2006年9月昆明【ASME取证研讨会】讲义

SGS Industrial Services in ChinaProduct and Import Certification
SGS-CSTC Standards Technical Services Co., Ltd. Industrial Services People's Republic of China

Introduction to SGS Group
Founded in 1878 inRouen, France
SGS is the global leader in verification, testing, inspection and certification services
Public listed Swiss company; CHF 3.3 bn revenues
Unrivalled geographic network
42,000 employees
845 offices, 338 laboratories
Present in 140 countries
Complete independence, transparency and integrity are the core values of the SGS Group

Principles & Characteristics
Fundamental Principles of SGS
Independence
Impartiality
Integrity

Characteristics of SGS Services
They help to minimize risks, across the globe
They are based on independent assessment, testing and verification, in local markets
They provide high level technical expertise, coupled with broad geographic reach
Our Business Segments
Agricultural Services
AutomotiveServices
Consumer Testing Services
Environmental Services
Industrial Services
Life Science Services
Minerals Services
Oil, Gas & Chemicals Services
Systems and Certification Services
Technical Staffing Services
Trade Assurance Services

SGS-CSTC China
SGS-CSTC Standards Technical Services Co. Ltd. was established in 1991
Joint Venture between SGS Société Générale de Surveillance (SGS) Group (65%) and China Standards Technical Development Corporation (CSTC) (35%)
Operational Control by SGS, which is the majority partner of the Joint Venture
SGS is a publicly listed company, whose shares are quoted on the Swiss Stock Exchange
The SGS Group was established in Rouen, France in 1878. It is now headquartered in Geneva, Switzerland
SGS Group has no manufacturing, trading or financial interests and is therefore able to offer a truly independent inspection & testing service
SGS-CSTCChina(cont’d)
SGS-CSTC was approved by Ministry of Commerce of People’s Republic of China (MOFCOM, ex-MOFTEC Ministry of Foreign Trade & Economy Cooperation) , and received its business license in October 1991 from State Administration for Industry & Commerce (SAIC)
SGS-CSTC obtained Certification of Qualification for Foreign FundedInspection Companies in 1996 from State Administration of Commodity Inspection
As an Approved Inspection Agency, SGS-CSTC meets all PRC Government requirements to operate legally within China (AQSIQ)
The inspection activities are accredited ISO/IEC 17020 (General criteria for the operation of various types of bodies performing inspection) and the laboratories are accredited according ISO Guide 17025 China Accreditation Committee for Laboratories (CNAL)
There are over 4,500 employees in China in 28 branches and offices
Product Certification definition
Definition Product Certification
(Mandatory or voluntary) Product Certification or Product Conformity Assessment programs involve certification or assessment against standards or regulations for which SGS is accredited or authorized by the competent authorities or by means of generally valid accreditations.
Normally, Product Certification of industrial products includes some sort of review of the design of the equipment, and personnel qualification in equipment fabrication and inspection, etc.
Industrial Services –
Product Certification (I)
Certification process for Industrial products generally involves one or more of the following activities:
Design Verification (or comparison of design with standard/code)
Technical Documentation or Quality System assessment (or combination)
Inspection during production and/or Witnessing of Testing of the product
Type Verification to assure produced products are identical to the approved Type (for series production only)
Import Certification, such as GOST (Russia), SASO (Saudi-Arabia) and Iran, could also be considered Product Certification programs.
Industrial Services –Product Certification (II) – government imposed
Certification of products based on government imposed regulations:
Pressure Equipment
European Pressure Equipment Directive (PED) [CE-marking]
Ministry of Manpower Singapore (MOM)
DOSH Malaysia
OSH New Zealand, AS Australia
and other national statutory requirements, such as
Japan (Fire regulations; Pressure Vessels Class 1, 2+3; High Pressure Gas control law)
India Boiler Regulations
South Africa (cylinder)
etc.
Machinery
European Machinery Directive [CE-marking]
European Low Voltage Directive [CE-marking]
European EMC-Directive [CE-marking]
Equipment for Explosive Atmospheres
European ATEX Directives [CE-marking]
Industrial Services –Product Certification(III) – standards based
Certification of products based on Industry standards and regulations:
‘Official’ Certification according to Industrial standards, by accredited bodies or qualified personnel.
ASME (USA and Quebec, Canada)
GB 150 + GB 151
AD 2000
Various industry standards require certification by accredited bodies (often EN 45011 or equivalent) or staff with personal accreditation.
For instance:
EN 877:1999 Cast iron pipes and fittings, their joints and accessories for the evacuation of water from buildings - Requirements, test methods and quality assurance.
EN 124:1994:Gully tops and manhole tops for vehicular and pedestrian areas : Design requirements, type testing, marking, quality control.
API and AWS certification based on personal and/or body accreditation.
‘Free’ Certification of Industrial parts and components, by any 3rd party
Conformity assessment with industry standards by a third party inspection company. Sometimes EN 45004 or equivalent is requested but often not even that.
This certificate has no legal status and is equivalent to any inspection report.
SGS helps Chinese manufacturers with
all steps to be taken for Product Certification
SGS realises that product certification is for many Chinese manufacturers something new
Therefore we provide more than just the minimum that is required for Notified Body certification
SGS provides know-how and expertise that goes beyond the regular certification service
We help you to understand the concept of diverse certification and the purpose of the various steps that are required
SGS supports you to take ownership of the product certification process, so that your company will gain new expertise
We help quality Chinese products to reach the world market!
European Union and European Economic Area
the 25 EU member states:
Austria
Belgium
Cyprus
Czech Republic
Denmark
Estonia
Germany
Finland
France
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
the Netherlands
Poland
Portugal
Slovakia
Slovenia
Spain
Sweden
the United Kingdom
And the 3 members of the EFTA
Iceland
Liechtenstein
Norway

