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Human resources appendixes question

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Guest user Created:   May 11, 2023 Last commented:   May 11, 2023

Human resources appendixes question

This week we're working on the Human Resources documents and a few questions came up:

1. On the company there are a few courses from Udemy and Coursera that some employees have taken and others that are currently taking them, ¿are these courses considered as training programs so I can put them on the 4.1 and 4.3 Appendix?

2. Are training records (4.2 appendix) fully necesary? It's just that we currently don't implement trainings to monitor performance and we don't have trainings to fill the document, also, I understand this appendix refers to trainings that are needed due to bad performance, ¿am I right? Let me know if it refers to something else. 

Thank you very much and I'll be waiting for your answer.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić May 11, 2023

1. On the company there are a few courses from Udemy and Coursera that some employees have taken and others that are currently taking them, ¿are these courses considered as training programs so I can put them on the 4.1 and 4.3 Appendix?

Yes, you can consider them as training and make records about it. You as Manufacturer must decide which training is necessary for your employees to have proper competencies for particular responsibilities or job positions.

2. Are training records (4.2 appendix) fully necesary? It's just that we currently don't implement trainings to monitor performance and we don't have trainings to fill the document, also, I understand this appendix refers to trainings that are needed due to bad performance, ¿am I right? Let me know if it refers to something else.

As stated in requirement 6.2 e), a training record is a must to maintain appropriate records of education, training, skills, and experience. Considering the monitoring of the performance, it is not necessary to make it for each training. You can state that for particular training performance monitoring is not necessary, meaning that you as the manufacturer can decide which training will require performance monitoring and which not.

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May 11, 2023

May 11, 2023