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ISO 31000:2009
ISO 31000:2018 provides guidelines on managing risk faced by organizations. The application of these guidelines can be customized to any organization and its context.
ISO 31000:2018 provides a common approach to managing any type of risk and is not industry or sector specific.
ISO 31000:2018 can be used throughout the life of the organization and can be applied to any activity, including decision-making at all levels.
INDUSTRIAL DOCUMENTATION, IMPLEMENTATION, CERTIFICATION, CONSULTANCY
Quality Products Inc.(India), GST NO : 24AMSPC2715L1ZZ
106, Solitaire Arcade, Nr. G, E.B, Dehgam Rd, Opp. Vitthal Plaza, New Naroda, Ahmedabad, Gujarat – 382330
Contact : +91 9726703733 / +91 9737725783 / +91 9924924123 / +91 9924990082
E.mail : qualityproductsinc2020@
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Related Products
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.
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
This document specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain:
a) to plan, implement, operate, maintain and update a FSMS providing products and services that are safe, in accordance with their intended use;
b) to demonstrate compliance with applicable statutory and regulatory food safety requirements;
c) to evaluate and assess mutually agreed customer food safety requirements and to demonstrate conformity with them;
d) to effectively communicate food safety issues to interested parties within the food chain;
e) to ensure that the organization conforms to its stated food safety policy;
f) to demonstrate conformity to relevant interested parties;
g) to seek certification or registration of its FSMS by an external organization, or make a self-assessment or self-declaration of conformity to this document.
All requirements of this document are generic and are intended to be applicable to all organizations in the food chain, regardless of size and complexity. Organizations that are directly or indirectly involved include, but are not limited to, feed producers, animal food producers, harvesters of wild plants and animals, farmers, producers of ingredients, food manufacturers, retailers, and organizations providing food services, catering services, cleaning and sanitation services, transportation, storage and distribution services, suppliers of equipment, cleaning and disinfectants, packaging materials and other food contact materials.
This document allows any organization, including small and/or less developed organizations (e.g. a small farm, a small packer-distributor, a small retail or food service outlet) to implement externally-developed elements in their FSMS.
Internal and/or external resources can be used to meet the requirements of this document.
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.
ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.
ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.
ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization’s OH&S policy, the intended outcomes of an OH&S management system include:
a) continual improvement of OH&S performance;
b) fulfilment of legal requirements and other requirements;
c) achievement of OH&S objectives.
ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization’s control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.
ISO 45001:2018 does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system.
ISO 45001:2018 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing.
ISO 45001:2018 does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.
ISO 45001:2018 can be used in whole or in part to systematically improve occupational health and safety management. However, claims of conformity to this document are not acceptable unless all its requirements are incorporated into an organization’s OH&S management system and fulfilled without exclusion.
To put it simply, an FCC-compliant device is one that follows the rules and regulations the FCC has laid down. The Federal Communications Commissions governs a wide range of communications devices, as well as electronics with the potential to interfere with them
A trademark can be any word, phrase, symbol, design, or a combination of these things that identifies your goods or services. It’s how customers recognize you in the marketplace and distinguish you from your competitors. … A trademark is used for goods, while a service mark is used for services.
What is a trademark? A trademark is a sign capable of distinguishing the goods or services of one enterprise from those of other enterprises. Trademarks are protected by intellectual property rights.
This document specifies requirements for establishing, implementing, maintaining and improving an energy management system (EnMS). The intended outcome is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance and the EnMS.
This document:
a) is applicable to any organization regardless of its type, size, complexity, geographical location, organizational culture or the products and services it provides;
b) is applicable to activities affecting energy performance that are managed and controlled by the organization;
c) is applicable irrespective of the quantity, use, or types of energy consumed;
d) requires demonstration of continual energy performance improvement, but does not define levels of energy performance improvement to be achieved;
e) can be used independently, or be aligned or integrated with other management systems.
Annex A provides guidance for the use of this document. Annex B provides a comparison of this edition with the previous edition.
RoHS means “Restriction of Certain Hazardous Substances” in the “Hazardous Substances Directive” in electrical and electronic equipment. This restriction is anchored in EU Directive 2011/65 / EU. … Examples of such substances are lead, mercury, hexavalent chromium and cadmium.
The RoHS Directive aims to prevent the risks posed to human health and the environment related to the management of electronic and electrical waste. It does this by restricting the use of certain hazardous substances in EEE that can be substituted by safer alternatives.
On commercial products, the letters CE mean that the manufacturer or importer affirms the good’s conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark
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