of factory testing resources for sample testing does not exempt, reduce or transfer the responsibilities of the designated laboratory and designated certification body for testing results and certification results as prescribed in the Provisions on Administration of China Compulsory Certification (CCC).

2.6 Implementation Requirements

Certification bodies shall formulate specific implementation procedures in according with the above principles, clarify the specific duties of each party during implementation, and sign relevant agreements with designated laboratories and factory laboratories to make arrangements for confidentiality, the safety responsibilities of engineers and other relevant matters.

In order to reduce the burden on enterprises, the assessment of factory laboratory and on-site testing may be conducted together. The assessment team shall first conduct the laboratory competence assessment, and testing shall be conducted only after the assessment is passed. To avoid unnecessary repeated assessments of the same factory laboratory by multiple certification bodies, designated certification bodies shall coordinate with each other, and the establishment of a mutual recognition mechanism based on harmonized technical requirements and assessment procedures is encouraged.

Testing using factory testing resources shall still follow the original principles for task assignment to designated laboratories.

2.7 Charges

TMP testing fees shall be charged at the higher of 50% of the Product Testing Fee Standard for China Compulsory Certification filed with the National Development and Reform Commission (NDRC) and the man-day costs for laboratory competence assessment and on-site testing, provided that the fee does not exceed 100% of the total testing fee. WMT testing fees shall be charged at the lower of 50% of the Product Testing Fee Standard for China Compulsory Certification filed with the National Development and Reform Commission (NDRC) and the man-day costs for laboratory competence assessment and on-site testing.

The above fees shall be collected by the relevant designated laboratory, and the certification body shall collect only the application fee, document review fee and factory inspection man-day fees.

3. Utilization of Other Certification Results

3.1 Scope

Product certification certificates and management system certificates issued by certification bodies approved and accredited by CNCA, provided that their implementation rules and related documents have been filed in accordance with national regulations and the certificates are within their validity period.

3.1.1 Product Certification

For components that, according to the implementation rules for compulsory certification, need to be tested together with the finished product, and that have already obtained voluntary certification whose certification results may be recognized for compulsory certification of the finished product as specified by CNCA, the designated certification body shall, on the basis of review, adopt the certification results and exempt such components from separate testing.

Designated certification bodies are encouraged to make relevant arrangements to adopt other voluntary product certification results or partial results, so as to avoid repeated testing and repeated review and thus improve certification efficiency.

3.1.2 System Certification

When implementing compulsory certification, for enterprises holding valid management system certificates (including service system certificates) issued by certification bodies approved by CNCA, the certification body shall evaluate according to the actual situation and decide to exempt the review of certain clauses related to the quality management system; other elements of factory inspection shall not be exempted.

3.2 Responsibilities

The utilization of voluntary certification results does not exempt, reduce or transfer the responsibilities of designated laboratories and certification bodies for testing results and certification results as prescribed in the Provisions on Administration of China Compulsory Certification (CCC).

3.3 Implementation Requirements

Designated certification bodies shall establish management procedures for utilizing other certification results, retain records of activities involving the utilizing of other certification results, and report annually to CNCA the utilizing of other certification results as part of the annual work summary.

3.4 Charges

For items and elements that are reduced or exempted as result of the utilizing of voluntary certification results, designated certification bodies and designated laboratories shall exempt or reduce the fees for the corresponding certification and testing activities in accordance with the relevant national fee regulations.