ISO 9000 QUALITY MANAGEMENT SYSTEM:

The International Organization for Standardization, commonly referred to as the ISO,

was founded to develop a common set of standards in manufacturing, trade, and
communications. The ISO is headquartered in Geneva, Switzerland, and is composed of the
national standards institutes and organizations of 97 countries, including the American National
Standards Institute

 (ANSI).

ISO 9000 is a set of quality systems standards that may be tailored to almost any
organization choosing to adopt the model, regardless of size or industry. The standards are used
on an international scale for quality management and quality assurance. The ISO 9000 objective
is to lay a foundation for a standard language in documenting an organization's quality
procedures and requirements. It requires a system to track and manage evidence that quality
control practices are instituted throughout the organization. (1)The quality system is required to be
documented and employees are expected to follow the documented procedures. After the quality
system is implemented the firms can obtain registration through an audit preformed by an
independent (third- party) registrar.

The ISO 9000 Standards Series has five subsections:

ISO 9000 - Quality Management and Quality Assurance Standards - Guidelines for Selection
and Use. This subsection contains guidelines to be used in conjunction with the other four
standards in the series.

ISO 9001 - Quality Systems - Model for Quality Assurance in Design/Development, Production,
Installation, and Servicing. This is the most comprehensive standard and is used by organizations
who want to show competencies in all areas of their operations from design and manufacturing
to distribution and packaging.

ISO 9002 - Quality Systems - Model for Quality Assurance in Production and Installation. This
model is less stringent than ISO 9001 and is commonly adopted by general manufacturing firms.
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ISO 9003 - Quality Systems - Model for Quality Assurance in Final Inspection and Test. This
model, the most limited and least used one in the series, is used in organizations who wish to
document their inspection and testing policies and procedures. It is estimated that less than 5% of
organizations who follow the ISO 9000 Series use this model.

ISO 9004 - Quality Management and Quality System Elements - Guidelines. This model
provides insight with regard to the various elements to be included in a quality system as well as
the system's expected structure.

Development of the ISO 9000 Series began in 1979. That year, the ISO formed Technical
Committee (TC) 176 to address the topic of quality management and quality assurance with
respect to the worldwide trend of increasingly stringent customer demands for high quality. The
committee also wished to lessen the growing confusion in international trade that resulted from
differing national and sub national quality system requirements.

The ISO 9000 Standards Series on quality management and assurance was published in 1987 and
revised in 1994. It was based on the work of TC 176 and considerable input from many
countries, especially the United States, Canada, and the United Kingdom. In particular, the ISO
9000 standards reflected the British Standards Institution's BS 5750 Series Quality Systems. The
standards are scheduled to be reviewed every five years to keep them up to date.

Currently, ISO 9000 is the national standard for over 60 countries (Breitenberg, 1993), including
Canada, Japan, Mexico, and the United States. Adoption of the standards by the countries does
not mean they are a government enforced requirement. It means customers or buyers in these
countries are requiting ISO 9000 of their suppliers. (1) Criticism of ISO 9000 generally relates to
the high level of paper work and documentation, a rigid system that does not support creativity
or empowerment, a standard that aims for consistency but not continuous quality improvement,
etc.
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ISO IMPLEMENTATION STRATEGY:

Implementation of ISO affects the entire organization right from the start. This
implementation results in “cultural transition” to an atmosphere of “continuous improvement”.
The process of implementing ISO 9000 depends on:
Sophistication of the existing quality program.
Size of the organization
Complexity of the process.
There are 14 steps which has to be followed in order to successfully implement ISO 9000
Quality management system.

Step 1: TOP MANAGEMENT COMMITMENT

The top management (managing director or chief executive) should demonstrate a

commitment and a determination to implement an ISO 9000 quality management
system in the organization. Without top management commitment, no quality initiative
can succeed. Top management must be convinced that registration and certification
will enable the organization to demonstrate to its customers a visible commitment to
quality. The top management should provide evidence of its commitment to the development
and implementation of the quality management system. This can be done by

Communicating the organization the importance of meeting the customer standards as

well as statutory and regulatory requirements.
Framing organization quality policy and bringing it to the notice of every employee.
Framing quality objectives at all levels and functions.
Ensure the availability of resources required for the development and implementation of
quality management system.
Appointing Management Representive (MR) to coordinate quality management system.
Conducting management review.
Step 2: ESTABLISHING IMPLEMENTATION TEAM

The second step deals with establishing the implementation team and appoint
Management Representative (MR) and its co-coordinators to oversee the implementation. The
team should include representative from all function such as marketing, design & development,
planning, production, quality control etc. MR is the person within the Organization who acts
as interface between organization management and the ISO 9000 registrar. His role
is, in fact, much broader than that. The MR should also act as the organizations
"Quality management system champion".

