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Tracking revisions and document numbering

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Guest user Created:   Aug 11, 2021 Last commented:   Aug 12, 2021

Tracking revisions and document numbering

I was wondering if you would be willing to share some thoughts on good practices for tracking revisions and document numbering for a specific situation.  We are working toward ISO accreditation and evaluating our current system of documents, especially SOPs. Our SOPs were originally set up as very topic based documents with a designated SOP number for each.  For example, the topic of "Facilities" was broken into 8 separate SOPs which had topics like pest control as an individual document.  As the Quality Manager this system does not feel necessary and I would rather see the content in a single document, but I'm not sure how to address the old numbers.  Our owner would like to reuse the document number for new content but that seems like it would only add confusion.  Any advice or opinions on that would be greatly appreciated.

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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.

Expert
Tracey Evans Aug 12, 2021

The essence of document control is to ensure that the correct, valid documents are available to the right people, in the right place, at the right time. There must be no confusion regarding the process and numbering. The system of review, revision, approval and implementation should also be simple and easy to implement. The actual system varies extensively between laboratories. Your approach also depends on how automated your document management system. A more funstional system provides for links to the correct documents so the impact / risk of a complicated naming and numbering system is less of an issue.

As you are still implementing you system, I suggest you look at the risk of change /adoption but also opportunity going forward and decide on what the best approach is for you. Best practices includes archiving and making documents or versions obsolete, so and you can decide, if risk is acceptable, to “retire” and recycle/reissue document numbers – as long as it does not create confusion or traceability issues.

Typically I would not advise on a single operational procedure document. A Quality Manual serves the purpose of stating policies and integrating all the processes and document in one place. For review and control purposes, separate procedures makes more sense and works better in terms of scalability as your laboratory develops. Either way the central document is your Document Control procedure and your List of internal documents and records.

For more information on document control, see the ISO 17025 toolkit document template: Document and Record Control Procedure at https://advisera.com/17025academy/documentation/document-and-record-control-procedure/

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Aug 11, 2021

Aug 12, 2021