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Implementation questions

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Guest user Created:   Feb 24, 2021 Last commented:   Feb 24, 2021

Implementation questions

1. How does one determine an organization has enough employees to do the work?
What sort of things need to be looked at, to ensure a company is adequately staffed?

2. What sort of things can we do to determine training effectiveness?  At the initial training we can have an on the job training or when someone observes you and signs you off on a particular task, but after
What are some industry standard practices.

3. Also if my company has an Asset Management, Gowning SOP, Environmental Monitoring and Pest Control procedure that cover the different points in your toolkit example for the infrastructure and work environment procedure will that be good enough or does the information need to live in one document titled “Infrastructure and Work Environment?”

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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.

Expert
Kristina Zvonar Brkić Feb 24, 2021
1. How does one determine an organization has enough employees to do the work? What sort of things need to be looked at, to ensure a company is adequately staffed?

The first step is to create an organizational chart that clearly defines every job function required to effectively operate your company. The next step is to define your processes, to see what are the expectations (key performance indicators, goals) on certain processes and how many people can fulfill those expectations. To define key performance indicators, you need to know very well your processes, what are the risks in it, how do you deal with those risks (what control measures you have implemented to control them); you need to understand your technology and equipment, what resources is necessary and so on.

The following articles can be helpful:

2. What sort of things can we do to determine training effectiveness? At the initial training we can have an on the job training or when someone observes you and signs you off on a particular task, but after What are some industry standard practices.

Usually, training effectiveness depends on the type of training performed. Here are some examples (but not all of course):

Test or quiz after the trainingSupervision of some work (employee who had training perform that work under the supervision of the mentor)During conducting the internal audit is a good place to check whether the employee is taking the necessary steps to perform a jobTransferring knowledge further to employees is also one way. For example, Management has conducted training for Department Heads, and then these department heads must transfer knowledge to the employees in their department.

Just keep in mind two things. It is important to determine training objectives before training, what you want to accomplish with it, what kind of knowledge training participants are expected to receive. Next thing is that for most training it is not possible to conduct an effectiveness assessment immediately, it takes some time for the acquired knowledge to be adopted and implemented. How much time is needed for this depends solely on each training, so you cannot say that you will always carry out an evaluation of effectiveness, for example, 3 months after the training.

For more reading, see the following articles:

3. Also if my company has an Asset Management, Gowning SOP, Environmental Monitoring and Pest Control procedure that cover the different points in your toolkit example for the infrastructure and work environment procedure will that be good enough or does the information need to live in one document titled “Infrastructure and Work Environment?”

No, it is not necessary to be in the document titled Infrastructure and Work Environment?. It is absolutely OK to have your own pr5ocedures. Just be sure that all requirements from the standard ISO 13485 are fulfilled.

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Feb 24, 2021

Feb 24, 2021

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