Documented Evidence of Training ISO 13485: 2016

QualAl

Starting to get Involved
#1
Hi Everyone,

I have a question in regards to Training. Has anyone in the forum experienced this during an audit. Is there a requirement in the standard (ISO 13485:2016) or Medical Health regulation requirement to provide proof that when a new hire joins your company. He is suppose to read all applicable procedures or work instructions applicable to his position or function. Yes, I believe they should be reading the applicable procedures or work instructions when they are performing that particular job or activity when the time comes. However, my question is; Is there a requirement to show proof that this person has read the applicable procedures or work instructions. Does this person have to sign off anywhere to show that he has read and understood the applicable procedures or work instruction. This goes the same for all management in the company. Up to the level of President, Vice President and so on. Do they have to sign off that they have read the Company Quality Policy, Quality Manual, Employee Manual. etc... as, well.

To my general knowledge, I haven't found anywhere in the Medical Device Standard (i.e. ISO 13485: 2016) stating that this is a requirement. Is this something new that I'm not aware of or I didn't read in between the lines carefully. I know that when we conduct training. We document this training as well as having the personnel being trained sign off on a sheet of paper that he has attended this particular training. But as for all levels within the company, have to sign off that they have read the procedures, work instructions, Quality Manual, Quality Policy etc...


Any feedback on this would be greatly appreciated.

Thank you,

Alan
 
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John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#2
Hi Everyone,

I have a question in regards to Training. Has anyone in the forum experienced this during an audit. Is there a requirement in the standard (ISO 13485:2016) or Medical Health regulation requirement to provide proof that when a new hire joins your company. He is suppose to read all applicable procedures or work instructions applicable to his position or function. Yes, I believe they should be reading the applicable procedures or work instructions when they are performing that particular job or activity when the time comes. However, my question is; Is there a requirement to show proof that this person has read the applicable procedures or work instructions. Does this person have to sign off anywhere to show that he has read and understood the applicable procedures or work instruction. This goes the same for all management in the company. Up to the level of President, Vice President and so on. Do they have to sign off that they have read the Company Quality Policy, Quality Manual, Employee Manual. etc... as, well.

To my general knowledge, I haven't found anywhere in the Medical Device Standard (i.e. ISO 13485: 2016) stating that this is a requirement. Is this something new that I'm not aware of or I didn't read in between the lines carefully. I know that when we conduct training. We document this training as well as having the personnel being trained sign off on a sheet of paper that he has attended this particular training. But as for all levels within the company, have to sign off that they have read the procedures, work instructions, Quality Manual, Quality Policy etc...


Any feedback on this would be greatly appreciated.

Thank you,

Alan
The short answer is "no".

The requirement is competency. The standard uses terms like...
* ...needed training,
* b) provide training or take other actions to achieve or maintain the necessary competence;



Beyond ...
* ...shall document the process(es) for establishing competence,
* e) maintain appropriate records of education, training, skills and experience


...it's up to the organization how competency will be achieved.

Is your organization be asked about or criticized regarding how your organization is managing this?

Hope this helps.
Be well.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#3
Is there a requirement to show proof that this person has read the applicable procedures or work instructions. Does this person have to sign off anywhere to show that he has read and understood the applicable procedures or work instruction.
No, there isn't. You might have encountered an auditorsaurus rex disguised as a CB auditor. Some of them have archaic, inane expectations and roam the plains of the RegistrantWorld seeking auditee prey, instead of performing value added conformity assessment jobs.

Push back. Forcefully. As you don't want an external auditor forcing you to spend time, money and effort in valueless bureaucracy.
 
#6
Does this person have to sign off anywhere to show that he has read and understood the applicable procedures or work instruction. This goes the same for all management in the company.
How then do you ensure that employees are made aware of the procedures? Typically, employees train to procedures and fill out a training record. If the process is complicated, the training process is more intense and involves verification of competence. If I were auditing you, I would be wondering how you demonstrate awareness and competence without these training records.

But as for all levels within the company, have to sign off that they have read the procedures, work instructions, Quality Manual, Quality Policy etc...
Employees should be made aware of the procedures applicable to their role in the company. For example, the CEO does not need to read a manufacturing work instruction, but that person show be made aware of the quality policy. How do you show this awareness?
 

Sidney Vianna

Post Responsibly
Leader
Admin
#7
If I were auditing you, I would be wondering how you demonstrate awareness and competence without these training records.
Record-based audits are very ineffective. Looking for a piece of paper (or digital record) to ascertain if someone is aware of something or competent is, for the most part, a waste of time. Auditors have to be able to interview personnel and assess if such individuals are aware of the applicable requirements of the PROCESSES (not procedures only) they are involved with. Proper auditing demands an effort by the auditor to familiarize themselves with the process being being audited well enough to ask pertinent questions of the auditees. A training record is, for the most part, inconclusive evidence of competence in anything.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#8
How then do you ensure that employees are made aware of the procedures? Typically, employees train to procedures and fill out a training record. If the process is complicated, the training process is more intense and involves verification of competence. If I were auditing you, I would be wondering how you demonstrate awareness and competence without these training records.

Employees should be made aware of the procedures applicable to their role in the company. For example, the CEO does not need to read a manufacturing work instruction, but that person show be made aware of the quality policy. How do you show this awareness?
Good day @indubioush ;
I don't believe the OP was implying they should not (do not) train nor that they should not (do not) keep records. In fact, the OP states that they DO these things.
The gist of the question(s)... (I infer from "during an audit" that at CB raised the issue), is summed up by...
- " Does this person have to sign off anywhere to show that he has read and understood the applicable procedures or work instruction..."
- "...is there a requirement in the standard (ISO 13485:2016) or Medical Health regulation requirement ..."


There simply is no such requirement.

Be well.
 

yodon

Leader
Super Moderator
#9
when a new hire joins your company. He is suppose to read all applicable procedures or work instructions applicable to his position or function.
Agree with everything posted, UNLESS you have an internal requirement that drives this. If your procedures were written by a (to play off @Sidney Vianna) soposaurus then you may have something like this. Be sure you haven't shot yourself in the foot first.
 

Tidge

Trusted Information Resource
#10
I feel as if there is some attempts to hew close to the line of the standard(s) without recognizing some basic human considerations.

Signing off that training was attended/participated in is a pretty straightforward risk control to pre-address circumstances where there is some sort of non-conformance that is attributed to (lack of/ineffective) training. If executive management implements a policy requiring associates be trained, provides the materials for training, and requires associates attest to the training (even if it is just "read and understand") it is more difficult for an auditor to find MWER at fault. (EDIT: I feel like the hypothetical nonconformance could either be attributable or systemic... pick your poison.)

I certainly don't believe that a QS auditor would (or should) automatically raise a finding specifically about this, but if there had been a review of nonconformances and the root cause investigation documented lack of training... and the company wasn't recording evidence of "read-and-understand" training (easiest done by a self-attestation by an associate)... I can understand why this sort of question would come up.
 
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