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Kirkstall Precision Engineering passes ISO13485 audit with flying colours

Kirkstall Precision Engineering’s ability to provide medical devices, and related services, which have consistently met customer and applicable regulatory requirements, has long been a mainstay of our core business ethos.

As we are governed by medical regulatory requirements every 3 years, we must undertake a 5-day re-certification audit for our ISO13485 standard. The ISO13485 is an internationally agreed standard, which sets out the requirements for a quality management system specific to the medical devices industry.

This re-certification audit would be unique compared to previous audits as we went live with a new ERP system in 2021 which incorporated large elements of our (Quality Management System) QMS.

Over the past 12-months Peter Newbould or QA / RA manager has been very busy re-writing the QMS. This audit would be the real measure of his achievements since joining Kirkstall Precision in Oct 2020. I am very happy to report that Kirkstall Precision gain passed the audit with flying colours and excellent feedback from the auditors.

Conducting the audit while developing employees

As part of our employee development program, it was agreed that this audit was also used as a valuable training program for Linus Gallagher, who is our apprentice Quality Engineer in the 3rd year of his apprenticeship. Linus is currently being mentored by Peter and shadowed him throughout the audit, this exposure gave Linus real hands-on experience in his training program.

Speaking about this, Peter commented that: “I would like to thank everybody in the Kirkstall Precision team for their continued work and effort that made this audit a success.

“With the development of the QMS along side our new ERP system the audit experience was very clear and concise over the 5 day period. Both our auditors were impressed with the level of control covered by the ERP system and particularly impressed with the clear links from the customer process through the business to despatch”.

Peter continued.

“This audit was also a good experience to introduce Linus to how our QMS, ISO13485 and our ERP system all work together to cover the regulatory requirements of the medical device sector. Linus had lots of questions at the end of each day on how the ISO13485 clauses have been adopted here at Kirkstall Precision and it shows how valuable these experiences are for an apprentice quality engineers development.

Confidence in our medical engineering capabilities

Kirkstall Precision Engineering has a long and respected track record in the world of medical precision engineering. Over the years the company has produced a wide range of medical devices, that have been key to helping people live more fulfilling lives.

This track record has extended into devices for the veterinary sector too, with devices also produced that are used in pet surgery, to ensure many beloved household pets can live longer and more fulfilling lives.

Speaking about this, and the ISO13485 audit, Kirkstall Precision’s new Managing Director, Iqbal Bahia, commented that: “Audits like these showcase the deep-rooted expertise and commitment to quality standards that we are proud of here at Kirkstall Precision. It’s the reason why we are used globally, by huge corporations, as well as smaller local companies and universities, to provide a wide range of precision engineered devices and implants for use in a wide range of surgical procedures, from knee and hip operations to broader and more regular procedures.”

Discover more about Kirkstall Precision’s expertise in the medical sector

From universities exploring new ways of performing complex procedures to aiding surgeons perform better. At Kirkstall Precision we have a passion for the medical Engineering sector. We have produced small batch solutions for individual surgeons to trial as well as large orders for both complex and simple surgical tools and implants. In fact, if you’ve had a hip or knee replacement, there’s a good chance it may have been made at Kirkstall Precision Engineering.

To find out what we can do or you, contact Iqbal Bahia, Managing Director at: