Sunday, September 9, 2018

Regulatory Standards and Regulatory Compliance


Compliance

Compliance means conforming to a predefined rule, like; specifications, policies, and standards.

Regulatory Compliance

Regulatory Compliance defines the goal that establishments aim to attain in their work to confirm that they know or are aware and they take steps to comply with applicable policies, rule and regulations.
Regulatory Compliance
Regulatory Compliance

Regulatory Standards

Benchmarks circulated by regulatory agencies that were made to impose the necessities of regulation or laws.
In detail we can say that, a standard (in French called as “norme” and in German called as “Norm”) is a statutory article that delivers instructions, procedures or characteristics for accomplishments or their outcomes. Standards are formed by getting together all concerned parties i.e. manufacturers, consumers and controllers of a specific material, product, process or service. Everybody profits from regulation by better product safety and quality as well as lesser operation costs.

Importance of Regulatory Standards

Regulatory Standards are important because, the final product will be complying with these standards and it will be easy for manufacturers for free-flow of their products in the market without any legal action.
These Regulatory Standards are varies from country to country and mainly depends on their respective local conditions like; health, safety and environmental. So, these standards give guidance to manufacturers to enhance their products before launching these products in the market.
Regulatory Standards make aware the Design engineers about the test parameters of the product. So, engineers follow these parameters in the design of the product from beginning. Also, will help the manufacturers for the certification of the products.

Regulatory Standards issues

Always development is going on and agencies use to update the standards with the new development. Very hard to keep pace with them. Sometimes in an amendment of a standard, it’s hard to understand the new requirements.
Sometimes these Regulatory Standards are varies from country to country. So manufacturers have to follow domestic and international Regulatory Standards.
Manufacturers have to contact different agencies for their product testing, if they target international markets. May be an international agency follows the Regulatory Standards, which is not followed by a domestic agency. So, manufacturer has to again comply and test the product according to that particular standard.
Standards are difficult to understand. Sometimes has to take help of external agency.

Regulatory Bodies

Below is the list of agencies or bodies who normally deals with creation of Regulatory Standards;

ANSI (The American National Standards)
It is a private non-profit association that supervises the growth of voluntary agreement standards for products, services, processes, systems, and personnel in the United States. The organization also organizes U.S. standards with international standards so American products can be used universally.

EC (European Community) Directives –
These are one of the legal instruments available to the European institutions for implementing European Union policies. Manufacturers who want to sell their product in the European Community must meet the relevant directives.

What is Directive? – It is a lawful action of the European Union which needs member states to attain a specific outcome without saying the means of attaining that result. On the other hand regulations are self-executing and do not need any executing actions. Directives usually leave member states with a definite amount of scope, as the precise guidelines to be accepted. Directives can be accepted by means of a selection of statutory processes liable on their matter.

EN (European Norm) –
Standards focussed more for the European market. These standards have been accepted by one of the three known European Standardization Organizations – CEN (the European Committee for Standardization), CENELEC (the European Committee for Electrotechnical Standardization) or ETSI (the European Telecommunications Standards Institute). It is formed by all interested parties through a clear, open and agreement based process.

IEC (International Electrotechnical Commission) –
It is an international standards society that makes and issues International Standards for all electrical and electronic technologies. IEC standards are available for power generation, power transmission, power distribution, home appliances, office equipment, semiconductors, batteries, solar energy, nanotechnology and many more.

CSA (Canadian Standards Association) –
It is a member of the CSA Group and provides product analysis and certification facilities for electrical, mechanical, plumbing, gas and many more products. To use an electrical or electronic product within Canada we have to follow this safety approval. A CSA endorsement can also be achieved through the Underwriter’s Laboratory (UL).

UL (Underwriter’s Laboratory) –
UL provides safety consulting and certification. It certifies, validates, tests, verifies, inspects, audits, advises and educates. UL does not “accept or approve” products. But it assesses items, components or parts, resources or materials and systems for compliance to particular necessities, and certifies suitable products to mark a UL certification. For USA it provides safety approvals for electrical and electronics products. A UL endorsement can also be achieved by the Canadian Standards Association (CSA).

ETSI (European Telecommunications Standards Institute) –
The European Telecommunications Standards Institute (ETSI) is a self-governing, non-profitable, standardization society in the telecommunications sector (for both equipment makers and network operators) in Europe. Their Regulatory Standards are mostly for telecom equipment and services. In other words we can say that ETSI creates globally-applicable criteria for Information and Communications Technologies (ICT), containing fixed telecom, mobile, wireless, broadcast and internet technologies.

Telcordia –
They make standards for telecom equipment in the United States. Along with Ericsson, they arranged a sequence of common vendor-neutral standards for general norms for telecommunication equipment’s, systems and services.

Conclusion

Now we are aware about Regulatory Standards, difference between Regulatory Standards and Regulatory Compliance, advantages and disadvantages of it and the agencies who are dealing with it. Even these standards and certification process for compliance of our product is costly and time consuming but it creates a good image of our product in market in terms of safety and reliability.

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