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What is ISO22301?


ISO22301 Business Continuity Management Systems (BCMS) is a globally recognised standard that ensures organisations have effective plans in place to respond to cyber-attacks through enhanced incident response and business continuity procedures. 


ISO22301 Business Continuity Management Systems (BCMS) is a globally recognised standard  that provides a structured framework for developing business continuity and incident response plans that protect organisations, their partners and customers from the adverse effects of cyber-attacks


The standard can be applied across a broad range of sectors and should be implemented by both developers of technology and deployers of IT systems such as hospitals, industrial facilities and medical laboratories.

By developing procedures, policies and documentation according to the best practice defined in ISO22301, organisations can minimise the business impact of cyber-attacks and enhance public safety.

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THE ISO42001 process

In a similar way to other commonly deployed standards (e.g. ISO27001), ISO42001 focuses on the development of robust governance frameworks for the management of technology based risks rather than a discussion of scientific technicalities. In order to successfully comply with ISO42001, organisations need to consider the following key principles.

ISO42001 Requires Executive Engagement 

To manage the risks of any AI solution effectively, its deployment needs to be seen as a strategic choice made by an organisation's leadership. Senior stakeholders must be engaged in defining the business use case of AI systems and in determining the business impact of any risks that are identified. Executive leadership will be responsible for signing off an organisation's AI policy.

ISO42001 Requires a Robust Risk Assessment

To maximise the benefits associated with AI, risks need to be identified, documented and quantified for a business in granular detail utilising a structured methodology. Documents such as risk registers and hazard logs will be required which catalogue risk scores based on severity and likelihood of each risk for a business and its customers. This process includes an analysis of any third parties in an organisation's supply chain that will interact with an AI system.

ISO42001 Requires the Implementation of Risk Management Controls

The purpose of any risk assessment is to determine how risks that threaten a business and its customers can be managed to an acceptable level. Doing this requires the identification, documentation and implementation of controls which will protect the business from the malfunction of AI systems.

ISO42001 Requires Ethical Data Management Processes

Due to the volume of data utilised by AI systems it is critical to have transparent data processing and management processes that are aligned with ethical regulatory requirements (e.g. GDPR; The EU AI Act) and which preserve the rights of citizens.

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Do I need ISO42001?

If you are developing or deploying AI systems in safety critical sectors such as healthcare, law enforcement and industrial facilities then it is highly advisable to, at the very least, develop documentation aligned with ISO42001.

Following ISO42001 provides your organisation, customers, partners and regulators peace of mind that you are responsible users of AI and that your solutions are optimised to minimise risks. This will enhance your position in your market and reduce the threat of regulatory or legal penalties.

Additionally, as regulatory agencies across multiple jurisdictions mandate stricter requirements for the use of AI systems it is likely that these will be aligned with ISO42001. Having ISO42001 documentation already prepared will be an effective demonstration of compliance preventing any barriers to business globally.

Contact our consultants today to find out how we can support your compliance with ISO42001.

Why choose The AbedGraham Group for ISO42001?

At The AbedGraham Group, we have an extensive track record working with companies, government agencies and regulators to  advise about and implement safety critical standards across the world. The benefits of using The AbedGraham Group as your trusted compliance provider include:

Track Record

We have managed safety standards for hundreds of products and taken organisations through all aspects of national and regional frameworks often supporting compliance as a part of direct bids for business. Our experience in this area and the granularity of our documents are unsurpassed in the marketplace.

Diverse Experience

Having covered over a hundred products in safety critical sectors such as healthcare with a team that has decades of frontline experience across all areas, we are well-placed to manage risk for any product coming to market. 

Peace of Mind 

Navigating safety in product development and deployment requires reliability, evidence-based information, and trustworthiness. With our extensive experience, we've encountered various requests and challenges. Many companies pay mere lip service to risk management, leading to complications with regulators and prospective customers. Our experts will ensure you avoid these issues expediting procurement and deployment of AI systems.

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Ready To Speak to One of the team?

If you need help with your ISO42001 or any other safety standard, partnering with The AbedGraham Group will ensure your applications run smoothly and that you are able to operate effectively in your sector.

​Contact The AbedGraham Group
Contact us today to leverage the power of clinically led consulting.
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