Typical questions of Chinese manufacturers about PED
China-EU Working Group on Pressure Equipment
中欧承压设备工作组会谈北京
What are the requirements and procedures for the pressure equipment and its materials manufactured outside EU when placing on the EU market?
In terms of the access to EU market, what is the difference between using European harmonized standards and using national standards in the field of pressure equipment including procedure and conformity assessment?
For ASME codes, US side made lots of efforts in complying with PED. Are these efforts useful for the products certified by ASME when placing on the EU market?
Are there the mandatory requirements for the implementation of European Harmonized standards in the field of pressure equipment?
Should the design drawing of pressure equipment or assemblies be reviewed by the inspector authorized by a Notified body when placing on the EU market?
How to choose the materials which complying with other standards or code (no ENs standards) in designing pressure equipment which will be placed on the EU market? Are there any special requirements for using materials complying with Chinese standards or ASME codes?
In PED, are there any requirements for subcontracting pressure parts such as heads or drums and safety accessories (for example, safety valve)?
According to PED, is it possible for manufacturers to use the Quality Manual based on ISO 9000 or ASME codes after incorporation of the requirements arising from PED?
Should the technical documentation of pressure equipment or assemblies bearing CE marking be reviewed or accessed by Notified Bodies? If yes, what is the scope of the technical documentation which are subject to review or assessment by Notified bodies?
CE-marking
EU Directives for CE-marking
There are over 25 Directives that prescribe CE-marking before a product is allowed onto the European market.
The most important for industrial products manufacturing industries:
Pressure Equipment Directive (97/23/EC)
Simple Pressure Vessels (87/404/EEC and amendments)
Machinery Directive (2006/42/EC; still valid is 98/37/EC)
Lifts Directive (95/16/EC)
ATEX Directive (electrical equipment for explosive environments; 94/9/EC)
EMC Directive (Electromagnetic Compatibility; 89/336/EEC and amendments)
Low Voltage Directive (73/23/EEC and amendments)
Pressure Equipment Directive (PED) - Scope
Applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar.
Pressure Equipment:
pressure vessels
boilers
installation pipes and piping
safety appendages
assemblies
Example:
A (piece of) pipe which is not yet part of a piping system is not classified as pressure equipment, but the same piece with flanges, safety valves, bends, etc, is classified as pressure equipment.

