MANAGING THE PROCESS FLOW WITH ISO 9000 FAMILY

A Consultant’s Point View

Focused and prioritized improvement opportunities. Efficient audit,

effective innovation and targeted customer satisfaction. Lower costs
and shorter cycle times trough effective use of resources. Improved,
consistent and predictable results. These are a few key benefits
resulting from the application of the process approach. This
newsletter will provide guidance on managing process flow in the
following 4 items:
1) The process approach of the ISO 9000:2000 Family
2) Understanding the Process Flow
3) Putting Together the Process Flow
4) Documentation of quality management system’s processes

1) The process approach of the ISO 9000:2000 family

Effectiveness and Efficiency!

A desired result is achieved more efficiently when activities and

related resources are managed as processes. No longer businesses
are considered to identify and manage processes limited to the
production or services operations. The new family of standards
considers every activities of the Quality management system as a
process.

The common quality management system model of ISO 9000 family

is logic and provides a framework for effective management of
organization’s process flow. The universality and versatility of this
common framework corresponds to the five key business process:

Quality Management System Process,

Top Management Process,
Resources management process,
Product realization process,
Measurement, analysis and improvement process.

Page 1 of 6
The ISO 9000: 2000 Family defines a process as: Set of interacting
activities, which transforms inputs into output. Input and output may
be tangible or intangible. Examples of inputs and outputs may include
equipment, materials, components, energy, information, human and
financial resources. To operate effectively the processes the
appropriate resources have to be allocated. A measurement system
can be used to gather information and data to analyze process
performance and input and output.
When the desired results of processes are achieved we talk about
process effectiveness. When the desired results are achieved with
the planned use of resources we talk about process efficiency.

ISO 9001:2000 model focuses on effectiveness, ISO 9004:2000

model focuses on efficiency. Process effectiveness and efficiency can
be assessed through internal or external audit and can be evaluated
on a maturity scale. These scales typically range in degrees of
maturity from ``no formal system`` to ``best in class performance``.
An advantage to this approach is that results can be documented and
measured to reach improvements objectives in real terms and in real
times!

2) Understanding the Process Flow

System approach to management!

Identifying, understanding and managing interrelated processes as a

system contributes to the organization’s effectiveness and efficiency
in achieving its objectives. The interactions between an organization’s
processes can often be complex, resulting in a network of
interdependent processes. The quality management system
comprises a number of interrelated processes. 1) Top management
process includes determination of quality policy and objectives,
communication process and management review. 2) Resources
management process involves determination and allocation of
resources, human resources and training, infrastructure definition and
work environment. 3) Product realization process involves planning,
customer related process, design and development process,
purchasing process, production and service provision, control of
monitoring and measuring devices. 4) Measurement analysis and

Page 2 of 6
improvement process comprises control of product conformity,
measurement of process effectiveness, measurement of customer
satisfaction, internal audit, analysis of data and continual
improvement.
Output from one process typically form part of the inputs into
subsequent process. Marketing specifications for product are output
from marketing process and input for design process. Product
specifications are output from the design process and input for the
production process. Customer perception on satisfaction is output
from the measurement process and essential input to the continual
improvement process.

3) Putting Together the Process Flow

The art of management!

Processes exist within the organization and the initial approach

should be limited to identifying and managing them in the most
appropriate way. ISO 9001 requires that all processes needed for the
quality management system be managed. There is not catalogue or
list of processes that has to be documented. Each organization
determine which process are to be documented on the basis of its
customer and applicable regulatory requirements, the nature of its
activities and its overall corporate strategy.

First, the organization needs to identify the global process flow of the
activities involved in the quality management system:
What are the processes between the customer’s demand and
customer use?
What are the inputs and outputs for each process?
Who is the process owner?
Are any processes outsourced?

Second, the organization should determine the sequence and the

interaction of these processes in the process flow:
What is the overall flow of our processes?
How can we describe this?
What are the links between the processes?
What documentation do we need?

