Guideline for Implementation Regulations of Import Boiler & Pressure Vessel Safety Licensing System

Transcription

1 Guideline for Implementation Regulations of Import Boiler & Pressure Vessel Safety Licensing System Chinese Edition was approved by the Ministry of Labour the People s Republic of China on May 14, 1996

2 CONTENTS 1. INTRODUCTION 2. GLOSSARY OF TERMS 3. GENERAL PROVISIONS 3.1 Legal status of safety quality licensing system 3.2 The Product List of Import Boilers and Pressure Vessels Subjected to Safety Quality Licensing System Boilers Transportable Pressure Vessels Stationary Pressure Vessels Safety Appurtenances of Boiler and Pressure Vessel 3.3 Forms of safety quality licensing The two forms of safety quality licensing Manufacturer Approval Type Approval Selection and validation of forms for safety quality licensing 3.4 Organizations relevant to safety quality licensing 3.5 Application procedures for safety quality licensing Application procedure for Manufacturer Approval Application procedure for Type Approval 3.6 Basic requirements for the product manufacturer Resource requirements Quality management requirements 1

3 3.6.3 Product safety quality requirements 4. APPLICATION 4.1 Preparation for application 4.2 Submitting the application Application intention Distribution of the related information & documents and the blank Application Forms Completion of the Application Form and submission of the application documents 4.3 Acceptance of the application Review and acceptance of the application Handling of acceptance Handling of non-acceptance 4.4 Notes to the applicant Non-acceptable conditions of application Application when the manufacturer has more than one sub-manufacturer or production facilities Application made by the manufacturer s representative agency Application made by both the representative agency and the product manufacturer Content, format and completion of the Applicant Form Commitment of the applicant 5. REVIEW, SURVEY AND ASSESSMENT 5.1 General description of safety quality licensing review, survey and assessment Basic principles and content of safety quality licensing review, survey and assessment Basic procedures of safety quality licensing review, survey and assessment 2

4 5.1.3 Basic requirements of safety quality licensing review, survey and assessment 5.2 Document Review Basic principles and requirements of the Document Review Main contents of the Document Review Time and method of the Document Review Validation of the Document Review results 5.3 Manufacturer Survey and Assessment Basic principles and requirements of the Manufacturer Survey and Assessment Main contents of the Manufacturer Survey and Assessment Basic requirements of quality system and assessment checklist Basic means for Manufacturer Survey and Assessment Basic procedures of Manufacturer Survey and Assessment Initial meeting of the review, survey and assessment team with related personnel of the manufacturer Initial tour of the manufacturer s facility Review of the documents provided by the manufacturer Review and assessment of the quality system documents Audit and assessment of the implemented quality system Checks or spot checks of product safety quality, and equipment & instruments Review and verification of the corrective action required by the previous Assessment Team Exit meeting of the Assessment Team with the manufacturer s personnel Validation and disposition of Manufacturer Survey and Assessment results 3

5 5.4 Sample Inspection & Test (only applicable to Type Approval ) Basic principles of Sample Inspection & Test Preparation of product samples Time, location and method of product sample selection Quantity of product samples Technical documents for the product samples The delivery and acceptance of the product samples Inspection and test of the product samples Time of inspection and test Personnel & location of inspection and test Equipment, instruments and conditions of the inspection and test Contents, item and method of the inspection and test Assessment of inspection and test records and results Guarantee of the fairness and correctness of the inspection and test Validation of the inspection and test results Disposal of product samples after inspection and test 5.5 Handling of disputes for review, survey and assessment results 5.6 Conclusion for the safety quality licensing review, survey and assessment Drawing conclusion Approval of conclusion Disposition of the non-conformities with safety quality licensing requirements 4

6 6. SAFETY QUALITY LICENSE AND LICENSING SYMBOL STAMP 6.1 Issuing and proclaiming of Safety Quality License Issue of the Safety Quality License Delivery of the Safety Quality License Contents, format and validity period of the Safety Quality License Proclamation for Safety Quality License 6.2 Renting of safety quality licensing Symbol Stamp Submitting samples of the product name plate and trademark details of the product (or manufacturer) Renting of licensing Symbol Stamp 6.3 Types of safety quality licensing Symbol Stamp 6.4 Use and control of the Safety Quality License 6.5 Use and control of safety quality licensing Symbol Stamp Drafting procedure documents for use and control of the Symbol Stamp Requirements for using the Symbol Stamp on products 7. ADMINISTRATION AND SUPERVISION AFTER OBTAINING THE SAFETY QUALITY LICENSING 7.1 Responsibility and notes for the license holder Quality control of safety quality licensing products Use and control of safety quality licensing Symbol Stamp Requirements for safety quality licensing products registration Documentation requirements for safety quality licensing products 5

7 7.1.5 Subsequent surveillance audit, checks or spot checks by the authorized agency Report and disposition in the event of major changes Notes for the license holder 7.2 Inspection, test and supervision of boiler & pressure vessel products exported to the People s Republic of China 7.3 Renewal procedure for the Safety Quality License Safety Quality License renewal application Review, survey and assessment for the Safety Quality License renewal Issue of the new Safety Quality License 8. FEES AND EXPENSES FOR SAFETY QUALITY LICENSING 8.1 Items, standard and payment of fees and expenses for applying for safety quality licensing Fee and expense items Standard and payment of fees and expenses Fee disposition of non-accepted application Fee disposition of canceled application 8.2 Items, standard and payment of fees and expenses for the subsequent surveillance, checks or spot checks to license holder 8.3 Items, standard and payment of fees and expenses for renewal of the safety quality licensing 9. SUPPLEMENTARY PROVISIONS 10. APPENDIX Appendix A Application Form Appendix B Quality System Requirements and Assessment Checklist 6

8 Appendix C Safety Quality License Appendix D Registration Form 1. INTRODUCTION This Guideline is formulated based on the stipulations of article 30 in Implementation Regulations of Import Boiler and Pressure Vessel Safety Quality Licensing System issued by the Ministry of Labour of the People s Republic of China (hereinafter referred to as the Implementation Regulations). This Guideline is a specific guidance document formulated for implementing the import boiler & pressure vessel safety quality licensing system by following the fundamental principles of the Implementation Regulations. This Guideline is provided mainly for foreign and overseas manufacturers or enterprises, and their representative agencies which export their boiler and pressure vessel products to the People s Republic of China. It is also provided for the review, survey and assessment personnel when assigned to conduct the safety quality licensing review, survey and assessment as well as other relevant personnel. This Guideline is aimed at helping its users to acquaint and understand the nature, content, requirements, procedures and the various stipulations of the import boiler & pressure vessel safety quality licensing system of the People's Republic of China and to ensure the correct execution. This Guideline was drafted by the Center of Boiler and Pressure Vessel Inspection & Research, the Ministry of Labour, the People s Republic of China, approved and promulgated by the Ministry of Labour, the People s Republic of China. The Center of Boiler & Pressure Vessel Inspection & Research of the Ministry of Labour, authorized by the Ministry of Labour of the Peoples Republic of China, is responsible for the interpretation of this Guideline. 2. GLOSSARY OF TERMS 2.1 Boiler & Pressure Vessel - A general designation of boilers, pressure vessels, gas cylinders, and safety appurtenances of boiler and pressure vessel. 2.2 Guideline - Guideline for Implementation Regulations of Import Boiler & Pressure Vessel Safety Quality Licensing System, unless otherwise indicated. 2.3 Implementation Regulations - Implementation Regulations of Import Boiler and Pressure Vessel Safety Quality Licensing System issued by the Ministry of Labour of the People's Republic of China. 2.4 MOL - Abbreviation for the Ministry of Labour of the People s Republic of China. 7

9 2.5 SACI - Abbreviation for the State Administration of Import & Export Commodity Inspection of the People s Republic of China. 2.6 OBA - Abbreviation for the Bureau of Occupational Safety & Health and Boiler & Pressure Vessel Administration of the Ministry of Labour of the People s Republic of China. 2.7 CBPVI - Abbreviation for the Center of Boiler & Pressure Vessel Inspection & Research of the Ministry of Labour of the People s Republic of China. 2.8 SQLO - Abbreviation for the Safety Quality Licensing Office for Import Boiler and Pressure Vessel of the Ministry of Labour of the People s Republic of China. 2.9 List - The Product List of Import Boilers and Pressure Vessels Subjected to Safety Quality Licensing System jointly promulgated by the Ministry of Labour of the People's Republic of China and the State Administration of Import & Export Commodity Inspection of the People s Republic of China unless otherwise indicated SQLS - Abbreviation for the Import Boiler & Pressure Vessel Safety Quality Licensing System of the People s Republic of China unless otherwise indicated Applicant - A general designation of foreign (or overseas) product enterprises, manufacturers or their representative agencies which apply for the Import Boiler & Pressure Vessel Safety Quality Licensing of the Ministry of Labour of the People s Republic of China License Holder - An applicant which has obtained and held a valid Safety Quality License for Import Boiler & Pressure Vessel issued by the Ministry of Labour of the People's Republic of China Application Form - The written application document submitted by the applicant in accordance with the content and format required in Appendix A of this Guideline Safety Quality License - The Safety Quality License for Import Boiler & Pressure Vessel authorized and issued by the Minister of Labour of the People's Republic of China Manufacturer - A general designation of a foreign or overseas company, product enterprise or product manufacturer which exports their boiler and pressure vessel products to the People s Republic of China. Also referred to as Product Manufacturer. 3. GENERAL PROVISIONS 3.1 Legal status of safety quality licensing system Legal basis of safety quality licensing system The Import Boiler & Pressure Vessel Safety Quality Licensing System of the People's 8

