ISO 35001: 2019 Biorisk Management for Laboratories 

OK everyone, we can go ahead and get started. My name is Julie Son and I am a consultant with Guidehouse supporting the CDC OneLab initiative. A couple notes before we get started and dive in. If you're having any technical issues throughout, please feel free to e-mail the OneLab inbox for support at OneLab@CDC.gov. If you have any questions throughout the session, please insert them into the Q&A function below using the Q&A icon. 

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Thank you, Julie. Before we begin the presentation, as Julie stated, I’ll share a CDC Health Alert Network, or HAN message, and then the release of a new OneLab training resource. On July 23rd, the CDC released a Health Alert Network message announcing the information about the disruption in the availability of the BD BACTEC blood culture media bottles. You can find links to resources and additional information in the chat, including a link to the July 15th LOCS call and the December 13th, 2023 OneLab Network event on diagnostic excellence, a new quality tool to prevent blood culture contamination. 

If you have any questions about the HAN message, please send them to LOCS@cdc.gov. Next slide, please. In an ongoing commitment to delivering high quality and accessible and relevant training, we are thrilled to announce the release of our first mini lesson, the Public Health Laboratories 101. It's a mini lesson that's designed to provide concise and engaging learning experience. It makes it easier to absorb key concepts, quality, and quickly efficient information. This mini lesson is informative. It's interactive, it's easily accessible, and it's available on OneLab REACH™. You can find the link in the chat. Next slide, please. Now I’ll read to you our P.A.C.E.® disclaimer and then introduce our speakers for today. 

CDC, our planners, and our presenters wish to disclose that we have no financial interests or other relationships with commercial product manufacturers, suppliers of commercial services and commercial supporters. Next slide, please. And I am thrilled to introduce our first presenter, Lieutenant Commander Folasade Kembi. Sade is a health scientist at the CDC's Division of Laboratory Systems Quality and Safety Systems Branch, where she provides technical guidance on biorisk management systems, biosafety and biosecurity, regulatory compliance and emergency preparedness in clinical and public health laboratories. Before joining DLS, she was a senior microbiologist and inspector in the Division of Select Agents and Toxins where she provided leadership, strategic planning and oversight to responsible laboratory officials registered with the Federal Select Agent Program. She is excited to share her knowledge in biorisk risk management systems implementation. 

Our second presenter is Dr. Mary Casey- Moore, a health scientist who is also with the Quality and Safety Systems Branch. In her role, she develops comprehensive training materials and resources to help clinical and public health laboratories implement robust biosafety practices and biorisk management strategies. Over the past two years, she has dedicated her efforts to empowering laboratorians, equipping them with the knowledge and tools to enhance various safety aspects and to mitigate potential risk. She is also excited to share insight into the ISO 35001 biorisk management standards and highlight the benefits of integrating this standard into your laboratory operations. Our presenters for today, Dr. Mary Casey-Moore and Lieutenant Commander Sade Kembi. Over to you all. 

OK, good afternoon, everyone. We appreciate the opportunity to present with you today. Our presentation will focus on ISO 35001, the standard for biorisk management for laboratories. As Alicia mentioned, I'm Mary Casey-Moore, and I'm joined by Commander Sade Kembi. We are both from the Quality and Safety Systems Branch within the Division of Laboratory Systems and our mission within this division is to improve public health, patient outcomes and health equity by advancing laboratory systems. 

Here are the objectives for today: First, we'll summarize the ISO 35001 standard and describe the biorisk management model. Next, we will discuss implementing a biorisk management system within the laboratory, including the initial steps in developing biorisk management objectives. Finally, we'll present a summary of the collaborative pilot project conducted with the Association of Public Health Laboratories (APHL) on implementing the ISO standard in four public health laboratories and highlight some of the resources provided. 

So what is ISO 35001? Let's first start with just ISO. ISO stands for the International Organization for Standardization. It is a global federation of national standards bodies with a representative organization from each member country. ISO develops voluntary, consensus-based international standards to promote quality, safety, efficiency and trade across nearly all industry sectors worldwide. ISO 35001 is titled "Biorisk management for laboratories and other related organizations." It was published in November 2019 and is 26 pages long. This standard was adopted from the CEN Workshop Agreement 15793, and is the first international standard that defines the requirements of a biorisk management system for laboratories. 

