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SQM  Group   2013    Presentation  Rev.  1.3  
SQM is technical team for Your business.
One of the main critical aspects for the success of
companies is ‘knowing-how’.
Our goal is our customer’s satisfaction.
SQM GROUP is a technical and legal organization
specialized in European safety Directives, CE marking, CE
Certification and Authorized Representative of foreign
importers / manufacturers.
Several decades of working experience as quality and
engineering department on behalf of importer companies,
together with manufacturers of electronic equipment,
consumer electronics, toys, home appliances, etc.
With branch offices in Asia, SQM GROUP is globally active
and offers a full range of Technical Services and Legal
Permit to ensure the products are in compliance with the
safety directives required by CE.
The depth of experience gained over the years allows us to
carry out the legal and technical activities related to the
application of European Directives both in the product
development and mass production stages to make sure our
customer and manufacturer follow the essential application
with EU Directives correctly, as well as ensuring the product
batches to be in compliance with the harmonized standards.
Our activities also extends to support our customers to
follow up the request from National Surveillance Authorities
(Customs - Market Surveillance Authorities , etc.).
  Presentation      
  Technical    
  Office  activities  
  
• Consultancy support
• Risk analysis
• Verification of compliance of
samples
• Checking TCF
• Factory audit
• Quality agreement
• Audit of the procurement
process and production
• Production surveillance
• AQL inspections
Compete in the market is uneasy.
Compete and survive in the European market without having the right
information and technical regulations is risky.
.
2  
	
  
FIELD EXPERIENCE
Our mission is to provide specialized support to
importers and producers for certificates related to CE
marking required by European Directives:
R&TTE 99/5 CE: Apply to telecommunications,
radiofrequency transmitting and receiving devices.
EMC 2004/108/EC: Electromagnetic compatibility. Apply
to products and equipment that might disrupt or
electromagnets influenced.
LVD 2006/95/EC: Low Voltage. Apply to products and
components that supply within certain voltage limits,
which could harm to people, animals and other things.
TOYS 2009/48/EC: Toys. Products intended for children
under 14 to play.
RoHS 2011/65/UE: Restriction in the use of banned
substances. Mainly electrical and electronic products.
ErP 2009/125/EC: Apply to products powered by
generated energy with the goal of minimizing the energy
consumption.
REACH 1907/2006: Regulation applicable to the
regulation of chemical substances and preparations.
Apply horizontally across through all sectors.
COSMETICS 1223/2009: Apply to all products intended
to be used on the surfaces on human body (epidermis,
nails, lips, long hair, hair system, etc.).
FOOD CONTACT 1935/2004: Apply to materials and
articles intended to come in contact with food and food
related ingredients.
SQM  was  founded  in  2006,  is  the  leading  
company  in  Italy  in  the  outsourcing  of  the  
technical  /  legal  within  the  product  
certification.  
  
Its  structure  has  developed  a   specialized  
expertise   unique   in   industry,   with   a  
working   group   established   in   the   Milan  
office   and   selected   network   of   partners  
and  consultants  
  
SOME  BRANDS  SUPPLIED  
  
  
  
  
SASO
IECC CB scheme
SQM  Group  
3  
	
  
Management of products released at the first stage of import.
The service is aimed at importer company evaluate the product in
compliance with European and national legislation,
and verify the features and specifications stated by the manufacturer.
This service includes the followings:
Identification of standards and directives to be applied:
To investigate every product with all the directives and the rules that are involved.
To evaluate and ensure the necessary technical documentation and samples are adequate provided
by importer or its manufacturer. If it’s inadequate, the importer will be notified. And we provide
compliance guidelines to manufacturer and importer.
! Assessment of technical documentation supplied by the manufacturer:
We evaluate the documentation provided by the manufacturer, together with the sample, to ensure
that the requirement is met. We establish a technical filing system to keep track of the
compliance documents provided by inspectors and officers.
! Sample Evaluation :
Our laboratory is equipped to perform the measurements in
accordance with the European standards for electromagnetic
Compatibility, safety and RoHS analysis.
We are able to perform the measurements for specific consumer
electronics, home appliances, toys, lighting products, etc.
! Emission of TCF and Declaration of conformity
We make sure to deliver the Technical Construction File and the declaration of conformity with the
essential requirement. This document must be kept available to Surveillance Authorities market.
SQM  Group  
4  
SQM  Group  
	
  
	
  
! Services required by European directives addressed to economic
operators.
European directives want economic operator to assure within their competence that the products
are conformed to the essential requirement of each Directive.
The table below shows the different types of economic operators defined by the European
Directives and the main duties that distinguish them.
Economic
operator
ACTIVITIES MAIN DUTIES
MANUFACTURER Means any natural or legal person
who manufactures a product or has
designed or manufactured, and
markets that product under his
name or trademark
design / manufacture or design /
make for others and affix their own
brand
• When releasing their products to the market,
manufacturers shall ensure that they have been
designed and manufactured in compliance with
the essential requirements
• prepare the required technical documentation
and carry out or have carried out the applicable
conformity assessment procedure
• keep the technical documentation and the EC
declaration of conformity for ten years
• ensure that procedures are necessary to ensure
that series production to remain in conformity
IMPORTER a natural or legal person
established in the community
places on the Community market a
product originating from a third
country
buy branded products from the
foreign manufacturer (the
manufacturer is not established in
the EU)
• importers place the product to the market.Only
products that comply to the local Directives.
• before placing a product to the market, importers
shall ensure that the manufacturer has carried out the
appropriate conformity assessment procedure. They
ensure that the manufacturer has drawn up the
technical documentation, the mark or marks of
conformity prescribed are affixed on the product, and
the product is accompanied the required documents.
DISTRIBUTOR a natural or legal person in the
supply chain, other than the
manufacturer or importer, who
makes a product available on the
market
buying products in the EU from
a manufacturer or importer
• when making a product available in the market
distributors shall act with due care in relation to the
applicable requirements.
• before putting a product available in the market
distributors shall verify that the product bears the
marking or the required conformity marking, and the
product is accompanied by the institutional required
documents and its safety information in a language
which can be easily understood by consumers and
end-users
SQM  Group  
5  
	
  
	
  
COMPLIANCE MANAGING
These service is offered to companies that are configured either as ‘manufactures’ and as ‘importers’ And
it is carried out in total autonomy and support regardstocertification.
If necessary, specific activities required may be provided.
The following activities are implemented by manufacturers (that affix their logo on the
product)
1. Implementation of factory audit procedure to ensure the ability of production in accordance with
the requirements of applicable Directives.
2. Contracted Quality agreement to ensure that manufacturers comply with the operating procedures
required by the Directives.
3. Safety assessment
4. Project management, issuance of documentation.
5. Verification of the technical documentation in regard of the product identification and documentation If
necessary, execution of testing and involvement of a notified body will be carried out.
6. Preparation of the EC declaration of conformity according to the newest standards set by the Directive.
7. Periodic review of the technical files, regulatory updates or changes in the product. Communications
regarding to the updated documentation with manufacturer.
The following activities are implemented by the importers who purchase private label
products from producers who aren’t established EC in the territories.
1. Verification and maintenance of technical documentation including the declaration conformity for 10
years from the last marketing unit.
2. Batch inspection in factory or verification of production stages to ensure that the series of
production remain in conformity.
3. Random testing of gold products
4. Collaboration with customers, reviewing/addressing complaint of non-compliant product.
5. Collaboration with customers, provide corrective action plans necessary to any non-compliant
products withdrawn or recalled. When the product presents risk, we prove to customer with the
provision of information to the competent national authority of the Member State in which it was
sold.
6. Following a request from a competent national authority, as technical office of customer, our
organization provides all information and necessary documentation to demonstrate the conformity of
the product and cooperate with that authority in any action to eliminate the risks posed by the products
placed in the market.
SQM  Group  
6  
	
  
	
  
Compliance & Inspections Asia Limited,
17 Canton Rd. TST. Kowloon HONG KONG------------------------------------------------------------------------------------------------------------------------------------------------------
CHINA R.O. D215, Hua Yuan Technology
Park, Bao Yuan Road, Xi Xiang, Bao An
District, ShenZhen, China.
Tel: (86) 755 8624 3785
Cell: (86) 186 170 701 20
Email: p.piras@coinasia.com.hk	
  
        
ia  p ivata  Alzaia   ,  
      (MI)    
el.     +         
    www.   
  Email:  in o@ 	
  
FACTORY AUDIT
Our qualified inspectors evaluate the manufacturing capability of the facility.
• Evaluated all the important elements such as: producer’s Quality
System, ethnicity, hygiene and environmental condition, cleanliness
the working environment , etc.
• The audit report provided allows buyers to efficiently evaluate
the quality of selected suppliers.
INITIAL PRODUCTION INSPECTION (IPI)
The inspector performs a visual inspection of raw materials and
accessories during the early stages of manufacturing using data sheets
and compliance reports. The IPI allows you to take prompt action on any
non- compliance in order to avoid compromising the entire production.
DURING PRODUCTION INSPECTION (DUPRO)
The inspector performs a visual inspection of the first assembled products,
accessories used and the final product using technical specifications and
compliance reports. If necessary, perform chemical analysis from a sample. This
activity is performed when at least 25% of production is completed.
FINAL RANDOM INSPECTION (FRI)
The inspector performs inspections of: compliance, quality and functionality of the
finished	
  product	
  and	
  packed	
  before	
  shipping.	
  The	
  invoice	
  
will	
  be	
  issued	
  together	
  with	
  a	
  certificate	
  of	
  compliance,	
  in	
  
the	
  event	
  of	
  payment	
  to	
  the	
  provider	
  by	
  letter	
  of	
  credit,	
  
including	
  the	
  documents	
  required	
  for	
  the	
  LC	
  negotiation.	
    

