Retroactive Training Records Necessary? ISO 13485

M

mr.mike

#1
Hi Everyone,

Some opinions sought...

According to ISO13485 (and other quality systems for that matter, FDA QSR, ISO9001...) training requirements and records should be maintained (to paraphrase).

So, I'm wondering how this applies to senior personnel/top management?

For example,
- A company is founded by a small number of people who manage the company
- Years later, the company wants to get quality system certified

So the question is: is it really necessary to create training records for these people? They run the show afterall, who the heck would "train" them?

Just wondering... :)

MM
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hi Everyone,

Some opinions sought...

According to ISO13485 (and other quality systems for that matter, FDA QSR, ISO9001...) training requirements and records should be maintained (to paraphrase).

So, I'm wondering how this applies to senior personnel/top management?

For example,
- A company is founded by a small number of people who manage the company
- Years later, the company wants to get quality system certified

So the question is: is it really necessary to create training records for these people? They run the show afterall, who the heck would "train" them?

Just wondering... :)

MM
Someone has to determine the need for training for these people. It can be you or the small number of people themselves. This need could be even as broad as understanding the ISO13485 QMS.
After all, the QMS is a success only with top management support and participation, and for this the correct understanding of the QMS structure and requirements and authorities responsibilities is a baseline.
When this happens by any means, then recording is not any big deal ~~~
:2cents:
 
Last edited:

Kales Veggie

People: The Vital Few
#3
Hi Everyone,

Some opinions sought...

According to ISO13485 (and other quality systems for that matter, FDA QSR, ISO9001...) training requirements and records should be maintained (to paraphrase).

So, I'm wondering how this applies to senior personnel/top management?

For example,
- A company is founded by a small number of people who manage the company
- Years later, the company wants to get quality system certified

So the question is: is it really necessary to create training records for these people? They run the show afterall, who the heck would "train" them?

Just wondering... :)

MM
One approach I have taken in the past is their resume / CV is evidence of competency.
 

Mikishots

Trusted Information Resource
#4
Hi Everyone,

Some opinions sought...

According to ISO13485 (and other quality systems for that matter, FDA QSR, ISO9001...) training requirements and records should be maintained (to paraphrase).

So, I'm wondering how this applies to senior personnel/top management?

For example,
- A company is founded by a small number of people who manage the company
- Years later, the company wants to get quality system certified

So the question is: is it really necessary to create training records for these people? They run the show afterall, who the heck would "train" them?

Just wondering... :)

MM
Your paraphrased statement is missing an important distinction: competency. It is different from training; training typically takes place if the required competency is not met. The records you are required to keep are not just training records - as Kales has noted, records of education, skills and experience are also cited.
 
Thread starter Similar threads Forum Replies Date
D Retrospective (Retroactive) Supplier Qualifications Supplier Quality Assurance and other Supplier Issues 5
D IEC EN 62366 Usability Retroactive Compliance Other Medical Device Related Standards 1
ScottK Retroactive FMEA and Control plan - is this a common thing? FMEA and Control Plans 12
Y Retroactive application of harmonized standards US Food and Drug Administration (FDA) 2
C Certification vs Accreditation Training (General) Training - Internal, External, Online and Distance Learning 1
A Corrective Action Training ISO 13485:2016 - Medical Device Quality Management Systems 1
A Self-training or Self-studying ISO 13485:2016 - Medical Device Quality Management Systems 8
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Employees training database Document Control Systems, Procedures, Forms and Templates 4
optomist1 Rates Daily or Hourly Process Improvement Training Consultants and Consulting 2
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
S IEC60601-1 Training recommendations Training - Internal, External, Online and Distance Learning 1
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
was named killer Onsite Level II N.D.T. Training in Florida Training - Internal, External, Online and Distance Learning 0
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
S Quality Audit Training Activities Quality Manager and Management Related Issues 2
M Audit Criteria Training Materials Internal Auditing 1
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
Anonymous16-2 Labelling Training Training - Internal, External, Online and Distance Learning 3
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 8
J Looking for a training organization that can provide in house DFMEA training FMEA and Control Plans 4
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
R What's the major difference between Green Belt and Black Belt in term of training and project Six Sigma 3
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 42
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
JAMESH Building a "Lean" Job Shop Training Program Training - Internal, External, Online and Distance Learning 0
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
I Root Cause Analysis as Training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Regulations for Medical Device Kit for Training Personnel? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
S IRCA Lead Auditor training and Exam tips Training - Internal, External, Online and Distance Learning 5
N ... and some have greatness thrust upon them - Training for novice QA manager ? Training - Internal, External, Online and Distance Learning 6
C Looking for APQP Training recommendations preferably in the aerospace industry APQP and PPAP 2
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
L Hazardous Waste - Tips for creating standardized training Miscellaneous Environmental Standards and EMS Related Discussions 2
R ISO 13485 QMS Implementation Training ISO 13485:2016 - Medical Device Quality Management Systems 7
R How to keep track of employee read-only training ISO 13485:2016 - Medical Device Quality Management Systems 13
I "On the job training" as a response to how someone was trained? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 75
J Getting training either from ASQ or from SAI Global - ISO 9001 Lead Auditor training Training - Internal, External, Online and Distance Learning 1
I Date of Quality Management System - Training Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
R Training Matrix for Document revisions ISO 13485:2016 - Medical Device Quality Management Systems 4
I Training records and "grandfather" clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Education authority requires approval of all courses - Training services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S ISO 9001 Clause 8.3 - Design & Development for training course center ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ESD (Electrostatic Discharge) Training Misc. Quality Assurance and Business Systems Related Topics 2
S Is Annual QMS Training Required? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom