The International Organisation for Standardisation (ISO) is an

international federation of
national standards involving more than 140 countries. ISO 9000 is a
well-known family of
guidelines and standards developed by the ISO. It has become popular
worldwide for its role in
setting up quality management systems within organisations.

What is ISO?
An internationally accepted
management model
that makes a company
document their
processes to maintain
consistent practices
Method that dictates how a
company should
produce their products
through a rigorous
documentation process
 This prevents repetitive errors
from occurring and
allows for improvement
 Focuses on ensuring a quality
product

ISO: A Brief History

 ISO 9000 created by the
International Organization for
Standardization
 International standardization
began with the International
Electrotechnical Commission (IEC)
in 1906
 This led to the development of the
International Federation of
National Standardizing Associations (ISA)
in 1926
 The reasons for international
standards are:
 a cheaper product
 less waste
 greater interoperability between
products
 improved usability
 ease of maintenance
But with the start of World
War II
 ISA operations was put on hold in
1942
 After the war in 1946
 A delegation of 25 countries met
in London and
decided to start over and form an
organization "the
object of which would be to
facilitate the international
coordination and unification of
industrial standards"
 ISO was formed the following
year in 1947 and
published its first standard in 1951
 ISO 9000 was conceived
.
The ISO:
The International Organisation for Standardisation (ISO) is an international federation of national standards
involving more
than 140 countries. A non-governmental organisation it was set up in 1947. The motto of ISO is to endorse the
growth of
standardisation worldwide to promote international trade and services. ISO promotes mutual collaboration
between various
organisations in the scientific, technology and economic related activities.
The evolution of ISO:
International standardisation was first initiated in the electro technical area. The International Electro Technical
Commission (IEC) was established in 1906. The International Federation of the National Standardising
Associations (ISA),
established in 1926, put in groundbreaking efforts in other areas. ISA focused mainly on mechanical engineering.
Its
activities came to an end in 1942.
In 1946, representatives from 25 countries convened in London and decided to form a new international
organisation, in
order to “make possible the international coordination and integration of organisational standards". The new
organisation,
ISO, formally became operative on 23 February 1947.
ISO standards -The process:
ISO has a well-defined process for incorporating standards.
First phase:
In any country a business segment puts forward the need for a standard before its national standards institute.
The latter
suggests this to the ISO. Once the necessity for an International standard has been acknowledged and officially
approved,
the technological feasibility of the standard is defined. This stage is usually performed in teams consisting of
professionals
from those countries that are interested in the particular standard.
Second phase:
Once the experts reach a conclusion on the technical parameters to be covered in the standard, the participating
countries
discuss in detail the specifics pertaining to the standard. This is the consensus-building phase.
Final phase:
The final phase comprises of the endorsement of the final draft of the International Standard. This report is
subsequently
made available in print as an ISO International Standard.
Many of the standards need regular reviews. Various factors contribute to make a standard obsolete: scientific
advancement, new techniques and equipment, changing trends in quality and safety procedures. To consider
these issues,
ISO has stipulated that all ISO standards should be evaluated every five years.
Continue the tour:

The ISO 9000

What Is ISO 9000?

 Founded in 1946 in Geneva, Switzerland.
ISO 9000 is an internationally recognised
quality management system developed
by ISO (International Organisation for
Standardisation).
 ISO standards provides the foundation on
which you can build your quality
management and quality assurance
systems, so you may ultimately achieve a
high
level of success.
 ISO 9000 series is the only system
accepted internationally.
 For those companies whose quality
systems are on the low end of a TQM
Continuu

 Certification also has the advantage of

putting the organization on a level field
with the competition worldwide.
 It is valid for a period of three years.
 Standard based on 8 quality management
principles:
Customer focus organisation
 Leadership
 Involvement of people
 Process approach
 System approach to management
 Continuous improvement
 Factual approach to decision making
 Mutually beneficial supplier relationship

