Quality Manual shall Outline Structure of Documentation - Clause 4.2.2

Little help is needed here. I am in the process of putting together our quality manual and i'm stumped by the simplest of parts.

In section 4.2.2, there is a line stating:

The Quality Manual shall outline the structure of the documentation used in the quality management system.

Well, we got a "concern" on ours from our first audit for registration. What is it exactly that they are looking for? Can someone actually give me an example? What i did (super paraphrasing it here) is i said basically said any document that has an affect on quality, a QMS, or any part of ISO 13485 is classed as a Class I or of high importance. Production documents and documents related to a job are Class II document or of moderate importance. and all the others are Class III, which is, of lower importance. So, i know this is a small problem but was wondering if i could get some help on this. can someone give an example or a suggestion? thanks in advance.

Firstly if you are new to ISO 13485 then I recommend getting a copy of ISO /TR 14696 which may give some better hints (guidance) as to what standard means.

That said there is no guidance there for 4.2.2

It is worth noting the requirement in question ("outline the structure") is special for medical devices, i.e. it is not part of ISO 9001. Thus it seems to have significance in the regulatory context.

As an auditor I was often looking at the way in which you could get from point A to point R in the quality system. Someone could easily point to a document tacked to a wall showing how they control environment in a warehouse. That's OK, but in the regulatory context you have to show how starting at the quality manual, you can get to that document, without asking anybody.

So I would interpret "structure" as meaning how you do this in practice. There are several ways to do this (usually depends on the size of the company), and in some cases it might sound like stating the obvious, but you would be surprised how often floating documents turn up that are not tied to the quality system. Your target is to avoid floating documents.

The structure should cover all the documentation listed in 4.2.1.

Hello and welcome to the Cove to both of you.

More discussion on the topic can be found on the following thread: ISO 13485 Clause 4.2.2 Documentation Structure - Quality Manual clarification.

In general, this is interpreted as either the general structure of the different documentation of the system (example, a pyramid with the quality manual at the top, followed by lower level documents) or the structure of each quality document (example, a documentation template indicating what document control
information should be included in each document.)

Hi!

This is an interesting topic and is open to interpretation by all parties!

It does not really need to be anything complicated as this requirement might well already be covered in a document control procedure or SOP you already have in place!

I make the assumption the hierachy will be something like the Quality Assurance Manua (QAM), Operating Procedures / Standard Operating Procedures followed by Work Instructions and perhaps the actual Forms your record the information on.

If it is something like this then you can either just have a heading Document Hierachy and simply list this heirachy as above in the QAM or even simpler refer to where you keep your document list as this will then be self explanatory! Just make sure you point the auditor in the general direction.

Quality Manuals need not be long winded as they are only usually read by (ahem) the Auditor and the Quality Staff!

Hope that helps?

Jonathan

Hello everybody

My company has just become AS9100 certified.

A new customer wants his product to be giverned by ISO 13485; I am making a gap analysis.

In order to meet the subject requirement, I believe I am covered by the QMS documents hyerarchy pyramid.

My concern is: Such pyramid is not included in the Quality Manual directly, it is in "documents control procedure", which is cited in the Quality Manual. Do you believe I am covered or I sould move the pyramid to the manual?

Thank you in advance

Mario Alberto83 said:

Hello everybody

My company has just become AS9100 certified.

A new customer wants his product to be giverned by ISO 13485; I am making a gap analysis.

In order to meet the subject requirement, I believe I am covered by the QMS documents hyerarchy pyramid.

My concern is: Such pyramid is not included in the Quality Manual directly, it is in "documents control procedure", which is cited in the Quality Manual. Do you believe I am covered or I sould move the pyramid to the manual?

Thank you in advance

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[FONT=Arial,Italic][FONT=Arial,Italic][FONT=Arial,Italic]The quality manual shall outline the structure of the [/FONT][FONT=Arial,Italic]documentation used in the quality management [/FONT][FONT=Arial,Italic]system.[/FONT][/FONT][/FONT]

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Seeing as this is an explicit requirement, the quality manual must act as the nexus of how your documentation is structured. Show how you do this (from the quality manual), and you will no doubt be covered.

Brian

insect warfare said:

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Seeing as this is an explicit requirement, the quality manual must act as the nexus of how your documentation is structured. Show how you do this (from the quality manual), and you will no doubt be covered.

Brian

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4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) ...
b) the documented procedures established for the quality management system, or reference to them,...

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The standard requires that the QMS procedures are included (or referenced) in the Quality Manual. As such, anything that is included in any and all QMS procedures is inherently included in the Quality Manual. In my understanding, inclusion by way of reference is allowed because of practical considerations, and doing so is normally viewed as being equivalent with actual inclusion.

Bottom line - as long as your document control procedure is referenced in the QM, you should be fine.

In general, the most important thing is that information is accessible without excessive effort at the time and place it is relevant, for those who need it and are authorized to access it. The rest is just mechanics

PS

ISO/TR 10013:2001 -- Guidelines for quality management system documentation:

4.4 Quality manual
(...)
4.4.6 Organization, responsibility and authority
The quality manual should provide a description of the structure of the organization. Responsibility, authority and interrelation may be indicated by such means as organization charts, flow charts and/or job descriptions. These may be included or referenced in the quality manual.

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(Emphasis added)

Cheers,
Ronen.

Ronen

Thank you so much for your useful response, I really appreciate it.

Regards from Mexico

Ronen E said:

The standard requires that the QMS procedures are included (or referenced) in the Quality Manual. As such, anything that is included in any and all QMS procedures is inherently included in the Quality Manual. In my understanding, inclusion by way of reference is allowed because of practical considerations, and doing so is normally viewed as being equivalent with actual inclusion.

Bottom line - as long as your document control procedure is referenced in the QM, you should be fine.

In general, the most important thing is that information is accessible without excessive effort at the time and place it is relevant, for those who need it and are authorized to access it. The rest is just mechanics

PS

ISO/TR 10013:2001 -- Guidelines for quality management system documentation:



(Emphasis added)

Cheers,
Ronen.

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Keep in mind that the requirement in section 4.2.2 of ISO 13485 applies to the medical devices industry, and this requirement will supersede any technical report or the information/guidance provided within it. Besides, TR 10013 was originally written around the ISO 9001 family of standards, and as such may not be fully applicable to ISO 13485. Especially the text italicized in blue...

I also realize that this may be a trivial requirement in the eyes of some, and there will be those who say "why does it even matter", but I say "if it doesn't matter that much, then why not do it by the numbers".

I still stand by my previous assessment, even though I would personally favor that approach, but I don't think doing it that way will technically meet the requirement as stated. I also did not see any ISO interpretations from ISO/TC 210 in Annex B (or any other source) regarding the precise application of this requirement, so if there is an elephant in the room, please let me know.

Brian