Training Records - How detailed? ISO 13485 Requirements

claudia_2023

Registered
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?
I preferred to be enlightened with answers and not questions.
Thanks
 

Bev D

Heretical Statistician
Leader
Super Moderator
I preferred to be enlightened with answers and not questions.
Thanks
Well this a FREE service manned by people who care deeply about quality and typically have 20-40 or more years of experience. Did I mention we do it for free? Many people just want to know the answer - but remembering is not the same as knowing let alone understanding. Quality professionals need to learn the fundamentals of quality and critical thinking. Otherwise they are just parrots who cannot add value; they are just a lookup device.

The answer you were given - even if in the form of a question - was excellent. THINK about what was said - and show a little respect for the FREE advice.

When someone comes here they often get several answers in the effort to help the poster learn. If all you want is answers you are better off paying for it.
 

claudia_2023

Registered
Well this a FREE service manned by people who care deeply about quality and typically have 20-40 or more years of experience. Did I mention we do it for free? Many people just want to know the answer - but remembering is not the same as knowing let alone understanding. Quality professionals need to learn the fundamentals of quality and critical thinking. Otherwise they are just parrots who cannot add value; they are just a lookup device.

The answer you were given - even if in the form of a question - was excellent. THINK about what was said - and show a little respect for the FREE advice.

When someone comes here they often get several answers in the effort to help the poster learn. If all you want is answers you are better off paying for it.
Thank you for your comment Bev.

Precisely because I know that this site is frequented by people with more than 20-40 years of experience, I decided to take a risk and try to get some clarification, as I have done a lot of research and am not sufficiently clear about this.

You should also consider the arrogance with which you treat people.
If anyone here on this forum has experienced this and can give me an answer or advice, I would be very grateful, otherwise I don't need to be "pushed" out of here by people I don't even know and I will leave gracefully.
 

yodon

Leader
Super Moderator
I preferred to be enlightened with answers and not questions.
Wow, certainly meant no offense and was certainly not trying to be arrogant.

The problem is that we can't know your exact situation so the questions are intended to help you determine the best course of action.

I could have said that you must or must not do training - but either answer would have been underinformed.
 

Randy

Super Moderator
I don't even know and I will leave gracefully.
You were given a good answer about changing your thought process from training to competence. Training is useless and a waste of time, effort and money unless that training can actually be utilized as intended in the manner intended. (called demonstrated ability to apply knowledge and skill or competence in ISO speak).

If anyone here on this forum has experienced this and can give me an answer or advice, I would be very grateful, otherwise I don't need to be "pushed" out of here by people I don't even know and I will leave gracefully.
OK how's this? I myself have well over 20 years as a 3rd party CB (ISO) auditor and I was instrumental in the development of multiple accredited Lead Auditor courses and delivered (taught) about 200 (+/-) Lead Auditor course myself to an estimated 2000-3000 professionals from around the globe (there are others in here as well with as much and even more experience). Many times our learning is accelerated by being asked questions that require us to rationalize and think things through (Ever hear of Plato?) Yodon was polite and clear so if you want to leave on his account and Bev's please don't let the door hit you as you exit.
 

claudia_2023

Registered
Wow, certainly meant no offense and was certainly not trying to be arrogant.

The problem is that we can't know your exact situation so the questions are intended to help you determine the best course of action.

I could have said that you must or must not do training - but either answer would have been underinformed.
Yodon, all of our services are subcontracted. In this particular case, we are asking to the warehouse perform a rework that basically consist of changing the IFU from one language to another. We have in place the template for rework and they are signing it everytime, but my question is regarding the training. According to my understing, the ISO stands for training records inside the company, I'm not sure about providing external trainings and recording it.
 

claudia_2023

Registered
You were given a good answer about changing your thought process from training to competence. Training is useless and a waste of time, effort and money unless that training can actually be utilized as intended in the manner intended. (called demonstrated ability to apply knowledge and skill or competence in ISO speak).


OK how's this? I myself have well over 20 years as a 3rd party CB (ISO) auditor and I was instrumental in the development of multiple accredited Lead Auditor courses and delivered (taught) about 200 (+/-) Lead Auditor course myself to an estimated 2000-3000 professionals from around the globe (there are others in here as well with as much and even more experience). Many times our learning is accelerated by being asked questions that require us to rationalize and think things through (Ever hear of Plato?) Yodon was polite and clear so if you want to leave on his account and Bev's please don't let the door hit you as you exit.
Thak you for your clariication.
 

Randy

Super Moderator
According to my understing, the ISO stands for training records inside the company
Exactly where are "training records" required?

These are all the "required" records.
Mandatory Records ISO 9001:2015

7.1.5.1 Record of Maintenance and Calibration of Monitoring and Measuring Equipment

7 .2 Competence Records

8.2.3.2 Product/Service Requirements Review Record

8.2.3.2 Record of New Requirements for Product or Service

8.3.3 Design and Development Inputs Record

8.3.4 Record of Design and Development Controls

8.3.5 Design and Development Outputs Record

8.3.6 Record of Design and Development Changes

8.4.1 Record of Evaluation of External Provider (supplier)

8.5.1 Record of Product/Service Characteristics

8.5.3 Record of Changes on Customer’s Property

8.5.6 Record of Changes in Production/Service Provision

8.6 Evidence of Product/Service Conformity

8.7.2, 10.2.2 Record of Nonconformity

9.1.1 Monitoring Performance Information

9.2.2 Internal Audit Program and Results

9.3 Management Review Results

10.2.2 Nonconformities and Corrective Action
 

claudia_2023

Registered
Exactly where are "training records" required?

These are all the "required" records.
Mandatory Records ISO 9001:2015

7.1.5.1 Record of Maintenance and Calibration of Monitoring and Measuring Equipment

7 .2 Competence Records

8.2.3.2 Product/Service Requirements Review Record

8.2.3.2 Record of New Requirements for Product or Service

8.3.3 Design and Development Inputs Record

8.3.4 Record of Design and Development Controls

8.3.5 Design and Development Outputs Record

8.3.6 Record of Design and Development Changes

8.4.1 Record of Evaluation of External Provider (supplier)

8.5.1 Record of Product/Service Characteristics

8.5.3 Record of Changes on Customer’s Property

8.5.6 Record of Changes in Production/Service Provision

8.6 Evidence of Product/Service Conformity

8.7.2, 10.2.2 Record of Nonconformity

9.1.1 Monitoring Performance Information

9.2.2 Internal Audit Program and Results

9.3 Management Review Results

10.2.2 Nonconformities and Corrective Action
 
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