Writing ISO 9001:2000 Procedures - Seeking trained opinion on my procedures

[bkspider]

I'd appreciate it if I could get some trained opinion on the procedures I'm attempting to create. Looking at the document control procedure attached, it's clear I've borrowed a format from another source, but much of the nuts-n-bolts are written in-house. It's rather ironic that our ISO team has approved the procedure, but they know almost nothing about the ISO standard itself. SO...I'd rather get qualified eyes to look at it, to see if I'm all wet or if I'm at least facing the right direction on this.

Any and all feedback/opinions are welcomed and greatly appreciated!!!

References to company name have been substituted with "the company"...to protect the not-so-innocent!

 

[Oriondad]

IMHO based on my experience

We are a design and build business specializing in unique one of a kind designs. Approx. 100 employees, two locations. We were just audited for ISO registration and passed (I am still in disbelief!!!). Our document control procedure was barely over 1 page. It is my belief that less is best. The more detailed you are the more opportunity you have for findings. Try to cover the entire scope in one page.

Also, I have determined that flow charts are acceptable. This is the avenue we are going to take in revising or creation of procedures. I spoke to an auditor about using flow charts in place of documents and they approved. So that may be another route you want to take. Much easier to create a flow chart vs. a documented procedure.

 

[Wes Bucey]

If I remember correctly, you're the guy beseiged by Perry Jonson sales people.

Your company is small. I doubt you deal in more than a few new documents per day and you have been operating for some time without such a ponderous document as your procedure.

Before I go further, I want to say there is nothing intrinsically WRONG with your procedure as written. It is fine and reminds me of some I have seen for huge transnational organizations which deal with hundreds of thousands of new documents and revisions every year with hundreds and even thousands of authors.

I suspect such a company is the source for your template - that, or one of these companies that promise to get you registered in 40 days before they ever see your operation.

Take some time and look at some samples other Cove members may supply of a new, less cluttered style of writing procedures.

If you'd like to try it yourself - think about how you would make a PowerPoint presentation of this 6 page document. You would simplify and get rid of the turgid text which fills six pages.

The first thing you should consider is your REAL AUDIENCE. Your real audience is the group of coworkers who will use this procedure to manage your documents. You want to avoid the MEGO factor when they look at it (MEGO = My Eyes Glaze Over.) Use action verbs. This procedure is a plan for what you do and will continue to do in your organization.

Think this way -- if someone put a gun to your head and said, "Tell me your Document Control Procedure in 50 words or less!" Could you do it? If yes, then those are the only 50 words you need.

 

[bkspider]

Does anyone else have any "proven" samples of a document control procedure much more brief than what I have? I would agree not to overstate the issue, nor put in place things more complicated than they should be, especially for a small company.

Thanks to any...and all.

 

[KimLoree]

Hi bkspider,
I am attaching a copy of our Tier 1 "Document Control" document. Tier 1 docs (at our company) provide the "What" we do to show compliance. I'm sure that this document could be simplified as well...but it works for us.

If you are interested, I can also provide you with the Tier 2 Procedure level, which provides a little more detail (the "Who-When" that does the "What").

I didn't see the need to develop a Tier 3 (step by step / "How") document for this section, because the process is accomplished electronically.

I'm sure that this is not the best example you are going to get....because as I've admitted on another thread, if I had it to do over again, I would have combined Tier one's and two's into one document.

Hope this is of some help....

 

[db]

I want you to think about this. Most of the items in procedures are not really necessary. There are only two requirements. 1) the procedure covers all of the "shalls" in the standard. 2) the procedure meets your needs.

As Wes stated...consider your audience.

I have an oversimplified procedure. But the idea is not to give you a procedure you can think about. The file actually has two separate procedures. One in text, and the other as a flowchart/procedure. They are not page 1 and page 2, but either a or b. Your procedure may be as simple as this.

Hopefully I did this right. Perhaps I need a work instruction on uploading documents (sorry wrong thread)

 

[amjadrana]

Writing ISO 9001:2000 procedures

I had a look at two different document control procedures. Both are okay, if these are working. I am working on upgrading my ISO 13485 standard and I will be revising present document control procedure. My document control would be very likely that as has been given in first attachment. The second from Triumph is too short and does not meet the standard requirements. At least not for ISO 9001.

In both procedures I do not see an approval process. Is the document writer also the approver? Where are the signatures (hard copies or even elctronic signatures)? How is the approved copy saved and where to find it? There is no mention of controlling documents of external origin. Documents of external origin are e.g. copy of ISO 9001:2000 standard. Controlling these documents ensure that always the latest revision of external document is being used. It is more pertinent, if safety standards are being met.

 

[Wes Bucey]

I want you to think about this. Most of the items in procedures are not really necessary. There are only two requirements. 1) the procedure covers all of the "shalls" in the standard. 2) the procedure meets your needs.

As Wes stated...consider your audience.

I have an oversimplified procedure. But the idea is not to give you a procedure you can think about. The file actually has two separate procedures. One in text, and the other as a flowchart/procedure. They are not page 1 and page 2, but either a or b. Your procedure may be as simple as this.

Hopefully I did this right. Perhaps I need a work instruction on uploading documents (sorry wrong thread)

I think db has captured the essence of what I had in mind.

I cringe in horror at some of the turgid prose I inflicted on my workers in the past. I sure wish someone had taken me aside for the "dutch uncle" talk 25 years ago. It would have saved a lot of folks, especially me, a lot of needless wasted time.

 

[MikeL]

Devil in the Detail

I think that procedures are to help remind trainers what they have to show the trainee.

What makes procedures long and tortous is the principle that you have to get every skerrit of information gleaned from years of experience onto paper.

If you think about a doc control procedure as being a trainer's reminder notes on how doc control works you will write it quite differently.

I liked the two short versions because they didn't try to explain life the universe and everything.