How to structure a controlled document template

[Adehanks]

Hi Everyone,

Hope you can help me on this. I'm rolling out a document management system and one of the first tasks is to create a new document template for review, prior to roll out. I have 3 example document templates mocked up for review with company logo, rev box, and all the usual input headings. However, all three documents are different in regards to the main headings and how that relates to standard requirement for ISO9001 (we are not certified, but will probably will be in the future, so I want to be cognizant that, when rolling out this initiate) Ok, so I have Purpose, Scope, Responsibilities, Definitions, Instructions, Forms and records, associated documents, Approvals...The list continues. I know a few of these are saying the same thing, but my question is, is there common way of laying out the document. I would be interested to hear what headings you have and what order they are in. I want to share the mock-ups, but also advise on where we should be heading with our internal team.

Thanks for your help, it's appreciated.

 

[JimS]

I don't think ISO has any specific requirements for the headings/sections in your document. That's another area where you do what works for your specific business and environment. As long as it's uniquely identified and can show controlled versioning (with the control process to back it up), the rest is what works for you. The headings you have listed are pretty standard and shoudl cover all the bases. Approvals don't have to be inside the document. If you have a good process and prefereably a decent eDMS, it's much more convenient to capure approvalss in the DMS.

 

[Adehanks]

I don't think ISO has any specific requirements for the headings/sections in your document. That's another area where you do what works for your specific business and environment. As long as it's uniquely identified and can show controlled versioning (with the control process to back it up), the rest is what works for you. The headings you have listed are pretty standard and shoudl cover all the bases. Approvals don't have to be inside the document. If you have a good process and prefereably a decent eDMS, it's much more convenient to capure approvalss in the DMS.

Thanks Jim. Great feedback.

 

[Randy]

I don't think ISO has any specific requirements for the headings/sections in your document. That's another area where you do what works for your specific business and environment. As long as it's uniquely identified and can show controlled versioning (with the control process to back it up), the rest is what works for you. The headings you have listed are pretty standard and shoudl cover all the bases. Approvals don't have to be inside the document. If you have a good process and prefereably a decent eDMS, it's much more convenient to capure approvalss in the DMS.

If you've read 9001 you'd see that it doesn't matter what you do, do what ever you want and whatever you think you need, just be consistant and maintain control. The only wrong is what doesn't work.

 

[Jen Kirley]

I personally like well-organized documents, but documented information is meant to cover a wide assortment of media. Drawings, travelers/work orders, videos, audio recordings, computer programs and/or eLearning, flip charts, signs, pamphlets, TV screens... these can be supplying the widespread information communication need, but could be too limited by thinking of things in terms of the controlled document system.

That is why, as Randy said, ISO no longer requires a documented procedure for managing it. Make sure it is accurate, current, readily available when and where needed, kept safe from unauthorized changes and keep some kind of revision history based on risk management of information loss.

What industry are you in? What is your product or service? Will you be certifying, and if so, to which standard?

 

[Adehanks]

I personally like well-organized documents, but documented information is meant to cover a wide assortment of media. Drawings, travelers/work orders, videos, audio recordings, computer programs and/or eLearning, flip charts, signs, pamphlets, TV screens... these can be supplying the widespread information communication need, but could be too limited by thinking of things in terms of the controlled document system.

That is why, as Randy said, ISO no longer requires a documented procedure for managing it. Make sure it is accurate, current, readily available when and where needed, kept safe from unauthorized changes and keep some kind of revision history based on risk management of information loss.

What industry are you in? What is your product or service? Will you be certifying, and if so, to which standard?

Hi Jen,

Thanks for the feedback. We manufacture control systems for the water industry. We have grown to the point whereby we desperately need control over our documentation along with developing our QMS (with an eye on 9001 certification somewhere down the line). I have some sample document templates that I'm going to suggest based on the feedback given. I'm also capturing our current state documentation (and there is a lot of it in a lot of places), along with a detailed project charter to get the Document Management Development initiative underway. Our goal is to have our QMS completed by Q3 of next year, so I have some time, but document control and all the processes that go along with that is an urgent requirement right now. Our current process is not sustainable.

Thanks again.

 

[Randy]

Point of note------- The more complex you make it, the greater your potential for failure becomes...... I see it all the time

 

[qualitymanagerTT]

... However, all three documents are different in regards to the main headings and how that relates to standard requirement for ISO9001 (we are not certified, but will probably will be in the future, so I want to be cognizant that, when rolling out this initiate)... but my question is, is there common way of laying out the document.

I don't know how "common" the approach may be, but there's a standard which may help: ISO 10013 Quality management systems — Guidance for documented information
ISO 10013:2021