With a focus on innovation, authenticity, and long-term growth, I am dedicated to helping businesses elevate their presence and make a lasting impact.
Let me guide your business through the ISO journey and implement a system that is simple to understand and to maintain.
ISO MANAGEMENT
ISO 9001 ISO 13485 ISO 14001
I can help guide your business through implementation of ISO ready for certification.
Already have ISO, but need help establishing existing ISO requiring further compliance and improvements? Then lets discuss options and bridge those gaps
auditing
I can help from conducting Internal Audits for ISO requirements to Internal Auditing required processes.
Are you needing to audit your suppliers for regulatory requirements, or due to multiple non-conformances, then I can assist you with this.
Initial steps
One of the initial steps is conducting a Gap Analysis to see where you may be not fulfilling ISO requirements. I will produce a proposed plan and framework to bridge requirements. I will explain where we can simplify existing processes to save time and money, whilst ensuring compliance.
You then have the option to continue the journey implementing yourself with my guidance and tools, or you can use my expertise to guide and implement for your business.
feel free to contact myself with any enquiries
initial consultation possibly shall be remote to discuss needs and requirements
I have over 20 years experience working with a manufacturing company producing medical devices.
In the last 10 years I was promoted to Quality and Regulatory Manager and started to implement my own quality management system which has proven effective throughout Notified Body audits, whilst ensuring complaince with the relevant ISO Standards and applicable regulations.
More recently, I also became Quality and Regulatory Manager of a digital electronics manufacturing and design company whilst continuing my role with medical devices. I was able to obtain ISO 9001 certification within 6 months.
Beyond my technical expertise, I possess a deep passion for simplifying and implementing improvements with companies on a meaningful level.
Every company I work with is treated as a unique canvas, where creativity and strategy come together to build a framework that resonates and drives results.
With a focus on innovation, authenticity, and long-term growth, I am dedicated to helping businesses elevate their presence and make a lasting impact.
Let me guide your business through the ISO journey and implement a system that is simple to understand and to maintain.
© Stacey Spruels Consulting