Understanding > The ISO 9000

The ISO 9000:
The goal of any organisation is to constantly accrue benefits through product innovation and efficiency in the use
of
resources. The critical aspect to achieve this is to attain all round quality performance. Quality is a basic
consumer
requirement. A customer prefers organisations reliable as far as its quality performance is concerned.
Consistently
manufacturing products and offering services of superior quality is the need of the hour worldwide. This is a
critical aspect
in sustaining customer loyalty and retaining the market base.
In order to attain this, organisations have to comply with a set of procedures that are not only acknowledged and
accepted
within a country but also internationally. ISO 9000 standards serve this purpose.
ISO 9000 is a well-known family of guidelines and standards developed by the ISO. ISO 9000 standards for a
Quality
Management System handles the processes concerned with the design, development and delivery of a product or
service.
The standard stipulates specifications for the control and assessment of a process for attaining quality
performance.
The 1987 version of ISO 9000 standard, (originally published as BS5750 by the British Standards Institute)
emphasised on
quality control by means of effective checking and corrective actions. Quality control (QC) is a management
function that
controls the quality of raw materials, products, components, and services concerned with production and
inspection
activities. It aims to prevent defects in the products or services.
The 1994 version of the ISO 9000 standard focused on quality assurance via preventive actions, and stipulated
the need
for documented procedures. Quality assurance (QA) comprises all measures taken to ascertain that the standards
and
procedures are in conformity and that the products or services meet the performance requirements.
An ISO 9000 certification indicates that the management is effectively controlling the processes that are ‘critical
to quality’
with respect to the customer. ISO 9000 is not just about service or product quality; it's about quality in
management.
These standards address aspects related to process management. This requires organisations to identify,
document and
control processes ranging from executive management to the production of different items.
An organisation could be successfully certified to ISO 9000 if it adhered to the specifications of the standard. In
order to be
certified, an organisation must submit to an accredited assessor’s examination. The assessor interviews staff
members to
ensure that they are aware of their roles and responsibilities in complying with the ISO 9000 standard. The
assessor also
examines the organisation's paperwork to check on ISO 9000 compliance. When all issues are addressed, the
organisation
is deemed for certification.
Continue the tour:

ISO 9000 series

STANDARD CONTENT APPLICATION
ISO 9000 Provides definition and concepts.
Explains how to select other
standards for a given business
All industries including software
development
ISO 9001 Quality assurance in design,
development, production,
installation and servicing
Engineering and construction
firms, manufacturers that design,
develop, install and service
products
ISO 9002 Quality assurance in production
and installation
Companies in the chemical
process industries that are not
involved in product design or
after sales service
ISO 9003 Quality assurance in test and
inspection
Small shops, divisions within a
firm, equipment distributors that
inspect and test supplied products
ISO 9004 Quality management and quality
system elements
All industries

The ISO 9000:94 Family

Understanding > The ISO 9000:94 family
ISO 9000:94 family is a set of international quality standards and guidelines that have become popular worldwide
for their
role in setting up quality management systems within organisations.
In the past, organisations preferred to implement any of the three ISO 9000:94 requirement standards i.e. the
ISO 9001,
ISO 9002 and ISO 9003. Moreover, there was a notion that ISO standards are applicable only in the
manufacturing sector.
ISO in a move to change this perception drafted some more guidelines that cater to the requirements of the
service sector,
small and medium scale industries and software companies. Given below is a list of ISO 9000:94 guidelines and
standards.
ISO 8402, Quality management and quality assurance – Vocabulary. Defines the essential terms used in the ISO
9000
family, which is necessary for avoiding misinterpretations.
ISO 9000-1, Quality management and quality assurance standards – Part 1: Sets the guidelines for selection and
use of
specific standards. Provides the scope for understanding and selecting the appropriate standards.
ISO 9000-2, Quality management and quality assurance standards –Part 2: Provides basic guidelines for the
application
of ISO 9001, ISO 9002 and ISO 9003. Helps in interpreting ISO 9001, ISO 9002 and ISO 9003.
ISO 9000-3, Quality management and quality assurance standards –Part 3: Sets guidelines for the application of
ISO
9001 1994 in the development, delivery, installation, and maintenance of computer software. Also provides a
specific
interpretation of the requirements of ISO 9001 for computer software development applications.
ISO 9000-4, Quality management and quality assurance standards –Part 4: Provides guidance on how to plan,
organise
and control resources to produce reliable and sustainable products.
ISO 9001, Quality systems – Model for quality assurance in design, development, production, installation and
servicing.
This is a requirement standard used to ascertain the process capabilities for the design and development of the
product or
service, as well as for installation and servicing.
ISO 9002, Quality systems – Model for quality assurance in production, installation and servicing.
This standard is used to ascertain process capabilities for production, installation and servicing (identical to ISO
9001except for design control requirement).
ISO 9003, Quality systems – Model for quality assurance in final inspection and testing. This is a requirement
standard
used to control product or service through final inspection and testing.
ISO 9004-1, Quality management and quality system elements –Part 1: Guidelines for implementation. This
optional
standard provides guidelines to implement a quality system to satisfy the customers’ and organisational
requirements.
ISO 9004-2, Quality management and quality system elements –Part 2: Sets guidelines for services. This
standard is
analogous to ISO 9004-1, but the guidelines are designed specifically to suit the requirements of the service
sector.
ISO 9004-3, Quality management and quality system elements –Part 3: Sets guidelines for processed materials.
ISO 9004-4, Quality management and quality system elements –Part 4: Sets guidelines for quality improvement.
Provides
guidelines for implementing continual quality improvement within the organisation using tools and techniques
based on
information compilation and evaluation.
ISO 10005, Quality management –Sets guidelines for quality plans. This standard provides guidance on how to
prepare
quality plans for the control of specific products, and projects.
ISO 10006, Sets guidelines to quality in project management
ISO 10007, Quality management –Sets guidelines for configuration management. Provides guidelines to ensure
that a
complex product continues to work in the desired manner even when certain parts are modified.
ISO 10011-1, Sets guidelines for auditing quality systems – Part 1: Provides guidelines for auditing a quality
system, and
verifying the system’s capability to achieve set quality goals. It can be used within the organisation or for
auditing the
suppliers.
ISO 10011-2, Sets guidelines for auditing quality systems – Part 2: Qualification criteria for quality systems:
auditors.
Provides guidance on the education, training, know-how, personal traits and management capabilities needed to
carry out
an audit.
ISO 10011-3, Sets guidelines for auditing quality systems – Part 3: Management of audit programmes. Provides
basic
guidelines for managing quality system audit programmes.
ISO 10012-1, Quality assurance requirements for measuring equipment – Part 1: It is a metrological
confirmation system
for measuring equipment. Provides guidelines on the key characteristics of a calibration system to ensure that
measurements are done with the projected accuracy.
ISO 10012-2, Quality assurance for measuring equipment – Part 2:
Sets guidelines for control of measurement processes. Provides additional guidance on the application of
statistical process
control whenever it is apt for achieving the objectives of Part 1.
ISO 10013, Sets guidelines for developing quality manuals. Provides guidelines for the setting up, organising and
controlling quality manuals customised to specific needs.
Continue the tour:
The ISO 9000:94 Quality System Elements

Understanding > The ISO 9000:94 Quality System Elements

The ISO 9000 Quality system elements:
An ISO 9000 compliant quality assurance system includes 20 system elements. Of the three system models (ISO
9001,
9002, and ISO 9003), ISO 9001 requires all 20-system elements whereas certain sub clauses have been omitted
in ISO
9002 and 9003. The 20 system elements that ISO 9001 requires are listed below:
4.1 Management Responsibility.
4.2 Quality System.
4.3 Contract Review.
4.4 Design Control.
4.5 Document and Data Control.
4.6 Purchasing.
4.7 Control of Customer – Supplied Product.
4.8 Product Identification and Traceability.
4.9 Process Control.
4.10 Inspection and Testing
4.11 Control of Inspection, Measuring and Test Equipment.
4.12 Inspection and Test status.
4.13 Control of Non-Conforming Product.
4.14 Corrective and Preventive Action.
4.15 Handling Storage, Packaging, Preservation, and Delivery.
4.16 Control of Quality Records.
4.17 Internal Quality Audits.
4.18 Training.
4.19 Servicing.
4.20 Statistical Techniques.
The ISO 9002 standard comprises of all the twenty clauses except Design control (clause 4.4)
The ISO 9003 standard comprises all the twenty clauses as in ISO 9000 barring Design control (4.4), Process
control (4.9),
Preventive action (4.14) and Servicing (4. 19)
The ISO 9000 Standard’s twenty system elements are explained in detail below.
.

