ISO 9001 Implementation
The following is
an overview of the key steps in implementing a quality management system based on the ISO 9001
standard:
Get the latest copy of the
ISO 9001 and ISO 9004 standards Familiarize yourself with
the requirements of the ISO 9001 standard and decide if certification to this standard makes good business
sense for your organization. The two main objectives organization have in using the ISO 9001 standard is to
improve the effectiveness of their business and to gain marketing advantage. Many larger organizations only
deal suppliers that are certified to ISO 9001 or similar bsuiness
standard.
The ISO 9004
standard provides useful guidelines in better understanding and implementing the ISO 9001 standard. To gain
deeper insight into how the the requirements of the ISO 9001 standard should be interpreted and
implemented, please read "Understanding ISO
9001".
Educate
yourself in quality management There is a variety of
training courses available to gain deeper insight into the requirements for system development,
implementation and auditing. Also read up on the subject matter. The more you read, the more informed you
will be in making choices and developing your QMS. There is plenty of useful articles and courses on this
website to get a good head start. Read everything I have made available to you. My objective is to provide
you more than enough to enable you to successfully implement an effective quality management
system.
Get management
commitment and
support Without
this, your chances of success is greatly diminished. Depending on the size of your roganization, there is
usually significant effort, time and resources needed to undertake an ISO 9001 implementation project. You
need management to step forward and provide the leadership, involvement, communication, support and review
of such a project. In addition, management needs to provide the environment and motivation for employee
participation and acceptance of change. Implementation of ISO 9001 controls involve the participation of all
employees to ensure sucess. This is where using an ISO 9001 Consultant is really worth the money as they are
experts in explaining to management and work force the importance and benefits of implementing ISO
9001.
Consider
using an ISO 9001 consultant
Experienced and expert consultants can fast track your QMS program development and
implementation with realistic and effective strategies and solutions in a cost effective and timely manner. A
consultant can provide focus and manage your implementation project. For more insights into using a consultant read
"Many Reasons To Use An ISO 9001
Consultant" on how to use an We have the expertise to assist you. Call us for a
no-obligation discussion of your needs. You should read "Tips On Using An ISO 9001
Consultant" before you use a consultant in your area.
Conduct a ‘Gap
Assessment” A gap assessment is an audit of your current
management system practices, controls and documentation, to determine the extent to which it conforms to those
required by the ISO 9001 standard. While a trained in-house quality practitioner can do this, it is best done by an
consultant (ex CB auditor), with the experience of hundreds of such audits. The audit findings are presented in an
audit report along with recommendations to address the
gaps. The Gap Assessment is the starting point for planning your
management system development.
Call us today at 905-593-8867 or email
us at artjlewis@rogers.com
for a no obligation review of your specific
needs
Plan -
strategy, resources and project The adoption of an QMS is a
strategic decision for the organization. It is vital that your top management provides leadership, resources,
involvement and support. In addition, you need to assemble a team to develop and implement your QMS.
You also need to plan your implementation steps, time line, responsibilities and resources needed. Here is a
sample of an ISO 9001 Implementation Plan. As far as possible you should involve employees
within each process in developing appropriate controls and documentation. Management can always fine-tune and
put in proper format once everyone agrees on the controls. This way you ensure acceptance and ownership by
employees instead of resistance to change.
Determine training
needs Training will be needed at various levels of the
organization. The nature and scope of training will vary according to each level. There are a wide range of
courses, workshops, and seminars available designed to meet these needs. We provide a number of these training
courses. Call us for more information. Management should get training in an overview of ISO 9001, what it can
do for the organization and their roles and responsibilities for implementing and maintaining it. The workforce
should get training in all ISO controls that affect their process and interaction with other processes. It is
understood that all employees get job-specific trainig.
Develop a QMS manual
Your QMS manual should describe the QMS policies and processes and their interaction.
Through the manual, you will provide an accurate description of the organization and the best practice adopted to
consistently satisfy customer expectations. Here is an example of a Quality Manual for a small
organization.
Develop procedures and
needed documentation Procedures describe the processes and
activities of your organization, and the best practice for effective planning, operation and control of these
processes. Other documentation could include work instructions, checklists, forms drawings, blueprints, schematics,
flowcharts. Use any combination of these as you deem necessary based on the culture and complexity of your
organization and stability and education of your work force. For more on documentation, read ISO 9001 Documentation.
Implement your QMS
Work to your implementation project plan. Communication and training are key to a
successful implementation. Monitor progress and get management support to overcome hurdles along the way.
Management should play an active role in this step to ensure that all project steps and timelines are
met.
Consider a
pre-assessment Consider having a preliminary evaluation of the
quality management system documentation and implementation by a Consultant or certification body. The purpose of
this is to identify areas of non-conformity and allow you to correct these issues before you begin the formal
certification process.
Select a certification
body
Your business relationship with the certification body (Registrar) will be in place
for many years, as your certification has to be maintained. Read our article on “Tips on selecting a Certification Body” before you
select your certification body or Registrar.
Maintain your ISO
9001 quality management
system Once your organization is ISO 9001 certified, your efforts do not stop. You must continue
to use the controls and tools that the ISO 9001 standard prescribes to maintain and continually improve your
quality management system. These include quality policy and objectives, control of nonconformity, corrective
and preventive action, internal audit, management review. These tools are very powerful when used
effectively. Again there is plenty of information on my website to learn more on
this.
Where can I get further
help? This article is an excerpt from my eBook, “Understanding ISO 9001:2000”. This book provides a
complete and in-depth coverage of all ISO clause requirements and well as key quality management principles and
concepts. It is an excellent guide for QMS development, maintenance or
improvement.
Need Training or
Consultancy help? Ask Art Solutions has significant expertise in all of the implementation steps and can help you
fast track your way to an effective and profitable QMS.
If you need help in developing or implementing your ISO 9001:2000 QMS, please call us
at 905-593-8867 for a no obligation review of your needs.
Your
Feedback is valuable If this article was informative or if you would like to provide feedback,
do send us an email with your comments.
If you feel this FAQ could help your supplier, customer or other
business associate, feel free to refer our website to
them
Call us today at 905-593-8867 or email
us at artjlewis@rogers.com
for a no obligation review of your specific
needs
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