Quality Systems

How Beike approaches controlled processing, traceability, testing and accreditation across cell-banking and preparation activities.

Quality claims should be specific and verifiable.

Beike's quality framework combines management systems, controlled facilities, documented processes and programme-specific testing. Accreditation statements on this site refer only to their documented scope.

Certification does not by itself establish that a therapy is approved, appropriate for a patient or clinically effective.

Cryogenic storage systems at the Shenzhen Comprehensive Cell Bank

Operating principles

Defined scope

The relevant facility, process, cell type and intended use must be identified before a certification or quality claim is applied.

Documented chain of custody

Material identity and custody are recorded from intake through processing, storage, testing and release.

Protocol-specific release

Testing and acceptance criteria are defined for the applicable programme rather than presented as universal clinical approval.

Independent evidence

Where third-party testing or accreditation applies, the issuing body and the scope of that evidence should be made clear.

Management systems and accreditation

Current certificates, validity dates and exact scope should be confirmed with Beike before being relied upon for procurement or regulatory decisions.

ISO 9001
Quality-management system
ISO 14001
Environmental-management system
ISO 45001
Occupational health and safety management
ISO 27001
Information-security management
AABB
Accreditation applies to the defined cell-banking activities and scope; it is not approval of every potential clinical use.

Review Beike's standards and standardisation work →

Request evidence for a specific programme.

Tell us the facility, process, cell type and intended use you are evaluating.

Contact the quality team →