Step 3: START ISO AWARENESS PROGRAM

The main reason behind the ISO 9000 awareness programs is to communicate the
employees
The aim of the ISO 9000 quality management system.
The advantage it offers to employees, customers and the organization.
How it will work, and their roles
Responsibilities within the system.
Suppliers of materials and components should also participate in these programs.
The awareness program should emphasize the benefits that the organization expects to realize
through its ISO 9000 quality management system. The program should also stress the higher
levels of participation and self-direction that the quality management system renders to
employees. Such a focus will go far to enlist employee support and commitment. The programs
could be run either by the implementation team or by experts hired to talk to different levels of
employees.

Step 4: PROVIDE TRAINING

In the implementation of ISO 9000 quality management system there will be many
changes in the current system which will affects all the areas and all personnel in the
organization. Hence training programs should be structured for different categories of employees
(senior managers, middle-level managers, supervisors and workers). The training should cover
The basic concepts of quality management systems and the standard and their overall
impact on the strategic goals of the organization.
The changed processes
The work culture implications of the system.
In addition, initial training may also be necessary on
Writing quality manuals
Procedures and work instruction
Auditing principles
Techniques of laboratory management
Calibration
Testing
When in-house capacity to carry out such training is not available, it may be necessary to
participate in external training courses run by professional training organizations. Alternatively,
an external training institution could be invited to conduct in-house training courses.

Step 5: CONDUCT INTIAL STATUS SURVEY

The next step in the implementation process is to compare the organization’s existing quality
management system with the requirements of the standard (ISO 9001:2000). For this purpose, an
organization flow chart showing how information actually flows from order placement by the
customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow
chart of activities in each department should be prepared. With the aid of the flow charts, a
record of existing quality management system should be established. This document should be
incorporated into the new quality management system. This is referred to as " gap analysis''. In
this analysis these things are analyzed
What is the present operation/process? What already exists?
Analyze the relevant sections of the quality standard - ISO 9001:2000.
What is actually required?
If necessary, supplement and change operational arrangements in accordance with the
standard, develop documents and records, and describe operations/processes.
 What is the desired operation/process?

Step 6: CREATE A DOCUMENTED IMPLEMENTATION PLAN

Once the organization has obtained a clear picture of how the quality management system
compares with the ISO 9001:2000 standard, all non-conformances must be addressed with a
documented implementation plan. Usually, the plan calls for identifying and describing
processes to make the organization’s quality management system fully in compliance with the
standard.
The implementation plan contains the following
Quality documentation to be developed
Objective of the system
Pertinent ISO 9001:2000 section
Person or team responsible
Approval required
Training required
Resources required
Estimated completion date

These elements should be organized into a detailed chart, to be reviewed and approved. The
plan should define the responsibilities of different departments and personnel and set target dates
for the completion of activities. Once approved, the Management Representative should control,
review and update the plan as the implementation process proceeds.

Step 7: DEVELOP QUALITY MANAGEMENT SYSTEM DOCUMENTATION

Documentation of the quality management system should include:

Documented statements of a quality policy and quality objectives
Quality manual
Documented procedures and records required by the standard ISO 9001:2000
Documents needed by the organization to ensure the effective planning, operation and
control of its processes.
Quality documentation is generally prepared in the three levels

Level A: Quality manual

States the scope of the quality management system, including exclusions and details of
their justification; and describes the processes of the quality management system and their
interaction. Generally gives an organization profile; presents the organizational relationships and
responsibilities of persons whose work affects quality and outlines the main procedures. It may
also describe organization's quality policy and quality objectives.

Level B: Quality management system procedures

Describes the activities of individual departments, how quality is controlled in each
department and the checks that are carried out.

Level C: Quality documents (forms, reports, work instructions, etc.)

Work instructions describe in detail how specific tasks are performed; include drawing
standards, methods of tests, customer's specifications, etc.
Presents forms to be used for recording observations, etc.

