Management System Standards

ISO 9001 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) 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 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 14001 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

ISO 14001 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. Consistent with the organization's environmental policy, the intended outcomes of an environmental management system include:
- enhancement of environmental performance;
- fulfilment of compliance obligations;
- achievement of environmental objectives.

ISO 14001 is applicable to any organization, regardless of size, type and nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective. ISO 14001 does not state specific environmental performance criteria.

ISO 14001 can be used in whole or in part to systematically improve environmental management. Claims of conformity to ISO 14001, however, are not acceptable unless all its requirements are incorporated into an organization's environmental management system and fulfilled without exclusion.

ISO 45001 is an Occupation Health and Safety Assessment Series for health and safety management systems. It is intended to help an organizations to control occupational health and safety risks. It was developed in response to widespread demand for a recognized standard against which to be certified and assessed.

ISO 13485 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 requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO 13485, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.

ISO 22000 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 ISO 22000 can be accomplished through the use of internal and/or external resources.

ISO 22000 specifies requirements to enable an organization
 -- to plan, implement, operate, maintain and update a food safety management system aimed at providing products that, according to their intended use, are safe for the consumer,
 -- to demonstrate compliance with applicable statutory and regulatory food safety requirements,
 -- to evaluate and assess customer requirements and demonstrate conformity with those mutually agreed customer requirements that relate to food safety, in order to enhance customer satisfaction,
 -- to effectively communicate food safety issues to their suppliers, customers and relevant interested parties in the food chain,
 -- to ensure that the organization conforms to its stated food safety policy,
 -- to demonstrate such conformity to relevant interested parties, and
 -- to seek certification or registration of its food safety management system by an external organization, or make a self-assessment or self-declaration of conformity to ISO 22000.

ISO/IEC 27001 specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within the context of the organization. It also includes requirements for the assessment and treatment of information security risks tailored to the needs of the organization. The requirements set out in ISO/IEC 27001 are generic and are intended to be applicable to all organizations, regardless of type, size or nature.

ISO 22301 specifies requirements to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from disruptive incidents when they arise.

The requirements specified in ISO 22301 are generic and intended to be applicable to all organizations or parts thereof, regardless of type, size and nature of the organization. The extent of application of these requirements depends on the organization's operating environment and complexity.

CE marking is a mandatory conformity marking for certain products sold within the European Economic Area (EEA) since 1985.[1]The CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in, the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense similar to the FCC Declaration of Conformity used on certain electronic devices sold in the United States.
The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.

ISO/IEC 20000-1 is a service management system (SMS) standard. It specifies requirements for the service provider to plan, establish, implement, operate, monitor, review, maintain and improve an SMS. The requirements include the design, transition, delivery and improvement of services to fulfill agreed service requirements.

ISO 3834-1 provides criteria to be taken into account for the selection of the appropriate level of quality requirements for fusion welding of metallic materials, among the three levels specified in ISO 3834-2 ISO 3834-3 and ISO 3834-4. It applies to manufacturing, both in workshops and at field installation sites.

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.

RoHS, also known as Lead-Free, stands for Restriction of Hazardous Substances. RoHS, also known as Directive 2002/95/EC, originated in the European Union and restricts the use of six hazardous materials found in electrical and electronic products.

Halal is Arabic for permissible. Halal food is that which adheres to Islamic law, as defined in the Koran. The Islamic form of slaughtering animals or poultry, dhabiha, involves killing through a cut to the jugular vein, carotid artery and windpipe.

Carbon credits are measurable, verifiable emission reductions from certified projects that reduce, remove or avoid greenhouse gas (GHG) emissions. Additionally they also empower communities, restore forests, protect ecosystems or reduce reliance on fossil fuels.

Through carbon markets, Organizations as well as Individuals can neutralize or offset their emissions by investing in emissions avoidance / reductions / in projects that remove carbon from the atmosphere. They can also pay other companies who have excess carbon allowance in their carbon budget.

Being FSC certified means that your forest, or supply chain, is managed responsibly; that you comply with our environmental, social, and economic standards. This covers much more than the trees themselves – among other things, it makes sure that local communities are respected, protects the habitats of endangered plant and animal species, and ensures workers are properly paid.