Implementation > Establishing ISO 9000 Quality Management System

Establishing ISO 9000 Quality Management System:
ISO 9000 family provides a basic structure to analyse and enhance organisations key activities - that are
particularly
involved in establishing and maintaining quality.
The best known of the ISO 9000 family are the ISO 9001, ISO 9002 and ISO 9003 standards - each defining
standards for
different aspects of an organisation.
For instance, while ISO 9001 specifies the model for quality assurance in design, development, production,
installation and
servicing, ISO 9002 specifies standards for production, installation and servicing, and ISO 9003 is applicable for
final
inspection and testing. Thus, before embarking on implementation every organisation should consider factors like
• The services and products it offers.
• Size of the organisation.
Regardless of the kind of standard adopted, organisations can go about their quality system implementation
through the
following steps:
Step 1: Top management commitment:
The first step towards establishing a QMS in accordance with ISO 9000 series of standards is the commitment of
the topmanagement.
Any measure taken towards the development of a QMS will be productive only when the top- management is
committed towards it.
The top-management must be convinced of the benefits of certification. They should realise how certification will
help them
improve their systems and demonstrate a visible commitment to quality to customers.
The top management can demonstrate their commitment to the implementation and enhancement of the QMS by
several
methods, some of which include:
• Developing effective strategies to communicate to their employees the importance of implementing the ISO
9000
QMS.
• Developing the organisation's quality policy and communicating it to all the employees.
• Establishing quality targets at all levels and functions of the organisation.
• Providing necessary resources to implement the QMS.
• Appointing a management representative drive the implementation of the QMS.
• Conducting management reviews.
Step 2: Establish an implementation team and allocate responsibilities:
The next step is to form an implementation team and appoint a management representative to streamline the
organisation¡¦s planning and manage the implementation program. Care should be taken that the team members
are from
all the functions in the organisation.
A management representative, is a person within the organisation who acts as an interface between
organisation¡¦s
management, it's employees and the ISO 9000 registrar. He should be the organisation's "quality management
system
champion," and should:
• Be committed to quality and particularly to implementing ISO 9000 standards.
• Demand the respect of managers and other levels of employees.
• Have knowledge of quality systems and ISO 9000 in particular.
• Have complete backing from the management.
Step 3: Start ISO 9000 awareness programs:
Enhancement of quality performance in an organisation does not occur by itself. The top-management should
motivate and
support the work force in their efforts to achieve quality improvement.
An organisation-wide awareness program should be conducted on ISO 9000 QMS. This will help employees gain
adequate
knowledge of ISO 9000 quality system. They should be able to understand:
• Why the organisation is opting for certification?
• What is the current status of the organisation when compared to the required standards?
• What is the desired objective of the management?
• What are the benefits of implementing quality system based on ISO 9000 standards?
Step 4: Provide training:
Once the above activities are performed, necessary training should be provided for different categories of
employees
- senior managers, middle-level managers, supervisors and workers. The duration may vary depending on the
need but
training is a must for all. This training needs to be comprehensive enough to include all the basic concepts of the
QMS, the
standards and their influence on the planned targets of the organisation.
The management representative along with the members of the implementation team, who conduct internal
audits, would
need an internal auditor-training course. Training may also be necessary on writing quality manuals, procedures
and work
instruction, auditing principles, techniques of laboratory management, calibration, and testing procedures.
If expertise is not available to conduct the training, it may be necessary to participate in external training courses
that
professional training organisations conduct. Alternatively, an external training consultant could be invited to
conduct inhouse
training courses.
Step 5: Conduct Gap analysis:
Gap analysis is an evaluation of the organisation's current policies and procedures to identify those that fall short
of what is
required by ISO 9000. Gap analysis enables the organisation to analyse its business plan, policies and strategies
and their
suitability.
Many organisations have the necessary procedures in place for a QMS but the question is whether they are in
accordance
with the required standards. Gap analysis assists in identifying such procedures. It also helps in identifying the
need for
new procedures.
A gap analysis generally uses a standard template of questions (questionnaire) on the current status of the
organisation's
processes. The analysis can be conducted internally i.e. by an in-house team, provided the required knowledge is
available.
Otherwise the services of an external consultant should be availed.
Step 6: Create a documented implementation plan (Action plan):
Once the organisation gets a clear picture of the status of its existing quality initiatives, all non-conformances
should be
