Hello,

My company is currently implementing ISO 13485 and I am attempting to do a GAP analysis. I just needed some clarifications as to what is required of the quality manual in the last paragraph of section 4.2.2 Quality Manual.
"The quality manual shall outline the structure of the documentation used in the quality management system"

Does this mean I have to do a chart mapping of all of our documents in the QAM?
If yes, can I just include those procedures which are required by ISO 13485?
Does anyone have any examples of what they did for their company?
:confused:

Any help would be greatly appreciated! :D

Hi QualitySysISOAdmin,

I have always believed in keeping things simplified, to which end I have addressed "The quality manual shall outline the structure of the documentation used in the quality management system" with this in the Quality Manual

"The quality management system document hierachry is -

i. Quality Manual (Include Quality Policy and Quality Objectives)
ii. Standard Operating Procedures/Work Instructions
iii. Forms & Records"

This statement is then backed up with a Document and Data Control Process which shows the full structure including procedures for change, retention periods etc.

Hope this helps, and im now wondering what other methods people use.

Thanks:thanx:. That makes sense and is much simpler than what I was thinking.

I have a "Procedure Cross Reference" section for each clause(s)/section of the manual. Here I list the quality procedures that are applicable. I also added an appendix that lists all the quality procedures by document number and name (I have about 33 listed.) This is a great way to quickly find that document number you keep forgetting for your calibration procedure. :notme:

Seeing you're in the 13485 medical arena....you might want to consider the following. Do you want to provide a cross reference somewhere to FDA (21CFR820) or other quality specs (Canadian, European, Japanese)? You would have to determine what is applicable to your business. I did have an auditor in here one time and she was whining about not being able to cross reference my documentation to 21CFR820. It seemed like a small point at the time but after I added this to my documentation, I did find myself referencing it. Just a suggestion.

We currently have a cross reference chart as an appendix to our QA Manual. If that will satisfy the standard then it seems that I could simply add on to the chart. Thanks for your input.

The manual I liked the most was one that flowmapped out each process (including management responsibility, document control, infrastructure management, regulatory compliance, you name it). Responsibilities were identified, and the relevant procedures and other QMS documentation were linked to the map on subsequent pages.

It wasn't lengthy (though I imagine it took a good while to create) but it was really effective IMO.

It was one of those manuals that people in the company actually used on a routine basis. A terrifying prospect indeed! :D


IIRC, they also had a couple of pages of executive summary for handing out to interested parties.

Great! :D
We currently already have a QMS flow chart and a product flow chart which lists out the procedures for those steps as well. In addition, I also realized that we included a pyramid mapping that shows the hierarchy of our different document types (procedures, work instructions, specifications, etc.)

My only other question is does it have to reference all documents that are required by the standard?
And is it ok to exclude those that are less important?
Is what we are currently doing enough? (cross reference chart, pyramid mapping, and flow chart references)