10 Republic of China is based upon the following laws, decrees and regulations: (1) Article 22 of the Law of the People's Republic of China on Import and Export Commodity Inspection, "The State, when deemed necessary, shall institute the Safety License System for important import and export commodities and their manufacturers." (Adopted by the sixth meeting of the standing committee of the Seventh National People's Congress on February 21,1989; Promulgated by the President of the People's Republic of China). (2) Article 38 of the Regulations for the Implementation of the Law of the People's Republic of China on Import and Export Commodity Inspection, "As required by the state, for important import and export commodities involving safety and hygiene, etc. and their manufacturers, an import safety quality license and export quality license system shall be implemented."(approved by the State Council on October 7, 1992 and promulgated by the State Administration of Import and Export Commodity Inspection of the People s Republic of China on October 23, 1992.) (3) Article 3 and article 4 of the Implementation Regulations of Import Commodity Safety Quality Licensing System, "The State Administration of Import & Export Commodity Inspection is responsible for formulation and promulgation of the List of Import Commodities Subject to Import Safety Quality Licensing System for commodities involving safety, hygiene, environment protection, and labour protection ; No commodities shall be allowed to export to the People's Republic of China unless obtained the Safety Quality License. (Promulgated by the State Administration of Import & Export Commodity Inspection of the People s Republic of China on June 30, 1993). (4) Products from kinds 35th to 38th covered in The Second List of Import Commodities Subject to Import Safety Quality Licensing System. (Jointly promulgated by the State Administration of Import and Export Commodity Inspection of the People's Republic of China and the Ministry of Foreign Trade and Economic Co-operation of the People's Republic of China on September 4, 1995). (5) The Product List of Import Boilers and Pressure Vessels Subject to Safety Quality Licensing System.(Jointly promulgated by the Ministry of Labour of the People's Republic of China and the Stated Administration of Import & Export Commodity Inspection of the People's Republic of China on September 6, 1995). (6) The Implementation Regulations of Import Boiler and Pressure Vessel Safety Quality Licensing System (Issued by the Ministry of Labour of the People's Republic of China on September, 29, 1993) Enforcement date of safety quality licensing system According to the aforementioned laws, decrees, and regulations, from October 1, 1997 onwards, no boiler and pressure vessel products which are covered in The Product List of Import Boilers and Pressure Vessels Subjected to Safety Quality Licensing System (hereinafter referred to as the List) shall be allowed to export to the territory of the People's Republic of China unless the foreign or overseas manufacturers have obtained the Safety Quality License issued by the Ministry of Labour (hereinafter referred to as MOL) of the 9

11 People's Republic of China Nature of safety quality licensing The Import Boiler & Pressure Vessel Safety Quality Licensing System of the People's Republic of China (hereinafter referred to as SQLS) is a legal and mandatory product safety quality certification system based upon the national laws and prescribed procedures. Obtaining the Safety Quality License issued by the MOL means that a manufacturer possesses the assurance capability of providing boilers and pressure vessels in accordance with the safety quality requirements and achieves the governmental import licensing certification of the People's Republic of China, thus possesses the prerequisite official qualification to export its products covered in the licensing scope to the People s Republic of China. The products shall also be subjected to commodity inspection and product safety performance quality inspection according to the stipulations of the Law of the People's Republic of China on Import and Export Commodity Inspection and the Provisions for the People s Republic of China on the Supervision and Control of the Import and Export Boilers and Pressure Vessels when the products are exported to the territory of the People s Republic of China. 3.2 The Product List of Import Boilers and Pressure Vessels Subjected to Safety Quality Licensing System The following four categories of boiler and pressure vessel products shall be subjected to import boiler & pressure vessel safety quality licensing system according to the List jointly promulgated by the Ministry of Labour and the State Administration of Import and Export Commodity Inspection of the People's Republic of China Boilers, including: 1) Steam Boilers- A general designation for stationary steam boilers in which steam is generated at a certain pressure in water service conditions. 2) Hot Water Boilers- A general designation for stationary hot water boilers operating at a certain pressure in water service conditions. 3) Organic Fluid Heaters- A general designation for stationary organic fluid heaters in vapour phase or in liquid phase service conditions Transportable Pressure Vessels, including: 1) Gas Cylinders- A general designation for various cylinders which are used in the normal ambient temperature (-40~60 C) with nominal working pressure MPa (gage pressure) and nominal volume L. 2) Truck Transport Tank Units- A general designation for truck transport tank units with the maximum working pressure in the tanks of not less than 0.1MPa. 10

