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Product Certification Requirements for Factory’s Quality Assurance Ability
Public Time:2006-12-06
  1.       Introduction

The document of the Product Certification Requirements for Factory’s Quality Assurance Ability, which includes the Requirements for certified product testing and the Requirements for Factory’s Quality System, is to ensure production be in accordance with the national standard for the product and comply with the type-test approved product. It is the qualification to get the product safety certificate and using the certification mark. And it is the lowest standard accepted. It will follow the Special Requirements for Voluntary Product Certification if there is any special request.

2.       Definition

2.1     Applicant

The Organization which is applying for Product Certification

2.2     Certificate Holder

The Organization which is holding the certificate

Note: It is called the Applicant before the certificate granted, and called the Certificate Holder after the certificate granted

2.3     Producer (Manufacturer )

The Organization which operates the quality system and controls the production of the certified product

2.4     Factory/Manufactory/ Workshop

The place where the certified product was last packaged/ or tested and the Certificate Mark is used.

3.       General rules

Factory shall ensure documented quality system which meets the Requirements of Chapter 4 implemented effectively and the production to comply with the type-test approved product. The inspection is implemented at least once per year (according to the sort of the certified product and the stabilization of the production) to ensure routine work and related processes on the acceptable level. During the follow-up inspection, sample test is needed to validate the consistency of the product with the certification standards and the type-test approved product.

The frequency of the follow-up inspection will be increased when the product is not in accordance with the standard for certification.

4.       Quality system

4.1     Responsibility and Resource

4.1.1          Responsibility

Factory shall regulate the responsibilities and inter-relations of all the personnel involved in quality activities. And factory shall appoint a responsible person for quality and a certification link engineer (or linkman) from the organization that, irrespective of other responsibilities, shall have responsibility and authority that include:

a)    Ensuring that quality system, which meets the requirements of this document, is established, implemented and maintained.

b)    Ensuring that the products with the certification label are produced in conformity with the standards to which they were certified.

c)  Submitting the modification of safety of the certified product to the certification body betimes

d)  Contacting with the certification body and coordinating about the certification

e)    Establishing documented procedure to ensure that certification labels are kept and used appropriately.

f)     Establishing documented procedure to ensure that the certification label is not borne on any non-conforming product or changed product that was not notified by certification body.

The certification link engineer who should be familiar with the certification service has to assist the responsible person to contact with the certification body.

4.1.2          Resource

Factory shall equip with necessary production facility and testing equipment in order to consistently manufacture the products in conformity with certification standards. In addition, factory shall provide relevant human resources, to ensure that personnel performing work affecting product quality is competent, and establish and maintain necessary environment suitable for manufacturing, test and inspection, storage etc.

4.2     Documents and Records

4.2.1 Factory shall establish and maintain documented quality plan or relevant documents for certified products, and needed documents in order to ensure that related processes to product quality are operated and controlled effectively. Quality plan shall define the objective of product design, realization process, test and related resource, as well as the requirements for changes (i.e. standard, technics, critical components etc.) to certified products, use and management of labels.

Design standard or specification, as one essential part of quality plan, shall not be lower than the requirements of national standard for the product.

4.2.2 Factory shall establish and maintain documented procedure to control the documents required in this document, to ensure that

a)   Documents are approved by authorized personnel prior to issue and re-approved after changes.

b)   Changes and current revision status of documents are identified to prevent unintended use of obsolete documents.

c) Relevant versions of applicable documents are available at points of use.

4.2.3 Factory shall establish and maintain documented procedure to define the controls for the identification, storage, protection and disposition of records. Records shall remain legible, integral to provide evidence of product conformity to requirements.

Factory shall maintain the records at least as follows:

l         Records of purchasing/ validating

l         Records of routine tests

l         Records of type testing

l         Records of inspection and test equipment

l         Records of function of the equipment testing records

l         Records of all complaints and the corrective action

l         Records of actions to Non-conforming Product

l         Records of internal audit

l         Records of the use of Mark

Records shall be retained for an appropriate period that should not be less than two years.

