Take the ISO 9001 course exam and get the
ISO 14001, ISO 13485, or ISO 45001 course exam for free
LIMITED-TIME OFFER – ENDS SEPTEMBER 29, 2022

Expert Advice Community

Guest

Numbering system

  Quote
Guest
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
0 0

Assign topic to the user

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
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/ 

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Apr 05, 2022

Apr 06, 2022

Suggested Topics

Anonymous Created:   Jul 27, 2022 ISO 17025
Replies: 3
0 0

Personnel feedback

Guest user Created:   Jul 13, 2022 ISO 17025
Replies: 1
0 0

Clauses 4.1.5 and 5.4

Guest user Created:   Jun 30, 2022 ISO 17025
Replies: 1
0 0

ISO 17025 audit