12 3) Railway Transport Tank Units- A general designation for railway transport tank units with the maximum working pressure in the tanks of not less than 0.1 MPa Stationary Pressure Vessels A general designation for stationary pressure vessels, includes stationary vessels with the maximum working pressure of not less than 0.1MPa, inside diameter of not less than 0.15m, volume of not less than cubic meters, and the contained medium as gas, liquefied gas, or liquid with the maximum working temperature of not less than its standard boiling point. Note: The typical stationary pressure vessels used in industrial installation of fertilizer, chemical engineering, petrochemical engineering, air separation, light industry, paper-making, metallurgy, building materials, power, medicine, and textile industries are as follows: 1.Classification of reaction, such as, varieties of reactors, synthetic towers, polymerizers, condensing-polymerizing kettles, shift converters, pyrolysis furnaces(towers), decomposer towers, oxidizing towers, reducing towers, and generators, etc. in which, chemical reaction takes place among the contained mediums. 2. Classification of separation, such as, various distillation towers, rectifying towers, fractionating towers, absorbing towers, extracting towers, scrubbing towers, crystallizers, concentrators, deaerators, and separators, etc. in which, mass transfer and/or mass separation takes place among the contained medium. 3. Classification of heat exchange, such as,varieties of heat exchangers, heaters, coolers, preheaters, evaporators, condensers, dryers, reboilers, autoclaves, stoving ovens, spherical digesters, and cold boxes, etc. in which, heat transfer and exchange takes place among the contained mediums. 4. Classification of storage, such as, all kinds of horizontal cylindrical tanks, vertical cylindrical tanks, spherical tanks, fermentation pots, and mixers, etc. mainly used in storage and/or mixing of mediums Safety Appurtenances of Boiler and Pressure Vessel A general designation for safety appurtenances for boiler and pressure vessel. These include: safety valves, rupture discs, pressure measuring devices, protection devices, main valves, pressure fittings, etc Forms of safety quality licensing The two forms of safety quality licensing There are two forms of import boiler and pressure vessel safety quality licensing, i.e. Manufacturer Approval and Type Approval Manufacturer Approval Manufacturer Approval is principally to confirm the capability and degree for a manufacturer to assure the safety quality of its products, through the survey of a manufacturer s manufacturing and inspection conditions, and the review and assessment of a manufacturer s quality system. For the manufacturer who has passed the review, survey and assessment, the MOL will issue the Manufacturer Approval Safety Quality License corresponding to the licensing scope and the Manufacturer Approval Symbol Stamp to the manufacturer according to the 11

13 stipulations of the Implementation Regulations. The Manufacturer Approval form is applicable to Boiler, Stationary Pressure Vessel, Truck Transport Tank Unit, and Railway Transport Tank Unit products in the List Type Approval Type Approval is principally to confirm the safety quality reliability of a type of products, through the review of design for a specific type of products, the survey and assessment of manufacturing, and the inspection and test of safety quality of a specific type of products. For the manufacturer and its products which have passed the review, survey and assessment, the MOL will issue the Type Approval Safety Quality License which applies to the corresponding product type and the Type Approval Symbol Stamp to the manufacturer according to the stipulations of the Implementation Regulations. The Type Approval form is applicable to Gas Cylinder, and Safety Appurtenance of Boiler and Pressure Vessel products in the List Selection and validation of forms for safety quality licensing The applicant may put forward the forms of safety quality licensing application according to the application product category and the stipulations of clause and clause of this Guideline and indicate the selection in the Application Form. For the Gas Cylinder, and Safety Appurtenance of Boiler and Pressure Vessel products, the applicant may apply for the addition of Manufacturer Approval. However, the applicant shall not be allowed to change to Manufacturer Approval. For all the other product categories, the applicant may also apply for the addition of Type Approval according to the specific product type. Forms of safety quality licensing application shall be finally validated by Occupational Safety & Health and Boiler & Pressure Vessel Administration (OBA) in the Application Form. 3.4 Organizations relevant to safety quality licensing SACI: the promulgation organization of the List and the proclamation organization of Safety Quality License holders. MOL: the issuing organization of Safety Quality License and the proclamation organization of Safety Quality License holders. OBA: the acceptance organization for the safety quality licensing application; the approval organization of safety quality licensing review, survey and assessment results; and the administration organization of Safety Quality License. CBPVI: the organization for safety quality licensing review, survey, assessment, inspection and test; the implementation organization responsible for subsequent surveillance and supervision; and the acceptance organization of import product registration for the license holder, authorized by the Ministry of Labour. SQLO: the routine administration office for implementing the import boiler and pressure vessel safety quality licensing system, jointly established by the OBA and the CBPVI of the MOL for simplifying the application procedures. This office is responsible for the receipt of safety quality licensing applications, liaison with the applicants, and the specific consultation 12

14 services related to safety quality licensing. 3.5 Application procedures for safety quality licensing Application procedure for Manufacturer Approval (Fig.1) Application procedure for Type Approval (Fig.2) application intention by the applicant completion and submission of Application Form (Submission of application documents) payment of application fee review and acceptance of application document review first manufacturer survey and assessment second manufacturer survey and assessment conclusion for safety quality licensing review, survey and assessment payment & balance of safety quality licensing fee issuing safety quality license issuing Symbol Stamp proclamation of license holder renewal of license subsequent surveillance & supervision to license holder and licensing products Fig.1. Application procedure for Manufacturer Approval 13

15 application intention by the applicant completion and submission of Application Form (submission of application documents) payment of application fee review and acceptance of application document review manufacturer survey and assessment (selection & choice of product sample) payment of inspection & test fee for product sample inspection & test of product sample conclusion for safety quality licensing review, survey & assessment, and inspection & test renewal of license payment & balance of safety quality licensing fee issuing safety quality license; issuing Symbol Stamp; proclamation of license holder subsequent surveillance & supervision to license holder and licensing products Fig.2 Application procedure for Type Approval 14

16 3.6 Basic requirements for the product manufacturer The product manufacturer shall possess the independent legal person status or be a manufacturer approved or registered in the local government according to national law where the product manufacturer is located, in addition to the following conditions: Resource requirements The product manufacturer shall possess the necessary resources and capability required for the manufacturing of its products and for the forms of safety quality licensing application, including product production site, manufacturing & fabrication equipment, inspection & test equipment, instruments and conditions as well as the suitable and appropriate technical personnel and human resources, etc Quality management requirements 1) Establish and maintain a quality system which shall be suitable for the products produced and be able to assure the product quality, meet the contract requirements and provide the confidence to customers; 2) The quality system shall be documented. A Quality Manual shall be prepared which shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system; 3) The quality system, Quality Manual and quality system procedures shall be effectively implemented; 4) The product manufacturer may make its own choice to establish its quality system according to the actual situation. However, the quality system established shall generally include the main quality elements listed in the ISO 9000 series standards and meet the requirements of clause of this Guideline; 5)Documented descriptions following China Safety Quality Licensing System requirements shall also be included in the quality system procedure document. It shall mainly include: custody control procedures for safety quality licensing Symbol Stamp; procedures for the registration of safety quality licensing products exported to P.R.C. and control procedures for exporting the safety quality licensing products to P.R.C.; documented procedures for providing the quality related documents to customers in P.R.C.; and a description of accepting the responsibility and obligation stipulated in the Implementation Regulations, etc Product safety quality requirements 1) In the China Safety Quality Licensing System, the product design, manufacturing and acceptance code or standard applied shall not be specified by the authorities, except for the inspection and test of product samples. The product design, manufacturing and acceptance code or standard applied shall follow the manufacturer s quality system and the purchasing contract requirements. 2) The product design, manufacturing and inspection shall conform to the requirements of the manufacturer s quality system and meet the product quality standard or criteria stipulated in the product purchasing contract. The product manufacturer shall be responsible for its product quality. 15

17 4. APPLICATION 4.1 Preparation for application The applicant is required to carefully read the Implementation Regulations and this Guideline as well as the relevant documents provided by the Safety Quality Licensing Office (SQLO). If deemed necessary, the applicant may also inquire to SQLO so as to have a thorough understanding of Safety Quality Licensing System of the People s Republic of China. 4.2 Submitting the application Application intention The applicant may start applying for safety quality license by submitting a written application intention (Chinese or English) or verbally expressing the application intention to SQLO of the MOL, the People's Republic of China. The application intention shall include or cover the following details: Full name, address, telephone and fax numbers of the applicant; Full name, address, telephone and fax numbers of the product manufacturer; A brief introduction of the product manufacturer and its products; A statement as to whether or not the intention is to get the blank Application Form or to get the further information related to the safety quality licensing. At the same time, the situation of products exported to the People's Republic of China (in the previous three years) should be described as far as possible. Submission of the application intention is not binding on the applicant Distribution of the related information & documents and the blank Application Forms After receiving the application intention, SQLO will distribute the following related documents and the blank Application Form to the applicant: 1)Documents related with the application procedure for safety quality licensing; 2)Description of the fees & expenses for safety quality licensing and the payment; 3)Other information & documents necessary for the application for safety quality licensing Completion of the Application Form and submission of the application documents Having made the final decision of application, the applicant shall complete the Application Form in triplicate in Chinese or in English. The completed Application Form shall be submitted by the applicant to SQLO, together with the related application documents required. Documents required for the safety quality licensing application are as follows: 1)General introduction of the manufacturer 2)Quality Manual of the manufacturer 3)Copy of the legal business documents approved or registered by the local government 4)Copy of registration or certification issued by an authority or organization obtained by the product manufacturer 5)Catalogue of typical products for which application is made 6)Product design drawings and specifications(applicable to Type Approval) 7)Other necessary supplementary documents 16