managed with a documented implementation plan (action plan). This requires identifying the non-conformance
process and
modifying them to make the QMS compliant to the required standard.
Gap analysis helps to obtain information pertaining to all the activities that an organisation practices. This
information
should be used to develop a new implementation plan.
This implementation plan should define:
• The documentation that needs to be developed.
• Vision and targets of the system.
• Relevant ISO 9000 section.
• Person or team responsible.
• Required resources, approval and training.
• Clear deadlines.
These elements need to be arranged in the form of a chart, to enable periodic reviews. This plan should define
the roles
and responsibilities of employees in different departments and specify the time limits for the completion of the
activities.
The implementation team should approve the action plan that is developed. While a quick action is essential it
should not
be the only norm. The management representative should control, review and update the plan as the
implementation
process proceeds.
Step 7: Develop QMS documentation:
Once the action plan is ready, the next step is documentation. Documentation is a common area of non-
conformance in
organisations willing to implement quality systems. In most organisations the documentation is either insufficient
or absent
in some areas. Areas like inspection and measurement are generally performed in every organisation, but very
few
document them.
Documentation of the QMS should include all the activities that have their profound impact on quality. This
generally should
include:
• Documented statements of quality policy and quality objectives.
• A quality manual.
• Documented work instructions and quality records.
• Documented quality plans and those that are required for operation and control of quality processes.
Step 8: Document control:
Once the necessary documentation is developed, a documentation system should be developed to control it.
These control
systems need to be simple and easy to operate.
Document control should include:
• Approval for adequacy by responsible persons before issue.
• Effective means for employees to access the documents.
• Revision, updating and re-approval of documents by authorised persons.
• Prevention of unintended use of obsolete documents.
Step 9: Implementation:
After developing the necessary documentation and systems for their control, the management representative
(quality cocoordinator)
needs to validate them. Then the actual QMS implementation can be initiated.
Implementation is putting down the written systems into practice. Care should be taken that the all activities in
the
organisation are in accordance to the documented standards.
It would be a good idea to initially evaluate areas where the chances of a positive evaluation are high. This helps
to
maintain the confidence of both management and staff in the merits of implementing the QMS.
Step 10: Internal quality audit (Phase-1 audit):
Internal quality audit can help identify the gaps in the quality system implementation that are not yet compliant
to the ISO
standards.
Internal audit process should be conducted properly and thoroughly. It helps to verify that the QMS is in
accordance with
the:
• Planned arrangements.
• Requirements of the standard.
• The organisation's requirements .
This may require modification of a particular system or procedure. Even after the system stabilises and starts
functioning,
internal audits should be planned and performed as part of an ongoing strategy.
Step 11: Pre-assessment audit (Phase-2 audit):
When system errors are no longer observed, it is normally time to apply for certification. However, before doing
so,
arranging a pre-assessment audit though not mandatory is advisable.
Phase - 2 audit generally conducted by an external agency could help organisations re-evaluate their QMS. This
may help
them identify defects that were not visible previously. Thus the organisation gets a certain a degree of confidence
before
going through the formal process of certification.
Generally, an independent and qualified auditor conducts the pre-assessment. In certain cases certifying agencies
provide
this service.
Step 12: Selecting a certifying agency:
Some criteria that organizations can consider while evaluating a certifying agency are:
• Background of certifying agency.
• Kind of organisations and industries audited by them previously.
• Number of organisations audited by them.
• Expertise in the implementation of ISO 9000 standards.
• Market feedback.
• Audit fees.
• The audit team deployed.
• Compatibility of audit firm's working with organisational culture.
Step 13: Certification and registration:
The next step is the certification. The certifying agency first conducts a document review to check for the
adequacy of
available documentation.
Once the documentation is found adequate, a conformity audit or a compliance audit is conducted. Such an audit
is
performed in accordance with the ISO 10011 auditing standard. On satisfying the conformance audit, the
certifying agency
grants certification.
Step 14: Surveillance and re-certification audits:
Establishment of a QMS in accordance with the ISO 9000 series of standards is not a one-time effort. ISO 9000
standards
need to be adhered to by the QMS once it is implemented in the organisation.
Hence, organisations need to ensure that the systems implemented are also established. Regular surveillance
audits are
necessary for this. They help to ensure that the organisation continuously adheres to the required quality
standard. In
general, the certifying agency conduct these surveillance audits.
The certification issued is valid for a period of 3 years. After which a re-certification audit is conducted.

