c ETI (Ethical Trading Initiative)- ETI was set up in 1998 to promote ethical business practices. The Ethical Trading Initiative is a ground-breaking initiative which brings together a wide range of organisations from all parts of society. ETI aim to improve the lives of poor working people around the world. ETI is an alliance of companies, NGOs and trade union organisations working to promote and improve the implementation of corporate codes of practice which cover supply chain working conditions. Let De System be your professional consultant for ETI audit.
c FLA (Fair Labour Association)- FLA was established in 1999 to improve the lives of thousands of workers around the globe. By bringing together multiple stakeholders, calling for greater accountability and transparency from manufacturers, factories and others involved in global supply chains, and creating lasting solutions to exploitative labor practices, FLA is making steady progress toward fulfilling it's mission: protecting workers' rights and improving working conditions worldwide. De system assists you in im plementing FLA requirements in your organiation.
Other Certifications:
ISO 9001:2008
ISO 9001:2008 specifies requirements for a quality management system where an organization
aNeeds to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
aAims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
(Click here to learn more)
ISO 14001:2004
ISO 14001:2004 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those, which it can control, and those, which it can influence. It does not itself state specific environmental performance criteria.
ISO 14001:2004 is applicable to any organization that wishes to establish, implement, maintain and improve an environmental management system, to assure itself of conformity with its stated environmental policy, and to demonstrate conformity with ISO 14001:2004
(Click here to learn more)
HACCP
HACCP stands for Hazard Analysis and Critical Control Points. HACCP is an industry-wide effort approved by the scientific community as well as regulatory and industry practitioners. It is a Food Safety methodology that relies on the identification of Critical Control Points (CCP's) in food production and preparation processes. Closely monitored CCPs will ensure that food is safe for human consumption.
The approach was originally derived from Engineering System's - "Failure Mode and Effect Analysis". It was further developed by Pillsbury / NASA for the American Space Programme. Hazard Analysis Critical Control Points reduced the risk of astronauts suffering from the effects of consuming contaminated food whilst in space.
(Click here to learn more)
ISO 22000:2005
ISO 22000 is a generic food safety management system standard. It defines a set of general food safety requirements that apply to all organizations in the food chain. Unlike some standards, ISO 22000 does not follow a prescriptive checklist approach. Instead, it allows an organization to develop a food safety management system that meets the needs of its suppliers and customers. ISO 22000 was published in September 2005, to provide a framework of requirements, and confirm a global approach for an international industry. The standard was developed within ISO by experts from the food industry, along with representatives of specialized international organizations. Additional cooperation came from the Codex Alimentarius Commission, which was established by the United Nations' Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards
(Click here to learn more)
ISO 27001:2005
ISO/IEC 27001:2005 covers all types of organizations (e.g. commercial enterprises, government agencies, not-for profit organizations). ISO/IEC 27001:2005 specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System within the context of the organization's overall business risks. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.
ISO/IEC 27001:2005 is designed to ensure the selection of adequate and proportionate security controls that protect information assets and give confidence to interested parties.
(Click here to learn more)
ISO 20000
ISO/IEC 20000-1:2005 defines the requirements for a service provider to deliver managed services. It is based on BS 15000-2, which has been superseded.
It may be used
1. By businesses that are going out to tender for their services;
2. To provide a consistent approach by all service providers in a supply chain;
3. To benchmark IT service management;
4. As the basis for an independent assessment;
5. To demonstrate the ability to meet customer requirements;
6. To improve services.
(Click here to learn more)
ISO 13485(Medical Devices)
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It provides a framework for companies to meet their customer and regulatory requirements. The main goal is to provide a harmonized model for quality management system requirements in the international market since different countries might have different standards. De System's comprehensive ISO 13485 and regulatory support program for the Medical Device Industry enables your organization to implement an effective ISO 13485 quality management system and meet domestic and international regulations for medical device, while achieving overall business improvement.
(Click here to learn more)
C-TPAT
C-TPAT - Customs-Trade Partnership Against Terrorism
OHSAS 18001 (Occupational Health & Safety Analysis System)
OHSAS 18001 is an assessment specification for Occupational Health and Safety Management Systems. It was developed in response to the need for companies to meet their health and safety obligations in an efficient manner.
