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ISO (the International Organization for Standardization) is an international standard development organization composed of representatives from the national standards organizations of member countries. The organization develops and publishes standardization in all technical and nontechnical fields other than electrical and electronic engineering, which is handled by the IEC. Its headquarters are in Geneva, Switzerland, and it operates in 167 countries as of 2023.
Management system
standards
ISO 13485:2016 Medical devices
Medical devices: Quality management systems — Requirements for regulatory purposes.
Requirements for a quality management system that can be used by an organization involved in one or more stages of the life cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or in the provision of associated supply, service, technical or support activities.
Conformity with ISO 13485 is a mandatory requirement in many countries, controlled through regulatory bodies including TGA, FDA, MHRA, EMA, and EU MDD.
ISO 14001:2015 Environment
Environmental management systems – requirements with guidance for use.
Specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. It 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 22000:2018 Food safety
Food safety management systems — Requirements for any organization in the food chain.
Specifies requirements for a food safety management system (FSMS) to enable an organization that is directly or indirectly involved in the food chain, to provide products and services that are safe, in accordance with their intended use, and comply with applicable statutory and regulatory food safety requirements.
It is often compared to Hazard Analysis Critical Control Point (HACCP) which is a food safety management system which specifies risk control and prevention of food hazards, that can cause food to become unsafe, unhygienic and contaminated.
ISO 22000 focuses on the analysis of all food safety risks to create a formal FSMS, whilst HACCP only focuses on food safety matters.
ISO 27001:2022 Information security
Information security, cybersecurity and privacy protection — Information security management systems — Requirements.
Specifies requirements for establishing, implementing, maintaining and continually improving an information security management system, including requirements for the assessment and treatment of information security risks relevant to an organisation.
An effective ISMS preserves the confidentiality, integrity and availability of information by applying a risk management process to give confidence to interested parties that risks are adequately managed.
ISO 45001:2018 Health and safety
Occupational health and safety management systems – Requirements with guidance for use.
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. Fulfilment of legal and any mandated requirements must be demonstrated.
ISO 50001: 2018 Energy
Energy management systems — Requirements with guidance for use.
Specifies requirements for establishing, implementing, maintaining and improving an energy management system (EnMS). The intended outcome is to achieve continual improvement of energy performance, and meet climate change mitigation goals by reducing energy-related greenhouse gas emissions. An EnMS can be integrated with an Environmental Management System, as part of an organisation’s overall environmental and sustainability strategy.
AS 9100D Advanced Quality for aerospace
Quality Management Systems — Requirements for Aviation, Space and Defense Organizations.
AS9100D includes all of the content from ISO 9001 and inserts additional requirements that meet the needs of the aerospace industry. It is maintained by the Aerospace division of SAE International and the International Aerospace Quality Group (IAQG) It is a particular requirement for organisations looking to supply the aviation, space or defense industries.
Support services
Compliance Monitoring
Advice on changes to standards, health and safety laws, environmental laws, industry regulations and statutory and regulatory requirements for business.
System Maintenance
Document control, internal audits, reviews, corrective actions and improvements, risk reviews, legislation updates, external auditor selection, preparing and attending external audits.
Plain-English writing
Operations manuals, franchise manuals, safety and environmental management plans, staff induction handbooks, HR manuals, forms, work instructions, SWMS.
Training
Safety and environmental hazard and risk management, enterprise risk management, internal auditing and reviews, understanding the Standards and compliance, guide to integration.
Internal auditing and 2nd party auditing
Quality, Safety, Environmental, Medical Devices, Food Safety, IT Security, RAWS
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