Quality management

Quality & ISO certification

Our quality management system controls laboratory procedures, documentation, and health and safety practices. It covers equipment supply and service as well as laboratory work.

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LRQA UKAS-accredited ISO 9001:2015 certification mark LRQA UKAS-accredited ISO 13485:2016 certification mark

Certified by LRQA under UKAS accreditation · Winchester, Carlsbad and Diémoz

Certification

LRQA certificates under UKAS accreditation

Both certificates were issued on 15 December 2025, continuing earlier NQA certification without interruption.

LRQA UKAS ISO 9001 mark

ISO 9001:2015

Quality management systems

Approval number
00051584
Certified since
14 December 2021 (NQA 174608/1)
Current expiry
13 December 2027
Sites
Winchester (head office), Diémoz (BTF) and Carlsbad (BTLLC)

Scope

The supply of freeze dryers and other specialist equipment, servicing, calibration, preventative maintenance and breakdown/repairs of equipment supplied, and the provision of freeze-drying and other analytical services including research and development, consultancy, production, training courses, instrument sales and installations.

View certificate (PDF)
LRQA UKAS ISO 13485 mark

ISO 13485:2016

Medical devices quality management systems

Approval number
00051583
Certified since
15 July 2021 (NQA 128184)
Current expiry
14 July 2027
Sites
Winchester (head office) and Carlsbad (BTLLC)

Scope

The freeze-drying of customer-supplied components, including storage, assembly and packing of components to customer specification. Design and development of Lyobead production device.

View certificate (PDF)

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In practice

What the quality system covers

  • Controlled laboratory procedures and documentation for CDMO projects
  • GMP manufacturing to EU GMP Annex 1 in our Winchester facility
  • Calibration and certification of the analytical instruments we build
  • Service, calibration and maintenance records for customer equipment
  • Installation qualification support, with FAT/SAT protocols supplied or written to your specification
  • Health and safety practices across laboratories and field service
Scientist working in the cytotoxic handling suite

Audit feedback

From our certification audits

I couldn’t fault Biopharma Group’s QMS system as the system is robust, up to date and maintained.

ISO Lead AuditorIndependent audit feedback

Well done – John has been doing these audits for years and to achieve a result like this, is commendable.

ISO AuditorIndependent audit feedback

Request certificates for supplier approval

We can provide copies of our certificates and supporting quality documentation.

Email the quality team