About ISO CE Marking
The CE marking requirements covers different aspects of a product�s design, production and distribution. Typically, various companies are involved in the design, manufacturing, distribution and placing on the market of products.
The European CE marking directives, intend to make one person the main responsible and accountable for CE compliance Certificate. The way to identify that responsible person is rather unique for these directives.
ISO 14001:2015 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,
The ISO 9001:2015 certification is an international standard that defines good management practices. The certification aims at providing a global standard that spells out quality and trust. To meet the requirements for the ISO 9001:2015 certification, an organisation should demonstrate its ability to consistently provide products that meet applicable regulatory requirements and continue to meet changing expectations of customers..
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997).
ISO/IEC 20000 is the renowned international standard for IT Service Management. ISO/IEC 20000 standard is for organizations involved with for IT Service Management. ISO/IEC 20000 standard was released in 2005 based on the IT Infrastructure Library and was updated in 2011. ISO/IEC 20000 standard allows implementation of proven best practice in IT management and help organizations in achieving continual improvement in IT Service Management.
ISO/TS 16949:2009, in conjunction with ISO 9001:2008, defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive-related products.ISO/TS 16949:2009 Certificate is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured.
RoHS, short for Restriction of Hazardous Substances, is specific to the European Union. The law revolves revolves the handling of hazardous materials, ranging from the manufacturing to the disposal of the material. While created inside of Europe for members of the European Union, other regions around the world have utilized and created offshoots of the ROHS Certificate. This includes nations throughout Asia (China, Japan and South Korea) and versions of it inside of North America as well.
ISO 22000:2005 Certificate is a Food Safety Management Certification Scheme. This means that a company can achieve Certification to ISO 22000. Certification shows customers and potential customers that the company has a comprehensive and effective management system to control food safety hazards. The current revision of the Food Safety Management System Standard is ISO 22000:2005
ISO CONSULTANTS & CERTIFICATION IN DELHI, INDIAISO CONSULTANTS & CERTIFICATION IN DELHI, INDIA
The ISO 9001 standard helps you develop a Quality Management System
(QMS) to meet your customers' quality requirements while continually
improving operational processes. Since the standard is neither industry-
nor product-specific, it may be used by any organization that provides a
product or service.
The result of using ISO 9001 is shorter lead times, high delivery reliability, and consistently high quality of services and products, benefiting both your customers and your business.
This standard is based on a number of quality
management principles including a strong customer focus, the motivation
and implication of top management, the process approach and continual
improvement. These principles are explained in more detail in the pdf
Quality Management Principles. Using ISO 9001:2015 helps ensure that
customers get consistent, good quality products and services, which in
turn brings many business benefits.
Good Manufacturing Practice (GMP)
A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff, Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.
Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.
The CE marking is a key indicator (but not proof) of a products compliance with European Union (EU) health, safety and environmental protection directives and regulations. If your product comes under the scope of a directive requiring CE marking you must ensure the product complies with the applicable requirements and affix the CE mark before placing it in the market in the European Economic Area (EEA) (see Countries In Which The CE Marking Is Required below for a description of the countries that are included in the EEA). This is equally valid if your product is manufactured outside the EEA. Second hand products from outside the EEA that are placed in the EEA market for the first time, also require CE marking.
"CE marking" is also a process that applies to a wide variety of products and one which manufacturers located in the EU or importers of goods into the EU must complete. The CE mark is affixed to the product as the final stage of this process and is effectively a statement from the manufacturer (or importer) that the process has been successfully completed and that the product meets the essential requirements of the relevant CE marking Directives.
HACCP auditors must understand the federal regulations that govern production of food and drugs. Certification ensures that a person is aware of such procedures and is well-versed in inspection of proper protocols to ensure safety. Certification examines the ability of an applicant to identify, evaluate and make recommendations on the steps in the production process that may be inadequate.
Certification for ISI mark is given by the Bureau of Indian Standards (BIS), the National Standards Body of India, involved in the development of technical standards (popularly known as Indian Standards), product quality.
We offer one of the best services as ISI consultants to all the companies irrespective of their sizes and nature. We provide with ISI certification services in which we help you achieve ISI certificate by improving you management system and thereby your quality standards. By this you not only get an ISI certificate but your company benefits on a whole as it starts working in a better manner. By our efforts, we have also gained the position of one of the renowned ISI certification consultants in India.
The Product Certification Scheme of BIS aims at providing Third Party Guarantee of quality, safety and reliability of products to the ultimate customer. Presence of ISI certification mark known as Standard Mark on a product is an assurance of conformity to the specifications. The conformity is ensured by regular surveillance of the licensee's performance by surprise inspections and testing of samples, drawn both from the market and factory.
ISO 13485:2012 is suitable for all the organizations involved in the medical device life-cycle and looking for an improvement in the way it is operated and managed. In recent years, ISO 13485:2012 has become the worldwide reference standard for the companies dealing with medical devices.
ISO 13485:2012 is in part designed to produce a management system that facilitates compliance to the requirements of customers and per-eminently various global regulators. While being certified to ISO 13485:2012 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organizations management system to the requirements of the FDAs Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, ISO 13485:2012 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.