Page 3 of 6
 What documentation is required?

Third, the organization should determine the criteria and methods for
process control and operation:
What are the product or service characteristics?
What are the criteria for process control and process operation?
What are the economic issues (cost, time, resources)?

Fourth, the organization should ensure the availability of resources

and information necessary to support the operation of these
processes:
What are the resources needed for each process?
What are the communication channels?
What relevant data do we need to collect?
What records do we need to keep?

Fifth, the organization should measure and analyze these processes:

Do we measure product conformity?
Do we measure process capability?
Do we measure customer satisfaction?
Do we measure supplier’s performance?
What does the result of this analysis tell us?

Sixth, the organization should act to achieved planned results and

Continual improvements of these processes:
How can we improve the processes?
How can we improve the results?
What corrective and preventive actions are necessary?
Have these actions been implemented?
Are they effective?

4) Documentation of Processes

Do more with less!

ISO 9001:2000 specifically requires the organization to have

“documented procedures” for the following six activities: Document
control, control of records and data, control of non-conforming
product, internal audit, corrective action and preventive action. Some

Page 4 of 6
organizations may find it convenient to combine the procedure for
several activities into a single documented procedure (for example,
corrective action and preventive action) may choose to document a
given activity by using more than one documented procedure (for
example, Internal audits). Both are acceptable. Some organizations
(particularly larger organizations, or those with more complex
processes) may require additional documented procedures
(particularly those relating to product realization processes) in order
to implement an effective QMS.

Other organizations may require additional procedures, but the size

and/or culture of the organization could enable these to be effectively
implemented without necessarily being documented. However, in
order to demonstrate compliance with ISO 9001:2000, the
organization has to be able to provide objective evidence (not
necessarily documented) that its QMS has been effectively
implemented.

In order for an organization to demonstrate the effective

implementation of its QMS, it is necessary to develop documents
other than documented procedures and quality policy manual. There
are several requirements of ISO 9001:2000 where an organization
could add value to its QMS and demonstrate conformity by the
preparation of other documents, even though the standard does not
specifically require them. Examples may include:

Process flow charts,

Process maps,
Descriptions matrix,
Matrix of priorities,
Organization charts,
Specifications,
Work instructions,
Pictures, Graphs, Diagrams
Computer Information system,
Production schedules,
Approved supplier lists,
Test and inspection plans,
Quality plans

Page 5 of 6
 Select the right frame!

For the organizations that are in implementation of QMS the Process

Framework of ISO 9000:2000 family emphasizes a strong process
approach. This includes better identification of processes needed for
the effective operation of quality management system, better
understanding of interaction of these processes, better quality and
less volume of the documentation to the extent necessary to ensure
their effective operation and control. Analysis of processes is the
driving force for defining the amount of documentation needed for
quality management system, taking into account the requirements of
ISO 9001:2000.
For the organizations that are in transition to the new ISO 9001:2000
standard the Process Framework will facilitate the structure of quality
management system and the update to the ISO 9001:2000
requirements. Organizations may use the new standard for
simplification, consolidation of existing documents and to find new
opportunities for improvements and new improvement objectives.
More process integration and less process fragmentation will be the
results of the transition to the new standard. However an organization
that has not used a process approach in the past, will need to define
the process flow with clear sequence and interaction of its processes.
There is no doubt that the customer focus by process approach with
continual improvement brings new dynamics into the company quality
management system. The ISO 9000:2000 family provides the right
frame for managing the process flow that will elevate company
performance and business results!

Branimir Todorov
President
BTA INC
Consulting and training on business management systems
1010, Sherbrooke street West, suite 1800,
Montreal, Quebec, Canada
H3A 2R7
Phone: 514-843-5115
Fax: 514-286-6078
Web: http://www.bta.qc.ca/index1.html
E-mail: btd@bta.qc.ca

Page 6 of 6