18 The completed Application Form is a formal application document (equivalent to a contract) put forward by the applicant. Once signed and mailed, the application shall be binding on the applicant. 4.3 Acceptance of the application Review and acceptance of the application After SQLO receive the completed Application Form, the related documents and the application fees, and upon confirming their completeness & correctness, the Bureau of Occupational Safety & Health and Boiler & Pressure Vessel Administration (OBA) will review them and decide whether or not the application can be accepted. If OBA accepts the application, the forms (Manufacturer Approval or Type Approval or both) of safety quality licensing will be determined at that time Handling of acceptance If OBA accepts the application, SQLO will inform the OBA's acceptance decision in writing to the applicant within fifteen days. One copy of the Application Form which has been signed by OBA for the acceptance approval shall be returned to the applicant. The applicant shall also be informed for the preparation and arrangements for the manufacturer review, survey and assessment Handling of non-acceptance If OBA's decision is non-acceptance of the application, SQLO will inform the OBA's decision to the applicant in writing and describe the reason for the non-acceptance. 4.4 Notes to the applicant Non-acceptable conditions of application Under the following conditions, the application will normally be unacceptable: 1)If no product manufacturer is indicated in the Application Form, the application is unacceptable; 2)If the product manufacturer does not possess the independent legal person status or is not approved or registered with the local government according to national law where the product manufacturer is located, the application is unacceptable; 3)If the application products are not covered in the List, the application is unacceptable; 4)If the product manufacturer does not establish a documented quality system or has not submitted the quality manual, the application will be suspended; 5)If the application documents are not adequate or the application fee is not received, the application will be suspended; 6)If the application does not indicate the address of the product manufacturer or does not indicate the product category, series or type or specification, and standards or codes applied for the Type Approval, the application will be suspended. 17

19 4.4.2 Application when the product manufacturer has more than one sub-manufacturer or production facilities 1)If all the sub-manufacturers or production facilities of the manufacturer are located in the same city, the application may be made either in one Application Form or separately. If the applications are made in one Application Form, the addresses, production conditions, product categories, forms of safety quality licensing application of all the sub-manufacturers or production facilities as well as whether the quality system and quality manual are applicable to all the sub-manufacturers or production facilities shall be indicated or described. 2)If the sub-manufacturers or production facilities are not located in the same city, the application for safety quality licensing shall be made separately. If the applications are made in the same Application Form, the acceptance, review, survey and assessment of the safety quality licensing for the sub-manufacturers or production facilities which are not in the same city shall be handled independently. 3)One Safety Quality License shall be issued for each application. The address of the product manufacturer shall also be indicated in the Safety Quality License Application made by the product manufacturer s representative agency 1)The applicant shall indicate the product manufacturer s name, address as detailed in the Application Form and submit the required application documents. The applicant shall also be required to submit a valid document describing that the product manufacturer has agreed and promised to accept the review, survey and assessment, product inspection & test, and the subsequent surveillance audits & supervision as required by the safety quality licensing system. 2)One Safety Quality License shall be issued to the applicant. The name, address of product manufacturer shall also be indicated in the Safety Quality License Application made by both the representative agency and the product manufacturer Two original copies of the Safety Quality License may be issued to the representative agency and the product manufacturer respectively. The names and addresses of the two applicants shall also be indicated in the Safety Quality License simultaneously Content, format and completion of the Application Form See Appendix A Commitment of the applicant The responsible officer of the applicant shall express his/her commitment by signature under the following declaration in the Application Form: I hereby declare that my party is willing to apply for the safety quality licensing of the People's Republic of China by following the Implementation Regulations of Import Boiler and Pressure Vessel Safety Quality Licensing System issued by the Ministry of Labour of the People's Republic of China. My party will accept the review, survey and assessment, product inspection & test, subsequent surveillance audits & supervision, and provide the necessary working conditions, and pay the relevant fees and expenses as stipulated. 18

