Overview : know all about iso certification,ce certification & WHO GMP Certification,Process to obtain,benefits & Required documents for iso ce & GMP certification in india www.luxefinalyzer.com
Overview : know all about iso certification,ce certification & WHO GMP Certification,Process to obtain,benefits & Required documents for iso ce & GMP certification in india www.luxefinalyzer.com
ISO 9001:2015 Quality management System specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
ISO 22000:2005 Food Safety Management ISO 22000 sets out what an organization needs to do to ensure their food is safe for public consumption. It contains guidelines that can be used at all points in the industry, no matter the size of the business.
ISO 14001-2004 is an obsolete Standard, this certification is not in operation and any certificate issued under this standard is void now. New version of the Environmental Management System is ISO 14001:2015. ISO 14000 refers to a family of standards including ISO14001, 14004, 14005 among others. These standards can help organizations deal with environmental issues such as reducing raw material use, reduce energy consumption, improve efficiency and reduce waste. In this family, ISO 14001:2004 can be certified against. The ISO 14001 standard deals with the environmental management system requirements; ISO 14001:2004 certifications are intended for any organization whose processes impact the environment.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
ISO 27001:2005 is an international standard specifies the management of security system and manages the risks to the security of information you hold. The certification to ISO 27001 allows you to demonstrate your clients that you are managing, operating, monitoring, measuring, reviewing, executing and improving a documented Information Security Management System under your control. ISO 27001:2005 provides a set of standardized requirements for an information security management system, to implement the security controls which are customized to the needs of individual organizations. The standard covers all types of organizations
ISO 50001:2011 specifies requirements for establishing, implementing, maintaining and improving an energy management system, whose objective is to enable an organization to follow a organized approach in achieving continual improvement of energy performance, including energy efficiency, energy use and consumption. ISO 50001:2011 specifies requirements applicable to energy use and consumption, including measurement, documentation and reporting, design and procurement practices for equipment, systems, processes and personnel that contribute to energy performance. ISO 50001:2011 applies to all variables affecting energy performance that can be monitored and influenced by the organization.
ISO/IEC 27001:2013 is an information security management standard. It defines a set of information security management requirements. The official complete name of this standard is ISO/IEC 27001:2013 Information technology - Security techniques - Information security management systems – Requirements The purpose of ISO IEC 27001 is to help organizations to establish and maintain an information security management system (ISMS). An ISMS is a set of interrelated elements that organizations use to manage and control information security risks and to protect and preserve the confidentiality, integrity, and availability of information.
OHSAS 18001:2007 certification Adaption of ohsas 18001 should be an planned Decision of any Organization; Design & Implementation & time required is basically depend on the various factor.OHSAS 18001: "Quality Management System". ISO 9001:2015 standards basically focus what the organization do to fulfill:
· CE Marking Certification-CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards.
Good manufacturing practice (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. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.
Documents Required for ISO Certification/CE Certification/GMP Certification
Registration Certificate
Scope of Business
2 Sale purchase bill
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