What Every Employee Needs to Know About ISO 9000
Thousands of organisations strive to gain
ISO 9000 certification quality system standard. It can improve
the way an organization is managed as well as the quality
of processes, products and services. There are twenty ISO
9000 Standards. Each standard describes how an area of a
company should be documented; the kinds of written policies,
procedures and work instructions that should be available
to let employees know exactly how to do a good job. Also
what types of records need to be kept to show the results
of doing the job? This system can lead to better product
and service quality since detailed documentation (and good
training on how to use the documents), provides a more reliable,
consistent method of teaching employees how to do quality
work.
The ISO 9000 standard was adopted by the European
Economic Community about ten years ago but since has spread
to almost 100 countries throughout the world. It is the
biggest force in quality assurance today and many customers
require this certification since they believe it leads to
good business practices, better documentation for traceability,
and lower internal costs. For the most part, employees
will continue to do their jobs in the same manner as they
had in the past. The effectiveness of the ISO 9000 system
relies on increased awareness in specific areas of each
person’s work routines. The following are some of the main
areas every employee needs to be familiar with the company’s
Quality Policy statement, the 4 levels of ISO 9000 documentation,
what authorizes an employee to do their job and what qualifies
them for it.
The 4 Levels of Documentation
ISO 9000 requires 4 levels of documents in
every area of the company that effects product, or service
quality. All documents must be current and have correct
data including titles, numbers, dates, revision letters
and authorizing signatures.
Basic Things
to Know About Your Job:
Where all the paperwork and material comes
from before it is routed
What to do with incorrect paperwork, or wrong
material.
How to identify, report or segregate defective
material.
The following paragraphs are based on many
years of experience accumulated by the ACA consulting staff
working with dozens of companies nationwide. Experience
comes from both large and small companies and covers all
types of manufacturing industries, process industries, service
companies, local and state agencies, hospitals and universities.
As we provide training to these organisations
as well as consulting services, we have learned from people
on the shop floor, the administrative support groups, and
all levels of management that, although every company has
a unique personality and unique competitive advantages,
there are common, core fundamental that must be embraced
by every employee to ensure the company’s journey to World-Class
standing in the marketplace. The ACA consultants specialize
in providing these core fundamentals and are pleased to
present the following example as a service to the global
community via the Internet.
The following paragraphs cover 9 important
ISO 9000 issues. These paragraphs are not intended to cover
the 20 standards, but will familiarize you with the most
important general issues.
QUALITY POLICY
Every ISO 9000 certified company has an established
quality policy. You should know and understand it. It incorporates
the company’s mission statement and may list specific actions
for achieving the mission. You should all be able to state
the quality policy in your own words and you should be familiar
with the actions that allow a company to achieve the policy.
Procedures and Work Instructions
From a production point of view, you will
be doing a few things differently under the new quality
system. You will notice that your work processes are now
documented in written procedures and written work instructions.
Your responsibilities are now defined in the procedures
manual that has been developed by the company. Make sure
you understand and follow these procedures and make sure
they are accurate. From now on, if you want to change the
way you do things in your work, you will have to make the
appropriate changes in the procedures manual also.
DOCUMENT CONTROL
Under this new quality system, all documents
relating to your job will be controlled documents. That
means they will be reviewed and approved before issue, and
distributed under a formal system of control. You will no
longer assume that procedures and work instructions are
correct or complete before you use them. Before using any
of these documents, you should look at the header information
that identifies the document name, document number, revision
date, and authorization signature. These must be verified
as correct. And finally you will ensure that you have the
correct revision of the document either through the “CONTROL
COPY” stamp or through reference to the Master Document
Index.
CALIBRATION
All instrumentation used to measure critical
characteristics of the product must be calibrated. A calibrated
instrument is identified by a calibration sticker listing
its date of calibration, and the date when that calibration
expires. Do not use an instrument to measure any critical
product characteristics unless you have assured yourself
that the instrument is calibrated. Of course, you have to
know which measurements are critical product characteristics.
INTERNAL
QUALITY AUDITS:
The ISO 9000 quality system requires an internal
audit programme. From time to time, employees from different
departments will come to your department and audit the effectiveness
of the ISO 9000 system. This is done to ensure that department
personnel have received good training, and are complying
with the approved procedures and work instructions. When
there are problems in a department, it will be audited more
often; less problems mean it will be audited less often.
Different employees will perform the audits to ensure different
viewpoints. The internal auditors have a special training
for this job. There are no surprise audits; they will be
scheduled in advance. There are three types of things an
auditor may find
You may be receiving more training than you
had in the past, and it will be recorded on a training record.
These records will be an assurance that you get full credit
for any training you have completed during the course of
your work. When an auditor asks how you do a job you should
answer that you’ve have been trained to do that job. It
may have been formal classroom training, or on-the-job training,
or you may have been trained at another company or school
before you came to work at your present company. In all
cases, your training record list all the various types of
training you have had and you should be aware of who has
your training record and whether they are keeping it up
to date.
Corrective Action
There is an emphasis on corrective action
in the new quality system. Whenever one finds a significant
problem in the process it is not only corrected but a Corrective
Action Request is filled out to document it. These forms
will go to the quality systems group where they will be
reviewed and analysed for further preventive actions. Everyone
should consider a problem in the system to be an opportunity
to correct the problem and improve the system.
NONCONFORMING PRODUCT
We should always know when our process or
product is within specifications and when it is not. Additionally
when the process or product is out of specification it is
our responsibility to make every effort to isolate or re-direct
the nonconforming product for later processing, and initiate
corrective action to bring the process back into specifications.
We should additionally recognise the difference between
the product or process being out of a defined control range
and when it is out of specification.
Quality Records
Throughout the process, there will be records
to fill out and file. All required entries on a record form
must be completed. If an entry cannot be made because a
part of the process was broken or inoperable, then a small
note to that effect should be made in the entry block. All
record entries must be legible. Data or information that
cannot be understood is as bad as putting no data on the
form. Care must also be taken to keep it clean, and not
ruined by water, grease or dirt. All records are filed when
one finishes with them. The fling system is organized to
facilitate record retrieval when necessary.
