Where can I take ISO 13485 lead auditor training?

S

sonic85

#1
Hi Guys,

Could anyone please let me where can I take an ISO 13485 lead auditor training. I need to take that course within the next 2 weeks.

Any help would be really appreciated !!!:confused:
 
Elsmar Forum Sponsor
#2
Well, where are you in the World? We can't help you much if you don't say where you are - or are you prepared to fly anywhere?
 

somashekar

Staff member
Super Moderator
#4
Why do you have to have Lead Auditor training? Awful waste of money if it isn't necessary
There is a dearth of qualified and trained 13485 auditors across most of the recognized CB's. The OP is certain of his requirement.
Sonic85: You need to see which of the recognized CB's are offering this training in your area.
Check with BSI, SGS, UL, TUV Sud, TUV Rhienland
 
J

JohnF46

#5
For Lead Auditor training (with reference to EU Directives/regulation) check out online training and certification on the deGRANDSON Global website.
 
Last edited by a moderator:
#6
There is a dearth of qualified and trained 13485 auditors across most of the recognized CB's. The OP is certain of his requirement.
Sonic85: You need to see which of the recognized CB's are offering this training in your area.
Check with BSI, SGS, UL, TUV Sud, TUV Rhienland
Be sure, also to check with nonCB training like Omnex, Oriel Stat-A-Matrix, Excel Partnership, etc. - CB's are only one source of training to consider.
 
S

sonic85

#7
Hi Thanks everyone,

I am located on the east cost in the US.

You guys provided some good information. So I wanted to say that i need this training as I am transitioning from compliance engineering to Regulatory in my company. I would need to do ISO 13485 Audits at Multiple location all over the USA. So my company offered me two options:

1- get a one day training from a senior auditor on ISO 13485 here at my company
2- Look for a class that teach ISO 13485.

So i though option 2 is better for the long run, can someone confirm that? since some of you mentioned the class might be a waste of time.

Also I am looking at course offered by STAT A MATRIX. is this company good??

Also are these course carry any value for future job opportunities ?

Thank you all again very much:thanx:
 
#10
So the training is worth it, right?

Would it help in future career opportunities??
It depends on what career you are pursuing. I was a Lead Auditor but the course hasn't done anything for me, except I was a CB auditor and a Supplier Quality Manager. Having a course isn't going to get you a job as an auditor, really. The course costs around $1500 and the company is going to send you? The option is one day with someone? Neither sound much of an option. If you have not done audits before, you'll need more than 1 day. Coaching is a better option, frankly. A 4 day LA course may not be really what you actually need. Perhaps an internal auditor course, with the experienced auditor providing some coaching is the "best" solution.
 
Thread starter Similar threads Forum Replies Date
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
V Where to add SOP of writing a Technical File in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
P Where to buy ISO 13485:2012 ISO 13485:2016 - Medical Device Quality Management Systems 10
Q Where to buy the ISO 13485 standard in a pocket sized book ISO 13485:2016 - Medical Device Quality Management Systems 19
X Where to start with ISO 13485 and Registrars near Seattle ISO 13485:2016 - Medical Device Quality Management Systems 2
A I need the ISO 13485 Standard manual. Where can I buy it? ISO 13485:2016 - Medical Device Quality Management Systems 9
R Where can I get ISO 13485:2003 Introduction Training Videos Training - Internal, External, Online and Distance Learning 3
T Where can I buy ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
R Where to Document Exclusions per ISO 13485 and ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 2
P Where can I buy ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 3
G New to ISO 9001 - Where to begin? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
qualprod Statistics - Where to start in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
W Where to begin with an ISO 9001:2015 internal audit Internal Auditing 13
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
Marc Where do you buy your ISO and other various standards? Various Other Specifications, Standards, and related Requirements 3
R QMS and ISO - Where to start? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S ISO 17025 - Help in Getting accreditation- Where to start from ISO 17025 related Discussions 8
E Where can I buy ISO-15223-1 CD with graphic symbols? Other Medical Device Related Standards 13
I Where to buy ISO 10001, 10002, 10003 & 10004 (latest) Other ISO and International Standards and European Regulations 3
M When was ISO started and Where? Other ISO and International Standards and European Regulations 3
B Where can I buy the ISO 9001:2015 Standard in pdf? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Where in the ISO 9001 standard it asks for process based auditing? Process Audits and Layered Process Audits 6
M Where to buy ISO 3951-1 and ISO 3951-2 standard copy Other ISO and International Standards and European Regulations 1
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
P Where to start to helping other companies to get ISO IEC 27000? Consultants and Consulting 1
Q Where does 5S technique fit into ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
MichaelDRoach Where in ISO 9001 is White Out on Forms and Records Prohibited? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Where to purchase ISO 9001:2008 and ISO 9000:2005? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K ISO 9001:2008 Logo on objects/documents/brochures/logos where we advertise ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
W Working in a company where we try to implement ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 9
L Where to purchase ISO/IEC 27001:2013 IEC 27001 - Information Security Management Systems (ISMS) 3
A ISO 9001 to ISO 17025 where to start ISO 17025 related Discussions 3
I ISO 9001:2008 4.2 Documentation - Where to put a Procedure Quality Manager and Management Related Issues 7
J Where to begin to move our company towards ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P Where do training documents fit into the ISO 9001 categories? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Customer Property Cl. 7.5.4 - Where does ISO 9001 stop and ISO 27001 start? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
A Where to define Process Tailoring Form used in CMMI in the ISO 9001 Quality Manual? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D ISO 26262 (Road Vehicles - Functional Safety) - Where to start implementation? Other ISO and International Standards and European Regulations 7
N ISO 9001 Implementation - I am still confused on where to start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
S Planning and Costs to Implement ISO / IEC 27000 - Where to start? IEC 27001 - Information Security Management Systems (ISMS) 2
G ISO 14040/44 - Are these 2 seperate documents and where to buy? Miscellaneous Environmental Standards and EMS Related Discussions 2
K Where to buy ISO/IEC 17025:2005 ISO 17025 related Discussions 4
R In ISO 9001, where are New Customer Orders addressed? Manufacturing and Related Processes 4
J ICT Assets and ISO 9001 Clause 7.5.3 - Where Traceability is a Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Where can I buy EN ISO 14971:2009 (Medical Device Risk Management)? ISO 14971 - Medical Device Risk Management 11

Similar threads

Top Bottom