LEVEL 1: QUALITY MANUAL

The quality manual as a
highest level
document at the peak of a
pyramid
outlining the quality system
and acting as
a directory for the documents
and
procedures below. It will
outline the
company’s policy and
commitment to
quality.
Documentation > Documentation of ISO 9000:1994
Documentation:
Documentation can help an organisation to
• Provide a road map to the organisations quality activities.
• Allow large and complex tasks to be easily comprehended.
• Save the time new employees spend to learn tasks.
• Provide the basis for internal audits.
Documentation is the most common area of non-conformance within organisations implementing ISO 9000:1994
quality
management systems. In most organisations the documentation is either insufficient or absent in many areas.
ISO 9000:1994 standards necessitate an organisation’s quality management system to be documented and
controlled. But
most organisations fall short of their defined goals and objectives due to improper planning i.e. lack of an
organised
approach.
The 1994 version of ISO 9000 unlike the 1987 version included a new clause-Quality planning. This requires
preparation of
quality plans showing how the requirements of quality are going to be met.
Thus, before embarking on documentation an organisation should first analyse what to document and what is
already
documented. Mere documentation is not sufficient. Documentation will be effective only if it is properly planned
and
managed in stages.
Common problems:
• Employees prepare the documents unaware of the difference between a procedure and a work instruction.
• The terminology is not clearly defined and used consistently.
• Obsolete documents often still in use.
• Absence of a process for tracking changes.
Given below are some guidelines for developing the documentation for a QMS
1. Provide a structure for documentation:
ISO 9000:1994 standards do not address the details of the quality system. Instead, they specify that an
organisation must
have defined processes for areas such as quality, process documentation, and verification.
Therefore, organisations need to first identify the processes that impact the quality of their products or services.
Then, a
basic approach is to be developed involving all these processes and their interrelationship. These processes
generally
include
• Material, equipment and the resources that need to be obtained.
• Production and administration processes and their conformance with the design norms of product or service.
• Targets of the organisation’s QMS.
• Training, purchasing and material checking/testing procedures.
• Inspection, validation and control procedures.
Once the processes are identified, a model, which acts as the base for the documentation is to be outlined. ISO
9000:1994
follows a three-tier model - quality manual, process guides and work instruction respectively.
• The quality manual explains the quality policy, quality goals and targets. The organisational structure needed
to
fulfil the ISO 9000 requirement.
• Process guides are documents that describe how an process is to be carried out.
• Work instructions are documents that specify how a job or activity is to be done.
2. Check the clauses of ISO 9000:
After outlining the model for documentation, organisations need to check all the clauses of ISO 9000:1994
standards.
The family of ISO 9000:1994 series specify three different standards, namely ISO 9001, ISO 9002 and ISO 9003-
each
specifying standards for different aspects of the business.
Hence, organisations (before preparing the quality manual or process guides) initially need to verify the standard
appropriate to them. This requires an extensive clause-by-clause inspection of the elements in the organisation.
Check lists
are used for this purpose. These checklists present a clear picture of the organisation’s existing quality system
and ensure
that there is nothing overlooked.
3. Review the process map:
This forms the most crucial stage of the entire documentation process. Many organisations view the quality
system as the
responsibility of the quality manager alone. However, the quality system is the responsibility of the entire
organisation.
Thus, top-management needs to first evaluate their process map and analyse existing systems and those planned
for the
future. Employees’ viewpoints need to be considered to make the documentation more effective.
4. Write Quality manual:
Once the inadequate processes are identified, they need to be rectified and new documents prepared. There is no
standard
format for writing a quality manual but it is essential to keep it simple.
If the organisation consist of complex processes, it may even be necessary to create functional manuals (defining
every
function). The criteria should not be the style and size but the needs of the users of the manual.
Document control:
Some tips to maintain an effective document control system are explained below:
Keep It Simple:
Documentation should be comprehensive, short and user-friendly. It should be simple so that everyone can
comprehend it
easily. It should be precise and adequate enough to cover all the necessary activities.
Have the right amount of documentation:
Too much documentation may prove burdensome while too little could prove insufficient and ineffective.
Other tips:
• Document only relevant and important activities.
• Retain the old documents unless they are no longer useful.
• Keep it simple and easily comprehendible.
• Describe the process route for every activity. Avoid following ISO 9000 clause by clause if it is inappropriate to
the organisations business.
• Integrate the quality manuals of other companies if found beneficial.
• Never start documentation without a plan.

