ROHS AND OTHER PRODUCT TESTINGS

RoHS

In late 2002 the European Parliament approved two directives related to the reduction of electrical and electronic waste, namely the Waste Electrical and Electronic Equipment (WEEE) and Restriction of the use of certain Hazardous Substances (RoHS) Directives. The WEEE Directive aims to regulate the reuse, recycling and recovery of waste electrical and electronic equipment; the ultimate goal is to prevent the disposal of this waste.

In the RoHS Directive, the use of the aforementioned substances in most electrical and electronic equipment will be banned or severely restricted. The RoHS Directive calls for the elimination of these substances from most electronic equipment starting 1 July 2006.

RoHS, also known as Lead-Free, stands for Restriction of Hazardous Substances. RoHS Directive 2002/95/EC restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market afterJuly 1, 2006 must pass RoHS compliance. RoHS impacts the entire electronics industry.

Restriction of Hazardous Substances (RoHS)

The Reduction of Hazardous Substances (RoHS) regulations set limits for the following substances:

• Lead
• Mercury
• Cadmium
• Hexavalent Chromium
• Polybrominated Biphenyls (PBB)
• Polybrominated Diphenyl Ethers (PBDE)

To certify to the above compliances, these substances must not be intentionally added to the product AND cannot exceed the following maximum allowable levels as a trace substance:

0.1% (1,000 ppm) for: Lead*, Mercury, Hexavalent Chromium, PBB and PBDE

0.01% (100 ppm) for: Cadmium

Lead as an alloying element in copper alloys is allowed up to 4.0% (40,000 ppm); in steel up to 0.35% (3,500 ppm) is allowed; in aluminum alloys up to 0.40% (4,000 ppm) is allowed.

Compliance Assurance System

Restricted Substance Controls (RSC) defines the actions and mechanisms you can take to prevent restricted substances from inclusion in your products. To ensure RSC are effective, the procedures should be integrated into an overall Compliance Assurance System (CAS).

EU Enforcement authorities and OEM customers are requesting documentation of producer’s RoHS compliance procedures to demonstrate that appropriate systems are in place to ensure on-going compliance.

Compliance procedures should be integrated into your quality management system or environmental management system if one exists.

Vital Certifications and Benchmarkings helps you in developing your ‘Compliance Assurance System’

Other Services:

ISO 9001

An ISO 9001 standard is one of the most widely known standards, which is introduced in the 1987 and implemented in 162 countries. The ISO 9001 standard has become the international reference for an Organization of any size or any sector to demonstrate their ability and expertise to perform.

• Meeting the customer requirements.
• Following the applicable regulatory requirements.
• Enhancing the customer satisfaction.
• Continual Improvement.

ISO 14001

ISO 14001 is primarily concerned with the approach of “Environmental Management System” and with the worldwide growing concerns regarding the living environment, ISO 14001 is regarded as an organization’s high level commitment to environmental protection.

This standard is widely recognized as a “Generic Environmental management System Standard”. This can be applied any organization whether it is small or big whatever its product or service.

This standard provides guidance to organization in order to

• Minimize harmful effects on the environment caused by business activities and
• Achieve continual improvement of environmental performance.

ISO 22000

The ISO 22000 international standard specifies the requirements for a food safety management system that involves the following elements:

• interactive communication
• system management
• prerequisite programs
• HACCP principles

Critical reviews of the above elements have been conducted by many scientists Communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain. This implies communication between organizations both upstream and downstream in the food chain. Communication with customers and supplies about identified hazards and control measures will assist in clarifying customer and supplier requirements.

ISO 27001

The ISO 27001 standard was published in October 2005, essentially replacing the old BS7799-2 standard. It is the specification for an ISMS, an Information Security Management System. BS7799 itself was a long standing standard, first published in the nineties as a code of practice. As this matured, a second part emerged to cover management systems. It is this against which certification is granted.

