ISO 13485:2016 - Internal Auditor Training vs. Lead Auditor Training

C

Chuck in QA

#1
Have any of you trained to Oriel Stat A Matrix Internal auditor training and/or Lead Auditor training? Both are to 13485. I have a QA person I want to send to the training. I took the Lead auditor training a few years back and was wondering if the internal auditor training was pretty much the same. There is a $1000 difference between them. Any advice?
 
Last edited by a moderator:
Elsmar Forum Sponsor

Colin

Quite Involved in Discussions
#2
I can't speak specifically about the courses you mention, or ISO 13485 but generally internal and external audit skills are very similar. In both cases you will need to prepare for the audit, interview people and collect evidence and report your findings.

Where they differ is in the scale of the audit and the depth to which you go into the standard. For the internal audit a person needs to have a broad understanding of what the requirements are but for the external audit s/he needs a thorough understanding.

Usually an internal auditor will take a process/area/department to audit whilst an external auditor will be looking at the whole company.

Which one to go for - internal first every time for me and then if you need to, progress to the LA course in the future.
 

Marcelo

Inactive Registered Visitor
#3
Lead auditor trainings are usually certified, that's why there's a difference in price (besides the usual longer time).
 
R

randomname

#4
My guess is that the internal audit course will focus primarily on planning-conducting-reporting audits, while the lead auditor will focus on this PLUS a significant review/understanding of 13485. However, internal auditors don't necessarily need to focus to 13485, but instead to your internal policies & procedures.

It really comes down to the level (breadth, depth) of competencies you want to develop.
 

BoardGuy

Quite Involved in Discussions
#5
One major deference between Internal Auditor and Lead Auditor certifications is course content. Both types of auditors must understand basic audit guidance of ISO 19011 but a Lead auditor must also understand the requirements from certification bodies found in the ISO 17021 series of Standards.
 
Thread starter Similar threads Forum Replies Date
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 9
JoCam Difference between Approval and Registration - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
L ISO 13485:2016 Clause 8.4 - Analysis of Audit Observations ISO 13485:2016 - Medical Device Quality Management Systems 8
S When is ISO 13485:2016 6.4.2 Contamination Control appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Templates for three ISO 13485:2016 SOPs ISO 13485:2016 - Medical Device Quality Management Systems 8
C What falls under the 'Customer Property' according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 10
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
F ISO 13485:2016 Quality Policy Requirements Other ISO and International Standards and European Regulations 3
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
J ISO 13485:2016 sample exam/test ISO 13485:2016 - Medical Device Quality Management Systems 3
M Informational Questionário – Análise crítica sistemática – ISO 13485:2016 (Portuguese-only) Medical Device and FDA Regulations and Standards News 0
M Informational ISO 13485:2016 under systematic review Medical Device and FDA Regulations and Standards News 5
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
J ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
D ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control ISO 13485:2016 - Medical Device Quality Management Systems 2
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
S ISO 13485:2016 and GDRP EU 2016/679 ISO 13485:2016 - Medical Device Quality Management Systems 5
JoshuaFroud Interpretation of Clause 5.5.2 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
A ISO 13485:2016 Applicable regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 13485:2016 Registration - NC on full cycle of internal audits ISO 13485:2016 - Medical Device Quality Management Systems 7
C Will anyone please share training material for ISO:13485:2016 for best practices Training - Internal, External, Online and Distance Learning 0
T ISO 13485: 2016 Internal Audit - Is sampling on projects allowed? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
S What records are required to show compliance to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Non Applications in ISO 13485:2016 for component contract manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom