SMi Systems

About you

I’m the Chief Operating Officer and have been in role from the start of SMi’s scale up (2 years). My primary role is in leading the team who is taking our proof-of-concept instrument through product development and on to manufacture. Later, I’ll be building the operational teams needed to sell, install and maintain our products.

Until SMi, I had been involved in a several ISO 9001 based QMS audits over the years, always as an auditee.

About your company

SMi is nearly 6 years old, the first 4 years were spent refining ideas and experimenting with prototypes which resulted in the company being awarded a prestigious Innovate UK award to develop next generation diagnostic capabilities. Venture capital soon followed and we opened our UK HQ (close to Cambridge), our US laboratory (in Washington State) and started scaling up. Currently we’re 16 people with plans to more than double that in the next 2 years.

SMi’s business has a dual industry focus: Research and Diagnostics…

For the research industry we’re developing next generation imaging systems that enable the detection, quantification and characterisation of single molecules for biomedical research. Our accuracy and throughput will set an industry precedent in the fields of diagnostic screening, drug discovery and vaccine development.

For the diagnostic industry SMi uses its core imaging technology to directly visualise and quantify disease-causing particles. Our highly automated, simple to use, platforms deliver extremely fast and highly accurate diagnostic data across an almost limitless spectrum of disease types for both humans and animals; there are even potential applications in contaminant detection for foods and the environment.

This truly is an exciting company to be a part of.

About auditing

SMi is working towards ISO 13485:2016 Quality Management System certification. We’ve built our QMS with help from quality consultants and our eQMS provider. Outside help has been essential, but we recognised that for our QMS to be truly effective we needed to own its development from the start.

I’m a firm believer in leading by example and that effective systems need total management commitment. That’s why the rest of the management team agreed I should complete internal audit training. This would allow SMi to gauge progress and ensure we were building a QMS that would work for us.

Our inhouse audit team is just me at present but we’ll be hiring early next year to help us grow. During the development of our systems our consultants have provided support that ensures the QMS is reviewed by a third-party and that we comply to UK, EU and FDA regulations.

About the course

I attended the classroom-based ISO 13485:2016 internal audit training course with Batalas. I’d previously completed some online ISO 13485:2016 training, but felt the need for some more direct, hands-on training to more effectively implement our QMS.

About Batalas

The course was excellent. A rapid recap of the standard followed by practical experience on day 1. The mock audit sessions brought the subject to life and quickly demonstrated that objectively seeking evidence to support compliance was both a helpful and effective auditing technique. Day 2 gave us an opportunity to reaffirm these lessons. Whilst not the primary goal, the training also gave me a far better appreciation of how to be a better auditee and how to implement a more effective QMS. Understanding the type of evidence that is needed for compliance helped in the development of our systems to ensure that the evidence was a natural by-product of doing things properly ~ our QMS ensures that SMi is achieving the highest standards.

About experience

Since completing the training I’ve assisted in a full system internal audit and an external supplier audit (both led by our consultants). I’m currently drawing up our internal audit programme, so will be leading the next round of internal audits very soon. I’m using the learning from the training daily as we build towards our stage 1 certification audit.

About your career

SMi is growing quickly and is providing fresh and exciting challenges every day. Implementing a new QMS is only the first step, and we’ll be refining the effectiveness of what we’re doing for the foreseeable future. We also have plans to open a UK lab which is going to involve new working practices and procedures ~ I’ll not be writing those, but I’ll be auditing them, in part using knowledge I have gained from the Batalas training.

About advice to new auditors

Auditing has helped me in my role of developing our business to deliver quality products that help make a difference to people’s lives. As the Chief Operations Officer, auditing has been an enabler rather than my full-time job. That being said, if anyone with an eye for detail and a personable nature asked me if they should think about auditing as a career I’d definitely encourage them.