Master Control Lists for Records and Documents

[Ahmed.]

Hi, I have a question regarding QMS. Does a manufacturer complying to the ISO 13485 standard, require a Master Control document and Master control Record List as part of conformance to 4.24. anf 4.2.5 o teh standard?

Is it possible to conform to the following requirement without having maintained a Master Control List of Documents and Records which would have all the listed documents and templates or forms utilized to generate records and also used to oversee revision control and status of current viable docuements and records?

The question being, if an organization doesn't maintain a list of documents and records, is it bad practice or noncompliance?

The documents and records are maintained but not in an available list for instant overview.

"The organization shall docuemnt procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records."

 

[shimonv]

A typical QMS/eQMS would have many different kind of lists: SOPs, Records, NC's, CAPA's, etc. It's an industry practice and a good of knowing what you have, status, where it's at, etc.
Without such lists you are bound to get into trouble.

Shimon

 

[ChrisM]

Control of Documented Information: You need to maintain a register or list of documents that are under control. Not only this, but that list itself needs to be under control, as was previously pointed out to us on one external audit when I worked in Medical Devices..... so your Master List needs some form of reference number and version control, so that you can show what the revision status was at any time of all relevant QMS documents

 

[yodon]

Control of Documented Information: You need to maintain a register or list of documents that are under control. Not only this, but that list itself needs to be under control, as was previously pointed out to us on one external audit when I worked in Medical Devices.....

What was the requirement cited?

 

[ChrisM]

This was a few years back and no longer have access to the NCR that was written up. However I think it was related to clause 4.2.4 Control of Documents.... and "Documents required by the quality management system shall be controlled". If you don't know what documents are required (i.e. if you have no master document list), then how do you know what documents need to be controlled? ... also how do you know what documents are required by the QMS if you don't have a list, specifying them? It wasn't my decision to accept the NCR but that of my then-Boss

 

[Tidge]

I never saw a list maintained, but there was an established hierarchy for the QMS documentation. Records would be required by certain QMS procedures, and the mechanism for how those were generated, archived, and retrieved would be described in the governing policy.

It would have been crazy to try to maintain a live list, as every new inspection record etc. would have to be added to it.

 

[yodon]

If you don't know what documents are required (i.e. if you have no master document list), then how do you know what documents need to be controlled?

Going back to paper-based systems, it was binders. For non-eQMS systems, I've seen where dedicated folders work just fine (basically electronic binders). For eQMS systems, the software basically manages. I've never had nor ever had any customers that I helped manage controlled lists of documents or records (and it's never been an issue).

Auditors do tend to like them because it makes life easier for them. I'm not opposed to them but as @Tidge points out, that is just another point for failure - presuming the list is manually maintained. If maintaining lists makes your system more effective, by all means do it; but I don't think there are *requirements* to maintain such lists.

 

[Jean_B]

ISO 13485 does not require it. Sometimes regulations do, but then auditors might need to write against regulations instead of the familiar ISO 13485.
Try Brazil's RDC 665/2022, article 33: "A list of current documents shall be maintained to identify the current situation of the documents and ensure that only current and approved documents are in use."

 

[was named killer]

Master Doc Lists are a thing of the past. Most all documentation is in electronic format and located in named directories. ISO and AS do not require MDL.