Internal audit consultant ISO 13485 (English speaker)

#1
Hello,

I am QA/RA manager in a french start-up (first product in development) and we are ISO 13485 certified since early this year.
I am looking for a consultant with experience in auditing ISO 13485 QMS to perform an internal audit by the end of the year. We made our first internal audit with a french consultant but our external audits are performed in English and the certification audit was a hard exercise for me - my English tends to be very bad when I'm anxious and it was very frustrating!
We decided to do our next internal audits in English (native or fluent in English) so we will be better prepared for our next external audits.
Do you have any suggestion of experienced internal auditor in Europe (UK, Germany, Belgium, ...)? A consultant used to work with start-ups would be a plus!

Thank you very much!
Mhalik
 
Elsmar Forum Sponsor

JoshuaFroud

Involved In Discussions
#2
Hi Mhalik,

I probably cannot help you myself, however, letting people know roughly where the audits would need to be conducted would be useful information? If you dont want to give a full address thats fine but a country or region would help people as distrance of travel may well be a key thing in selecting an consultant auditor.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
What kind of devices? Is the company a specification developer or do you also have manufacturing in-house?
 
Thread starter Similar threads Forum Replies Date
P Can an outside consultant audit all the AS9100 requirements including Internal Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
S Internal Audit for a Design Consultant Company Internal Auditing 9
M Can external quality consultant carry out internal audit? Internal Auditing 17
salaheddine96 Internal audit planning Internal Auditing 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
Q Internal audit plan template Internal Auditing 6
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
S Internal audit discrepancy - We missed a few audits that were scheduled Internal Auditing 12
Raffy ISO 14001 9.2.2 Internal Audit Programme Content Internal Auditing 10
N Internal Audit Schedule – Who gets to set the schedule? Internal Auditing 16
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
T Internal Audit Schedule when Hiring Out Internal Auditing 7
D ISO 9001:2015 Internal Audit Training Advice Internal Auditing 10
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
F Internal Audit - Procedure example Internal Auditing 5
C Internal Audit - Process Clause Matrix / Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 7
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
M Internal Audit Plan in Retail Internal Auditing 10
D Management of NC after internal system audit IATF 16949 - Automotive Quality Systems Standard 7
A Purchasing - Internal Audit Questions Internal Auditing 8
N Comprehensive Compliance Matrix for Internal Audit Checklist Other Medical Device Regulations World-Wide 1
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
E Informational Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work) Internal Auditing 149
E ISO 9001:2015 - Internal Audit Plan Clauses General Auditing Discussions 8
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
S Internal Audit - Risk and Opportunity (ISO 9001:2015 ) Internal Auditing 1
F API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits. Oil and Gas Industry Standards and Regulations 22
Ashland78 IATF 16949 Internal Audit Checklist Manufacturing and Related Processes 11
Ed Panek Root Cause CAPAs from internal audit ISO 13485:2016 - Medical Device Quality Management Systems 16
K Student wanting Case Study about Internal Audit Report Internal Auditing 1
R How far apart can you schedule separate areas or departments in your internal audit? Internal Auditing 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10
J Microsoft Teams to manage Internal Audit System? Internal Auditing 3
tony s An organization's Internal Audit Office certified to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
Tagin Does ISO 9001:2015 require a full internal audit annually? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21

Similar threads

Top Bottom