ISO 13485 Consultant Recommendations

[Al Rosen]

In Reply to Parent Post by JanJohn

Hi Westley,

I'd like to suggest you consider Kristine King at QPA, Inc. She has huge experience in quality management system development, for systems ranging from automotive to medical device manufacturers. She also brings her experience with lean process development into her guidance for QMS development.

Phone: 763.561.2428
www.qpa.com

Best regards,

SAI Global Lady

Jan, what personal experience have you had with her? Have you used her for help in developing a QMS and to what standard? What was the size of the organization and did it have some system in place before you engaged her services? Can you provide some details of your experience?

[JanJohn]

In Reply to Parent Post by Al Rosen

Jan, what personal experience have you had with her? Have you used her for help in developing a QMS and to what standard? What was the size of the organization and did it have some system in place before you engaged her services? Can you provide some details of your experience?

Hi Al,

I have personnally audited several of her clients so I've had a first row view of her success as a consultant. The systems she helps to build are all unique, relavent to the client's business and scope of accreditation, yet with similar core engines for improvement. She doesn't do that cookie cutter drop-n-go thing that leaves the client gasping for breath at the registration audit. She started QPA Inc over ten years ago and initially worked a lot with QS-9000. She lives in Minnesota so her focus has changed to medical device and ISO 13485 work.