Quality and Accuracy Control Initiatives
For BML, quality assurance is a paramount concern, superseding everything else.
Quality Management Meeting the International Standard for Laboratory Testing
We have obtained international standard ISO 15189 certification and continuously work to improve quality.
ISO 15189 was introduced in 2003 as an international standard applicable specifically to clinical laboratories. Pilot certification reviews were launched in Japan in October 2004.
Agreeing with the standard’s requirements concerning testing quality and the ability to maintain quality continually, BML has participated from the outset of the pilot program. BML’s laboratory testing quality and capabilities were assessed as meeting the international standard, earning BML General Laboratory ISO 15189 certification in September 2005.
We have since passed ongoing reviews and are making efforts to improve quality.
- *For the ISO 15189 certification scope and activity list, click here [PDF:1.85MB].
Utilizing External Audit Programs Such as US CAP
BML maintains accreditation from the prestigious College of American Pathologists (CAP) and actively utilizes the CAP Survey Program.
BML General Laboratory first earned CAP accreditation in 1991, undergoing third-party evaluations to ensure our laboratory service standards are always high.
CAP has a survey program required for accreditation, covering a wide range of test items. BML has actively participated in this program, utilizing it to maintain and improve testing accuracy.
We will continue proactively utilizing external accuracy control programs, including the CAP Survey Program, to confirm the level of our testing and improve our quality.
Thorough Quality Assurance System
We rigorously audit and guide all divisions throughout the company with BML’s unique quality assurance system, leveraging our internal auditing department and external accreditation bodies.
As an organization accepting specimens and carrying out testing, accuracy control is of the utmost importance. Accordingly, we have a Testing Quality Department as an internal accuracy control department to perform rigorous checks. To further ensure quality, we also have a Reliability Assurance Department as a quality control auditing department completely independent of our testing departments, providing objective improvement guidance.
Additionally, we have established a thorough quality assurance system that includes unannounced on-the-spot inspections by prefectural specialist committee members and on-site inspections by external accreditation bodies.
Other Accreditations and Registrations Speaking to Our “Reliability” in Quality Assurance
ISO27017
In December 2022, BML obtained ISO 27017 certification, the international standard for information security management systems (ISMS), for our cloud-based electronic patient chart service (Qualis Cloud).
Cloud services have rapidly gained popularity in recent years due to their convenience, scalability, and cost benefits. Given this environment, we obtained this certification to improve and strengthen our security management system as a company handling highly confidential medical information.
Our test result inquiry service, “B-Report,” also obtained this certification in December 2021.
- Services we offer as a cloud service provider:
- 1Cloud-based test result inquiry service (B-Report)
- 2Electronic patient chart service (Qualis Cloud)
- ISMS cloud service management systems we use as a cloud service customer:
- 1Intec Private Cloud
- 2AWS
ISO14001
This is the international standard for environmental management systems issued to reduce environmental impacts and risks posed by products, services, and organizational activities and prevent pollution.
ISO27001
This is the international standard for information security management systems. (For computer system center operations related to laboratory testing business, electronic patient chart development, and cloud service development, operation, and maintenance)
Medical-related Services Mark Certification
The Japan Health Enterprise Foundation sets necessary requirements for high-quality medical-related services and certifies services, products, and providers meeting standards through unannounced on-the-spot inspections.
Privacy Mark
This program certifies the establishment of appropriate personal information handling systems and permits using the “Privacy Mark” as proof of certification.