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ISO 9001:2015
ISO 9001:2015 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 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
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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ISO 45001:2018
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.
ISO 29990:2010
ISO 29990:2010 specifies basic requirements for providers of learning services in non-formal education and training.
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.
ISO 20000:2011
ISO/IEC 20000-1:2011 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 fulfil agreed service requirements.
ISO/IEC 20000-1:2011 can be used by:
- an organization seeking services from service providers and requiring assurance that their service requirements will be fulfilled;
- an organization that requires a consistent approach by all its service providers, including those in a supply chain;
- a service provider that intends to demonstrate its capability for the design, transition, delivery and improvement of services that fulfil service requirements;
- a service provider to monitor, measure and review its service management processes and services;
- a service provider to improve the design, transition, delivery and improvement of services through the effective implementation and operation of the SMS;
- an assessor or auditor as the criteria for a conformity assessment of a service provider’s SMS to the requirements in ISO/IEC 20000-1:2011.
FDA COMPLIANCE
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.
CE COMPLIANCE
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
SA 8000:2014
What is SA 8000?
SA 8000 (Social Accountability 8000) is the first international certification on social responsibility. Its main objective is to guarantee workers’ rights in such a way that everyone involved wins: companies, workers, trade unions, government.
FCC COMPLIANCE
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
TRADEMARK
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.
HACCP
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level.
ISO 13485:2016
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 50001:2018
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.
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