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ISO & ISO 9000 STANDARDS

What is ISO?

ISO is the International Organization for Standardization and has its headquarters at Geneva. It is made up
of some 140 national standards institutes from countries large and small, industrialized and developing, in
all regions of the world. ISO develops voluntary technical standards which contribute to making industrial
production and supply more efficient, safer and cleaner, and to making trade between countries easier and
fairer. ISO standards also serve to safeguard consumers and users in general of products and services - as
well as to making their lives simpler.

How ISO works?

The work of preparing international standards is normally carried out through ISO technical committees.
Each member national institute interested in a particular subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. Draft international standards adopted by
technical committees are circulated to the member bodies for voting. Publication as an international
standard requires approval by at least 75% of the member bodies casting a vote.
ISO standards are adopted by all countries as their national standards, with or without any changes.

What are ISO 9000 standards?

ISO 9000 series of standards are quality management system standards, and are among the most widely
known and successful of the 13000 plus standards published by ISO since its inception in 1947. These
standards have become an international reference for quality requirements in business to business dealings.
First edition of these standards were published in 1987. These were revised in 1994 and again in December
2000. While 1994 revision was restricted to some editorial changes and providing clarifications on some
requirements, year 2000 revision is very extensive.

General principles & concepts of ISO 9000 standards

ISO 9000 standards are
systems standards
ISO 9000 standards bring
transparency in working
ISO 9000 standards work
on checking and
controlling deficiencies at
each stage, both in
working and in product
quality
Analyzing & correcting
problems to avoid their
repetition
ISO 9000 systems are
person independent
ISO 9000 systems are
internally audited
Provides complete
customer satisfaction
Systems means way of working. If working is strictly as per specified systems, quality will
always be OK. Systems include procedures for working – what, when & how.
Everything is in written form. What is not written, is not accepted. Write what you are
doing & then Do what you have written. Check & ensure that you are working as per
written procedures. Correct any deficiencies observed and work as per corrected system.
Deficiencies in way of working – not following written procedures, not filling up forms,
not recording what you have done,
Deficiencies in product quality – at incoming stage (raw materials), in-process stages
(products at various stages of production), final product ,
Products having any problem should be stopped at that stage and should not be used till
problem is solved.
Problem can be in any area. Problems are properly analyzed for possible reasons.
Both short term and long term actions are decided and implemented to avoid repetition of
the problem in future.
Procedures, specifications, work instructions, check list etc., are all in written form.
Responsibility and authority of each person is clearly defined. Alternative arrangement for
each function is also defined to make the system person independent.
Implementation of ISO 9000 systems is periodically audited by company’s auditors to
determine its adequacy and effectiveness & to continually improve it.
Customer satisfaction is defined for all areas such as, conformance to standards, delivery,
after sales service and other related activities (both stated and implied).

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ISO 9001:2000 specifies requirements for a quality management system for any organization that needs to
demonstrate its ability to consistently provide products that meet customer and applicable regulatory
requirements and aims to enhance customer satisfaction. This standard has been organized in a user-
friendly format with terms that are easily recognized by all business sectors. It is now the only standard in
the ISO 9000 family against whose requirements a quality management system can be certified by an
external agency. The standard recognizes that the word "product" applies to services, processed material,
hardware and software intended for, or required by the customer.

There are five sections in the standard that specify activities that need to be considered when you
implement the system. The organization will need to describe the activities it uses to supply its products
and may exclude the parts of the Product Realization section that are not applicable to its operations. The
requirements in the other four sections – Quality management system, Management responsibility,
Resource management, and Measurement, analysis & improvement– apply to all organizations and the
organization will be required to demonstrate how it applies them in the organization, and specify the same
in its quality manual or other documentation.

Together, the five sections of ISO 9001:2000 define what an organization should do consistently to provide
products that meets customer and applicable regulatory requirements. In addition, organization will also
seek to enhance customer satisfaction by improving its quality management system. ISO 9004:2000 can be
used to extend the benefits obtained from ISO 9001:2000 to all parties that are interested in or affected by
organization’s business operations. Interested parties include organization’s employees, owners, suppliers
and society in general.

New ISO 9000 standards apply a process approach. Processes are recognized as consisting of one or more
linked activities that require resources and must be managed to achieve predetermined output. The output
of one process may directly form the input to the next process and the final product is often the result of a
network or system of processes. The eight quality management principles provide the basis for continual
improvement of organizational performance.

Typical goals of any organization may be :

• Be more efficient and profitable
• Produce products and services that consistently meet customer requirements
• Achieve customer satisfaction
• Increase market share
• Maintain market share
• Improve communications and morale in the organization
• Reduce costs and liabilities
• Increase confidence in the production system.

Most new users of ISO 9000 standards obtain measurable benefits early in the process of deploying the
standard requirements in their operations. These initial benefits are generally due to improvements in their
organization and internal communication. The benefits must be strengthened through effective internal
auditing and management review of system performance. Like all systems, it either improves or becomes
less effective. It does not remain static for long.

When an organization adopts ISO 9001:2000, it must strive for the satisfaction of its customers and the
continual improvement of the quality management system. Continual improvement is a process of
increasing the effectiveness of the organization to fulfill its quality policy and quality objectives. ISO
9001:2000 requires planning and managing the processes necessary for the continual improvement of the
quality management system. It is recommended that the organization obtains data from various sources,
both internal and external, to assess the appropriateness of its quality system goals. This information can
also be used to improve the performance of organization’s processes.

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Some organizations may expand their management systems by extending the ISO 9001:2000 structure to
include the requirements of ISO 14001, Environmental management systems. The structural and
organizational requirements of the two management systems have been designed to be compatible.