Now, before diving into biorisk management systems, I want to first discuss what is biorisk management. Biorisk management is a coordinated activities to direct and control biosafety and biosecurity risk. Biorisk management could be divided into three primary components: assessment, mitigation and performance. Assessment covers both biosafety and biosecurity, ensuring a comprehensive understanding of potential hazards. Mitigation involves implementing strategies to achieve safety and security. This means putting controls in place to reduce or eliminate the risk identified during the assessment.

 Performance is a systematic process aimed at achieving improved levels of organizational objectives and goals. It involves providing direct evidence so that the organization can understand and effectively reduce risk to an acceptable level. Just as a three-leg stool stands firm only when all three legs are strong, effective biorisk management relies on the support of each component. Now these three components, assessment, mitigation and performance, are collectively known as the AMP model. 

Now onto biorisk management systems. This is a systematic approach to identify, assess, control, and monitor biosafety and biosecurity risk associated with hazardous biological material. Here we're taking the concept of the AMP model, assessment, mitigation, and performance, and now bringing in a system to govern those actions. ISO 35001, which I’ll just refer to as ISO in the future, breaks down and defines the essential components for a biorisk management system in a way that the organization can integrate it into its overall governance, strategy, planning management systems, reporting processes, policies, and culture. It assigns clear roles and responsibilities to personnel in the institution, with leadership having ultimate responsibility. When discussing biorisk management systems in the context of ISO, I want to highlight two key aspects. 

The first thing that the standard is structured around a management system approach emphasizing performance over prescriptive measures. This framework allows for the implementation of biorisk management practices and laboratories with diverse resource capabilities. The second is that ISO promotes a culture of continual improvement through the Plan-Do-Check-Act cycle, ensuring ongoing evaluation and enhancement of biorisk management practices. So in the following slides, I’ll explore more of these two fundamental elements in greater detail. Here is the first item I highlighted. As I previously mentioned, the ISO standard is based on a management system approach, which integrates best practices and procedures to help ensure an organization can achieve its organizational objectives, which are the biosafety and biosecurity objectives. 

Just as a brief example, an organization may create specific biosafety and bio security objectives towards managing biorisk within its laboratory. However, to achieve those objectives, the laboratory must perform certain tasks and to perform those tasks correctly, a set of policies, processes, and procedures must be in place. The management system approach is the framework of policies, processes, and procedures set by the organization to ensure that they can perform the task correctly required to achieve those biosafety and biosecurity objectives. Applying a management system approach leads to several benefits and I have a few of them, listed here on this slide. 

First, it allows for defining the system itself by identifying and developing processes relevant to the organization's objectives towards managing biorisk. Second, it enables structuring the system for efficiency, organizing the processes in a manner that achieves these objectives most effectively. Third, it promotes the understanding of interdependencies between various processes within the system, recognizing how they interact and impact with one another. Fourth, it encourages resource awareness, establishing resource limits and allocating them appropriately before taking action. And finally, this is the second item I highlighted on the previous slide. It facilitates continuous improvement by incorporating the PDCA cycle. 

So let's talk more about the Plan-Do-Check-Act as it is a fundamental concept in ISO. The standard not only promotes the PDCA cycle as an ongoing process for improvement, but also has the cycle built into its standard or its standard structure. And I’ll show you how later in the presentation. Within the cycles, the steps are as follows. The Plan step is where you establish objectives, programs and processes in accordance to your laborator's policy. 

In the Do, the stage involves implementing the processes you've outlined in the planning stage. After implementation, we have the Check stage, which involves monitoring and measuring the activities and processes against the policies set during that Planning Stage. It's about gathering data and understanding how well your strategies are performing. And in the final Act stage, you take action to continuously improve that performance, ensuring your laboratory's practices are not just maintained but consistently improved to achieve those intended outcomes. Now let's dive into the structure and components of the ISO standard itself. The standard is organized into ten major sections. 

The first section covers the scope of the standard. This standard is applicable to any laboratory or organization involved in working with storing, transporting, or disposing of hazardous biological materials. 

It can be integrated into organizations of any scale, making it adaptable to the nature and size of different organizations. It's important to note, however, that this standard is not intended for those working with microorganisms or toxins in food or feedstuffs, nor does it cover the use of genetically modified crops in agriculture. The scope is then followed by two other sections, references and terms and definitions, which I do not have listed here on the slide, but the core content list starts in section four, titled "Context of the organization" and goes all the way from four to section ten, titled "Improvement." These sections break down the essential components for the biorisk management system and contain detailed guidelines of how the standard can be applied within each of these organizational contexts. 