20 5. REVIEW, SURVEY AND ASSESSMENT 5.1 General description of safety quality licensing review, survey and assessment Basic principles and content of safety quality licensing review, survey and assessment Manufacturer Approval is principally to confirm the capability and degree for a manufacturer to assure the safety quality of its products, through the survey of a manufacturer s manufacturing and inspection conditions, and the review and assessment of a manufacturer's quality system. The contents of review, survey and assessment include: the review of documents and the survey and assessment of the production site (i.e. Manufacturer Survey and Assessment). Type Approval is principally to confirm the safety quality reliability of a type of products, through the review of design for a specific type of products, the survey and assessment of manufacturing, and the inspection and test of safety quality of a specific type of products. The contents of the review, survey and assessment include: the review of documents, the comprehensive inspection and test of product samples (i.e. Sample Inspection & Test), and the necessary survey and assessment of the production site (i.e. Manufacturer Survey and Assessment) Basic procedures of safety quality licensing review, survey and assessment Step 1. Document Review of the documents submitted by the applicant. After the confirmation of conformance to the specified requirements for documents submitted, the applicant will be advised to prepare for acceptance of the Manufacturer Survey and Assessment. Step 2. Implementing the Manufacturer Survey and Assessment. Step 3. For Type Approval, the Sample Inspection & Test shall also be conducted after the manufacturer has successfully passed the Manufacturer Survey and Assessment. Step 4. Upon the completion and passing the final Manufacturer Survey and Assessment or Sample Inspection & Test, the authorized review, survey and assessment, inspection & test organization -CBPVI will compile the results of safety quality licensing review, survey and assessment, inspection & test and draft a report to OBA for its review and approval. Step 5. When the results meet the safety quality licensing requirements, the Ministry of Labour will issue the Safety Quality License and make the proclamation Basic requirements of safety quality licensing review, survey and assessment 1)The review, survey and assessment of safety quality licensing shall be performed by strictly following the requirements of the Implementation Regulations and this Guideline in order to assure its objectiveness, impartiality, correctness and reliability. 2)Part of the Document Review shall be carried out before the Manufacturer Survey and Assessment, the other part of the Document Review shall be carried out in the product manufacturer combining with the Manufacturer Survey and Assessment. The Manufacturer Survey and Assessment shall be carried out at the product manufacturer s facilities. 19

21 The selection and choice of product samples for Sample Inspection & Test shall be carried out in the product manufacturer s facility combined with the Manufacturer Survey and Assessment. The inspection and test of "product sample" will be carried out in the laboratory of CBPVI or an accredited laboratory entrusted by CBPVI. 3)The organization & personnel carrying out the review, survey & assessment, inspection & test shall keep confidential the design, manufacturing, inspection techniques and the inspection results of the product manufacturer and the product by following the international custom and practice and at the request of the applicant. 4)The applicant shall cooperate well, following the requirements of Implementation Regulations and this Guideline. 5.2 Document Review Basic principles and requirements of the Document Review The Document Review is principally to review the documents submitted by the applicant for their completeness, correctness and effectiveness in order to determine whether or not they satisfy the requirements of Manufacturer Survey and Assessment and/or Sample Inspection & Test, whether or not conforming to the requirements of quality system documents and product standards, whether or not conforming to the requirements for controlling the product safety quality, and whether or not conforming to the stipulations of the relevant laws, regulations of the People's Republic of China and the requirements of Safety Quality Licensing System. The applicant shall submit the necessary documents in accordance with the stipulations of this Guideline and the notification of SQLO as well as the request of the review, survey and assessment team. All documents submitted shall be in Chinese or English language unless agreed by SQLO or by the review, survey and assessment team beforehand Main contents of the Document Review, including: 1) Review of the documents related with the manufacturer s basic condition and of the application documents; 2) Review of the documents related with the production conditions, manufacturing and fabrication equipment, inspection & test equipment and instruments as well as the technical personnel situation etc.; 3) Review of the manufacturer's quality system documents (Quality Manual and the quality system procedure etc.); 4) Review of the documents related with the product design and the records and reports of product manufacturing, inspection & test, etc Time and method of the Document Review Review of the documents related with the manufacturer's basic conditions and the application documents is generally carried out before the Manufacturer Survey and Assessment. The review of all the other documents is usually carried out in the product manufacturer s facility in combination with the Manufacturer Survey and Assessment. For the Type Approval, the review of documents related with product samples is generally performed before the Sample Inspection & Test. 20

22 The method of Document Review takes the form of going over the documents, asking questions or explanation by the manufacturer Validation of the Document Review results For the Document Review results, if any addition or change to the documents is deemed necessary, the manufacturer shall make up the additional documents or modify the documents after joint confirmation by the review, survey and assessment personnel and the representative of the applicant. The addition or change of the document will be validated by CBPVI. 5.3 Manufacturer Survey and Assessment Basic principles and requirements of the Manufacturer Survey and Assessment The Manufacturer Survey and Assessment is principally to survey the production and inspection conditions, to check the manufacturing process technology, and to assess the established and implemented quality system of the manufacturer. It will be carried out in combination with the survey and assessment of the typical product manufacturing, inspection and test The Manufacturer Survey and Assessment shall be carried out twice for the Manufacturer Approval The first Manufacturer Survey and Assessment is a comprehensive review, survey and assessment of the manufacturer, performed by a team organized by Center of Boiler and Pressure Vessel Inspection & Research (CBPVI). The review, survey and assessment results shall be given and the arrangement of the second Manufacturer Survey and Assessment shall also be suggested by the team. The valid working period of the Manufacturer Survey and Assessment usually is not more than four days. The members of the team performing the Manufacturer Survey and Assessment usually will not be more than three people. The second Manufacturer Survey and Assessment shall be performed by a joint team with team members coming from CBPVI and OBA. It is mainly to joint survey and assess the implementation of quality system of the manufacturer, to verify the first Manufacturer Survey and Assessment results, and to review, verify and validate the corrective action taken as requested by the first Manufacturer Survey and Assessment team. The conclusion of the Manufacturer Survey and Assessment will also be given by combining the two Manufacturer Survey and Assessment results. The second Manufacturer Survey and Assessment is usually arranged within two months after the completion date of the first Manufacturer Survey and Assessment. The valid working period of the Manufacturer Survey and Assessment is not more than three days. The members of the team performing the Manufacturer Survey and Assessment usually will not be more than three people For Type Approval, the Manufacturer Survey and Assessment will be usually carried out once and will be performed by a joint team with team members coming from CBPVI and OBA. The selection and choice of product samples used for Sample Inspection and Test shall be carried out at the manufacturer s facilities before the completion of the Manufacturer 21

