Quality / ISO 9001
ISO 9001 CERTIFIEDISO 9001 quality management
Our quality management system is certified to ISO 9001. In practice that means every lot follows a documented route from collection to release, and that route is auditable, by us and by you.
- 9001
- Certified QMS
- Every lot
- Documented release
- Audited
- Annual surveillance
What it covers
Scope of the system
ISO 9001 is a management standard rather than a product standard. It governs how we work, which is what determines whether a lot arrives as described.
Supplier control
Collection partners assessed and approved before material enters our chain.
Traceability
Every lot traceable from donor or production batch through to dispatch.
Document control
Procedures versioned and controlled, with staff trained against them.
Nonconformance
Deviations recorded, investigated and closed with corrective action.
Equipment
Freezers monitored and alarmed, instruments calibrated on schedule.
Continual review
Management review and internal audit on a defined cycle.
Documentation
What we can provide
Procurement and quality teams routinely send us supplier approval questionnaires. Send yours at the enquiry stage rather than after ordering and we will return it before you commit. Questions about terms used here are answered in the glossary and FAQs.
Ethics
Consent and collection
Quality and ethics are the same question for human material. All material we supply is collected ethically, in line with the regulations of the country of collection, and remains deidentified throughout.
Shipping
How material reaches you
Frozen material is shipped on dry ice; other formats ship at the temperature specified for that product. Documentation is supplied for your forwarder and receiving site.
Common questions
For your quality team
Can we see your ISO 9001 certificate?
Yes, on request. We can also supply the scope statement so your team can confirm it covers the activities relevant to your supply.
Will you complete our supplier questionnaire?
Yes, and we would rather do it early. Send it with your enquiry and it will come back before you place an order.
Can we audit you?
By arrangement, at either the Cambridge laboratory or remotely. Customers manufacturing regulated products frequently do.
What happens if a lot fails specification?
It is not released. If a problem is identified after dispatch we notify affected customers, investigate the cause, and confirm what corrective action was taken.
Questions for our quality team
Documentation requests, supplier questionnaires and audit enquiries are welcome before you order.