To better visualize how these sections relate to each other, as well as how the Plan-Do-CheckAct cycle is built within the standard, let's take a look at the biorisk management system model. So on this side I'm showing the ISO sections on the left-hand side, and on the right I have a topdown pyramid view of the biorisk management system model. Which we will go through section by section. First is the foundational layer of the pyramid. This is the context of the organization, section four. This is what's going to help you understand the organization and its context. It's helping define the scope, the boundaries of your biorisk management system, as well as all the stakeholders involved. 

The next layer is leadership, section five, which emphasizes top management's role in leading the biorisk management culture within the organization, and also helps delineate the roles and responsibilities for key personnel within the biorisk management framework. Now moving to the Plan-Do-Check-Act cycle. We have planning in section six. In this section you're identifying the hazards by performing risk assessments and also creating those biorisk management objectives. The Do in section eight is titled "Operation," which describes the execution and management of processes necessary to meet biorisk management system requirements. This involves equipment maintenance, security, biological materials inventory, PPE usage, waste management, and many others. 

The Check is section nine, "Performance Evaluation." Here's where we're focusing on how to do internal audits and management reviews to check the processes we have in place. Lastly, in this cycle, we have Act in section ten, which is titled, "Improvement." This is where we take action to continuously improve by reporting, investigating, managing incidents and nonconformities, and also taking corrective actions. We then tie everything together with section seven, Support, which discusses the necessary resources to carry out this cycle, such as training and competencies, workforce management, and also documentation. 

So, I hope this slide really emphasized the comprehensive nature of the standard and how implementing ISO will inherently have the Plan-Do-Check-Act model within the biorisk management processes. Now that we understand the biorisk management system model outlined in ISO and how these various elements are structured, let's shift our focus on how to implement the standard. For successful ISO implementation, I want to highlight five important elements. First being top management commitment. Leadership must authorize biorisk management integration, communicate its importance, and provide the necessary resources. Second is planning. 

A major component to implementing ISO is creating specific biorisk management objectives aligned with lab functions to develop and incorporate them, and we'll talk about more biorisk management objectives later in the presentation. Third, we have documentation and control. Thoroughly document the objectives, policies, procedures, everything essential for the system's effectiveness. Ensure documents are current, available, and protected. Fourth, we have training and staff awareness. Identify the training needs, provide the appropriate training to build competencies, and also assess staff understanding. And finally, we have teamwork and communication. Implementation requires collaborative effort and active participation across the organization. 

When it comes to implementing the ISO standard a strategic approach is key, so let's walk through the system or the steps involved in this process. Step one, develop a tool to perform a systematic gap assessment of your laboratory's biosafety and biosecurity processes. This tool should simplify the ISO document into a manageable checklist, making it easier to evaluate your current practices against the standard's requirements. Step two: With the gap assessment tool in hand, perform a comprehensive analysis of your existing processes. Identify areas that already meet the ISO standards and those that need improvement. These steps will provide a clear picture of where your organization stands in relation to biorisk management. 

Step three: Based on the results from the gap assessment, define a structured process for implementation. And this involves creating those specific biosafety and biosecurity objectives aimed at addressing the areas that need improvement. The goal is to prioritize these objectives based on their importance and available resources, ensuring that the most critical areas are tackled first. With developing a gap assessment tool being step one, our team has done just that and here's a glimpse into that process. We developed a gap assessment tool based on the ISO standard for the pilot project in collaboration with APHL. 

This tool is Excel-based and has a dedicated tab within the workbook for each of the seven major sections of the standard. We essentially copied and pasted the guidelines from the ISO document into their respective sections, resulting in a total of 184 line items across all sections. Now during the creation of this gap assessment, it's also important to consider how you would like to quantitatively assess or score your organization's compliance, if that's something you would like to do. In our case, we used a simple Yes/No scoring system for each line item and leveraged Excel's capabilities to calculate average percentage conformance for each individual section. 

This allowed us to set goals for the desired increase in compliance over time with our laboratories. However, we've also seen other scoring systems where organizations could use a range, such as zero to three, where zero means not applicable, one indicates nothing is in place, and three means full compliance. Again, similar to our system, the goal would be to increase the overall scores over time. The scoring approach can be tailored to best suit the needs and preferences of your laboratory. Once the tool is completed, we are able to move on to step two, performing the gap assessment itself. 

By going through each line item with the laboratory, we could more easily identify what areas needed to be addressed. And then with those results, we can then proceed to step three, defining a structured process for implementation and creating those by risk management objectives to address those areas. And this is what Commander Folasade will discuss in the following slides. 