(Click here to learn more)
TS 16949
ISO/TS 16949:2002 is an ISO Technical Specification, which aligns existing American (QS-9000), German (VDA6.1), French (EAQF) and Italian (AVSQ) automotive quality systems standards within the global automotive industry, with the aim of eliminating the need for multiple certifications to satisfy customer requirements. This standard is applicable in automobile industry.
(Click here to learn more)
GMP/WHO GMP (Good Manufacturing Process)
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product, which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
(Click here to learn more)
BRC
In 1998 the British Retail Consortium (BRC) developed and introduced the BRC Technical Standard and Protocol for companies supplying retailer branded food products. The standard was developed to assist retailers in their fulfillment of legal obligations and protection of the consumer, by providing a common basis for the audit of companies supplying retailer branded food products.
(Click here to learn more)
Kaizen
Kaizen is a system that involves every employee - from upper management to the cleaning crew. Everyone is encouraged to come up with small improvement suggestions on a regular basis. This is not a once a month or once a year activity. It is continuous. Japanese companies, such as Toyota and Canon, a total of 60 to 70 suggestions per employee per year are written down, shared and implemented.
(Click here to learn more)
Six Sigma
Six Sigma is a business management strategy, originally developed by Motorola, that today enjoys widespread application in many sectors of industry.
Six Sigma seeks to identify and remove the causes of defects and errors in manufacturing and business processes. It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization ("Black Belts" etc.) who are experts in these methods. Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified financial targets (cost reduction or profit increase).
(Click here to learn more)
ROHS (Restriction of Hazardous substances)
RoHS (Restriction of Hazardous Substances) is a new European Directive that became effective on July 1, 2006. Electrical and electronic equipment sold in Europe after this date must comply with the strict regulations in this Directive.
The Directive requires that electrical and electronic equipment sold in the EU does not contain lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBBs) or polybrominated diphenyl ethers (PBDEs) above the legal threshold. This will effect any organization involved in the production, sale or distribution of electrical and electronic equipment destined for an EU market, such as manufacturers, retailers, brand managers, traders and distributors.
There are two main areas of ROHS compliance risk:
Product material risk: From selecting materials and components in products and using indirect materials in the manufacturing process.
Supplier risk: From product variation, engineering or manufacturing changes, multiple suppliers and contamination through the supply chain.
(Click here to learn more)
CE Marking
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and "CE Marking" officially replaced it in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term.
(Click here to learn more)
FDA Registration
Every company that exports food, cosmetics, drugs and devices to United States has to take FDA registration.
Simple and Affordable Solutions.
As the market leader in FDA registrations, register-FDA offers a comprehensive solution for a complete FDA registration process. We assist companies with complying with the FDA regulations; we provide representation in the United States for those companies and keep our clients' registrations with the FDA current. As a company with long-standing experience in global trade and supply chain, we developed a comprehensive solution tailored to companies who export to the USA to overcome the new and ever developing requirements. We focus on efficient solutions that are effective at the lowest cost. We use automated systems where warranted to reduce errors and to expedite the process. Our services allow companies of all sizes to continue to export to the USA and avoid significant delays by the authorities at the border. Our 15 plus years experience in global trade, U.S. government agencies, compliance issues and exports to the USA will support anyone's exporting business.
What happens if I don't register?
The Bioterrorism Act makes failure to register a prohibited act. The Federal government can bring a civil action in Federal court to enjoin persons who commit a prohibited act; or the Federal government can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a foreign facility fails to register and also attempts to import food into the U.S., the Bioterrorism Act requires that the food be held at the port of entry unless FDA or U.S. Customs directs otherwise. If the food must be moved, the private parties involved (i.e., the owner, purchaser, importer, or receiver of the food) must arrange for moving it and promptly notify FDA of its location. The private parties are responsible for any costs associated with moving or storage of the food.
(Click here to learn more)
c FLA (Fair Labour Association)- FLA was established in 1999 to improve the lives of thousands of workers around the globe. By bringing together multiple stakeholders, calling for greater accountability and transparency from manufacturers, factories and others involved in global supply chains, and creating lasting solutions to exploitative labor practices, FLA is making steady progress toward fulfilling it's mission: protecting workers' rights and improving working conditions worldwide. De system assists you in im plementing FLA requirements in your organiation.