OHSAS 18001

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.

OHSAS helps in a variety of respects... it helps: minimize risk to employees/etc; improve an existing OH&S management system; demonstrate diligence; gain assurance; etc. The OHSAS specification is applicable to any organization that wishes to:

• Establish an OH&S management system to eliminate or minimize risk to employees and other interested parties who may be exposed to OH&S risks associated with its activities
• Assure itself of its conformance with its stated OH&S policy
• Demonstrate such conformance to others
• Implement, maintain and continually improve an OH&S management system
• Make a self-determination and declaration of conformance with this OHSAS specification.
• Seek certification/registration of its OH&S management system by an external organization

CE Marking

The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements.
If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the members states of the European Economic Area (EEA), then you must apply CE Marking to your product against the essential requirements of all these applicable directives.

RoHS regulation (Directive 2002/95/EC)

RoHS, also known as Lead-Free, stands for Restriction of Hazardous Substances. RoHS Directive 2002/95/EC restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market after July 1, 2006 must pass RoHS compliance. RoHS impacts the entire electronics industry.
WEEE stands for Waste from Electrical and Electronic Equipment. WEEE Directive 2002/96/EC mandates the treatment, recovery and recycling of electric and electronic equipment (90% ends up in landfills). All applicable products in the EU market after August 13, 2006 must pass WEEE compliance and carry the "Wheelie Bin" sticker.

GMP

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.

ISO 13485

ISO 13485 is an international standard that specifies requirements for medical device manufacturers. The main goal of ISO 13485 is to provide a harmonized model for quality management system requirements in the international market.  ISO 13485 compliance is therefore of critical importance. A quality management system is critical to ensure your medical product will be manufactured to your specifications for safe intended use every time. With every product submission, the regulatory bodies require proof that your product has been manufactured under a certified quality management system. With the UL ISO 13485 registration service, you will not only have the confidence that your system meets global quality system accreditation requirements, but you will also save time and resources by taking advantage of our local, integrated audits, no matter where in the world your manufacturing, design, packaging, or distribution is done.

SA 8000

SA8000 is a global social accountability standard for decent working conditions, developed and overseen by Social Accountability International(SAI).
Rising public concern about inhumane working conditions in developing countries led to the creation in 1997 of the Council on Economic Priorities Accreditation Agency. Its purpose was to draw up a universal code of practice for labor conditions in manufacturing industry, so that consumers in developed countries could be confident that the goods they were buying - in particular clothes, toys, cosmetics and electronic goods - had been produced in accordance with recognized set of standards.
SA8000 Elements

1.   Child Labor
2.   Forced Labor
3.   Health and Safety
4.   Freedom of Association and Right to Collective Bargaining
5.   Discrimination
6.   Discipline
7.   Working Hours
8.   Compensation
9.   Management Systems

BSCI

The BSCI monitoring system is the European approach to tackling this challenge by improving social performance in supplier countries through a uniform social standards monitoring solution for retail, industry and importers
The BSCI is based on the labour standards of the International Labour Organization (ILO) and other important international regulations like the UN Charta for Human Rights, as well as on national regulations. The Initiative aims at continuously improving the social performance of suppliers, leading to Best Practice like SA8000 certification or equivalents and thus sustainably enhancing working conditions in factories worldwide.

C-TPAT

The Customs-Trade Partnership Against Terrorism and its focus on strengthening supply chain security is an important layer in U.S. Customs and Border Protection's cargo enforcement strategy. It is a voluntary US government-business initiative to build cooperative relationships that improve overall international supply chain and U.S. border security. This initiative was launched to assist the trading community in the war against Terrorism based on the below criteria:

• Business Partner Requirements (Security Procedures)
• Container Security (Seals, Container Inspection etc)
• Physical Access Control
• Procedural Security
• Security Training and Awareness
• Physical Security
• Information Technology.

TS 16949

BRC

ISO 22000

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