Good afternoon. As Dr. Casey-Moore highlighted, the gap assessment is crucial in identifying areas that require attention. One effective way to address this gap is through the creation of goals and biorisk management objectives. The ISO 35001 standard specifies that organizations should establish biorisk management objectives at relevant functions and levels. Before we create this objective, let's first clarify the distinction between goals and objectives. A goal is an observable and measurable end result having one or more objectives to be achieved within a fixed time frame. So we should aim our resources and efforts towards the outcome. 

Objectives should describe the desired outcomes, applying specific milestones to monitor progress, and defining time frames for completion. These are the steps we need to take in a fixed time frame to move towards and achieve the outcome. When setting objectives, organizations should consider potential risks, regulatory requirements, and other factors. Using one of the requirements of the ISO 35001 as a goal, the organization shall ensure that an accurate, verifiable and up-to-date inventory or itemized record of biological materials with biological agents and toxins specified is established and maintained based on the organization's biorisk assessment. 

So the goal statement indicates that the organization should determine a process for checking, reviewing, updating, and reporting the biological materials inventory. The outcome to be achieved by the goal statement should include what constitutes an accurate inventory. How is the inventory verified for accuracy? What details must be included in the inventory? How frequently must the inventory be updated or reviewed? Who is responsible for maintaining the inventory? After the goal statement, we then create SMART objectives to meet the goal. The SMART objective should be specific. 

That is, it should answer the "whats" and "whos." It should be detailed, focused and clearly address what needs to be accomplished. It should be measurable. That is, how many? How long? It should be quantifiable and trackable to monitor progress and determine when the objective is met. It should be achievable. It should be achievable with this task and all the challenges defined. It should be realistic and attainable within the available resources. It should be relevant. That is how important. What is the impact? It should be aligned with the organization's mission and related to long term biorisk management implementation. It should be time-based: that is, when. 

It should have a defined target completion date and deadline. So on the screen are examples of SMART objectives to meet the goals of maintaining an accurate, verifiable inventory of biological materials. The first one is, "Conduct a comprehensive biorisk assessment of all laboratory activities and materials by the end of the third quarter of 2024 to identify biological agents requiring inventory control." 

Another example is, "Develop and implement standard operating procedures for inventory management, verification, documentation, and reporting by the fourth quarter of 2024, ensuring compliance with ISO 35001 requirements." And the last example we have is, "Train 100% of laboratory staff involved in handling controlled materials on proper inventory management procedure, including the new SOP's, by the first quarter of 2025." 

So after setting the goals and objectives, we have to plan for the implementation and continuous improvement of the objectives. And we have four steps. The first one will be delegating roles and responsibilities for each objective. Assigning clear ownership of responsibilities ensures accountability. It also helps to determine who is in charge, who makes decisions, or who is consulted when needed, and what actions are specific responsibilities for each role to accomplish an objective. 

The second is establishing performance indicators and measures. How can we be sure we're achieving what we set out to achieve? So, we have to define metrics to track the progress, monitor advancements towards the set goal and objectives, and identify opportunities for improvement. When opportunities for improvements are identified and justified, the organization needs to decide how they are to be implemented based on the available resources. 

Number three, conducting regular gap assessments by assessing the effectiveness of the biorisk management process, identifying nonconformities, and implementing corrective actions. And the fourth one is reviewing and updating the objectives periodically. This is necessary to align objectives to changing organizational needs, if there is any. Incorporate lessons learned and maintain relevance and continuous improvement. So we have provided an overview of the ISO 35001 standard biorisk management model and steps to implement a biorisk management system. So now let's talk about our collaboration pilot project with the Association of Public Health Laboratories. APHL. 

In the first phase of the project, the CDC and APHL identified two public health laboratories, which I will name Lab 1 and Lab 2. They are the pilot sites for implementing the biorisk management system in 2022. Then step two, initial visits were conducted using the Gap Analysis Checklist created for that purpose. The goal was to review existing process in those laboratories and to support the adoption of ISO 35001. Step three. Findings from the site visit analysis were used to define elements for ISO 35001 implementation. Nonconformities were identified and made known to the laboratories. Resources were provided to help the laboratories address the identified gaps and nonconformities through virtual meetings. 

