Laboratory Assurance
What laboratory assurance means
Laboratory assurance is independent verification that your laboratory’s systems, processes, and documentation are fit-for-purpose, do what they say they do and meet regulatory requirements.
Certification and accreditation to required standards and regulations are only part of this. A laboratory can be certified and accredited and still fail under operational pressure. Assurance goes further. It means the laboratory management systems actually work, the documentation reflects practice, and the people running the laboratory can maintain operations and compliance.
Laboratory certification and accreditation support
Laboratory certification is formal recognition by the regulator that a laboratory meets the required regulatory requirements to operate.
Accreditation is recognition from an independent accreditation body that a laboratory meets a defined standard.
Preparing for certification or accreditation is a process, not an event. Most laboratories that struggle treat it as one.
We support laboratories at every stage:
A structured assessment of where your current systems, documentation, and practices sit against the requirements of your target regulations and standards.
Building or refining the laboratory management systems your assessors will examine. Critical systems include quality management, containment management, biological risk management and the laboratory management system itself.
Working through assessment requirements, reviewing documentation, and identifying and resolving potential compliance issues.
Keeping the systems compliant and fit-for-purpose between assessments. We understand what certifiers and assessors are looking for, not just what the standard says.
Laboratory due diligence
Investors and funders evaluating a laboratory need an independent technical view. Financial due diligence tells you what the numbers look like. Technical due diligence tells you what the laboratory can actually do – its systems, its risks, and the gap between what it claims and what it can demonstrate.
We provide independent laboratory due diligence assessments for investors, boards, and funders. This is a niche service with limited availability in New Zealand.
Technical writing and review
Laboratory documentation is a compliance requirement. It is also a practical operational tool. SOPs, policies, risk assessments, and laboratory manuals that are written correctly ensure laboratory operations work as they should and regulatory compliance is maintained.
We write and review laboratory technical documents to required regulations and standards:
- Standard operating procedures
- Quality management documentation
- Biosafety manuals and risk assessments
- Policies and governance frameworks
If you have existing documentation that needs review, we can assess it against the relevant regulations and standard and recommend required revisions.
How we work
Every laboratory is different. The regulations and standards are fixed – the pathway to meeting them it is not.
We start with your specific context: your work, laboratory environment, your current documentation, your regulatory history, and your timeline. From that, we build a practical plan specific to your operation.
Learn more about Richard’s background and approach to laboratory consulting.
Get started
If you are approaching a certification or accreditation assessment, working through a quality management gap, or need independent assurance of your laboratory’s systems, get in touch.
If your laboratory also has biosafety requirements, we can help with those too. Learn about our biosafety services.
