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Many thanks to those who responded to my question about ISO and its
requirements when making changes to a document. Here are the seven
responses I received.
--Dan
1) -----------------------------
If the original doc is 4567-01, you must renumber it to
4567-02 if you change it. You must keep a list of the latest doc
versions. The auditors like to ask, "How do you know you are using the
latest doc version?" If you use a change page, you must renumber the
revised doc and be sure that ALL copies are changed. Much easier to do
if your docs are online.
Bob Morrisette
writer -at- sabu -dot- EBay -dot- sun -dot- com
Survivor of the Audit from Hell
2) -----------------------------
ISO 9001 requires that you have a process in place to ensure that
whatever your business does, it is done in a quality way. ISO
standards do not tell you to republish the book or to insert a
change page. The ISO standards leave the decision up to the your
company. What the ISO standards do require is that there is a system
in place
that documents the decisions made concerning the change to the manual.
What does it mean to do something in a "quality way"? For us, it means
only authorized technical writers may change manuals. Writers are
authorized by management to make changes. Writers may, in turn,
authorize others to make changes to manuals (for
example, technical illustrators). It means that no change is made to a
manual without an approved Engineering Change Order. We must have
changes to the manual reviewed by the appropriate people. (For
example, changes to service information is reviewed by the
service organization.) I could go on, but the essence of the answer to
your question is, it is up to the business to decide what the
appropriate action is. ISO standards only require that you can
document why you did what you did and that you have a "feedback loop"
to correct mistakes when they occur.
Chuck Melikian chuck -dot- melikian -at- tek -dot- com
Measurement Business Customer Documentation
Tektronix, Inc.
3) -----------------------------
Republish just the changed page.
Identify the change(s) by any of several
methods, including black bar or narrative summary.
joyce flaherty
flahertj -at- smtpgw -dot- liebert -dot- com
4) ------------------------------
I can understand why you're getting conflicting information. ISO is as
fraught with misleading opinions as a political convention, and for
much the same reasons.
In truth (since I've worked in ISO, I can say that), ISO doesn't
require anything either way. In fact, ISO is rather loose and vague
about documentation requirements...and with a good reason. ISO isn't a
standard. It's a standard for creating company standards. Thus, if
you're just reissuing one or two pages, then make that a company
standard and adhere to it. If you'd rather reissue the whole thing,
make THAT your standard.
Of course, all this assumes that your auditor buys into the scheme. In
large measure, your ISO requirements are the ones that the auditor
imposes. Some auditors are anal retentive, while others seem like old
Hippie burnout cases. If the auditor accepts your standard, then go
with it. If he doesn't, well you'll have to do things his way. His
company is issuing registration certificate, after all.
The safest thing to do, if at all possible, is to completely reissue.
Then you're Caesar's wife. Otherwise you may find yourself making
explanations to a rather excitable gentleman who may not be as
understanding as he might be.
ISO would only require that you have a clear-cut, fully documented
procedure to handle this, and that you adhere to the procedure,
whatever it is.
Dan
6) -----------------------------------------
My company is in the process of ISO certification, and here's what I
understand concerning your question:
>What does ISO require if you have a change or two on one page of a
>document: republish the whole document or is just a change page ok?
>I am getting conflicting information.
ISO probably doesn't have a specific requirement, rather they require
that -you- come up with a plan that will work, and then stick to the
plan.
We haven't dealt with that issue, but if they came to me and asked for
me to solve the problem, here's what I'd do:
1) I'd point out that our pages all have the date and revision letter
at the bottom.
2) I'd suggest that we add the date and revision letter to the first
page of the manual. "Revision B, April 2, 1996."
3) I'd then suggest that we add a "List of effective pages" to
immediatly follow the title page. When the book is revised, the page
might say "Pages 1-100, April 2 1996."
4) A month from today, we change one page. We print that page, issue
it with a new title page, and ship this as a "change kit" to the
customers. The change kit contains:
A) New title page that says "Revision B, April 2 1966; Change 1 May 2
1996." B) The list of effective pages says "Pages 1-49, April 2 1996.
Page 50, Change 1, May 2 1996. Pages 51-100, April 2 1996."
C) The new page 50, with Change 1 and May 2 1996 at the bottom.
I hope this helps.
Rick Lippincott
Boston Technology
Wakefield, MA
rjl -at- bostech -dot- com
7) ---------------------------------
Dan, I'm not an ISO expert but I'm puzzled about this issue. Why
would the ISO care if you sent out an entire document or just the
pages that changed? The ISO 9000 standard is a standard regarding
quality processes in the workplace. Documented procedures are a key
ingredient of the quality process. That is the only connection
between technical writing and the ISO (at least that I know of).
To get back to your original question - it all depends. In my tech
writing group (we manage about 18,000 pages of policies and procedures
in a large organization), we assess every situation differently. If
you improve things for your end user by reissuing the whole document,
then do it. If not, just publish the pages that have changes. The
concepts to keep in mind are user needs and costs to produce.
I hope this helps a bit but I'm still unsure if I understand your
question.
