De System is a world leading consultancy organization specialized in global product & system certifications such as: ISO 9001 (QMS), ISO 14001 (EMS), ISO 13485, ISO 27001 (ISMS), ISO 22000 (FSMS), OHSAS 18001, US FDA registration and compliance, European Union & EFTA product safety requirement- CE Marking, ROHS compliance, ISO standards, HACCP, OHSAS, C-TPAT, GMP, EUREPGAP, SA 8000, BSCI, WRAP etc. De System has presence in India and other parts of Asia. We are having our presence in following geographical areas:NEW DELHI, CHANDIGARH,HARYANA Panchkula, Faridabad, Gurgaon, Bahadurgarh, Bhiwadi, Panipat,UTTAR PRADESH- Ghaziabad, Kanpur, Allahabad, Lucknow, Agra, Meerut, Varanasi, Bhadoi, Rampur, Noida,UTTRANCHAL Mandi, Baddi,GUJARAT- Ahmedabad, Surat, Bhavnagar MAHARASHTRA - Mumbai, Nagpur, Pune, JAMMU & KASHMIR - Jammu, PUNJAB Ludhiana, Faridkot, Amritsar, Chandigarh KARNATAKA- Bangalore, Tumkur, Mysore, TAMIL NADU - Chennai, Tirupur, ANDHRA PRADESH Hyderabad, MADHYA PRADESH- Bhopal, ORISSA Raurkela, Bhuwneshwar, Katak WESTBANGOL Kolkata, Durgapur BIHAR- Patna, Gaya, JHARKHAND- Ranchi. Jamshedpur.
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Who is ISO?
ISO (International Organization for Standardization) is a network of standards institutes from 159 countries with a central office in Geneva, Switzerland, that coordinates the system.
ISO is a non-governmental organization that forms a bridge between the public and private sectors, and is the largest standards organization in the world.
Many of its member institutes are part of the governmental structure of their countries, or are mandated by their government.
Some members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.
ISO 9001:2008
ISO 9001 is the internationally recognized standard for Quality Management Systems (QMS). It provides your company with a framework and set of principles that ensure a common sense approach to the management of your business activities to consistently achieve customer satisfaction. The International Standard ISO 9001: 2008 (latest version in ISO 9000 series) is officially published on 15-November-2008
The new ISO 9001:2008 revision specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements.
ISO 14001 is the international standard for environmental management systems now the most widely used EMS in the world, with an estimated 111,000 organizations certified in 138 countries world-wide. ISO 14001 is the principal management system standard which specifies the requirements for the formulation and maintenance of an EMS. Organizations of all types, sectors and sizes can improve their environmental performance through the implementation of this standard.
ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption. It is applicable to all organizations, regardless of size, which are involved in any aspect of the food chain and want to implement systems that consistently provide safe products. The means of meeting any requirements of ISO 22000 can be accomplished through the use of internal and/or external resources.
The ISO 27001 standard was published in October 2005, essentially replacing the old BS7799-2 standard. It is the specification for ISMS, an Information Security Management System. The ISO27001 standard provide guidance on designing, implementing and auditing Information Security Management Systems to protect the confidentiality, integrity and availability of the information assets on which we all depend.
ISO 13485, published in 2003, and now fully recognized in many countries, is based on the ISO 9001 process model approach. These standards provide a good base model, recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements.
An ISO 13485 certificate proves your commitment to the quality of medical devices. It enables you to demonstrate that your quality management system has been assessed and found compliant in order to meet regulatory requirements and customer needs.
C-TPAT
The Customs-Trade Partnership Against Terrorism (C-TPAT) is a joint effort between the United States government and businesses involved in importing goods into the United States. C-TPAT is part of the ever evolving nature of the United States Customs, and recognizes that border security will be much more efficient if Customs involves businesses in the process of securing and inspecting cargo. Membership in C-TPAT is available to most businesses who import goods into the United States including freight carriers, brokers, manufacturers, and importers, as long as they agree to the guidelines of C-TPAT membership. We provide compliance services against this standard.
The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States. We provide registration & authorized representative services.
The European Union (EU) has implemented a system to protect the health of consumers and workers as well as the condition of the merchandise and the environment.
If you manufacture or import products which fall into the scope of one or more of the New Approach Directives you will then need to apply for CE marking.
CE marking on a product indicates to governments that the product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA), Ensures the product can move freely throughout the European Single Market, Indicates to customers that the product meets designated minimum safety standards and therefore a minimum level of quality, Promotes public health and safety, Enhances product credibility, Leads to improved sales and greater customer satisfaction.
EurepGAP is a private sector body that sets voluntary standards for the certification of agricultural products around the globe. EurepGAP is an equal partnership of agricultural producers and retailers which want to establish certification standards and procedures for Good Agricultural Practices (GAP). EurepGAP is a pre-farm-gate-standard that means the certificate covers the process of the certified product from before the seed is planted until it leaves the farm. EurepGAP is a business-to-business label and is therefore not directly visible for the consumers.
RoHS
RoHS is the acronym for Restriction of Hazardous Substances. RoHS, also known as Directive 2002/95/EC, originated in the European Union and restricts the use of specific hazardous materials found in electrical and electronic products. All applicable products in the EU market after July1, 2006 must pass RoHS compliance. We provide compliance services.
Factory Compliance
We provide compliance guidelines for factory premises. Once you avail our services you will be able to address all national & international norms.
Business Social Compliance Initiative (BSCI) was founded in 2003 for the purpose of developing the tools and procedures for the European Business Social Compliance Programs. Business Social Compliance Initiative (BSCI) is the common European platform of retailers, industry and importing companies for monitoring and improving social standards in supplier countries for all consumer goods. The BSCI is based on the labour standards of the International Labour Organization (ILO) and other important international regulations like the UN Charter for Human Rights, as well as on national regulations.
Social Accountability 8000 (SA8000) has been developed by Social Accountability International (SAI), known until recently as the Council on Economic Priorities Accreditation Agency. SAI is a non-profit affiliate of the Council on Economic Priorities (CEP). SA8000 is promoted as a voluntary, universal standard for companies interested in auditing and certifying labour practices in their facilities and those of their suppliers and vendors. It is designed for independent third party certification.