Other Certifications:
ISO 9001:2008
ISO 9001:2008 specifies requirements for a quality management system where an organization
aNeeds to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
aAims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All requirements of ISO 9001:2008 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
(Click here to learn more)
ISO 14001:2004
ISO 14001:2004 specifies requirements for an environmental management system to enable an organization to develop and implement a policy and objectives which take into account legal requirements and other requirements to which the organization subscribes, and information about significant environmental aspects. It applies to those environmental aspects that the organization identifies as those, which it can control, and those, which it can influence. It does not itself state specific environmental performance criteria.
ISO 14001:2004 is applicable to any organization that wishes to establish, implement, maintain and improve an environmental management system, to assure itself of conformity with its stated environmental policy, and to demonstrate conformity with ISO 14001:2004
(Click here to learn more)
HACCP
HACCP stands for Hazard Analysis and Critical Control Points. HACCP is an industry-wide effort approved by the scientific community as well as regulatory and industry practitioners. It is a Food Safety methodology that relies on the identification of Critical Control Points (CCP's) in food production and preparation processes. Closely monitored CCPs will ensure that food is safe for human consumption.
The approach was originally derived from Engineering System's - "Failure Mode and Effect Analysis". It was further developed by Pillsbury / NASA for the American Space Programme. Hazard Analysis Critical Control Points reduced the risk of astronauts suffering from the effects of consuming contaminated food whilst in space.
(Click here to learn more)
ISO 22000:2005
ISO 22000 is a generic food safety management system standard. It defines a set of general food safety requirements that apply to all organizations in the food chain. Unlike some standards, ISO 22000 does not follow a prescriptive checklist approach. Instead, it allows an organization to develop a food safety management system that meets the needs of its suppliers and customers. ISO 22000 was published in September 2005, to provide a framework of requirements, and confirm a global approach for an international industry. The standard was developed within ISO by experts from the food industry, along with representatives of specialized international organizations. Additional cooperation came from the Codex Alimentarius Commission, which was established by the United Nations' Food and Agriculture Organization (FAO) and World Health Organization (WHO) to develop food standards
(Click here to learn more)
ISO 27001:2005
ISO/IEC 27001:2005 covers all types of organizations (e.g. commercial enterprises, government agencies, not-for profit organizations). ISO/IEC 27001:2005 specifies the requirements for establishing, implementing, operating, monitoring, reviewing, maintaining and improving a documented Information Security Management System within the context of the organization's overall business risks. It specifies requirements for the implementation of security controls customized to the needs of individual organizations or parts thereof.
ISO/IEC 27001:2005 is designed to ensure the selection of adequate and proportionate security controls that protect information assets and give confidence to interested parties.
(Click here to learn more)
ISO 20000
ISO/IEC 20000-1:2005 defines the requirements for a service provider to deliver managed services. It is based on BS 15000-2, which has been superseded.
It may be used
1. By businesses that are going out to tender for their services;
2. To provide a consistent approach by all service providers in a supply chain;
3. To benchmark IT service management;
4. As the basis for an independent assessment;
5. To demonstrate the ability to meet customer requirements;
6. To improve services.
(Click here to learn more)
ISO 13485(Medical Devices)
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. It provides a framework for companies to meet their customer and regulatory requirements. The main goal is to provide a harmonized model for quality management system requirements in the international market since different countries might have different standards. De System's comprehensive ISO 13485 and regulatory support program for the Medical Device Industry enables your organization to implement an effective ISO 13485 quality management system and meet domestic and international regulations for medical device, while achieving overall business improvement.
(Click here to learn more)
C-TPAT
C-TPAT - Customs-Trade Partnership Against Terrorism
- C-TPAT is a joint government-business initiative to build cooperative relationships that strengthen overall supply chain and border security.
- C-TPAT recognizes that Customs can provide the highest level of security only through close cooperation with the ultimate owners of the supply chain- importers, carriers, brokers, warehouse operators and manufacturers.
- Through this initiative, Customs is asking businesses to ensure the integrity of their security practices and communicate their security guidelines to their business partners within the supply chain.
