Thornbury Manufacturing

A three-year ISO 13485 partnership that resolved into mentoring TML’s own internal audit team

Client Challenge

Thornbury Manufacturing (TML) is a Plymouth-based medical device manufacturer, certified to ISO 13485. Q! supported TML for over three years, keeping their quality management system current between formal certification cycles.
Over time, this developed from carrying out the day-to-day system work into mentoring TML’s own internal audit team, advising them directly through their own audit process.
“We’re always sad to see a client go, but still pleased to have helped them escape our clutches!”
Key challenges included:

Sustaining quality system currency between certification cycles

Keeping on-site visits consistent across the Plymouth-Swindon distance

Handing audit ownership back to TML’s own team over time

Maintaining momentum across occasional, quarterly-paced visits

Outcomes achieved

Quality management system kept current for over three years

TML’s own internal audit team fully mentored to lead their own audits

External surveillance audits supported throughout the partnership

The Advisory relationship concluded once TML’s team was self-sufficient

Gosh, you shouldn’t have…

Kind words from our clients

Related case studies

Client: QFactorial

Our own B Corp journey: practising what we preach

Read more
Client: Client anonymised - new lab premises not yet public.

Pacing ISO 17025 groundwork to match the build of a brand new laboratory

Read more

Ready to build audit confidence in-house?

If you want your own team leading internal audits with confidence, our mentoring can get you there.

Our sectors of expertise: