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Numbering system

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Guest user Created:   Apr 05, 2022 Last commented:   Apr 06, 2022

Numbering system

I was hoping you could give advice on a numbering system for cross reference between the different documents ? Also do you have experience with 510K application at the FDA ? I have a local manufacturer who is busy the process
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Apr 06, 2022

You asked

I was hoping you could give advice on a numbering system for cross reference between the different documents ?

The naming convention and file structure is up to you, guided by your document management system platform. We find the folder structure we use for the ISO 17025 toolkit works well for small to medium laboratories. You could as an alternative, if you prefer, use the clause numbers as a folder number, e.g 6.4 Equipment however this can become unclear when you combine procedure together that cover multiple clauses, e.g. the recommended Complaint_Nonconformity_and_Corrective_Action_Procedure. Either way use your Quality Manual and Procedures to cross reference and or hyperlink to your files. Also use the List of Documents and records registers for cross referencing and control.

You also asked

Also do you have experience with 510K application at the FDA ? I have a local manufacturer who is busy the process."

If you are interested in requirements for Medical devices, please visit the Advisera ISO 13485 Academy at https://advisera.com/13485academy/ and ISO 13485 & EU MDR - Expert Advice Community from https://community.advisera.com/ The experts answer to the subject Differences between EU MDR and US FDA regulations may be of assistance. Available at https://community.advisera.com/topic/differences-between-eu-mdr-and-us-fda-regulations/ 

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