4.3     Purchasing and Incoming Inspection

4.3.1 Control of Supplier

Factory shall establish the procedure that defines the criteria for selection, evaluation and routine supervision of supplier, which provide critical components and material, to ensure the supplier has ability to provide the critical components and material in accordance with requirements.

Records of the evaluations and routine supervision shall be maintained.

4.3.2 Inspection/Verification for Critical Components and Material

Factory shall establish and maintain procedure of inspection or verification for purchased critical components and material, and procedure of periodic verification inspection, to ensure that critical components and material meet specified certification requirements.

Inspection for purchased critical components and material may be carried out by factory or by supplier. Where inspection is performed at supplier’s premise, factory shall state the intended inspection requirements to supplier.

Factory shall keep a record of inspection/verification for critical components and material, the qualification from the supplier and the relevant data, etc. There should be a signature of the responsible person in the qualification.

4.4 Monitoring and Measurement of Processes

4.4.1 Factory shall identify critical production processes and arrange operators with appropriate qualification at the processes. Where product quality can not be guaranteed when no operating document, appropriate operating instructions shall be prepared to make production processes under control.

4.4.2 Where environment condition is required, factory shall meet the requirements.

4.4.3 Factory shall monitor and control appropriate process parameters and product characteristics, as applicable.

4.4.4 Factory shall establish and maintain maintenance procedure for manufacturing facility.

4.4.5 Production shall be inspected at appropriate stages of manufacture to ensure that components, sub-assemblies, wiring runs etc. are in accordance with the certification approved sample.

4.5. Routine Tests and Verification Tests

Factory shall establish and maintain documented routine tests and verification tests procedures to verify and demonstrate that products are in accordance with relevant requirements. The procedures shall include test items, contents, method, acceptance criteria etc. Test records shall be maintained. Routine tests and verification tests shall meet the requirements specified in relevant product certification implementation rule.

Routine tests are line tests performed on 100% of production and are normally carried out at the final stage of manufacture. Normally no further operations, except for labeling and packing, may be carried out after these tests.

Verification tests are tests in addition to the routine tests on samples taken randomly in order to verify and demonstrate that products consistently meet standard requirements.

4.6. Inspection and Test Equipment

The equipment used for inspection and test must be regularly calibrated and checked for correct operation, and meet inspection and test capacity requirements.

4.6.1 Calibration and verification

Inspection and test equipment used for determining the conformity of the products being manufactured shall be calibrated or verified on a regular basis. All calibrations and verification undertaken on such equipment must be traceable to national or international standards. Where no measurement standards exist, calibration method, acceptance criteria, calibration interval etc. shall be documented. Calibration and verification status of equipment shall be easily identified by user and management personnel.

Calibration and verification records shall be kept.

4.6.2 Functional Check

The equipment used for routine tests and verification tests shall undertake an functional check in addition to daily check. When functional check is found to be not satisfying specified requirements, arrangements shall allow previous production to be traced and re-tested if necessary,. Operator shall be instructed on what action is to be taken if a functional test is found to be unsatisfactory.

The results of functional check and all subsequent corrective action taken must be recorded.

4.7. Control of Non-conforming Product

Factory shall establish procedure of control of non-conforming product, which shall includes identification method, segregation, disposal, corrective action and preventive action. Repaired and reworked product shall be re-inspected. Records of repairing for critical components or sub-assemblies and disposal of non-conforming product shall be maintained.

4.8. Internal Audit

Factory shall establish documented internal audit procedure to ensure that product quality system is implemented effectively and certified products compliance. The results of internal audit shall be kept.

Factory shall keep a record of all complaints known, especially to a product’s compliance with requirements of relevant standard, and make these complaints as one of input information of internal audit.

Corrective action and preventive action shall be taken to detected nonconformities and records shall be maintained.

4.9. Compliance with Certified Product

Factory shall control production to comply with the type-test approved product, to make certified products consistently be in conformity with relevant standard requirements.

Factory shall establish procedure to monitor changes of the critical component, material, construction and factors that may affect compliance with relevant standard.

The changes on certified products must be notified to the issuing certification body for authorization, prior to their implementation.

4.10. Packing, Handling and Storage

Finished products shall be packaged, stored and handled in such a way as to ensure that they will continue to comply with the applicable standards.


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