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Insignia Medical Systems A fresh look at an existing ISO 13485 QMS to realign with the business.
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Fabrinet UK ISO 13485 certification for manufacture of electronic medical devices

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Success Stories

Insignia Medical Systems

Insignia Medical Systems are a UK-based PACS provider specialising in creating software for medical imaging and storage. The business works for and provides medical imaging technology to private health organisations and NHS trusts.

When Insignia found themselves without a consultant after several years of over-reliance, they felt it was the ideal time to bring in some fresh thinking to update and simplify their existing Quality Management System. The legacy QMS had not been designed specifically for Insignia and contained many materials from previous systems which were now irrelevant. QFactorial were engaged to establish ownership of the QMS within Insignia and to redefine it in a more relevant context for the business.

1

newly designed, bespoke QMS

1

re-engaged leadership team

QFactorial Service offering

Quality Strategy
Management Systems
Business Processes
Leadership Tools
Assurance Programmes

Implementation

QFactorial re-defined operational meetings and procedures and helped support Insignia to re-write their QMS based around processes which fully describe effective ways of working. As their new consultants, we facilitated, coached and developed the personnel in Insignia to work within their QMS.

This project really highlighted the fact that it is never too late to revamp an existing quality system – whether the business has grown arms, legs and heads since it was last written, or the previous system never seemed like it fitted properly, a simple and bespoke QMS is never a pipedream. Taking the time to understand your business processes and align them to your processes, there is value in choosing the right consultant to guide, collaborate and steer you through any ISO process.

The Outcome

The major win for Insignia was that their leadership team were able to, once again, own their own processes and be in a position to improve and develop them. Their modernised, bespoke QMS is now entirely digitised and, more importantly, aligns completely with their business.

 

Q! Feedback

After phase1, diagnostic and planning: “Phase 1 is complete and very cathartic it has been too…”

Then on completion: “I wanted to take the opportunity to thank you and in particular Alistair for your help and advice.  Alistair has been excellent. He has helped us enormously and given us the confidence to simplify and modernise our QMS processes.”

Arron Edwards

Director of Software Development

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