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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
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E.mail : qualityproductsinc2020@
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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 22000:2018
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.
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.
APEDA REGIATRATION
What is APEDA Licence?
The Agricultural and Processed Food Products Export Development Authority (APEDA) was established by the Government of India under the Agricultural and Processed Food Products Export Development Authority Act passed by the Parliament in December, 1985.
What is the role of APEDA?
APEDA is mandated with the responsibility of export promotion and development of the following scheduled products: Fruits, Vegetables and their Products. Meat and Meat Products. Poultry and Poultry Products.
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
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 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.
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.
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.
Organic Compliance
What is meant by organic certification?
Organic certification system is a quality assurance initiative, intended to assure quality, prevent fraud and promote commerce, based on set of standards and ethics. It is a process certification for producers of organic food and other organic plant products.
Purpose of certification
Organic certification addresses a growing worldwide demand for organic food. It is intended to assure quality and prevent fraud. For organic producers, certification identifies suppliers of products approved for use in certified operations.
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.
FSSAI
The Food Safety and Standards Authority of India (FSSAI)
has been established under Food Safety and Standards Act, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments.
FSSAI registration is mandatory compliance that ensures the safety of food products supplied or manufactured by various establishments in India. It is a food safety certificate issued by the respective food authority of India. … Obtaining an FSSAI license is mandatory before starting any food business operation in India.
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