And step four, in 2023 second site visits were conducted to laboratories in phase one to assess their improvement, support their adoption of ISO 35001, and close out phase one of the pilot project. The second phase, which I would say, the labs are Laboratories 3 and 4, started in December 2023 and January 2024. Site visits were conducted to Laboratories 3 and 4 following the same steps: step one, step two, and step three. Nonconformities were identified and are currently being addressed. 

The second site visits are currently in the planning stage. So, the following few slides will show findings from each of the laboratories. Laboratory 1 has 82% conformities and 8% nonconformities. Some of the nonconformities identified were lack of biorisk management objectives, and where there were biorisk management objectives, they were not defined or they are not included in management reviews. Except in departments where inventory was mandated by regulation, inventory was determined by departmental supervisors. Lack of emergency training, except in departments where emergency training was regulatory, as in Federal Select Agent Program and where it was conducted, it was not documented. Another observation is the internal audit program focused on quality management issues and did not expand to biosafety or biorisk management documentation, and corrective actions were not followed. In Lab 2, there were 84% conformities and 8% nonconformities. 

And some of the nonconformities identified were the roles, responsibilities and authorities for biorisk management were not defined and not communicated or included in laboratory processes, such as in their incident investigation, in their SOP review competence evaluation, they were not included. Another nonconformity is the understanding of different positions, relationships, priority, and needs, to complete biorisk management activities, such as lab inspection findings, incident investigations, they differ substantially. The biorisk management advisors were stretched too thin and were at times unable to provide necessary and timely support to staff. 

For instance, BSL-3 qualification training, risk assessment, completion of occurrence management and incident investigations. Not all staff understand the role of quality and safety or biorisk management staff and what is done to ensure safety. Then the last one is biorisk management objectives were not defined and where they were defined, it was not documented or reviewed. Now the labs in phase two. Lab 3 has 84% conformities and 5% nonconformities. Some of the nonconformities were lack of organizational biorisk management objectives or specific biorisk system metrics that are evaluated. Internal audit policy and procedure mostly cover the quality management system. It does not specifically include safety topics or biorisk management objectives. 

Then there's not much exercising of procedures for spills, exposures, threats, and so on and so forth. Then Lab 4, they have 43% conformities and 45% nonconformities. Some of the nonconformities in Lab 4 include no overarching biorisk management policy for the organization. Each department runs its own program with varying levels of documentation, competency, assessment training, and so on and so forth. There's no management review of the biorisk management system. There were no risk management objectives. The roles, responsibilities, and authorities for biorisk management were not defined and were not communicated to all laboratory department leaders or included in laboratory processes. Metrics were not tracked, and documents such as SOP or risk assessments were not regularly reviewed to assess areas for improvement. 

No real system exists to conduct internal audits, and there is lack of biorisk communication among staff. So as a result of the observation from the pilot studies, some of the suggestions made to the laboratories include how to commit to a biorisk management system by establishing a biorisk management committee oversigh, documentation of various management expectations, practices, rules, authorities, and metrics. 

That they should develop biorisk management objectives. Define the risk assessment process, including how it is conducted, by whom; how it is documented, by whom, when; and how it is reviewed and approved. And how the selected risk mitigation practices are evaluated and changed as needed. They should provide insider threat training. Then helpful resources such as risk assessment tools and biorisk management program guidance from CDC and APHL were shared with the laboratories. 

So if you in the audience today are also interested in the resources, the Division of Laboratory Systems shared with the labs, we are still offering free access to the ISO 35001 standard to clinical and public health laboratories within the US. And this is how the process works. Your institution will select a POC that is responsible for biorisk management. It can be the laboratory director biosafety officer, or their designee. Then the POC will e-mail the DLS biosafety mailbox, which is DLSbiosafety@cdc.gov. DLSbiosafety@cdc.gov. 

They will request access to the standard along with your institution's name and physical address. Then the DLS will notify your POC via e-mail with further instruction if your institution is approved. The POC must then submit names of individuals within your institution who would like to receive the ISO standard, including their work e-mail addresses and the individual roles in the organization. Please contact DLSbiosafety@cdc.gov if you want free access to ISO 35001. So in summary, today we have covered sections of ISO 35001. Highlighted how they collectively create a robust biorisk management system. 

We described the critical components for a successful implementation, including top management commitment and continual improvement. We discussed the use of gap assessment and creating SMART biorisk management objectives. We also shared experience collaborating with APHL to implement ISO 35001 in four public health laboratories. At this time, we wish to acknowledge the contribution of the DLS Biosafety Core Team, APHL, and the pilot sites. And here on the screen are the resources that are relevant to the presentation today. They include the same workshop agreements and links to some other documents, and it's being dropped in the chat right now. Thank you so much. Questions? 