PED for Chinese Manufacturers -Products in accordance with EU Directives
Required to meet Essential Safety & Health Requirements (ESR’s)
Manufacturer is free to use any standard he wishes to use
GB, JB, DIN, ASME, BS, AS, NZS, NEN, …
Manufacturer has to
do a Risk Assessment and
assemble a Technical File to prove that his product meets the requirements of the Directives
Harmonised EN standards provide ‘Presumption of Conformity’
(so then no need to prove conformity)
but they are not mandatory to use
Notified Body will verify conformity via
Design Appraisal
Audit(QA-modules)
Inspection(Inspection modules)
Personnel qualification
PED for Chinese Manufacturers -
CE-stages
General
Which directives apply?
Which standards are available?
Risk Assessment
Users Instructions
Technical File
Notified Body
EC-Declaration of Conformity
CE-marking
PED for Chinese Manufacturers –
Technical File for Pressure Equipment
The Technical File is to indicate that the equipment complies with the requirements of the Directive:
Drawings and calculations
Reference to Annex I of PED [A summary of the relevant requirements (ESR’s)]
A summary of the standards and specifications used
All records and reports during manufacturing shell be included in the Technical File, for example:
Qualifications of personnel involved (Welders; NDT engineers)
Welding Procedure qualification records (WPQR)
Certificates of components or the whole assembly
Material Certificates
Material Approvals
Hydrostatic pressure tests
Declarations of Conformity (for components)
Results of Risk Assessment including description of preventive measures
Description of preventive measures and considerations explaining why measures have or have not been taken
A copy of the User Instructions (installation manual)
PED for Chinese Manufacturers –
Categories of Pressure Equipment
There are four classes of Pressure Equipment, each higher class requiring more control from the Notified Body
(Conformity Assessment modules)
Category I:Self Assessment (No Notified Body)
Category II:Notified Body supervision of the Production control or Final assessment
Category III: Design Appraisal and Product Inspection
Category IV: Design Appraisal, Production control, Product Inspection and Final assessment

Conformity Assessment Modules (II)
Conformity Assessment Modules (III)
ModuleScope of moduleNoBo involvement

AInternal production controlN/A (self assessment)
A1internal manufacturing checks with
monitoring of the final assessmentFile examination and final acceptance test (witnessing)
BEC-Type examinationFile examination and (witnessing of) testing of a type-sample (against the technical documentation and standards used)
B1EC-Design examinationFile examination and (witnessing of) testing of the product/unit (against the technical documentation and standards used)
C1Conformity with the TypeUnexpected visits; Verification that random samples are identical to the type examined in B
DProduction Quality AssuranceAudit of the manufacturers production QA system without design (like former ISO 9002:1994). Regular audits and sometimes unexpected visits.
D1Production Quality AssuranceAudit of the manufacturers production QA system without design (like former ISO 9002:1994).Regular audits and sometimes unexpected visits.
EProduct Quality AssuranceAudit of the manufacturers final test system (like former ISO 9003:1994) Regular audits and sometimes unexpected visits.
E1Product Quality AssuranceAudit of the manufacturers final test system (like former ISO 9003:1994) Regular audits and sometimes unexpected visits.
FProduct VerificationFile examination, Qualification of Welders and NDT-personel and (witnessing of) testing of every product (against the essential requirements).
GEC-unit VerificationDesign Verification, File examination, Material assessment, Welding procedure approval, Qualification of Welders and NDT-personel, Production Supervision and test (witnessing) of the product/unit.
HFull Quality AssuranceAudit of the manufacturers complete QA system including design (like former and ISO 9001:1994 and present ISO 9001:2000) Regular audits and sometimes unexpected visits.
H1Full quality assurance with design examination
and special surveillance of the final assessment) Audit of the manufacturers complete QA system including design, (like former and ISO 9001:1994 and present ISO 9001:2000) Regular audits and sometimes unexpected visits. Design Verification and File examination and high frequency unexpected visits during final acceptance tests.
How to use the tables in Annex II
There are 9 tables in total
Categories listed in tables
Pressure x Volume(vessels) or Pressure x Diameter(Pipes)
Insert outcome in table between the border lines
The lines have been calculated, and have not been determined graphically:
The tables are not to be used graphically!
Working with the PED in practice

PED for Chinese Manufacturers -Particular Material Appraisal
Particular (specific) Material appraisals should be used on a job by job basis
for inspection modules,
or on a range of equipment for quality modules.
They would be used by the equipment manufacturer.
If a material manufacturer wants to get a material specification approved they would need to obtain a EAM.
Another PED opportunity is that material manufacturers need the Quality system certified by a European certification body. This is not a material specification approval, but a ISO 9001 system audit.
Evaluation of used material is also part of the Risk Assessment for the PED.

