Clinical Polymer Technologies recertified to ISO 13485:2016 by LRQA

Clinical Polymer Technologies has successfully completed reassessment of its quality management system to ISO 13485:2016. LRQA has issued an updated certificate valid to 29 March 2029, maintaining continuous certification since our original approval in March 2017.

For a contract manufacturer of medical silicone components, ISO 13485 certification is a fundamental operating requirement. Every device manufacturer supplied by CPT relies on the certificate to qualify the business as an approved supplier, to reference the QMS within their own technical file, and to demonstrate to Notified Bodies that the elastomeric components in their device are produced under a controlled, validated and auditable system. Continuity of certification is therefore essential to remaining in the medical supply chain.

Scope of certification

The certificate covers the manufacture of elastomeric components and assemblies for medical applications. The scope statement is intentionally broad because CPT's activities are broad: liquid silicone rubber (LSR) and high-consistency rubber (HCR) moulding, silicone-to-substrate overmoulding, cleanroom assembly, dimensional and visual inspection, controlled packaging, and management of sub-contract sterilisation. All operations that affect a customer part number fall within the certified scope.

• Certificate number: 10749203
• Approval number: 00008993
• Original approval: 30 March 2017
• Current issue: 30 March 2026
• Expiry: 29 March 2029
• Issued by: LRQA Limited

What a reassessment audit involves

A three-yearly reassessment is a substantially more extensive exercise than the annual surveillance visits between recertification cycles. LRQA reviewed the full quality management system end to end rather than sampling individual clauses. In practical terms, this involved several days on site with the auditor tracing evidence across every area of the operation.

The areas examined included:

• Design and development controls — including our role in customer-led development, DFM contributions and the boundary of design responsibility captured in quality agreements.
• Risk management touchpoints under ISO 14971, and how process risk feeds back into pFMEA and control-plan updates.
• Supplier controls — approval records, ongoing performance monitoring and change notifications from raw-material suppliers including NuSil, Wacker, Shin-Etsu and Momentive.
• Incoming inspection of medical-grade silicone, pigments, additives and inserts, with material certificates traced through to finished-goods release.
• Cleanroom manufacture operated to ISO 14644, including environmental monitoring trends, gowning validation and change control on the classified environment.
• Process validation for silicone moulding cells and secondary operations — IQ, OQ, PQ documentation, revalidation triggers and evidence of ongoing statistical process control.
• Batch traceability from raw-material lot through moulding record, in-process inspection, packaging batch and final release, all reconcilable in both directions.
• CAPA, complaint handling and non-conformance — trending data, root-cause analysis quality and effectiveness verification.
• Management review outputs and the closed loop back into objectives, resourcing and continual improvement.

Particular attention was paid to the process validation evidence for the LSR moulding cells, cleanroom monitoring data, and the change-control history across the press line-up, including the MAPLAN 160T press commissioned in 2023, which was introduced through the QMS under formal change control with its own IQ/OQ/PQ.

Continuous certification since 2017

CPT's original ISO 13485 approval was issued in March 2017 and the certificate has been maintained without interruption through every surveillance and reassessment cycle since. Continuity of certification carries greater weight than the certificate expiry date in isolation: customers auditing CPT's history can see an unbroken record of external verification.

What this means for customers

For device manufacturers referencing CPT in their technical files, this recertification carries three practical implications:

• No change to supplier status — CPT can continue to be relied upon in MDR, UK MDR, FDA 21 CFR Part 820 and equivalent submissions without a re-qualification exercise triggered by lapsed certification.
• An up-to-date certificate is available on request for customer supplier-quality files, valid to 29 March 2029.
• The scope statement is unchanged. Parts and part families qualified under the previous certificate remain within the certified scope.

A copy of the current certificate is available from the Quality page, along with the underlying quality policy and details of the wider quality framework. For a signed copy for a customer audit file, please contact CPT and a copy will be issued directly.