We'll take a few minutes to answer as many questions as possible. If we do not answer your question today or you have a question after today's event, please feel free to e-mail the OneLab inbox at OneLab@cdc.gov. Let's see what we have. We have several questions in here asking, where can they find the gap assessment tool? Or the Excel sheets? 

OK, let me take that one. That is the checklist that we came up with. And it is not available to everybody. It's not even available because it's based on the ISO standard. 

And if you want to have access, you have to go through a paid subscription. So if you have the access to this standard, you can come up with your own checklist, and that is the standard which DLS is currently offering for free right now. So if you have access to the standard, you can come up with your checklist, but because it is based on the ISO standard, we will not be at liberty to share currently. Thank you. 

Oh, you're welcome. Let's see. That one. 

Are there any accrediting agencies to grant the ISO 35001 certification or compliance? 

Thank you for that question. Currently there is none. 

OK. 

We shared access to the free link for you to download. Actually got several of those questionnaires. Considering that this is an international standard for ISO, will there be work with other labs beyond the US? So because your program really only does, you're doing only the US labs, the question is that we at some point, would you all be considering labs outside of the US? 

Well, currently, we are not considering that. But we know of organizations that may be interested in collaborating with international labs. At least somebody has approached us who is interested, so maybe very soon you may be having the information if they are still interested. But currently we are still working with laboratories within the US. Thank you. 

Oh, this is also good one. They want to know how often should SOPs be assessed for biorisk or biosafety? 

Well, anytime you make changes, then you review your update. But even if you don't make changes, at least annually go in there. Check your SOPs, what has changed in your practice, update it. So it's a good practice to review at least annually. 

But throughout the year, if your procedure changes, if you are adding another work objective, then go in there, update your SOPs. 

OK. 

I’ll answer this one. 

Why are the standards not intended for those working with microorganisms or toxins and food? 

I can take this one. Can you hear me? Yes, ma'am. Yeah. So there's just a couple of reasons that that I know of why ISO is not intended for microorganisms and food and feedstuffs. And from one, it's just the types of risks encountered in food testing or agricultural biotechnology differ from those in clinical and public health laboratories working with infectious agents and toxins. Which is why ISO 35001 just focuses on managing biorisk specific for those laboratory environments. 

Because they have certain biosafety and biosecurity measures, and also there is already established standards and regulations that specifically address the risk associated with food testing. I think, for example, ISO 22000 is one specific for food testing. So that would be my reason why. This is a good question. Do you believe biorisk management standards would be incorporated into the CAP inspection for labs in the future? 

Well, I would say nobody knows, but for good practices, for continual improvement, it's just good to tap into the standard. But nobody knows when; I don't know. That is just the answer. But then for the good of the lab and for the good of everybody, I mean, we just improve the laboratory processes, but I don't know. I can't answer that question. 

Right. So someone wants to know, who would be members of a biosafety committee? And I'm assuming they're asking, like within the lab, who would be good members for the committee? 

I think that's, and that's me talking, I think that would be dependent on your laboratory. But I will say probably your laboratory director, but when I say laboratory director, it differs from lab to lab, there are some big laboratories where laboratory directors cannot be part of it. But then their designee can be part of it. Biosafety managers definitely. Our quality manager then lead techs. And maybe some laboratorians as well. So it actually depends. It differs if we are talking of our research institutions, we may be talking about our research admin, all the top-level people, and it's good for the top-level people to have a buy in. 

When Mary was talking, I saw this ISO standard 35001 actually encourage commitment from the top leaders. So it differs from lab to lab, but it's always good for people at the top to have buy in and to be interested in what is going on. So if it is a very big lab, were the laboratory director cannot be part of the team, he or she can have a designee. Then the biosafety manager, the quality people. It depends. 

It depends on your lab and your setup. 

OK. Thank you so much for the great presentation and we hope to have you all back soon. 

Thank you, ma'am. 

And I will go ahead and state, we are still getting a lot of questions about the checklist. As Doctor Kembi said, that is actually an internal document that is used, so you would not be able to get access to that. However, there is a link in there where you can get access to the actual standards so you can do that. We are offering one P.A.C.E. ® credit for today's webinar, the P.A.C.E. ® credit certificates are immediately available on OneLab REACH in your My Learning Hub for easy access. 

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