OHSAS 18001 (Occupational Health & Safety Analysis System)
OHSAS 18001 is an assessment specification for Occupational Health and Safety Management Systems. It was developed in response to the need for companies to meet their health and safety obligations in an efficient manner.
(Click here to learn more)
TS 16949
ISO/TS 16949:2002 is an ISO Technical Specification, which aligns existing American (QS-9000), German (VDA6.1), French (EAQF) and Italian (AVSQ) automotive quality systems standards within the global automotive industry, with the aim of eliminating the need for multiple certifications to satisfy customer requirements. This standard is applicable in automobile industry.
(Click here to learn more)
GMP/WHO GMP (Good Manufacturing Process)
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the consumer from purchasing a product, which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time.
(Click here to learn more)
BRC
In 1998 the British Retail Consortium (BRC) developed and introduced the BRC Technical Standard and Protocol for companies supplying retailer branded food products. The standard was developed to assist retailers in their fulfillment of legal obligations and protection of the consumer, by providing a common basis for the audit of companies supplying retailer branded food products.
(Click here to learn more)
Kaizen
Kaizen is a system that involves every employee - from upper management to the cleaning crew. Everyone is encouraged to come up with small improvement suggestions on a regular basis. This is not a once a month or once a year activity. It is continuous. Japanese companies, such as Toyota and Canon, a total of 60 to 70 suggestions per employee per year are written down, shared and implemented.
(Click here to learn more)
Six Sigma
Six Sigma is a business management strategy, originally developed by Motorola, that today enjoys widespread application in many sectors of industry.
Six Sigma seeks to identify and remove the causes of defects and errors in manufacturing and business processes. It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization ("Black Belts" etc.) who are experts in these methods. Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified financial targets (cost reduction or profit increase).
(Click here to learn more)
ROHS (Restriction of Hazardous substances)
RoHS (Restriction of Hazardous Substances) is a new European Directive that became effective on July 1, 2006. Electrical and electronic equipment sold in Europe after this date must comply with the strict regulations in this Directive.
The Directive requires that electrical and electronic equipment sold in the EU does not contain lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBBs) or polybrominated diphenyl ethers (PBDEs) above the legal threshold. This will effect any organization involved in the production, sale or distribution of electrical and electronic equipment destined for an EU market, such as manufacturers, retailers, brand managers, traders and distributors.
There are two main areas of ROHS compliance risk:
Product material risk: From selecting materials and components in products and using indirect materials in the manufacturing process.
Supplier risk: From product variation, engineering or manufacturing changes, multiple suppliers and contamination through the supply chain.
(Click here to learn more)
CE Marking
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and "CE Marking" officially replaced it in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents. "CE Mark" is also in use, but it is NOT the official term.
(Click here to learn more)
FDA Registration
Every company that exports food, cosmetics, drugs and devices to United States has to take FDA registration.
Simple and Affordable Solutions.
As the market leader in FDA registrations, register-FDA offers a comprehensive solution for a complete FDA registration process. We assist companies with complying with the FDA regulations; we provide representation in the United States for those companies and keep our clients' registrations with the FDA current. As a company with long-standing experience in global trade and supply chain, we developed a comprehensive solution tailored to companies who export to the USA to overcome the new and ever developing requirements. We focus on efficient solutions that are effective at the lowest cost. We use automated systems where warranted to reduce errors and to expedite the process. Our services allow companies of all sizes to continue to export to the USA and avoid significant delays by the authorities at the border. Our 15 plus years experience in global trade, U.S. government agencies, compliance issues and exports to the USA will support anyone's exporting business.
What happens if I don't register?
The Bioterrorism Act makes failure to register a prohibited act. The Federal government can bring a civil action in Federal court to enjoin persons who commit a prohibited act; or the Federal government can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a foreign facility fails to register and also attempts to import food into the U.S., the Bioterrorism Act requires that the food be held at the port of entry unless FDA or U.S. Customs directs otherwise. If the food must be moved, the private parties involved (i.e., the owner, purchaser, importer, or receiver of the food) must arrange for moving it and promptly notify FDA of its location. The private parties are responsible for any costs associated with moving or storage of the food.
(Click here to learn more)
Other Social Certifications
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