Tip on how to use our Tips on ISO 9001 Compliance:
Edit the tips to fit your company and email one ISO 9001 Tip
per week to all your employees.
Continuous Improvement
Implementing ISO 9001:2008 is not a one-time benefit to our
company. ISO 9001:2008 actually provides us with tools (and
the requirement) to continuously improve ourselves. This is
a very important aspect because companies that don’t
continue to improve are soon overtaken by the competition.
Quality Control Software
There are several software solutions on the market that can
help you track audits and corrective action. Though many
people think that ISO 9001 software will make their ISO 9001:2008
system very easy to maintain, we found specialized software
more of a burden. Except for very large, centralized
companies, a good and lean ISO 9001:2008 quality system should be
easy to maintain without specialized software. Our ISO 9001
quality manuals and forms do not require any specialized ISO 9001 software.
What is Document Control?
Document control means that the right persons have the
current version of the documents they need, while
unauthorized persons are prevented from use.
We all handle many documents every day. These documents
include forms that we fill out, instructions that we follow,
invoices that we enter into the computer system, holiday
schedules that we check for the next day off, rate sheets
that we use to bill our customers, and many more.
An error on any of these documents could lead to problems.
Using an outdated version could lead to problems. Not
knowing if we have the latest version or not could lead to
problems. And so on.
ISO 9001 gives us tools (also referred to as “requirements”)
that help us control our documents. Take a look into the
Quality Manual for more information and simple instructions.
ISO 9001 Documents
There are no “ISO 9001 documents” that need to be
controlled, and “non ISO 9001 documents” that don’t need
control. The ISO 9001 system affects our entire company, and
all business related documents must be controlled. Only
documents that don’t have an impact on our products,
services or company don’t need to be controlled – all others
need control. This means, basically, that any business
related document must be controlled.
However, how much control you apply really depends on the
document.
▪ The extent of your approval record, for example, may vary
with the importance of the document
(remember, documents are
approved before they are published for use).
▪ The Quality Policy, an important corporate policy
document, shows the signatures of all executives.
▪ Work instructions often have merely a note in the footer
indicating approval by the department
manager.
▪ No approval record is needed for a document that doesn’t
need separate approval if the person who
prepared it is also
responsible for the content (e.g., the Quality Manager
prepares instructions for
his auditors).
▪ On the other hand, identifying a document
with a revision
date, source and title is basic. It really should
be done as
a good habit for any document we create.
Please note that documents could be in any format: hardcopy
or electronic.
Responsibility for Document Control
Document control is the responsibility of all employees. It
is important that all employees understand the purpose of
document control and the tools (requirements) that help us
control our documents.
Please be aware that if you copy a document or print one out
from the Intranet and then distribute it, you are
responsible for controlling the distribution! The original
author won’t know that you distributed more of his
documents, so the original author can’t control that
distribution.
Dating Documents
ISO 9001 requires us to show on every document when it was
created or last updated. Many of us thought about using the
automatic date field for this, but...
Should we use the automatic date field on documents?
Generally not. If you enter the automatic date field into a
document, the field will automatically be updated to always
show the current date, no matter when you actually created
or updated the document.
Example:
For example, if you use the automatic date field in a fax
and you save the fax on your computer for future reference,
you won’t be able to tell when you wrote the fax: when you
open the fax, it will only show the current date.
Another Example:
Another example is entering the automatic date field in the
footer of a document that you frequently change and then
print. You may have used the automatic date field as an easy
way to see on your printouts when they were printed; the
idea here was that the document with the latest date is the
most current printout. However, you may make one printout
today and another tomorrow without having made any changes
to the document. Though both printouts are identical, they
now show different dates. This will inevitably lead to
confusion.
Document control requires us to show on any document when it
was created or last updated. The automatic date field is not
suitable for this. Therefore, as a general rule, don’t use
the automatic date field to identify revision status.
Controlling Forms
Yes, a form must be controlled as long as the form has an
impact on our services or our company.
Blank forms are similar to instructions as they guide the
user to provide certain information. If the form is outdated
or incomplete, the user will not be prompted to supply all
the necessary information. It is, therefore, important to
control blank forms like any other document.
Once a form is filled out, however, it has become a record.
At this point, we need to be concerned with filing, storage,
archiving and eventually destruction. Our Record Retention
Guide specifies how long records must be kept and how we can
get rid of them (e.g., do we need to shred them or is the
recycle bin okay?).
Complete ISO 9001 Documentation
Our ISO 9001:2008 Quality Management System is documented through:
▪ the Quality Manual, which includes corporate Policies and
Procedures affecting the entire company
▪ Work instructions
▪ Records
Policies and Procedures
Our ISO 9001 Quality Manual includes the corporate Quality
Policy and all required ISO 9001 Procedures! While most
procedures affect only managers, all employees must be
familiar with the Quality Policy and with the Document
Control procedure.
Process Identification
Management at each business unit or individual location
needs to identify all key processes (or activities). The
number of processes depends on how detailed you want to be.
For the purpose of meeting ISO 9001:2008 requirements, about
10 key processes or less should be sufficient to describe
the entire department, office or facility.
Once the key processes are identified, management needs to
describe how the processes interact with each other. A
flowchart is a good way of identifying processes and their
interaction.
Flowcharts
Flowcharts are great ways to describe the interaction of
processes. Flowcharts are often used to show how the key
processes (or activities) in an office or at a production
facility work together; flowcharts are also often used as
work instructions and procedures.
The following shapes are sufficient for most flowcharts (the
arrows are used to connect the different shapes in the
correct order):
 |
This is the shape used to describe a process (or
activity). In this example, the process is called
“Check invoice”. |
 |
This is the shape used to describe a decision. A
decision in a flowchart has usually two possible
outcomes. In this example, the decision is “Is
the invoice correct?” and the two possible
outputs are “yes” and “no”.
Some decisions have three possible outcomes: the
decision “From which supplier is the invoice?”
could have either of the outcomes “Supplier A”,
“Supplier B”, or “Supplier C”. |
 |
This shape describes a document. In this example,
the document is called “Invoice”. See example
below on how this shape is used. |
Example using all three shapes: |
 |
Microsoft Visio is an excellent program to create
flowcharts; also Microsoft Word and PowerPoint can be used
for some basic flowcharting.
Whichever tool you use, please keep it simple for the user.
Some sophisticated shapes might make much sense to you, but
most users will be confused as they won’t understand the
subtle differences.
Audit Preparation
ISO 9001 audits are typically more challenging for
management than for workers. ISO 9001 is a quality MANAGEMENT
system and provides many requirements on activities of
managers and executives; in many cases, ISO 9001 directly
affects how the company is managed.
All audits may cover any or all sections of the ISO 9001
quality manual. As a general rule, all audits cover Goals &
Objectives, Customer Feedback, Management Reviews, Audits
(especially if NCs from prior audits have been properly
corrected), and Corrective Action. An extensive list of
audit preparation tips is included in
9001Simplified.com’s ISO 9001 Forms Collection.
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