Isospeed7’s quality management system has been independently assessed and certified to ISO 9001:2015. Our last compliance update noted that there is no certificate at the end of an ONR inspection. This time, there is a certificate.
Isospeed7 has achieved certification to ISO 9001:2015, the internationally recognised standard for quality management systems. Certification follows a formal, independent assessment of how the operation is planned, run, measured and improved, carried out by the British Assessment Bureau, a UKAS accredited certification body. The certified scope covers our core activity: the secure transport of radiopharmaceuticals, dangerous goods and time-critical healthcare consignments.
What ISO 9001 certification involves
ISO 9001 is not a product standard and it is not a paperwork exercise. It sets requirements for the management system that sits behind the service: how customer requirements are captured, how work is planned and controlled, how competence is maintained, how problems are identified and corrected, and how the business demonstrates improvement over time.
Certification is assessed in stages. The certification body first reviews the documented system, then audits the operation in practice, sampling records, interviewing the people doing the work and following processes through from enquiry to delivery. A certificate is only issued when the system is shown to be operating, not merely written down.
Accreditation adds a further layer. UKAS, the United Kingdom Accreditation Service, is the UK’s national accreditation body, and part of its role is to assess the assessors. A certificate issued under UKAS accreditation means the body that certified Isospeed7 is itself independently examined.
How this sits alongside our ONR inspection
Earlier this year, the Office for Nuclear Regulation completed a transport compliance inspection of Isospeed7 and rated the operation green in all twelve areas assessed. That inspection tested our compliance with the legal duties placed on a carrier of Class 7 dangerous goods. ISO 9001 certification examines something different: the management system as a whole, including the parts a regulator does not look at.
The two are complementary. One is the judgement of the independent regulator for radioactive material transport. The other is the judgement of an independent certification body against an international standard. Both were reached by examining evidence, and both reached a consistent conclusion about how this operation is run.
What this means for our customers
For many organisations in healthcare, pharmaceuticals and other regulated sectors, ISO 9001 certification is a prequalification requirement before a supplier can be considered at all. For those already working with us, it provides an independently verifiable answer to a standard audit question, alongside the regulator’s own published inspection record.
In practical terms, it means documented processes with defined responsibilities, records kept on every movement, and a formal mechanism for investigating and correcting anything that falls short. Customers do not have to take our word for that. It has now been audited.
A certificate that has to be kept
ISO 9001 certification is not awarded once and framed. The certificate is maintained through surveillance audits and periodic recertification, which means the system must keep operating to the standard between visits. That suits us. As we said of our ONR inspection, arrangements that only hold up on inspection days are not arrangements at all.
Working with Isospeed7
Isospeed7 has specialised in the secure transport of radiopharmaceuticals, dangerous goods and time-critical healthcare consignments since 2008. If ISO 9001 certification is part of your supplier requirements, our team can provide the details your procurement or quality function needs.