EC Declaration of Conformity
Ultimately always issued prior to commissioning / sale
Based on content of Technical File
Written and Signed by Manufacturer (in EEA), his representative in EEA or Importer in EEA
To be kept during the life of the product
Other applicable directives also to be included
Only if all directives have been complied with
(It can be kept together with the TF)

Functions of the National Board
The National Board is comprised of Chief Boiler Inspectors representing government agencies from across North America.The functions include:
Helping to maintain quality within the boiler and pressure vessel industry through the process of third-party inspection during the manufacturing process as well as promoting the establishment of manufacturing, maintenance, and repair standards for boilers and pressure vessels.
Offering an extensive training program for inspectors and other industry professionals, involving continuing education in various disciplines of the boiler and pressure vessel industry.
The commissioning of inspectors who pass an extensive examination administered by the National Board, enabling the qualified inspection of boiler and pressure vessels.
Functions of the National Board(Continued)
Maintaining a pressure relief testing laboratory – setting the industry standard for testing pressure relief devices and other appurtenances.
Maintaining detailed records of all National Board registered boilers and pressure vessels.
Accrediting qualified repair organizations and owner/user inspection organizations for repair and alteration of pressure-retaining items and pressure relief devices.
Investigating accidents and code compliance problems involving boilers and pressure vessels.
Educating the general public and government representation on the need for safety standards.
Developing inspection, repair, and alteration standards (National Board Inspection Code).
What is the National Board Inspection Code?
It is the only standard recognized worldwide for inservice inspection repairs and alterations of boilers and pressure vessels.This American National Standard has been adopted by a number of states, jurisdictions, as well as by federal regulatory agencies including the U.S. Department of Transportation.
Resources available from the National Board:
Boiler and pressure vessels accident data from National Board jurisdictions.
Information concerning boiler and pressure vessel laws of National Board jurisdictions.
Access to knowledgeable industry professionals.
Important construction data on every boiler and pressure vessel registered with the National Board (stored at the Columbus, Ohio, USA headquarters) for the life of the boiler or pressure vessel.
The Background of the ASME and NB Stamps and the Related Technical Aspects of Issuing These Stamps
S – Power Boilers
A – Assembly of Power Boilers
PP – Pressure Piping
M – Miniature Boilers
E – Electric Boilers
V – Boiler Safety Valves
H – Heating Boilers/Cast Iron Sectional Heating Boilers
HLW – Lined Potable Water Heaters
HV – Heating Boiler Safety Valves
U – Pressure Vessels (Div. 1)
UM – Miniature Pressure Vessels
UV – Pressure Vessel Pressure Relief Valves (Div. 1 and Div. 2)
UD – Pressure Vessel Pressure Relief Devices (Div. 1)
U2 – Pressure Vessels (Div. 2)
U3 – High Pressure Vessels (Div. 3)
UV3 – High Pressure Vessel Pressure Relief Valves (Div. 3)
RP – Fiber-Reinforced Plastic Vessels

ASME (III) - company
Application procedure of ASME stamps:
Sign a contract with consultant company
This is an ASME Authorized Inspection Agency (AIA),
like SGS.
The consultancy company will help the manufacturer to complete forms and prepare for the audit.
Issue the application form to ASME association
In USA
Pay contribution for audit to ASME association in USA.
ASME (IV) - product
Manufacturer shall be a stamp holder accredited by ASME association
Apply for U-stamp services by AI before export
AI work includes:
Design approval
Personnel qualification (Welders, NDT)
Inspection
Witnessing final test and final inspection
Sign the data sheet
Witness the stamping
Other certification schemes for Pressure Equipment
IndiaAustralia & New ZealandSingaporeSouth-Africa
JapanRussiaMalaysiaSaudi-Arabia and Iran

What is MOM?
Singapore Ministry of Manpower
Issues and controls the regulation and requirements for
pressure vessels exported to Singapore
MOM
Scope of approved overseas inspection agency
On satisfactory completion of the fabrication survey, a survey/inspection certificate/report will be issued
The approved inspector shall sign all certificates, reports and endorsement relating to works carried out and shall also stamp these documents with his individual stamp and the organisation stamp
The pressure vessel shall bear a unique number that is to be hard stamped with his stamp and shall appear on a prominent location on the body of the pressure vessel. This unique number must tally with the inspection certificate issued by the inspection agency
What types of Pressure Vessels are governed by the Factories Act and which of them require approval before use?
Air Receiver - a container of air under pressure, which includes blasting pots, compressor air tanks and headers.
Steam Boiler - a closed vessel in which steam is generated at a pressure greater than atmospheric pressure which includes autoclaves, steam generating heat exchangers, sterilisers, vulcanisers, economisers and superheaters.
Steam Receiver - any vessel or apparatus which contains steam under pressure which includes autoclaves, blow down tanks, deaerators, headers, heat exchangers, sterilisers and vulcanisers.
Refrigerating Plant Pressure Receiver - a container of refrigerant under pressure.
Cast-iron Underfired Vulcanizer - a steam boiler in which steam is generated within it for the purpose of vulcanizing rubber products.
The pressure vessels above are known as Statutory Pressure Vessels (SPV).

Comparison Table between ASME and other schemes

What is IBR?
Regulation for export of Boilers and steam pipes to India
Which Boiler and Pipes are Regulated by IBR?
only steam Boilers and steam Pipes (not for regular pressure vessels and pressured pipes)
What is the procedure?
Approved inspection agency inspects the boilers and pressured pipes in manufacturing
Owner has to Register the equipment before use (in India)
Registration renewal set by certain periods
Codes:
IBR has it’s own code
Accept foreign codes, such as ASME, BS, etc.

Personal qualification of inspectors:

Required age and training for qualifying admission for first class boiler engineers proficiency examination
Required age and training for qualifying admission for second class engineers proficiency examination
Age and training of first second class certificate of competency candidates
Age and training of second class certificate of competency candidates

What is DOSH?
Department of Safety & Health Malaysia
Regulation and requirement for pressure vessel exported to Malaysia

Which pressure equipment are Regulated by DOSH?
PV
Boiler
Safety component

SGS as Certification Body for DOSH
What do we do
Same as ASME, PED, etc.
SGS accreditation
Accredited in Japan and Korea
This is a global accreditation and all SGSIND affiliates can use it
What is it
Both countries have similar Occupational Health & Safety regulations
These demand only the use of safe products in their territories
New Zealand is often based on ASME (even ask for U-stamp)
Australia asks for AS (Australian Standards) or ASME – use same system as Japan Class 1 & 2
What do we do
Perform inspections and certification according ASME or Aus/NZ rules
Similar to ASME, PED, etc.
3rd party accreditations
Based on SGS affiliates
What is it
South-Africa has Occupational Health & Safety regulations that demand the use of safe products
It is often based on BS (British Standards) or ASME
What do we do
Design review, inspections, Final Acceptance Test (witnessing)
Similar to ASME, PED, etc.
SGS accreditation
SGS China is accredited for cylinders by South-Africa Ministry of Labour
Exports to Russia –
GOST R Certificates of Conformity
Issued by:
GOST R Certification Body (SGS) accredited by Rostekhregulirovanije (ex Gosstandart)
Concerns:
Consumer Product & Equipment subject to mandatory GOST R certification
Why Needed :
To confirm that equipment conforms to the Russian qualitystandards (GOST)
When Needed :
By the moment of customs clearance
Issued on the basis of :
Documents / Test results
SGS as Certification Body for GOST-R
What do we do
Similar to CE-marking, like PED
Laboratory testing is often needed (in Russia)
Often for GOST manufacturers need to send a sample to Russian test lab (we can help with support of SGS Russia)
SGS can issue GOST-R for pressure equipment based on PED conformity (CE-marking)
We can help with RTN Permit to Use in Russia
SGS accreditation
SGS has a global accreditation as GOST-R ‘Certification Body’ (CB)
Personal qualifications (GOST Expert)
(to qualify, pass examination in Russia, in Russian language)
Iran
Islamic Republic of Iran has a mandatory import certification scheme
Iran:
(almost) Every product exported to Iran has to be inspected prior to shipment, by one of the authorised inspection companies
Often de buyer in Iran has a strong say in the choice of inspections company and he makes final decision of acceptance
Standard: ISIRI
SGS can provide all mandatory certificates for export of pressure equipment to Iran.
Saudi-Arabia (SASO)
Saudi-Arabia:
Many products need mandatory certification by an accredited inspection body.
Standards from the following entities listed below should be used for conformity assessment:
SASO (Saudi Arabian Standards Organization)
GCC (Gulf Cooperation Council)
International Standards (ISO-, -IEC…)
National Standards (NF-, BS-, DIN-…)
Manufacturers standards / specifications
SGS can provide all mandatory certificates for export of pressure equipment to Saudi-Arabia.