ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 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 14001:2015 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 14001:2015 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 14001:2015 does not state specific environmental performance criteria.

ISO 14001:2015 can be used in whole or in part to systematically improve environmental management. Claims of conformity to ISO 14001:2015, however, are not acceptable unless all its requirements are incorporated into an organization’s environmental management system and fulfilled without exclusion.

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.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable 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 regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

Halal in terms of food means that food must be:

• Does not stem from or consists any part or item from animals that are forbidden (pig, carrion, having claws, talons or fangs, etc.) to Muslims by Islamic Law.
• Food when prepared, processed, manufactured, packaged, stored or transported does not come in get in touch with or stored near any food that is forbidden and contain impurities as defined by Islamic Law.
• Animals that are allowable and been slaughtered according to Islamic Law, not killed by strangulation or killed by wild animals.
• Food that is ready processed or manufactured using tools or utensils that are free from infections as defined by Islamic Law.
• Food, be it animal, vegetable, fruit or grain must be healthy and does not contain any substance that is considered impure (alcohol) in Islamic Law.

Halal is an Arabic word that means “permissible.” In terms of food, it means food that is permissible according to Islamic law. For a meat to be certified “halal,” it cannot be a forbidden cut (such as meat from hindquarters) or animal (such as pork.)

ATEX designates hazardous materials such as explosives. It imposes requirements for companies that handle and transport those dangerous materials, and it requires those companies to protect their employees from the risk of explosion.