The underlying purpose of an Environmental Management System (EMS) is to support an organizations environmental, and increasingly, its sustainable mission. An EMS helps identify shortfalls in an organizations structure related to its environmental responsibilities and helps determine the various and interdependent resources needed to achieve its stated environmental, social and governance (ESG) goals.
EMS programs, as a part of the organizations business enterprise, have proven their value by effectively streamlining operations, controlling and reducing related environmental compliance costs, and helping to identify areas where waste can be reduced and efficiencies can be increased, thus saving monies and other resources for the organization. Business-savvy organizations in both the private and public sector have experienced first-hand the benefits of implementing an EMS as a management tool to plan for and exceed ever-growing environmental performance expectations of both stakeholders and employees.
The ISO/IEC 20000 series draws a distinction between the best practices of processes, which are independent of organizational form or size and organizational names and structures. The ISO/IEC 20000 series applies to both large and small service providers, and the requirements for best practice service management processes are independent of the service provider's organizational form. These service management processes deliver the best possible service to meet a customer's business needs within agreed resource levels, i.e. service that is professional, cost-effective and with risks which are understood and managed.
This International Standard ISO 22000:2005 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 this International Standard can be accomplished through the use of internal and/or external resources.
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.
The ISO/TS 16949 was jointly developed by the IATF members and submitted to the International Organization for Standardization (ISO) for approval and publication. The document is a common automotive quality system requirements catalog based on ISO 9001:2008, and specific requirements from the automotive sector. This document, coupled with customer-specific requirements defines quality system requirements for use in the automotive supply chain.
The IATF has developed a common registration scheme for supplier 3rd party registration to the ISO/TS 16949. The registration scheme includes third party auditor qualifications and common rules for consistent global registration.
The main purpose of NABH accreditation is to help planners to promote, implement, monitor and evaluate robust practice in order to ensure that occupies a central place in the development of the health care system. Quality Assurance should help improves effectiveness, efficiency and in cost containment, and should address accountability and the need to reduce errors and increase safety in the system.
Thus the objective of NABH accreditation is on continuous improvement in the organizational and clinical performance of health services, not just the achievement of a certificate or award or merely assuring compliance with minimum acceptable standards.
National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories.
OHSAS 18001:2007 is an occupational health and safety (OH&S) standard.
Use it to establish your occupational health & safety management system (OHSAS).
OHSAS 18001:2007 and accompanying OHSAS 18002, Guidelines for the implementation of OHSAS 18001,have been developed in response to customer demand for a recognizable occupational health and safety
management system standard against which their management system can be assessed and verified.
Occupational Health and Safety is based on:
The process of recognizing that a hazard exists (source or situation with
the potential to cause harm in terms of human injury or ill-health)
The process of evaluating the risk arising from the hazard (combination
of the likelihood of a hazardous event or exposure and the severity of
injury or ill health that can be caused by the event of exposure)
Determination of applicable controls
Measures relevant to eliminate or reduce risk to an acceptable level.
Measures are based on the hierarchy of control measures.
RoHS, short for Restriction of Hazardous Substances, is specific to the European Union. The law revolves revolves the handling of hazardous materials, ranging from the manufacturing to the disposal of the material. While created inside of Europe for members of the European Union, other regions around the world have utilized and created offshoots of the RoHS. This includes nations throughout Asia (China, Japan and South Korea) and versions of it inside of North America as well. Manufacturers of hazardous material must become ROHS compliant in order to sell and distribute the product inside of the European Union, which is exactly why it is so good for a company to obtain these credentials. The specific process set in place to assist these companies is rather straight forward though, so it should not prove difficult to follow through with the RoHS certification and RoHS compliance regulations.
The SA 8000 Certification is the Social Accountability System standard. It is applicable to companies of any size that wish to address the social and ethical aspects of their business. A Social Accountability System proves to customers that the company holds adequate provisions for the protection of workers' rights. Further, it ensures ethical production of all goods manufactured by the company.
SA 8000 is the first audit able standard in this field. The initiative is based on the well-known ISO 9001/ISO 14001 certification structure, conventions of the International Labor Organization (ILO), the Universal Declaration of Human Rights and the UN Convention on the Rights of the Child.
TL 9000 Certification eliminates the need for multiple telecom quality management standards, reduces costs of doing business and ultimately results in better products and services to consumers. Whats more, it provides the consistent set of quality expectations needed to drive efficiency and performance across the global telecommunications supply chain.
The TL 9000 Quality Management System requires an organization to engage in continual improvement of products, services or processes. TL 9000 is both a quality management and measurement system comprised of two parts.
This part of ISO 15000 describes and specifies a new approach to the well-understood problem of the lack of information interoperability between applications in the e-business arena. Traditionally, standards for the exchange of business data have been focused on static message definitions that have not enabled a sufficient degree of interoperability or flexibility. A more flexible and interoperable way of standardizing Business Semantics is required. The Core Component solution described in this specification presents a methodology for developing a common set of semantic building blocks that represent the general types of business data in use today and provides for the creation of new business vocabularies and restructuring of existing business vocabularies.
ROHS Certification & Consultants
National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programmer for healthcare organizations.
National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the aegis of Department of Science & Technology, Government of India, and is registered under the Societies Act.
HACCP involves a system approach to identification of hazard, assessment of chances of occurrence of hazards during each phase, raw material procurement, manufacturing, distribution, usage of food products, and in defining the measures for hazard control.