Step 8: DOCUMENT CONTROL

Once the necessary quality management system documentation has been generated,
a documented system must be created to control it. Control is simply a means of
managing the creation, approval, distribution, revision, storage, and disposal of the
various types of documentation.
Document control should include

Approval for adequacy by authorized person (s) before issue

Review, updating and re-approval of documents by authorized person (s)
Identification of changes and of the revision status of documents
Availability of relevant versions of documents at points of use
Identification and control of documents of external origin
 Assurance of legibility and identifability of documents, and
Prevention of unintended use of obsolete documents.

The principle of ISO 9000 document control is that employees should have access to
the documentation and records needed to fulfill their responsibilities.

Step 9: IMPLEMENTATION
Once the documentation is over it is a good practice to implement the quality
management system. This step is more effective in larger firms. In smaller firms quality
management system is implemented all at once throughout the organization. In larger
organization phased implementation takes place in order to evaluate the effectiveness in the
particular area.
It would be a good idea initially to evaluate areas where the chances of a positive
evaluation are high, to maintain the confidence of both management and staff in the merits of
implementing the quality management system. The implementation progress should be
monitored to ensure that the quality management system is effective and conforms to the
standard. These activities include internal quality audit, formal corrective action and
management review.

Step 10: INTERNAL QUALITY AUDIT

Once the system is being installed, its effectiveness should be checked by regular internal
quality audits. Internal quality audits are conducted to verify that the installed quality
management system:

Conform to the planned arrangements, to the requirements of the standard (ISO

9001:2000) and to the quality management system requirements established by the organization

Is effectively implemented and maintained.

Even after the system stabilizes and starts functioning, internal audits should be
planned and performed as part of an ongoing strategy. A few staff members should be trained to
carry out internal auditing. Use ISO 19011 for guidance in auditing, auditor qualification and
programmes.
Step 11: MANAGEMENT REVIEW

When the installed quality management system has been operating for three to six
months, an internal audit and management review should be conducted and corrective
actions are implemented. The management reviews are conducted to ensure the
continuing suitability, adequacy and effectiveness of the quality management system.
The review should include assessing opportunities for improvement and the need for
changes to the quality management system, including the quality policy and quality
objectives.

The input to management review should include information on:

Results of audits.
Customer feedback.
Process performance and product conformity.
Status of preventive and corrective actions.
Follow-up actions from previous management reviews.
Changes that could affect the quality management system.
Recommendations for improvements.

Step 12: PRE-ASSESSEMENT AUDIT

When system deficiencies are no longer visible, it is normally time to apply for
certification. However, before doing so, a pre-assessment audit should be arranged
with an independent and qualified auditor. Sometimes certification bodies provide this
service for a nominal charge. The pre-assessment audit would provide a degree of
confidence for formally going ahead with an application for certification.

Step 13: CERTIFICATION & REGISTRATION

Once the quality management system has been in operation for a few months and has
stabilized, a formal application for certification could be made to a selected certification agency.
The certification agency first carries out an audit of the documents (referred as an "adequacy
audit"). If the documents conform to the requirements of the quality standard, then on-site audit
is carried out. If the certification body finds the system to be working satisfactorily, it awards the
organization a certificate, generally for a period of three years. During this three-year period, it
will carry out periodic surveillance audits to ensure that the system is continuing to operate
satisfactorily.

Step 14: CONTINUAL IMPROVEMENT

Certification to ISO 9000 should not be an end. The company should continually seek to
improve the effectiveness and suitability of the quality management system through the use of:
Quality policy
Quality objectives
Audit results
Analysis of data
Corrective and preventive actions
Management review

ISO 9004:2000 provides a methodology for continual improvement.

BIBLIOGRAPHY:

Books:

S K SINGH (2000), ‘ISO 9000 AND TOTALQUALITY MANAGEMENT’ (2 nd edition),

Commonwealth Publishers, New Delhi.

Journals:

(2002) TOTAL QUALITY MANAGEMENT, Volume (13), Page no 53-67.

Hormozi, Amir M. (1995) SAM Advanced Management Journal: Understanding and

implementing ISO 9000: a manager's guide.

Websites:

http://www.iso.org/iso/home.htm

http://www.thefreelibrary.com/Understanding+and+implementing+ISO+9000%3A+a+manager
%27s+guide.-a018194396

http://www.theriac.org/pdfs/startsheets/iso9000.pdf