Can I accomplish ISO 13485 Lead Auditor Training online?

SGquality

Quite Involved in Discussions
Could I accomplish the ISO 13485 Lead Auditor Training online ? Is that recognized ?

If yes, any recommendations on good institutes who provide ISO 13485 Lead Auditor Training online ?

Thank you
 

AndyN

Moved On
I'd suggest that part of the benefit of doing a class-room based course, is the interaction with people - not just the academics. Sitting in front of a computer is no substitute for the dynamics in the role playing, for example. I'd suggest that on-line is sterile compared to actually doing all the tasks of an audit, real time, which is what you get in a conventional class type environment.
 
R

Reg Morrison

Could I accomplish the ISO 13485 Lead Auditor Training online ? Is that recognized ?
No, you can't. In order to become a Lead Auditor, you must attend a recognized course. Part of the course requirements is for auditor-candidate to be assessed in hir/her ability to communicate (including verbal) with auditees. That could not be accomplished online if you have no interaction with other people.

During a Lead Auditor Course, candidates are assessed on many things. The written test at the end of the course is ONE of a number of assessments the candidate goes through.
 

MIXOLYDIAN

Starting to get Involved
No? Reg, how can that be said when it's not in the standard (if it is, please take me there). There are some junk courses out there that are done in a classroom setting charging 1k plus for the course. I say search and educate yourself. If you can afford the classroom type, go for it. If online; go for that.
LNR
 

AndyN

Moved On
No? Reg, how can that be said when it's not in the standard (if it is, please take me there). There are some junk courses out there that are done in a classroom setting charging 1k plus for the course. I say search and educate yourself. If you can afford the classroom type, go for it. If online; go for that.
LNR

Having taught the LA course for a (significant) number of years, I can confirm that an on-line course - if such were available - wouldn't be very effective in delivering what's needed to learn and then demonstrate competency in this role. There's sufficient grumbling that 36 hours doesn't make an competent lead auditor in a class room setting anyway - and that's WITH the dynamics that ONLY instructor led training can provide. A "blended" approach to the learning MIGHT work, but I'd suggest that the key parts of becoming a "lead" (audit team leader) can ONLY be demonstrated effectively in a class room environment.
 
Thread starter Similar threads Forum Replies Date
J How to accomplish ISO 13485 Clause 8.2.3 Monitoring and Measuring? ISO 13485:2016 - Medical Device Quality Management Systems 5
Ajit Basrur How to accomplish section 5.9.2 of ISO 17025 ? ISO 17025 related Discussions 10
T What does Tool Validation Accomplish? Design and Development of Products and Processes 14
D How to verify a process that uses software to accomplish certain tasks? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Inspection & Verificaton of Incoming Material - How best one can accomplish ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
L How do you accomplish TS 16949 Clause 6.2.2.4? Employee Motivation and Awareness Training - Internal, External, Online and Distance Learning 4
Marc Americans work more, accomplish less World News 2
S "Level of Control" over Suppliers - How do you Interpret and Accomplish Supplier Quality Assurance and other Supplier Issues 1
S ISO 17025 Documented Procedure for 6.2.5.e - authorization of personnel ISO 17025 related Discussions 2
P ISO 17050-1 & -2 Manufacturing and Related Processes 4
Z ISO 13485 Non-applicable clauses ISO 13485:2016 - Medical Device Quality Management Systems 2
C Question on Finding - BSI Stage 2 ISO 13485:2016 Certification - PMS ISO 13485:2016 - Medical Device Quality Management Systems 5
J Complaints Handling ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
C How to to become an ISO 9001:2015 consultant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Clean Room Class ISO 8 EU Medical Device Regulations 3
S What is the relation between EU Annex 1 and ISO 14644 requirements? Manufacturing and Related Processes 2
A ISO 13485 CERTIFICATION WITH REGULATORY ISO 13485:2016 - Medical Device Quality Management Systems 2
P ISO 20243 vs. AS5553 vs. CISA ICT SCRM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G ISO 17025.2017 Clause 7.8.4.3 Certificate of Calibration Label ISO 17025 related Discussions 5
R ISO 13485:2016 DESIGN TRANSFER Forum News and General Information 0
Donetta Notified Body Unresponsive - Cancelled ISO Cert Early Registrars and Notified Bodies 5
Y Environmental Monitoring in ISO 13485 production areas ISO 13485:2016 - Medical Device Quality Management Systems 2
A QMS Roll out with guidance from ISO 9001 Quality Management System (QMS) Manuals 8
B ISO 9001Exclusion of clause 8.5.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Merging two ISO systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
cscalise ISO training and auditing resources for Korea MDA regulations Other Medical Device Regulations World-Wide 0
C Computerized System Validation in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M What is meant by "operating criteria" at closed 8.1 of ISO 14001:2015 ISO 14001:2015 Specific Discussions 0
Q Experience Records - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Sidney Vianna Informational ISO/TC 176/ TG4 Updated summary of emerging themes document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A ISO 9001 & API Q1 Approved Supplier/Sole Agent ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Can an organization be ISO certified if it doesn't comply with each clause? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Matrix to determine what's needed to create a QMS v ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Feedback process ISO 13485:2016 clause 8.2.1 ISO 13485:2016 - Medical Device Quality Management Systems 2
N ERP for ISO 13485 QMS solution, your experience, reviews ? ISO 13485:2016 - Medical Device Quality Management Systems 1
GStough ISO 17025 Lead Auditor Training - Punyam Academy ISO 17025 related Discussions 6
M Integrating ISO 9001:2015 audits with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
W ISO 10993-6 Implantation Other Medical Device Related Standards 1
R ISO 13485 Certification for an Internal Warehouse? ISO 13485:2016 - Medical Device Quality Management Systems 1
Q ISO 13485 Contract Manufacturer Controls and Quality System Requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001: 2015 MR Outputs - "any need for changes to the quality management system' Management Review Meetings and related Processes 13
Dirk S Contact duration (ISO 10993-1) vs. body contact days (ISO TS 21726) Other Medical Device Related Standards 2
O ISO 14971 for Biologics? ISO 14971 - Medical Device Risk Management 6
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 7
A ISO:13485 Strategy for a Startup ISO 13485:2016 - Medical Device Quality Management Systems 5
G ISO 13485 and CE certification strategy ISO 13485:2016 - Medical Device Quality Management Systems 7
A Small Company Implementing ISO 13485 Timeline/Process/Steps Advice ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Informational ISO 45002:2023 General guidelines for the implementation of ISO 45001:2018 Occupational Health & Safety Management Standards 1
K ISO 17025 Query Relating to Monitoring of Equipment ISO 17025 related Discussions 3
A ISO 27001_Audit IEC 27001 - Information Security Management Systems (ISMS) 6

Similar threads

Top Bottom