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Eu hot topics alliance presentation
 

SQM Compliance Insp. Rev 1.4

  • 1. SQM  Group   2013    Presentation  Rev.  1.3   SQM is technical team for Your business. One of the main critical aspects for the success of companies is ‘knowing-how’. Our goal is our customer’s satisfaction. SQM GROUP is a technical and legal organization specialized in European safety Directives, CE marking, CE Certification and Authorized Representative of foreign importers / manufacturers. Several decades of working experience as quality and engineering department on behalf of importer companies, together with manufacturers of electronic equipment, consumer electronics, toys, home appliances, etc. With branch offices in Asia, SQM GROUP is globally active and offers a full range of Technical Services and Legal Permit to ensure the products are in compliance with the safety directives required by CE. The depth of experience gained over the years allows us to carry out the legal and technical activities related to the application of European Directives both in the product development and mass production stages to make sure our customer and manufacturer follow the essential application with EU Directives correctly, as well as ensuring the product batches to be in compliance with the harmonized standards. Our activities also extends to support our customers to follow up the request from National Surveillance Authorities (Customs - Market Surveillance Authorities , etc.).  Presentation        Technical      Office  activities     • Consultancy support • Risk analysis • Verification of compliance of samples • Checking TCF • Factory audit • Quality agreement • Audit of the procurement process and production • Production surveillance • AQL inspections Compete in the market is uneasy. Compete and survive in the European market without having the right information and technical regulations is risky. .
  • 2. 2     FIELD EXPERIENCE Our mission is to provide specialized support to importers and producers for certificates related to CE marking required by European Directives: R&TTE 99/5 CE: Apply to telecommunications, radiofrequency transmitting and receiving devices. EMC 2004/108/EC: Electromagnetic compatibility. Apply to products and equipment that might disrupt or electromagnets influenced. LVD 2006/95/EC: Low Voltage. Apply to products and components that supply within certain voltage limits, which could harm to people, animals and other things. TOYS 2009/48/EC: Toys. Products intended for children under 14 to play. RoHS 2011/65/UE: Restriction in the use of banned substances. Mainly electrical and electronic products. ErP 2009/125/EC: Apply to products powered by generated energy with the goal of minimizing the energy consumption. REACH 1907/2006: Regulation applicable to the regulation of chemical substances and preparations. Apply horizontally across through all sectors. COSMETICS 1223/2009: Apply to all products intended to be used on the surfaces on human body (epidermis, nails, lips, long hair, hair system, etc.). FOOD CONTACT 1935/2004: Apply to materials and articles intended to come in contact with food and food related ingredients. SQM  was  founded  in  2006,  is  the  leading   company  in  Italy  in  the  outsourcing  of  the   technical  /  legal  within  the  product   certification.     Its  structure  has  developed  a   specialized   expertise   unique   in   industry,   with   a   working   group   established   in   the   Milan   office   and   selected   network   of   partners   and  consultants     SOME  BRANDS  SUPPLIED           SASO IECC CB scheme SQM  Group  
  • 3. 3     Management of products released at the first stage of import. The service is aimed at importer company evaluate the product in compliance with European and national legislation, and verify the features and specifications stated by the manufacturer. This service includes the followings: Identification of standards and directives to be applied: To investigate every product with all the directives and the rules that are involved. To evaluate and ensure the necessary technical documentation and samples are adequate provided by importer or its manufacturer. If it’s inadequate, the importer will be notified. And we provide compliance guidelines to manufacturer and importer. ! Assessment of technical documentation supplied by the manufacturer: We evaluate the documentation provided by the manufacturer, together with the sample, to ensure that the requirement is met. We establish a technical filing system to keep track of the compliance documents provided by inspectors and officers. ! Sample Evaluation : Our laboratory is equipped to perform the measurements in accordance with the European standards for electromagnetic Compatibility, safety and RoHS analysis. We are able to perform the measurements for specific consumer electronics, home appliances, toys, lighting products, etc. ! Emission of TCF and Declaration of conformity We make sure to deliver the Technical Construction File and the declaration of conformity with the essential requirement. This document must be kept available to Surveillance Authorities market. SQM  Group  
