At Kirkstall Precision Engineering we have always strived for excellence in everything we do, and that includes our Business Management System. Part of our mantra in striving for excellence has always been about being prepared for the unexpected and being audit ready 24/7 365 days of the year. And recently, this mantra paid off handsomely.
Our ISO9001:2015 recertification mid-year audit took place recently during the height of lockdown and we are proud to announce that we have again achieved ZERO non-compliances and best in class recognition for our Business Management System.
This followed on from our early excellent achievement in January where we again achieved our re-certification for our Quality Management System – ISO 13485:2016 again with ZERO non-compliances and best in class recognition.
What being ISO13485 certified means to our business.
Being ISO13485 certified helps consolidating business and employees’ trust, an essential requirement in the medical device manufacturing industry. ISO13485 has become the worldwide accepted standard in medical manufacturing industry and certifies the conformity to regulatory requirements.
Organisations in the industry are expected to provide proof for quality management system implementation throughout the entire production cycle.
After having two very successful, but tough, audits in six months some companies would sit back with relief and pat themselves on the back. That mentality is not in the Kirkstall Precision DNA, especially when you are a Key Supplier to the world leading medical OEM’s you are always on the radar for un-announced and announced audits.
Auditing during lockdown.
So, it came as no real surprise when we were contacted by BIS that they had been approached by a key medical OME to carry out a full two-day systems audit on our ISO13485:2016 accreditation.
Work for re-accreditation audits, governing body audits and customer audits is continuously ongoing at Kirkstall Precision. Quality Manager, Andrew Townsend, contacted the lead medical auditor at BSI and finalised the processes for the 2-day audit using an all-day remote video call and shop floor live streaming during which they were able to audit and validate all our processes and systems in use to ISO1348:2016.
BSI concluded the audit after 2 days with zero non-compliances and best in class recognition for its Business Management System, the auditor stating in the closing meeting “The processes I have witnessed and audited put some corporate organisations I have audited in the shadows compared to Kirkstall Precision”.
Andrew Townsend commented after he received the final audit report from BSI “This is an incredible achievement and a testament to the incredibly high standards Kirkstall Precision holds itself to.”
Operations Director, Iqbal Bahia said, “Serving some of the biggest OEM’s in the medical sector we are always on a ‘war footing’ for audits, this is another momentous day for our business, having successfully passed a tough 2-day BSI full systems audit on our ISO13485:2016 standard.
Iqbal further added that, “This is an important moment for us as a business, as it visibly demonstrates our full commitment to quality and to our customers. It also demonstrates that having a robust Business Management System which fully integrates our Quality Management System will be key to our success”.
Managing Director, Adam Thornton also commented that “I’d like to acknowledge the team who have contributed to this, it’s a demonstration of commitment on all parts and at all levels within Kirkstall Precision and congratulations to Iqbal and Andrew, on another excellent result, we are all proud of this great achievement.”
Adam continued “This audit was at relative short notice and driven by major medial OEM who are looking at selecting Kirkstall Precision as their key supplier for medical instruments, this fantastic audit report from BSI gives them the confidence that Kirkstall Precision is the correct choice.”