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Coding Documentation

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Renzo Luzzatti Created:   May 22, 2018 Last commented:   May 26, 2018

Coding Documentation

Is it required by the standard to have a coding system for your documentation? Before we started our ISO 13485 certification, we would organize the documents by folders and name the documents according to their contents, then revisions and sometimes dates. For example, "1 Quality (Folder) > Quality Manual Rev 03.docx (Document name). Will this be satisfactory for our organization and control of documents?
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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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Strahinja Stojanovic May 26, 2018
Hi Alexis,

The standard does not explicitly requires organizations to establish document coding system ,although it is very common. All the standard requires is for documents and records to be identifiable and this can be accomplished by coding or by giving the documents unique titles, such you mentioned in the question.

From the perspective of the standard, your approach is completely OK.

Best regards,

Strahinja
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