Environmental Policy

Spotlight Pathology provides AI-driven in vitro diagnostic medical devices [software as a medical device (SaMD)] to aid in the diagnosis of blood cancers. We recognise that our operations affect the environment, particularly through the design, development and manufacturing of our devices.

Our Senior Management Team (SMT) establishes, implements and maintains this policy within the defined scope of our environmental management system. It reflects our purpose, operating context, and the nature, scale and environmental impacts of our activities, products and services.

We commit to:

Protecting the environment and preventing pollution. We will identify and manage our environmental impacts, prevent or reduce pollution where applicable, and maintain controls to minimise environmental harm during normal operations and foreseeable emergencies.

Addressing our environmental priorities. We will promote efficient use of energy and computing resources throughout software development, model training and operation. Where we can control or influence associated water consumption, we will seek practicable reductions. We will prevent waste through asset maintenance, reuse and responsible management of electronic equipment at end of life.

Meeting our compliance obligations. We will fulfil applicable environmental legal requirements and other environmental requirements that we are required to, or choose to, adopt. We will keep these obligations under review and evaluate our compliance.

Setting and reviewing environmental objectives. This policy provides the framework for our environmental objectives. We will establish objectives consistent with these commitments, taking account of our significant environmental aspects, compliance obligations, and risks and opportunities. We will assign responsibilities and resources, monitor progress, and review results.

Continually improving our environmental management system to enhance environmental performance. We will use performance monitoring, audits, corrective actions and management reviews to identify and deliver improvements.

We will maintain this policy as controlled documented information, communicate it within the organisation, and make it available to interested parties through our website and on request.

We will review the policy during planned management reviews and following significant changes to our activities, environmental impacts, operating context or compliance obligations, to ensure it remains appropriate.

Spotlight Pathology establishes and maintains environmental objectives consistent with this policy, taking account of its significant environmental aspects and associated compliance obligations, and considering its risks and opportunities. Objectives are measurable where practicable. Each objective has assigned responsibilities, required resources, a completion timescale and a method for evaluating results. Progress is monitored and reviewed during management reviews, and objectives are updated as necessary.

Our Senior Management Team (SMT) is accountable for implementing this policy and providing the resources needed to support it. 

The Quality Manager maintains the EMS, monitors performance and ensures compliance.

All Spotlight personnel are responsible for adhering to applicable policies and procedures, and for reporting incidents in a timely manner.

Spotlight Pathology is committed to the continual improvement of its EMS by:

Conducting regular internal audits and management reviews

Monitoring performance against environmental objectives

Implementing corrective and preventive actions (CAPAs)

Reviewing risk assessments and updating controls as required

Continual learning from incidents, near misses, and external developments (e.g. emerging threats, regulatory updates etc.)

ISO 14001 Improvement activities outlined above are documented and tracked within the QMS, aligned with ISO 13485:2016 continuous improvement requirements.

Environmental risks are identified, analysed, and evaluated following internal processes. Patient safety and product performance is considered for all risks, and controlled through technical procedures.

All risks are reviewed periodically to ensure accuracy throughout product lifecycles, and reviewed ad hoc following significant changes to either the product, customer or regulatory framework.

Documents and References

POL 0440: Our Management System and its Processes

POL 0520: Our Top-Level Policies

POL 0610: Our Risks and Opportunities