23 Survey and Assessment by following the requirements of clause to of this Guideline. The valid working period of the Manufacturer Survey and Assessment will not be more than four days. The members of the team performing the Manufacturer Survey and Assessment will normally not be more than four people Main contents of the Manufacturer Survey and Assessment include: 1) Survey, checks or spot checks of the product production conditions, manufacturing and fabrication equipment, inspection & test equipment and instruments as well as the technical personnel qualifications etc.; 2) Review and assessment of the quality system documents of the manufacturer; 3) Audit and assessment of the implementation of the manufacturer s quality system; 4) Checks or spot checks of the product safety quality; selective inspection or test of the product safety performance may be conducted, if deemed necessary; 5) Other checks, or review, survey and assessment if deemed necessary by the review, survey and assessment personnel Basic requirements of quality system and assessment checklist Basic requirements of the manufacturer's quality system and quality elements and the assessment checklist for the implementation of quality system documents and the quality system are listed in Appendix B Basic means for Manufacturer Survey and Assessment The survey and checks of the product production conditions, manufacturing and fabrication equipment, inspection and test equipment and instruments as well as the technical personnel qualifications etc. will be carried out mainly in the form of inspection tour, verification, checks and spot-checks, etc The review and assessment of the quality system documents will be carried out mainly by means of a review of documents and through inquiring & querying questions, etc Audit and assessment of the implementation of the quality system and quality elements will be carried out mainly by means of checking and witnessing, asking questions, tracing and inquiring, verifying material & objects, on-site spot checks etc. in combination with the design, manufacturing, inspection, test of the typical products, and the typical procedures or processes The inspection and spot-checks of the product safety quality will be performed mainly by means of on-site inspection, spot checks, test of completed products or in-process products. For the manufacturer applying or products being applied for Type Approval, products shall also be selected to carry out the inspection and test of safety quality performance in the manufacturer s facility. 22

24 5.3.5 Basic procedures of Manufacturer Survey and Assessment Initial meeting of the review, survey and assessment team (hereinafter referred to as Assessment Team) with related personnel of the manufacturer The initial meeting is a meeting of the Assessment Team with manufacturers management personnel, responsible personnel of related departments, and quality management personnel of the manufacturer. The meeting usually covers the following topics: 1) Introduction of personnel of the two parties. 2)The manufacturer s personnel shall give an introduction covering the following contents: A brief introduction of the manufacturer and its quality system; The supplementary situation and corrective action taken since the previous Manufacturer Survey and Assessment (applicable to the second Manufacturer Survey and Assessment for the Manufacturer Approval). 3) The Assessment Team leader shall give an introductory speech including the following main contents: Verifying the main contents of safety quality licensing application (applicable to the first Manufacturer Survey and Assessment); Describing the purpose, tasks and responsibility of the Assessment Team; Introduction of the Safety Quality Licensing System of the People's Republic of China (applicable to the first Manufacturer Survey and Assessment); Describing the main contents, methods, procedures and requirements of the current Manufacturer Survey and Assessment; Presenting the relevant requirements and the necessary supplementary document list to be provided by the manufacturer; suggested current Manufacturer Survey and Assessment schedule. 4)An address by the manufacturer s responsible personnel. 5)Exchange views and make the arrangements for the working schedule, supplement documents, working conditions, and coordination etc. between the two parties Initial tour of the manufacturer s facility The initial tour of the manufacturer s facility will normally be arranged after the initial meeting. The Assessment Team will make a quick tour of the related departments, workshops and test laboratories under the guidance of the relevant personnel of the manufacturer so as to have a initial understanding of the manufacturer s situation, production conditions, product structures, manufacturing processes, inspection conditions, etc Review of the documents provided by the manufacturer After the initial understanding of the manufacturer s situation, the Assessment Team will review the documents provided by the manufacturer and exchange views, inquire and verify, with related personnel of the manufacturer concerning the problems (including doubtful points, and the completeness and correctness etc.). The necessary records shall be made. If problems or findings exist, they shall be agreed and confirmed by the two parties. 23