2. Implementing a quality management such as ISO 9001:2008
requires transforming the culture. It will affect the entire
company, not just the quality department. More people in the
organization are affected by it than just the management
representative, or the person spearheading the effort.
Implementing a quality system to the point of certification and
registration is a daunting task but is achievable with your
current resources. Implementation times can vary but it can
be accomplished.
When considering implementation of a quality system such as
ISO 9001:2008 you should consider "why are you doing it?"
Companies pursue quality system implementation for various
reasons, to become better, their customer's are requesting it,
they are having quality problems or they would like the
recognition of being certified. In either scenario, the
circumstances are different as will be the driving force to
implement the quality management system. An organization
should consider the benefits of having an ISO 9001:2008
quality system and are not concerned about flying the flag.
The following steps best describe the implementation process:
3. 1. Why do you want to implement an ISO
quality system?
2. Educate Top Management
3. Commitment from Top Management
4. Select a Management Representative
5. Select Implementation Team
6. Understand the current system and
processes
4. 7. Understand the Standard
8. Gap Analysis
9. Create an Implementation Plan
10. Employee Training
11. Monitor
12. Internal Auditor Training
6. Why implement a quality manual template such as ISO
9001:2008 To understand why you would consider implementing
a quality management system, let us understand the various
quality management systems. There is the ISO 9001:2008
standard along with the industry specific standards such as
ISO/TS 16949 (Automotive), TL 9000 (Telecommunications) and
AS9100 (Aerospace). In addition to these standards is the
Malcolm Baldrige Award.
7. The ISO 9000 standards cover all areas of control which has a
potential to impact the degree of compliance of a product or
service. The standard is not a cookie cutter quality system that
means you will have the same quality system as your
competitor, or customer. It means you will have quality systems
that meet the minimum requirements but the details of how the
requirements are met can vary dramatically.
There are several misconceptions surrounding the standard,
one is it creates a great deal of non value added paperwork,
another misconception is it does not provide any value because
all I have to do is "say what I do and do what I say" and they
third misconception is it restricts creativity by burdening
employees with structured approaches.
8. Addressing the first concern of generating non value added
paperwork. The belief is you must document, document,
document everything you do. Actually, the standard requires one
quality manual, six procedures, instructions where necessary
and 26 records. This may sound like a lot but it really is not. The
need for extensive documentation can be mitigated with a
thorough training program that reinforces what is to be done and
how it should occur. It is common for companies to utilize more
documentation than the standard requires, simply because they
find it valuable. When you are in an environment of continuous
change and improvement, processes, duties and tasks are
continually changing to keep pace with improvement. It could be
extremely hard to know what the agreed upon method was
without a formal documentation and change process. The end
process would drift because the tasks within the process drift. It
would be analogous to not having maximum speeds posted; they
would be verbally communicated from area to area.
9. The second misconception is that the standard does not really
benefit a company because it simply means you documented
what you do (even if it is wrong) and you can show you do it. I
recall an example when I was touring a manufacturer and I
could see they were lacking in quality systems. I asked the Vice
President of Quality if they considered adopting an ISO quality
system. He replied, "ISO is nothing more than doing what you
say you'll do. We could make cement life jackets and we could
get certified. Our customers wouldn't buy cement life jackets". I
listened to what he said (laughing inside) and suggested he get
some training on the standard, because that is not the intent.
The current standard focuses on ensuring you provide a product
or service that continually meets the requirements of the
customer with the aim of improving customer satisfaction. To
make a long story short you could have a system that is
extremely well documented and everyone follows the
procedures and instructions. If this system is not producing an
output that is meeting the requirements of your customer you
will not get certified, end of story. Understand, the
documentation portion of the standard is a tool or method, the
end game is customer satisfaction and meeting you business
goals.
10. The third misconception perceives the standard as restrictive
in that it binds employees into a specific, structured way to do
their job. It removes creativity and replaces it with a
mundane repetitive approach. This is to some degree true and
dependent upon the organization. The level of control is at the
discretion of the company. My experience supports having a
level of structure that is consistent with achieving the desired
output of the process. For example, if the process is
purchasing, the desired output is to have quality product
delivered on time in the correct quantities.