4.17 Internal quality audits:

The purpose of this element is to help management determine if the implemented quality system is effective in
achieving
required quality objectives. This is an evaluation technique organisations use to verify processes.
They collect the data from a variety of sources and crosscheck them for the purpose of Internal quality audits.
This data is
analysed and loopholes identified. Management is required to take the necessary action on the loop holes
discovered and
implement the suggestions of the audit team.
Some aspects of this clause that relate to measurement, analysis and improvement are:
• Planning and scheduling of audits (measurement and analysis).
• Recording results of audits to take up timely corrective action (Improvement).
“The 2000 version of this clause is similar to 1994 version, but it allows employees who have the responsibility
and who
actually carry out the activity to conduct auditing. It necessitated that the procedure included the requirements
for
ensuring the autonomy of the audit.”

Audit:
External auditors (NSAI) were astonished to see the ARB’s drive for continuous enhancement. Very few areas
were
noticed for possible improvement contrasting the expectation of large number of non-conformities. Thus the audit
resulted in a series of reforms and revisions instead of disciplinary remedial actions focussed at individual
performance
as expected. Contradicting to the view of ARB as the bottom line of the business chain, the unit was cited as the
“Most
improved” business unit.

Auditing process:
SMI appointed teams to undertake the internal auditing programme. These teams, comprising three members
had to
conduct audits of different departments, and evaluate the workers with regard to their responsibilities and
functions. The
leader of the audit team then wrote a summary, which included strengths and opportunities for improvements. If
the
auditors recorded any non-conformance or deviation, the concerned departments had to take up corrective
actions and
document the same. The results of the internal audits were then submitted to Steel Related Industries (SRI),
which was
the external auditor. SRI also conducted surveillance audits of SMI every six months.
The auditors were allowed to evaluate people from other departments, and this gave scope to cross-functional
learning.
The internal audits helped team members to learn about procedures and functions of other departments. This
enhanced
communication between departments.
The 17-member in-house team, which undertook the ISO 9002 Internal Auditing task for SMI, received the first
“Steelworkers of the Year” award from New Steel. This award honours the services of a team of plant floor
steelworkers
whose quality, productivity, safety, profitability and problem-solving skills are a model for the entire steel
industry. Within
two years of starting the ISO process, SMI found that external customer complaints had dropped by an amazing
74%,
and the final-chemistry non-conformance of its steel had reduced by 80%.
The ISO programme has also helped SMI in providing enhanced training to new employees. During the training
process,
new employees study the ISO procedures stored on the computer and understand their job responsibilities. They
also
gain a good understanding about the functions and procedures in individual departments.
ISO also brought about functional improvements in SMI’s sales department. Earlier, the sales department would
communicate only with a few departments to check if new customer requirements could be fulfilled. The
introduction of
ISO brought in a stringent rule, that all department managers must be consulted while considering a new
customer’s
request.
Being a paperless system, ISO enabled SMI’s workers to become more computer-literate. All the instructions,
work rules
and procedures are now maintained on Lotus Notes software. This eliminated paper work.
SMI not only used ISO to improve consistency of its processes, but also for improving safety at the workplace.
The
analyses of job safety, along with instructions to perform jobs safely are also documented and stored on the
Lotus
software. In consequence, the number of shop-floor accidents at SMI has dipped to almost zero. Thus, ISO
served as a
platform for developing consistency, improving quality, productivity and safety.

2. ISO 9000 - An introduction:

ISO 9000 is a series of standards and guidelines for establishing a QMS in any kind of organisation. This
document gives
a brief insight of what ISO is, guidelines for selection and use of ISO 9000, what ISO 9000 consists of, how it can
be
useful for organisations in different businesses and the flow chart for implementing ISO 9000.
http://www.isoeasy.org/selusee.pdf

3. ISO 9000 Documentation:

One of the most intimidating aspects of ISO 9000 is the documentation. Documentation was often found
inadequate or
ineffective or even absent in many organisations. This page gives a detailed explanation of the five areas that
need to be
addressed by organisations in order to develop an effective quality system, with less paper work. The five areas
included
are process definition, structure, tools, format/grammar, and flexibility.
http://www.cavendishscott.com/articles/Documentation.htm
5. Implementation:
This PDF provides an elaborate explanation of the various steps involved in the certification process of ISO
9000:1994
standards.
http://www.dkminc.com/documents/pway_iso.pdf