ISO 13485:2016 – Medical Devices Quality Management System: 

Safety and quality are non-negotiable in the medical device industry.

Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practices in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical device industry.

ISO 14001:2015 – Environment Management System: 

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;
• fulfillment 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 45001:2018 – Occupational Health & Safety Management System: 

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 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:

1. a) continual improvement of OH&S performance.
2. b) fulfillment of legal requirements and other requirements;
3. 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 27001:2013 – Information Security Management System: 

ISO/IEC 27001:2013 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 established in ISO/IEC 27001:2013 are generic and are intended to be applicable to all organizations, regardless of type, size or nature.

ISO 22000:2018 – Food Safety Management System

The consequences of unsafe food can be serious. ISO’s food safety management standards help organizations identify and control food safety hazards, at the same time as working together with other ISO management standards, such as ISO 9001. Applicable to all types of producers, ISO 22000 provides a layer of reassurance within the global food supply chain, helping products cross borders and bringing people food that they can trust.

ISO 20000-1:2018 – IT Service Management System

IT is essential to delivering today’s business. However, concerns are increasingly being raised about IT services, internal and outsourced, not aligning with the needs of businesses and customers. A recognized solution to this problem is to use an IT Service Management System (ITSMS) based on ISO/IEC 20000, the international standard for IT service management. Certification to this standard enables you to independently demonstrate to your customers that you meet best practice. ISO/IEC 20000 is based on and replaces BS 15000, the internationally recognized British Standard.