  • 4. 4   SQM  Group       ! Services required by European directives addressed to economic operators. European directives want economic operator to assure within their competence that the products are conformed to the essential requirement of each Directive. The table below shows the different types of economic operators defined by the European Directives and the main duties that distinguish them. Economic operator ACTIVITIES MAIN DUTIES MANUFACTURER Means any natural or legal person who manufactures a product or has designed or manufactured, and markets that product under his name or trademark design / manufacture or design / make for others and affix their own brand • When releasing their products to the market, manufacturers shall ensure that they have been designed and manufactured in compliance with the essential requirements • prepare the required technical documentation and carry out or have carried out the applicable conformity assessment procedure • keep the technical documentation and the EC declaration of conformity for ten years • ensure that procedures are necessary to ensure that series production to remain in conformity IMPORTER a natural or legal person established in the community places on the Community market a product originating from a third country buy branded products from the foreign manufacturer (the manufacturer is not established in the EU) • importers place the product to the market.Only products that comply to the local Directives. • before placing a product to the market, importers shall ensure that the manufacturer has carried out the appropriate conformity assessment procedure. They ensure that the manufacturer has drawn up the technical documentation, the mark or marks of conformity prescribed are affixed on the product, and the product is accompanied the required documents. DISTRIBUTOR a natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the market buying products in the EU from a manufacturer or importer • when making a product available in the market distributors shall act with due care in relation to the applicable requirements. • before putting a product available in the market distributors shall verify that the product bears the marking or the required conformity marking, and the product is accompanied by the institutional required documents and its safety information in a language which can be easily understood by consumers and end-users
  • 5. SQM  Group   5       COMPLIANCE MANAGING These service is offered to companies that are configured either as ‘manufactures’ and as ‘importers’ And it is carried out in total autonomy and support regardstocertification. If necessary, specific activities required may be provided. The following activities are implemented by manufacturers (that affix their logo on the product) 1. Implementation of factory audit procedure to ensure the ability of production in accordance with the requirements of applicable Directives. 2. Contracted Quality agreement to ensure that manufacturers comply with the operating procedures required by the Directives. 3. Safety assessment 4. Project management, issuance of documentation. 5. Verification of the technical documentation in regard of the product identification and documentation If necessary, execution of testing and involvement of a notified body will be carried out. 6. Preparation of the EC declaration of conformity according to the newest standards set by the Directive. 7. Periodic review of the technical files, regulatory updates or changes in the product. Communications regarding to the updated documentation with manufacturer. The following activities are implemented by the importers who purchase private label products from producers who aren’t established EC in the territories. 1. Verification and maintenance of technical documentation including the declaration conformity for 10 years from the last marketing unit. 2. Batch inspection in factory or verification of production stages to ensure that the series of production remain in conformity. 3. Random testing of gold products 4. Collaboration with customers, reviewing/addressing complaint of non-compliant product. 5. Collaboration with customers, provide corrective action plans necessary to any non-compliant products withdrawn or recalled. When the product presents risk, we prove to customer with the provision of information to the competent national authority of the Member State in which it was sold. 6. Following a request from a competent national authority, as technical office of customer, our organization provides all information and necessary documentation to demonstrate the conformity of the product and cooperate with that authority in any action to eliminate the risks posed by the products placed in the market.
  • 6. SQM  Group   6       Compliance & Inspections Asia Limited, 17 Canton Rd. TST. Kowloon HONG KONG------------------------------------------------------------------------------------------------------------------------------------------------------ CHINA R.O. D215, Hua Yuan Technology Park, Bao Yuan Road, Xi Xiang, Bao An District, ShenZhen, China. Tel: (86) 755 8624 3785 Cell: (86) 186 170 701 20 Email: p.piras@coinasia.com.hk         ia  p ivata  Alzaia   ,       (MI)     el.    +          www.    Email:  in o@   FACTORY AUDIT Our qualified inspectors evaluate the manufacturing capability of the facility. • Evaluated all the important elements such as: producer’s Quality System, ethnicity, hygiene and environmental condition, cleanliness the working environment , etc. • The audit report provided allows buyers to efficiently evaluate the quality of selected suppliers. INITIAL PRODUCTION INSPECTION (IPI) The inspector performs a visual inspection of raw materials and accessories during the early stages of manufacturing using data sheets and compliance reports. The IPI allows you to take prompt action on any non- compliance in order to avoid compromising the entire production. DURING PRODUCTION INSPECTION (DUPRO) The inspector performs a visual inspection of the first assembled products, accessories used and the final product using technical specifications and compliance reports. If necessary, perform chemical analysis from a sample. This activity is performed when at least 25% of production is completed. FINAL RANDOM INSPECTION (FRI) The inspector performs inspections of: compliance, quality and functionality of the finished  product  and  packed  before  shipping.  The  invoice   will  be  issued  together  with  a  certificate  of  compliance,  in   the  event  of  payment  to  the  provider  by  letter  of  credit,   including  the  documents  required  for  the  LC  negotiation.