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Customers, consumers and shareholders are increasingly demanding environmentally responsible products and services. They expect companies to comply with environmental standards and demonstrate their commitment to the environment in daily operations. Clients want proof of this commitment, and it is an opportunity for companies to leverage their sincere environmental actions. |
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ISO 22000: 2005 (Food Safety Management System) |
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Introduction: -Food reaches consumers via supply chains that may link many different types of organizations and may stretch across multiple borders. One weak link may result in unsafe food that is dangerous to health and if this happens, the haz ards to consumers may be serious. |
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ISO 22000 is therefore designed to allow all types of organizations within the food chain to implement a Food Safety Management S ystem These include feed producers, primary producers, food manufacturers, transport and storage operators and sub contractors, retail service outlets, producers of equipments, packaging materials, cleaning agents, additives and ingredients. |
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ISO 27001:2005 Information Security Management System |
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Information is critical to the operation and perhaps even the survival of your organization. Being certified to ISO/IEC 27001 will help you to manage and protect your valuable information assets. This helps you to protect your information assets and give confidence to any interested parties, especially your customers. The standard adopts a process approach for establishing, implementing, operating, monitoring, reviewing, maintaining, and improving your ISMS. |
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ISO/IEC 27001 is the only auditable international standard that defines the requirements for an Information Security Management System (ISMS). The standard is designed to ensure the selection of adequate and proportionate security controls.
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ISO 13485:2003 (QMS for Medical Instruments & devices) |
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The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.
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ISO 13485:2003 is the latest version of ISO 13485, published in July 2003. This standard is based on the ISO 9001:2000 process model approach.
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Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485 :2003 is the international standard recognized for medical device regulations around the world. |
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OHSAS 18001:2007 (Occupational Health & Safety Analysis System) |
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OHSAS 18000 is an international occupational health and safety management system specification. It comprises two parts, 18001 and 18002 and embraces BS8800 and a number of other publications.
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Registration to OHSAS 18001 by an independent, third party, certification body demonstrates a commitment to implement, maintain and improve the way in which you manage your Health and Safety system.
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Organizations registered to OHSAS 18001 can be more confident about meeting the requirements of Health and Safety legislation. The setting of targets through the Health and Safety policy, together with the ongoing measurement against it ensures a process of continual improvement. |
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FDA Registration |
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The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. |
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To carry out certain provisions of the Bioterrorism Act, FDA has established new regulations requiring that |
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Food facilities are registered with FDA, and |
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FDA be given advance notice on shipments of imported food. |
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SA8000(Social Accountability) |
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The SA8000 Standard is an auditable certification standard based on international workplace norms of International Labour Organisation (ILO) conventions, the Universal Declaration of Human Rights and the UN Convention on the Rights of the Child. The SA8000 Standard is available for download in various languages. A summary of the Standard elements follows: |
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Child Labor |
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Forced Labor |
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Health and Safety |
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Freedom of Association and Right to Collective Bargaining |
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Discrimination |
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Discipline |
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Working Hours |
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Compensation |
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Management Systems |
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RoHS (Restriction of Hazardious Substances) |
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Department for Business, Innovation and Skills (BIS), NMO is the UK Enforcement Authority for the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2008 (the “RoHS Regulations”). These Regulations implement EU Directive 2002/95 which bans the placing on the EU market of new electrical and electronic equipment containing more than agreed levels o f lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants.
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Manufacturers need to understand the requirements of the RoHS Directive to ensure that their products, and their components, comply. |
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The UK RoHS regulations apply to those businesses defi ned as producers that: |
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manufacture or assemble electrical or electronic equipment in the UK |
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import electrical or electronic equipment from outside Europe |
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re-badge electronic products as their own. |
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The RoHS Directive applies to products placed on the European market and each member state has its own legislation. |
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CE Marking |
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The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe.
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De System is a technical and professional organization specialized in the CE mark, CE marking, CE certification and Authorized Representation of products. De System, with offices in all across India, is active worldwide and offers a complete range of Technical and management system services ensuring that products comply to the CE mark, CE marking, CE certifications and CCC mark regulations.
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Our experts identify hazards, assess risks, and carry out all applicable tests to determine the appropriate measures to meet with CE mark, CE marking, CE certification and CCC mark regulations. |
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GMP (Good Manufacturing Practices) |
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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 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.
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BSCI (Business Social Compliance Initiative) |
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The BSCI’s ultimate goal is to promote socially acceptable production conditions. In agreement with the International Labour Organisation (ILO), the standard requires: |
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Adherence to national laws |
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Freedom of association and the right to collective bargaining |
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The prohibition of any form of discrimination |
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Adherence to the legal minimum wage and the provision of a living wage |
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A maximum working week of 48 hours and limited overtime |
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Clear occupational health and safety regulations and procedures |
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The prohibition of child labour |
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The prohibition of forced labour and disciplinary measures |
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Adherence to the minimum requirements for waste management, dealing with chemicals and other dangerous substances and their disposal, emissions and sewage treatment |
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