First qualified person
Qualification procedures need to be developed and implemented for a test or a certain manufacturing procedure. A test, OJT or validation should be included. However, who can be the "first" qualified person? For the validation of the qualification, there needs to be a person to compare. We are in the process of first developing the qualification procedure. Do we need to establish a procedure that specifies the first person to be qualified? Or can anyone or someone who had been doing the job become a first qualified person?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
The first qualified person is a person who, because of his/her knowledge, training and experience, is qualified to perform that task safely and properly. This person can be trained for example by the manufacturer of the equipment used in the validation process, or this person can even be someone who developed certain validation process.
In ISO 13495:2016 section 7.5.6 Validation of processes for production or service provision, there is no requirement for procedure that specifies the first person to be qualified.
For more information on how to manage the validation process, please read the following article:
Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
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Nov 20, 2019