1. Scope
This document applies to condom made of natural latex for contraceptive purposes and to assist in the prevention of sexually transmitted diseases for consumer (also called safe sheath).
2. Certification model
Product sampling test+ Initial inspection of the factory + Follow-up inspection
3. Major processes for certification
Application for certification(http://china-ccc-certification.com/171.html)
Product sampling test
Initial inspection of the factory
Evaluation of certification results and approval of certificate
Follow-up inspection
4. General requirements for certification
4.1 Application for certification
4.1.1 Defining application unit for certification
In principle, the product of the same manufacturing premises, the same product series, the same product structure shall be in a application unit, descriptions of defining application unit see appendix 1 Defining application unit for certification for natural latex rubber condom products.
4.1.2 Application documents
The formal application shall be submitted with the following documents:
1. The related material of registration and proofs of the factory;
2. Trademark registration certificate;
3. Product manual in Chinese (shall include statement and commitment of the stability and product quality shall meet requirements of standards in shelf life by the manufacturer);
4. List of main raw materials;
5. List of main equipment and devices for production/product inspection;
6. If there is any sub-contracting for the production process and the inspection, the materials related with the subcontractor and contract shall also be submitted;
7. Chart of the production technology;
8. Statement of the difference between products of different category in each application unit;
9. Packing/label product or drawing in application category.
10. Other documents.
4.2 Product sampling test
Generally, the factory inspection may be implemented after product sampling test is up to standard. According to requirement, product sampling test and the factory inspection may be implemented at the same time.
4.2.1 The persons for sampling
The samples for inspection shall be random sampling from the products by the persons appointed by the certification body.
4.2.2 The principle for sampling
In principle, The samples shall be random sampled by considering to the base number of 35,001-150,000 pieces,and they are taken by considering the product standard and GB/T2828.1 Sampling procedures for inspection by attributes-Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection.
4.2.3 Selecting of the samples
Generally, the samples shall be taken from conformity warehouse in manufacturing premises. In special case, after consulting with truster, it can be in other premises.
In principle, the most representative samples shall be taken from general type and/or super type in same application unit.
4.2.4 Quantity of the samples
Choose a lot and take 1200 pieces.
4.2.5 Testing body
Testing the samples shall be implemented by the testing bodies of which authorized by the state organization.
4.2.6 Standards, items and methods of sampling test
4.2.6.1 Test standard
GB 7544-2004 Natural latex rubber condoms—Requirements and test methods
4.2.6.2 Test items
See appendix 2-1 Test requirements for certification for natural latex rubber condom (general type) products and/or appendix 2-2 Test requirements for certification for natural latex rubber condom (super type) products.
4.2.6.3 Test methods
See appendix 2-1 Test requirements for certification for natural latex rubber condom (general type) products and/or appendix 2-2 Test requirements for certification for natural latex rubber condom (super type) products.
4.3 Initial inspection of the factory
4.3.1 Contents of the inspection
4.3.1.1 Assessment of factory quality assurance ability
The “Requirements of Factory Quality Assurance Capability” is the basic requirements for the initial factory inspection covered by this Rules (see appendix 3).
4.3.1.2 Check of product conformity
1) Witness test whethern the packing/manual is identical with certified products;
2) Check conformity of category and source of main raw materials with application documents.
4.3.2 Inspection scope
All the products to be certified and processing premises shall be covered for inspection of factory quality assurance ability .
4.3.3 Timing for initial factory inspection
Normally, the initial factory inspection should be implemented after application documents for certification accord with the requirement.
The timing for the factory inspection shall be determined by the amounts of application units of products to be certified and with the appropriate consideration the scale of the factory. It will normally take about 3 to 5 man-day for each processing premises.
4.4 Evaluation of certification results and approval of certification
4.4.1 Evaluation of certification results and approval of certification
The certification body shall evaluate the results of factory inspection and sampling test. After the factory inspection and sampling test conforms to the requirements, certificates for the products shall be issued according to application unit by the certification body.
The factory shall take corrective actions within 3 months if there are unqualified items in factory inspection, the certification body shall verify the corrective results with proper ways. For product test unqualified, it shall be taken corrective actions within 3 months and retested for all items. If factory inspection and/or product test are all qualified, the certificates will be issued. Otherwise, the certification will be terminated. The factory shall apply for certification again after taking corrective actions.
4.4.2 Time frame
The time frame for certification means the working days from the acceptance of complete application till issuance of the certificates, which should not exceed 90 working days in all.
