Three ways to control quality related documents (in compliance with ISO 9001:2015) – Genebra Quality
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18 de September de 2019
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Three ways to control quality related documents (in compliance with ISO 9001:2015)

There are 3 ways to show good document control to be in compliance with the ISO 9001 standard:
1) Create an operational procedure that describes the control form;
2) Describe the control form of each document in its attachment;
3) By control evidence, without documentation.

We’ll explain each item listed above, furthermore you will find a quote from the ISO 9001:2015 standard regarding control of documented information (7.5.3.2 requirement):

“The organization shall address the following activities, as applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of readability;
c) change control (version control, for instance);
d) retention and disposition.”

We interviewed different consultants, auditors, and checked supporting documents from ISO itself and companies that have already certified in the new version of the standard. As a result of this interview, we list the 3 most common ways to control documented quality information. Perhaps one of them is helpful in your business. Here they are:

1) Create an Operational Procedure

The most basic, traditional and least controversial way to demonstrate that you meet the 7.5.3.2 requirement of the standard is to make a single OP that describes how QMS documents are controlled. Some experts argue that each term described in the requirement should be individually considered:

  • Distribution
  • Access
  • Recovery
  • Use
  • Storage
  • Preservation
  • Change Tracking
  • Retention
  • Disposition

Other professionals prefer a lighter approach by grouping everything into macro items, for example:

  • Creation
  • Use
  • Discard

2) Describe the control form of each document

There are companies that prefer to keep this information described within each document as part of the footer or have a document session just for that purpose. This way, the information will be accessible to anyone who has the document at hand, even in print.

3) By control evidence, without documentation

This is the most practical way to comply with ISO 9001: 2015, in requirement 7.5.3.2, but at the same time controversial. The standard does not require you to document how you control documented information, but some consultants may ask you for that information.

And how do I show that this standard requirement is being met?

In an audit, you can show the software where you track documented information and ways to use it. The following is a list of each 7.5.3.2 requirement and how it is met by Genebra: 

  • Distribution: Sent by email to those responsible for the document;
  • Access: With a password. Once a document is uploaded into the system, under document info you are able to restrict document access by selecting who is able to view, print, and download the document;. 
  • Recovery: Under the search tab, you will be able to search for documents utilizing the filters provided;
  • Use: Those who were granted permission to edit the documents will be allowed to do so;
  • Storage: all files are stored on the Azure Blob Storage server
  • Preservation: daily backups ;
  • Change Tracking: every document revision will require a justification;
  • Retention: The document will remain in the system until it is replaced, inactivated, or deleted from the system;
  • Disposition: When the document is deleted, the digital file will be erased.

Conclusion

These are some ways to control quality documents based on ISO 9001:2015. Do you utilize any of them or have any other suggestions? There is a space for you to leave a comment below.


Fernanda Melo
Fernanda Melo
Marketing Assistant

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