When it comes to biotechnology and biotech research, one small unaccounted-for variable or error can have a serious impact on a project. Whether you’re developing a new life-saving medication or researching the human genome, the environment your team is working in must remain sterile. One small contaminant can destroy years of research or force you to restart costly experiments. This, of course, can greatly affect your research budget or impact your relationship with funding partners.
Many biotechnology companies have already created, tested, and updated both their internal quality management systems and their manufacturing practices. However, some have failed to take into account their facility cleaning and sanitation plans. They may simply outsource facility cleaning to the first company they come across and assume that company will provide them with the sterile environment their research requires.
Unfortunately, that’s not always the case. In the biotech industry, cleaning is more than simply mopping the floors. It’s about adhering to industry best practices that create a sterile, safe environment for your work. That’s why SourceOne is proud to offer facility cleaning services that meet ISO 9001:2015 certification standards. This certification is more than just a bragging point – it serves as the foundation of our services. Let’s take a look at what ISO 9001:2015 is and why it matters for biotech facility cleaning.
ISO 9001:2015 – What Does Having this Certification Mean?
The International Organization for Standards is an independent organization that sets voluntary standards developed and recommended by experts from around the world. These include the 9001 series of standards, all of which focus on quality. ISO 9001:2015 specifically focuses on Quality Management Systems (QMS). This standard addresses a number of key aspects, including managing processes, implementing risk-based thinking, the role of leadership in establishing quality policies, understanding customer expectations, and continually improving on these processes.
Working with a facility cleaning partner that is ISO 9001:2015 certified ensures your space is cleaned to these internationally-recognized standards. It’s the difference between hiring a basic janitorial service that doesn’t adhere to any standards and a professional who understands regulatory compliance. It means that every action done within your facility is held to the highest standards.
ISO 9001:2015 and Consistency
In any biotechnology facility, consistency is key in all areas, even cleaning. If your cleaning process vary from day to day, it’s all but impossible to fully monitor your environment. You cannot account for environmental factors simply because you will not know what has changed between cleanings. One day the cleaning company may fully sterilize the space, and one day they may simply take out the garbage.
Any cleaning partner that operates under these guidelines has a standardized plan that is followed on a daily basis. There is no discretion for individuals cleaning your facility. Instead, everyone who enters your space will follow a documented plan that has been developed and tested for years. This process ensures a variety of factors are kept consistent:
- Cleaning chemical dilutions are done the same every time.
- Disinfectant contact times are followed correctly.
- Cleanroom procedures, including coverings and other equipment, are followed without any shortcuts.
The Need for Continuous Improvement
When ISO 9001 was updated in 2015, a new emphasis on risk-based thinking was added to the standard. This type of thinking is especially important for biotechnology companies because it encourages their certified cleaning partners to be proactive. Cleaning firms that follow ISO 9001:2015 look for potential risks and get ahead of them, designing policies to avoid those potential risks and preparing responses to them in the event they do occur.
This is done by performing regular audits and reviews to look for potential risks, non-conformities, and other specific events that could cause issues. Once found, the ISO framework outlines how companies should perform an analysis to determine the root cause of these issues and then develop plans to mitigate or reduce the risk of such issues.
Transparency
Transparency typically involves documenting all decisions and proceses. This is why ISO 9001:2015 stresses that logs, training records, and other documents be created and maintained. These documents allow both the cleaning team and the biotech firm itself to make evidence-based decisions. They know when each lab was sanitized, how that process was done, who did it, and other relevant information that can be used for both internal and external audits as well as confirm that all regulations were followed.
The SourceOne Advantage
We know biotech facilities have unique needs and regulations they must follow. Various global regulators, including the FDA, have strict requirements that companies must follow. Any contractors or partners, including their cleaning teams, need to understand these regulations and meet them.
SourceOne brings over twenty years of experience to our partnerships. We understand that there can’t be a one-size-fits-all cleaning solution for biotech companies. We will work with you to create the cleaning solution that meets all of your needs and ensures that you meet all requirements.
Traceable Services
Regulatory inspectors may ask for your company’s cleaning logs during an audit or inspection, and they often expect you to be able to produce these logs quickly. With SourceOne, our detailed logs and other documents are available whenever you need them. Our commitment to traceability includes the following:
- Training verification: Every one of our cleaning technicians is trained on your site-specific protocols and safety information, and we maintain records outlining this training and related information.
- Ready for an audit: We maintain an internal audit plan that means we’re always audit-ready.
- Risk reductions: We strictly follow ISO 9001:2015 regulations, which reduces the risk of contamination or other issues that could lead to regulatory warnings or, worse, the loss of time and money.
Dealing with the Headache of Regulatory Compliance
Dealing with an audit can be stressful, especially if you have various vendors that need to provide you with information and they are uncommunicative. When you’re working with a cleaning partner who is not certified, you run the risk of inheriting their lack of processes. Any mistakes they make fall on you.
By working with an ISO 9001:2015 certified partner such as SourceOne, you are bringing in an expert who understands regulatory compliance and the audit process. You won’t be bringing on more problems; instead, you’ll have a partner you can rely on during regular cleanings, special needs, and audits.
Entrust Your Biotech Facility Cleaning to SourceOne
One of your biggest assets as a biotech firm is your facility. Unfortunately, it can also be a serious liability if it is not managed correctly. If you’re outsourcing your facility cleaning needs, having a partner who is ISO 9001:2015 certified can make all the difference.
With SourceOne, you can take advantage of everything a general cleaning partner has to offer plus the knowledge that comes with an ISO-certified expert. With two decades of experience and our high-level personalized cleaning solutions, you don’t have to worry about meeting regulatory requirements. Your customized plan will be fully compliant with all relevant regulations, plus we provide the transparency and traceability needed for any audit.
Are you ready to entrust your facility cleaning solutions to the experts?
If you’re worried about your next audit, SourceOne is here to take the facility cleaning compliance off your plate. We will put our ISO-certified knowledge and experience to work for you, allowing you to focus on what’s important: your work.
Reach out today to book a consultation and discover how pairing with an ISO-certified partner can ensure you’re ready for an audit and reduce your regulatory headaches.