4.5 Follow-up inspection
4.5.1 The frequency of follow-up inspection
4.5.1.1 The follow-up inspection shall normally be implemented at least once per year. The first follow-up inspection shall normally be implemented 12 months after the certificates granted. The intervals of each follow-up inspection shall not exceed 12 months.
4.5.1.2 The frequency of inspection should be increased in any of the following case:
1) The certified product has serious quality problems, or is seriously complained by clients, which has been verified to be the responsibility of the certificate holder;
2) The certification body doubts the conformity of the certified product against the requirements of safety standards with sufficient reasons;
3) Sufficient information indicates that the conformity or the consistency of certified products might be affected due to the changes of organization structure, production condition and the quality management system of the manufacturers, factories.
4.5.2 Contents of the follow-up inspection
4.5.2.1 Model of follow-up inspection
 Re-assessment of factory quality assurance ability + product sampling test
4.5.2.2 Re-assessment of factory quality assurance ability
Re-assessment of factory quality assurance ability shall be implemented according to the document of Requirements of Factory Quality Assurance Capability (see appendix 3). The time frame for re-assessment take 1to 3 man-day for each processing premises.
After the certificates granted , all the items in Requirements of Factory Quality Assurance Capability shall be covered within 4 years. In the fifth year after the certificates granted , an overall inspection shall be carried out according to Requirements of Factory Quality Assurance Capability and the related provisions of the certificate body. The content and time frame of the re-assessment is the same as initial factory inspection.The span for overall re-assessment is 4 years.
4.5.2.3 Check of product conformity
1) Use of CCC mark and certification certificates for certified products;
2) Conformity of source, ratio and production technology of main raw materials with that of initial certification.
4.5.2.4 Product sampling test after the certificates granted
Concrete methods and requirements for sampling shall be carried out according to 4.2 of this Rules.
Within 4 years after the certificate granted , safety property for the product getting the certificate and the representative unit products shall be inspected. In the fifth year after the certificate granted, safety property for the representative products shall be inspected according with certificated unit. The span for sampling is 4 years.
4.5.3 Evaluation of follow-up inspection results after the certificates granted
The certificates can be retained and the certification marks can be continuously used upon qualified inspection results . If there is any non-conformities found in the follow-up inspection, the corrective actions shall be taken within three months. Otherwise, the certificates will be withdrawn, the certification marks will be stopped using, and the relevant results will be announced.
5. Maintenance and change of the certificates
5.1 Maintenance of the certificates
In principle, the certificate of the products covered by this Rules itself does not indicate the closing date. The validity of the certificates depends on the follow-up inspection.
5.2 Contents covered by the certificates
According to the features of defining application units, the certificates shall include applicant name, factory name, code and address, product unit, implementation rules, product certification mark, certificate body name, signature, date and other contents by the certificate body.
5.3 Extension for covering products of the certificates
For extension for the scale of products on the same unit (i.e. has got certificate of smooth rubber condom (general type) already, require to add smooth rubber condom (super type)), the holders of certificates shall first make application. After confirmed by the certification body,  the sampling test will be arranged. The requirements of sampling test are as specified in 4.2 of this Rules.
5.4 Extend the the range of certified products
According to the principles of defining application unit in 4.1.1 of this Rules, for add new application unit or enlarge processing premises on the basis of original application unit, the holders of certificates shall make formal written application.
the holders of certificates shall submit formapplication documents, which shall be confirmed by the certification body before factory inspection or product sampling test.
5.5 Reduce the the range of certified products
For claim not preserve the certification quality of certain cerified application unit, which is reduce the the range of certified products, principle the holders of certificates shall make written application. The corresponding application unit will be cancelled after confirmation by the certification body. The certificates shall be returned back to the the certification body and the certification mark shall be stopped to use in the products of this application unit.
6. Use of the certification marks
The certificate holder shall follow the Regulations for Compulsory Product Certification Mark.
6.1 Design of the mark allowed to use
The mark of certification:
6.2 Application of the marks
Any one of the two methods: standard marks(http://china-ccc-certification.com/148.html) (labels) or print(http://china-ccc-certification.com/167.html) can be used.
6.3 Location of the marks
The certification marks shall be applied on the smallest packages and/or manual of products
7. Suspension, cancellation and withdrawal of the certificates
When the holders of the certificates violate this Rules and other requirements, the certificates shall be suspended, cancelled and withdrawn in accordance with the Regulation for Compulsory Product Certification.
8. Charge
The certification fee shall be charged by the certification body according to related regulations of China.

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