Training Records - How detailed? ISO 13485 Requirements

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JoeQNovice

I am somewhat familiar with the requirements of 6.2.2 under ISO 9001:2000 for competence, awareness and training, but recently underwent an audit for ISO 13485 where the auditor said that the Standard (ISO 13485) required specific job descriptions for each employee down to the work instruction level. Not unlike those required by ISO 16949. Does anyone have thoughts as to how accurate this is and how detailed job descriptions have to be under 13485 beyond what ISO 9001 will allow?

Joe:
 

Ajit Basrur

Leader
Admin
Re: ISO 13485 and training records

I am somewhat familiar with the requirements of 6.2.2 under ISO 9001:2000 for competence, awareness and training, but recently underwent an audit for ISO 13485 where the auditor said that the Standard (ISO 13485) required specific job descriptions for each employee down to the work instruction level. Not unlike those required by ISO 16949. Does anyone have thoughts as to how accurate this is and how detailed job descriptions have to be under 13485 beyond what ISO 9001 will allow?

Joe:

Hi Joe,

Welcome to the Cove :bigwave:

If you refer to the Note of ISO 13485, point 6.2.2, it states the following - NOTE National or regional regulations might require the organization to establish documented procedures for identifying training needs.

Thus with regards to regulatory aspects, this requirement has been aligned to FDA's 21 CFR Part 820.25 which states the following -

820.25 Personnel.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1) As part of their training, personnel shall be made aware of device defects, which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Thus FDA is bit more detailed. Hope this clarifies.
 
G

Gert Sorensen

Re: ISO 13485 and training records

Hi Joe,

Welcome to the Cove :bigwave:

If you refer to the Note of ISO 13485, point 6.2.2, it states the following - NOTE National or regional regulations might require the organization to establish documented procedures for identifying training needs.

Thus with regards to regulatory aspects, this requirement has been aligned to FDA's 21 CFR Part 820.25 which states the following -

820.25 Personnel.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1) As part of their training, personnel shall be made aware of device defects, which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

Thus FDA is bit more detailed. Hope this clarifies.

You're good :bigwave:
 
M

madannc

Re: ISO 13485 and training records

a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

This would be covered by CV's (resumes) held in HR, and during the interview and selection process when applying for a position in a company. The JD should list the pre-requisit qualifications/experience required.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

Induction courses and on the job training, with a record that the employee has attended, and if exam/test the results of the test.

(1) As part of their training, personnel shall be made aware of device defects, which may occur from the improper performance of their specific jobs.

Again on the job, some companies keep defect books or defect DVD's, that employees are trained on and can refer too. These need to be controlled.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job
functions.

The Validation team will perform training as part of the pre validation/verification activities, this would include knowing what defects could occur and what to do about them. A record of this should be in the project file.
 
R

Roland Cooke

Re: ISO 13485 and Training Records - How detailed?

Just be aware that ISO13485:2003 requires evidence of effectiveness of training (or other action), and a requirement to re-evaluate competency at appropriate intervals.


I've found that a few companies tend to struggle a bit here, by simply requiring a sign-off by an employee that he/she has read the procedures.

I think that's is a risky approach. For basic stuff you can arguably meet the requirement of ISO13485 by specifically indicating that simply reading the procedures will indeed be deemed to be adequate, (i.e. unless subsequent information causes that position to be reviewed).

But for many other activities, more is actually done (supervision, examination, additional QC inspection etc etc). Make sure that other activity is described and recorded somehow.
 
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JoeQNovice

Thanks to all. Roland, does ISO 13485 require an evaluation of the effectiveness of training above and beyond reviews for competence spelled out in ISO 9001?

Joe
 

Doug Tropf

Quite Involved in Discussions
Thanks to all. Roland, does ISO 13485 require an evaluation of the effectiveness of training above and beyond reviews for competence spelled out in ISO 9001?

Joe

I'm not Roland but believe this section from ISO 14969 (guide on the application of 13485) may address your question.

"Organizations should evaluate the effectiveness of training or other actions taken in order to ensure competency. Evaluation can consist of polling the trained employees to assess whether he or she feels thay have learned the required information, evaluating the work performance of the trained individual, and reviewing the trainer assessment of training effectiveness".
 

claudia_2023

Registered
Hello!

I would like to have some clarifications about the trainings according to ISO 13485 in regards of provide training to outsourced company. I'll try to explain better: my company has subcontractors for almost all services, in particular we have a subcontracted warehouse and sometimes there is a need to ask them to do a rework. Should the training recorded, I mean, someone inside company go to the warehouse facilities and train the people. Or, according to the ISO 13485 I'm only obliged to record trainings within the company?
 

yodon

Leader
Super Moderator
Recalibrate your thinking to competency. You need to ensure individuals assigned tasks are competent to do them. Training is only one way. How do you know that those individuals will properly do the rework? What's the risk if they do it wrong? You're always responsible for these tasks so it's incumbent on you to ensure the individuals have the necessary competency. And if you do training, how do you know it's effective?
 
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