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Controlling and improving processes are achieved through the use of documented
policies, procedures, and continual improvement activities.
The ISO 9001 Quality Management System is a business system designed to make it
easier for companies to comply with these principles.
The system establishes both the rules for identifying the customer requirements and the
policies and procedures for providing organizations with the means for delivering
products and services that comply with these requirements. It also creates a means for
ensuring consistency, stability, and the continual improvement of the processes used in
running a business. It's based on documentation and demands effective information
management, operational discipline, and accountability.
The ISO 9001 Quality Management System was developed and is managed by an
internationally recognized organization. The system was originally implemented in 1987,
subsequently revised in 2000, and is currently used in over 130 different countries by
over 350,000 companies.
Controls and policies placed on the management of the infrastructure including the
buildings, machinery, tooling, software and hardware, and the general working conditions
result in more reliable and better working conditions.
Corrective and preventive action programs and other continual improvement processes
provide a mechanism for preventing problems from reoccurring, finding and fixing
problems before they occur, and developing new and better ways of doing things.
Policies and procedures for managing process information, measuring instruments, and
the verification and validation requirements result in better products.
Changes in the way customer communication and product development are managed
result in better customer relations.
The system includes change processes that provide all employees with an opportunity to
make a difference in how a company is managed.
There's security in knowing that the system creates a more competitive position.
The instructions bridge interrelated responsibilities, which eliminates confusion and
reduces conflict.
The key word to remember is "potential." The benefits don't come automatically and
won't happen without a genuine commitment starting at the top, a system that is well
composed and managed, and a long-term commitment.
Documentation - On the surface it may seem that developing the ISO 9000
documentation shouldn't be that difficult. You must have a manual that includes a policy,
objectives, scope, and the interaction of the processes; and you must have written
instructions for:
The standard also hints at the need for additional instructions, e. g. referring to the work
instructions, section 7.1 states "shall determine the following, as appropriate," but
technically, aside from the manual and these six instructions, anything more is optional.
The reality, however, is that in order to get the most out of a quality management system
a great deal of additional documentation is required. A primary function of the system is
to establish consistency and eliminate misunderstandings, which is best facilitated with
clear and unambiguous written instructions. Policies, which are a pervasive part of any
system, have absolutely no value if they're not in writing, and enforcing accountability is
extremely difficult if the responsibilities are not spelled out.
System documentation and information management are the paperwork part of the
system. The operational changes are the action part and represent the part of the
implementation process that makes the system work.
An ISO 9001 quality management system is not limited to just the processes and
procedures required by the ISO 9001 Standard.
This International Standard does not include guidance specific to other management
systems, such as those particular to environmental management, occupational health and
safety management, financial management, or risk management. However, this
International Standard enables an organization to align or integrate its own quality
management system(s) in order to establish a quality management system that follows the
guidelines of this International Standard.
The implications are: 1) you're encouraged to use the ideas in the 9004 standard and
therefore not limited to building your quality management system exclusively around the
requirements in the ISO 9001 standard, and 2) you're free to combine processes and
instructions from other systems.
What makes this significant is the fact that the ISO 9001 requirements are far from
inclusive. There's nothing, for instance, in the standard to address inventory control, yet
this is a major concern for most companies and a logical addition to a quality
management system. The same can be said for product costing. It's difficult to develop
the cost of quality if you're not costing your products. Nor is there anything in the
standard to regulate environmental, safety, business planning, or financial concerns, all of
which have a significant impact on the way most people run their business.
The objective is to create a system that effectively manages the important activities of
your business, which means that if something is not included in the standard but
nevertheless important to your operation, not only can it be included it should be
included.
The authors of the standard have also made it clear that the outline of the standard is not
meant as an outline for the quality system documentation.
It is not the intent of this International Standard to imply uniformity in the structure of
quality management systems or uniformity of documentation.
[i]nfluenced by varying needs, particular objectives, the products provided, the processes
employed, and the size and structure of the organization.
The message is that you're responsible for structuring your own system. There is no
process list and no procedure list anywhere to be found in the standard, and nowhere in
the standard is it suggested that you should use the outline of the standard as a basis for
identifying your processes or developing your procedures.
While the "process approach" is one of the eight quality management principles listed in
section 4.3 of the ISO 9004 standards, and the use of the "process approach" is
recommended as a means for structuring your ISO 9001 system (refer to section 0.2 of
the standard), neither standard provides a clear explanation of what a process approach is.
The ISO 9004 standard defines the process approach principle as:
A desired result is achieved more efficiently when activities and related resources are
managed as a process.
The ISO 9001 standard defines a process as:
An activity using resources, and managed in order to enable the transformation of inputs
into outputs.
Our way of interpreting the meaning of a "process" is to group related activities based on
defining inputs and outputs. For example, the inputs and outputs of the human resource
process may be defined as:
Input = Rules for making sure employees are informed and capable of performing the
assigned responsibilities
Input = Rules and policies for managing the tangible assets used to support the business
Policies and procedures that affect such things as hiring, training, and performance
management would be part of the human resource process. Housekeeping, machinery
maintenance, network maintenance, and the maintenance of measuring devices would be
part of the infrastructure process.
The authors of the 9001 standard explain the "process approach" as:
The application of a system of processes within an organization, together with the
identification and interactions of these processes, and their management.
Standard, and you're not limited by the requirements of the standard. You establish
processes that represent the particular needs of your operation and develop the policies
and procedures that bring about the desired output of these processes. Then you make
sure these policies and procedures accommodate all of the requirements of the ISO 9001
Standard.
Procedures that are added to your system as a result of ideas taken from the ISO 9004
Standard, or from other systems, or simply because they are an important part of the way
you run your business are not subject to the compliance audit for ISO 9001 certification.
Only the requirements specified in the ISO 9001 standard are audited, but unless you
have been granted an exclusion you must comply with all of these requirements.
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