ISO 13485 is used as a regulatory standard and thus it is crucial that certified organizations remain in conformance. Errors with your system can cause regulators to issue fines and penalties or even cause you to stop business. Thus internal auditing needs to be very good. It need to find any issues before the regulators and it needs to provide solutions that are practical and yet still meet the requirements.
Cavendish Scott has been auditing medical device organizations for 25 years and has devised auditing approaches that are precise and ensure that all requirements can be carefully examined for conformance. Substantial and broad experience with management systems allows us to provide feedback about streamlining and improvement.
Our reporting contains clear objective findings quantified and supported by evidence to give management a clear understanding of problems and risks associated with regulatory compliance. Fixing these findings will basically take care of the regulatory posture of the organization. We also provide subjective findings, also supported by evidence where we make recommendations for improvement, streamlining and strengthening conformance.
Cavendish Scott audits against ISO 13485, FDA QSR and EU In-Vitro and Medical Device Directives and Canadian CMDCAS regulations. We are thorough, professional and precise. Our audits relieve you of the difficulties of resourcing these audits internally and getting good results. We provide clear assurance to let management rest easy that the organization will remain in compliance with regulatory requirements. Contact us for more information about giving you that assurance.
Internal Audits for ISO 13485
“This was by far the best auditing class I've attended and should we need more students trained, Cavendish Scott will be our choice for trainers. The interaction and exercises were phenomenal and the fact that we got audits completed that we can count towards our yearly schedule was a definite plus.”
– SG, Corporate Director Product Assurance, Aerospace services organization
“The [lead] auditor class was absolutely one of the best I’ve ever had the pleasure of attending and know Cavendish will be invaluable in the [ISO] process.”
– DS, Quality Manager, Metal Processing and Manufacturing Organization, Colorado
“Thank you all again for coming out and for all that you do for us. Despite a few challenges, we really do appreciate the value that your audit adds to our business … and that is not just from me; I hear it from other members of the management team.”
– [AS9100 Auditing Client] Manager – Quality Systems, Aircraft Maintenance, Refitting, Services
“It would have been a difficult course for most of us if it weren't for your patience and teaching skill. You have made us all better stewards of the taxpayer's money by making us proficient auditors.”
– [Training Client] Quality Assurance, Naval Shipyard
“This course gave me an excellent overview of the ISO 9001 standard and I now have an appreciation for and solid knowledge of the standard, its intent, and how to audit against it.”
– Documentation Coordinator & Auditor, Chemical Test Standards Laboratory
“The instructor tailored the course as much as he could to the requests and experience of the group present, which made it much more valuable.”
– Environmental Health and Safety Manager, Defense Microelectronics Agency
“This is actually the best class I have attended. Instructor was amazing and very knowledgeable.”
– Top Manager, Integrated Circuit Design and Manufacturing Company
“There were lots of real life examples shared on very open discussions and the workshop feeling where all could contribute was very effective.”
– [Training Client] Systems Analyst, Data Storage Products and Services Company
“Thank you so much for all you did getting us prepared for the ISO Certification. We passed with flying colors. We had 0 Nonconformance. I felt like we just won a gold medal. The ISO Auditor was very impressed with the documents that you set us up with and how well written the manual and procedures were.”
– [Consulting ISO 9001:2015] Debbie at Precision Machine Shop, Texas
“I just wanted to extend to you all my personal thanks for all the help that you’ve given me. Our ISO auditor was very impressed with the progress that we made within the last year. This progress would not have been possible if wasn’t for the professionalism and knowledge that you four displayed throughout the internal audits, consultations, (Continue Reading)”
– ISO Representative, Logistics, Resale and ReUse Organization, Aurora, Colorado