ISO Standards

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.

ISO quality standards guide companies and equip them with the necessary tools to continuously improve quality and ensure that customer demands are always met. ISO 9001:2015 is the only standard in the category that you can be certified to and lays down the criteria for a quality management system. There are over one million organizations in over 170 countries that are certified to ISO 9001. 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.

ISO 10002:2018

ISO 10002:2018 is an international standard provides guidance in defining and implementing processes to monitor and measure complaint handling in organization. It is intended for use by organizations regardless of type, size or product provided. The focus of this standard is on customers’ satisfaction. It adopts quality management system to enhance the customer satisfaction. The standard not only helps in handling the customer complaints but also helps in converting the customer complaints as an opportunity to improve the quality of the service. ISO 10002:2018 Certification in India is gaining more attraction towards the organizations to enhance customer satisfaction by handling complaints in smart way.

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 14001:2015

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 14001:2015  use tools such as audits, communications, lifecycle analysis and environmental challenges. This standard can be used by any organization regardless of the industry. More than 300,000 ISO 14001 certifications have been issued in 171 countries

ISO/IEC 17025:2017

General requirements for the competence of testing and calibration laboratories have been developed in order to build confidence in the laboratory activities. NABL Certification and Laboratory accreditation is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests / measurements, based on third-party assessment based on ISO/IEC 17025:2017 standard.

The ISO/IEC 17025 standard is developed based on the ISO Guide 25. ISO 17025 Accreditation is managed by International Laboratory Accreditation Co-operation Committee (ILAC) as well as Asia Pacific Laboratory Accreditation Co-operation Committee (APLAC) Mutual Recognition Arrangements (MRA). ILAC and APLAC are engaged in development and updating of guidelines connected with accreditation activities. Such international arrangements facilitate acceptance of test/calibration results between countries to which MRA partners represent. On accreditation of laboratory by such recognized body, the test / calibration report of laboratory gets global acceptance due to such mutual recognition.

General requirements for the competence of testing and calibration laboratory were initially published in year 1999 and then it was revised in 2005. At present the ISO/IEC 17025:2017 version is published. The ISO 17025:2017 standard for laboratory accreditation is mainly focused on independent testing and calibration laboratories as well as laboratories of company / other laboratory.

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.

ISO 22000:2018 Certification for Food Safety Management System in India

ISO 22000:2018 Certification for Food Safety Management System is a process control system designed to improve quality of the food organizations by identification, evaluation and control of the food safety hazards like physical, chemical, microbiological and other hazards in food production as well as entire food chain. ISO 22000 defines and follows HACCP guidelines, which includes steps designed to prevent problems before they occur and to correct deviations through a systematic way as soon as they are detected. Such preventive control systems with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food.
ISO 22000:2018 enables the producers, processors, distributors, exporters, etc., associated with food products, to utilize technical resources efficiently in a cost-effective manner, which assures food safety.

The ISO 22000:2018 standard outlines Food Safety Management System requirements for any organization in the food chain and is one of a family of standards focused at the development, implementation and improvement of a food safety management system.

ISO/IEC 27001:2022

ISO/IEC 27001:2022 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 27001:2022 are generic and are intended to be applicable to all organizations, regardless of type, size or nature

These standards help organizations manage the security of assets such as intellectual property, financial and employee data, and information held in trust for third parties. ISO/IEC 27001 is the most popular standard in this category and stipulates the specifications for the implementation of an Information Security Management System (ISMS). There are more than 34,000 certificates issued for this certification.

ISO 37001:2016

ISO 37001 – Anti-Bribery Management System helps organizations prevent, detect, and address bribery towards better ethical business culture. ISO 37001 sets out in a manner as to how an anti-bribery management system can function. ISO 37001 is can be applied and is adaptable to varied kinds of organizations. Even if a company had been effected because of incidents of bribery can implement these standards. ISO 37001:2016 Certification makes you bring the world toward better business environment. This certification makes you capable of complying with globally recognized anti-bribery best practices and proves your competence toward implementing and managing anti-bribery management system.
In order to achieve ISO 37001 Certification, organizations can take help from our ISO 37001 Consultant who has rich experience in the field of implementation of this standard.

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 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.

ISO/TS 22163:2023

 ISO 22163:2023 is the international standard for quality management systems (QMS) in the railway sector, replacing ISO/TS 22163:2017. It incorporates ISO 9001:2015 while adding rail-specific requirements such as project management, RAMS (Reliability, Availability, Maintainability, Safety), and life cycle cost analysis. This standard, central to IRIS Certification, aims to enhance supply chain quality and performance.
ISO/TS 22163:2017 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 this International Standard 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 37001:2025

ISO 37001 – Anti-Bribery Management System helps organizations prevent, detect, and address bribery towards better ethical business culture. ISO 37001 sets out in a manner as to how an anti-bribery management system can function. ISO 37001 is can be applied and is adaptable to varied kinds of organizations. Even if a company had been effected because of incidents of bribery can implement these standards. ISO 37001:2025 Certification makes you bring the world toward better business environment. This certification makes you capable of complying with globally recognized anti-bribery best practices and proves your competence toward implementing and managing anti-bribery management system.

In order to achieve ISO 37001 Certification, organizations can take help from our ISO 37001 Consultant who has rich experience in the field of implementation of this standard.

ISO 42001:2023

We offers ISO 42001 Certification consultancy to any organizations that provides or uses any products or services that utilize Artificial Intelligence (AI) management systems. Our team of ISO 42001 Consultants will help you implement artificial intelligence management system (AIMS) effectively and achieve ISO 42001 AIMS Certification from an internationally-accredited certification body in a time and cost-effective manner.

ISO 42001 Certification is given to an organisation by an accredited certification body on fulfilment of the requirements of ISO/IEC 42001: 2023 artificial intelligence management system (AIMS) standard by the organization. It is the world’s first AI management system standard, providing valuable guidance for artificial intelligence systems development, deployment and use.

ISO/IEC 42001 AIMS helps organizations in the ethical, secure, forward-looking and transparent design, development, and deployment of AI technologies. It addresses the unique challenges AI poses, such as ethical considerations, transparency, and continuous learning. With an ISO 42001 certified system, organizations can manage risks and opportunities associated with AI, balancing innovation with governanceIn order to effectively and quickly implement artificial intelligence management system (AIMS) and achieve ISO 42001 Certification, you can reach out to us. Our team of qualified and experienced ISO 42001 Consultants will provide you support at each step of your ISO 42001 Certification journey, exceeding your expectations. Any organisation that wishes to demonstrate compliance with ISO/IEC 42001: 2023 and/or improve their AI system controls can be benefitted by our ISO 42001 certification consultancy services.