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List for external documents – Non conformance

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Guest user Created:   Sep 12, 2019 Last commented:   Sep 12, 2019

List for external documents – Non conformance

The company I work for had the surveillance audit done and there were 2 minor NCs observed. I am trying to understand the Root Cause Analysis for it. The Non Conformance was for Clause 7.5.3.1 and 7.5.3.2. The comment said “List of documents for External documents (Standards, codes, guidelines etc) was not found maintained”). I am looking for probable RCAs for this finding. Could you help me out with that.

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Iciar Gallo Sep 12, 2019

The control of external documentation includes those documents and records necessary for the planning and operation of the QMS. As you mention this is a requirement of the clause 7.5.3.2 of ISO 9001:2015, and therefore you need to address the following activities in relation to that documentation of external origin as per 7.5.3.1, including:

a) distribution, access, retrieval and use;

b) storage and preservation, (including legibility);

c) control of changes (i.e. version of the document);

d) retention and disposition.

I recommend you to write a procedure containing how you control documents and records, including external a nd internal documented information.

For the external documentation you can, for instance, do the following:

  • relevant emails can be saved in an specific folder, for instance client email folder;
  • new standards and laws, can be saved in a legal compliance folder;
  • government and authorities letters can be stored in a government letters folder.

For each folder you will need to assign the person/s responsible for its updating and maintenance, as well as who will have access and right to edit those documents.

In addition, in the procedure of the control of documents and records you need to stablish a codification for each document and record, so you can easily control any change or update,

You can see these materials to help you with the control of list of external documents and records:

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Sep 12, 2019

Sep 12, 2019

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