It is critical for business, government, and academia to handle biological materials safely and securely. A vital component of accomplishing this is implementing an ISO 35001 biorisk management system, which enables an organization to efficiently recognize, monitor, and control any biosafety or biosecurity hazards associated with its operations. For a biorisk management system, ISO 35001 is the first International Standard. ISO 35001 standard was first released in November 2019 and is applicable to all businesses that test, store, transport, operate with, or dispose of hazardous biological products. To control and minimize any hazards associated with their use, it outlines the specifications and guidelines for laboratories and any other organization that works with biological agents. While many regional or national standards aid organizations in risk management and compliance with legal obligations, ISO 35001 is the first to harmonize them to give global best practices. The establishment of precise criteria for the management of biological agents is imperative for international laboratories, especially those in low-resource nations. Users would benefit from the standard, Patricia notes, “, especially in many countries without any national policies or regulations in place”. The biorisk management system, ISO 35001:
- Establishes the biorisk management principles that allow laboratories and related facilities to meet their biosafety and biosecurity goals
- Specifies the fundamental components of a biorisk management system framework to be integrated into a laboratory’s or other associated facility’s overall governance, strategy and planning, management, reporting processes, policies, values, and culture;
- It outlines a comprehensive biorisk management procedure that reduces biorisk (biosafety and biosecurity risks); and directs the application and usage of the standard, if necessary.
The biorisk management system was established on a management system approach, allowing an organization to efficiently detect, analyze, control, and evaluate the biosafety and biosecurity risks inherent to its activities. As a result, the paper aims to specify requirements that are compatible with the scope and nature of each organization. The foundation of the biorisk management system is the idea of continuous improvement, which is accomplished through a cycle of planning, executing, reviewing, and refining the procedures and activities that an organization takes to achieve its primary goals. The Plan-Do-Check-Act (PDCA) approach is used in this situation:
- Organisations utilize the PDCA model, an iterative process, to continuously improve their processes and products.
- Understanding and paying attention to the reasons behind nonconformities and occurrences is necessary for improving biorisk management.
- Improvements in performance and the management of biorisks result from systematic detection and correction of system flaws.
The following are some of the most crucial elements in developing and putting into practise an ISO 35001 biorisk management system standard:
- The dedication of the senior management to:
- Provide sufficient resources
- Ensures that all staff members receive enough ISO 35001 Awareness Training for Biorisk Management so they can better comprehend the standard.
- Make biosafety and biosecurity policy a priority and make it known
- Set performance goals and incorporate biorisk management across the entire organization
- Establish the root causes of occurrences and nonconformities to stop them from happening again
- Determine areas that could use improvement and prevention
- Keep your eye on the reward of improvement:
- Make pursuing continuous improvement a top priority for each employee in the company
- Identify potential improvement areas by conducting periodic assessments against the organization’s risk criteria
- The effectiveness and efficiency of procedures must be continually improved
- Prepare and keep up-to-date with the required ISO 35001 documents for improved system implementation and comprehension.
- Take corrective action when practices are hazardous or unstable, and encourage prevention measures
- Give employees in the company the necessary knowledge and training to support biorisk management, including the processes and instruments of continuous improvement
- Establish metrics and objectives for improvement, and acknowledge progress.