Benefits of ISO 9000 standards

There are number of benefits associated with the revised quality management systems standards. The
benefits are:
• Applicability to all product categories, in all sectors and to all sizes of organizations
• Simple to use, clear in language, readily translatable, and easily understandable
• Significant reduction in the amount of required documentation
• Connection of quality management systems to organizational processes
• Provision of a natural move towards improved organizational performance
• Greater orientation toward continual improvement and customer satisfaction
• Compatibility with other management systems such as ISO 14000
• Provision of a consistent basis to address the needs and interests of organizations in specific
sectors (e.g. medical devices, telecommunications, automotive, etc)
• The concept of the consistent pair - ISO 9001 covering the requirements and ISO 9004 for going
beyond the requirements in order to further improve the performance of the organization
• Consideration of the needs of and benefits to all interested parties.

Customers and users will benefit by receiving the products that are:
• conforming to the requirements
• dependable and reliable
• available when needed
• maintainable

People in the organization will benefit by:

• better working conditions
• increased job satisfaction
• improved health and safety
• improved morale
• improved stability of employment

Owners and investors will benefit by:

• increased return on investment
• improved operational results
• increased market share
• increased profits

Suppliers and partners will benefit by:

• stability
• growth
• partnership and mutual understanding

Society will benefit by:

• fulfillment of legal and regulatory requirements

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• improved health and safety

• reduced environmental impact
• increased security

ISO 9001: 2008 requirements

Section 4 -

4 Quality management system Clause 4.1 is the most important clause of ISO 9001. In a nutshell
4.1 General requirements it gives what ISO 9001 requires from a company.
4.2 Documentation requirements Clause 4,2 deals with preparing documentation - quality manual,
quality procedures, forms and work instructions etc.
4.2.1 General
Documented procedures are required to be established for
4.2.2 Quality manual 4.2.3 and 4.2.4
4.2.3 Control of documents
4.2.4 Control of records

Section 5 -

5 Management responsibility A pro-active top management is an essential requirement of ISO

5.1 Management commitment 9001. Commitment of the top management towards effective &
5.2 Customer focus efficient implementation of QMS should be visible. Top
management should establish a single purpose in the organization
5.3 Quality policy and should provide leadership and direction to all persons in
5.4 Planning achieving organizations aims and mission.
5.4.1 Quality objectives Top management should establish quality policy & objectives,
5.4.2 QMS planning define organizational structure, responsibility & authority of
5.5 Responsibility, authority and personnel, appoint a management representative, conduct
communication management review of system at defined intervals and strive for
continually improving the system ad its processes.
5.5.1 Responsibility and authority Top management should communicate all the above to all
5.5.2 Management representative concerned at all levels in an effective manner.
5.5.3 Internal communication Top management should establish an efficient and effective system
5.6 Management review for internal communication.
5.6.1 General While doing all above and any other activity, customer should be
5.6.2 Review input at the focus.
5.6.3 Review output

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Section 6 -

6 Resource management Top management should identify and provide resources needed for
6.1 Provision of resources effective implementation of quality management systems. It
6.2 Human resources should also regularly review the adequacy and effectiveness of
resources.
6.2.1 General Resources include infrastructure (building,machinery, equipment
6.2.2 Competence, awareness and etc), suitable work environment for processes and personnel, and
training competent man power to perform quality functions in an effective
6.3 Infrastructure & efficient manner.
6.4 Work environment

Section 7 -

7 Product realization Identifying and planning various processes for

7.1 Planning of product realization product/service realization.
7.2 Customer related processes Identifying and establishing various customer related
7.2.1 Determination of requirements processes to achieve and enhance customer
related to the product satisfaction.
7.2.2 Review of requirements related to Determining and reviewing customer requirement
the product before accepting any contract.
7.2.3 Customer communication Establishing an effective & efficient system for
7.3 Design and development communication with customer.
7.3.1 Design and development planning Design & development processes, if applicable.
7.3.2 Design and development input Identifying and establishing purchasing processes,
7.3.3 Design and development output information and verification of purchased products.
Planning and control of production/service provision.
7.3.4 Design and development review
Identification and validation of processes required
7.3.5 Design and development
for product/service provision.
verification
Establishing a system for identification and
7.3.6 Design and development validation
traceability during product/service realization.
7.3.7 Control of design and development Identification and control of any customer property.
changes
Establishing systems for proper handling, storage,
7.4 Purchasing and condition monitoring of materials in stores.
7.4.1 Purchasing process Identifying monitoring/measurement parameters,
7.4.2 Purchasing information suitable monitoring & measuring devices and
7.4.3 Verification of purchased product ensuring their accuracy through calibration.
7.5 Production and service provision
7.5.1 Control of production and service
provision
7.5.2 Validation of processes for
production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and
measuring devices

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Section 8 -

8 Measurement, analysis and Identifying monitoring and measurement processes and

improvement their controls.
8.1 General Establishing suitable systems and processes for measuring
8.2 Monitoring and measurement customer satisfaction.
8.2.1 Customer satisfaction Organizing internal audits through trained internal/external
8.2.2 Internal audit auditors and reviewing audit reports for any corrective and
8.2.3 Monitoring and measurement preventive actions. Reporting audit results to top
of processes management for review.
8.2.4 Monitoring and measurement Identifying data for analysis, review and continual
of product improvement.
8.3 Control of nonconforming Taking corrective actions on observed nonconformities.
product Taking actions for preventing potential nonconformities.
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action

Why Get Certified?

There are many reasons to implement a ISO 9000 compliant Quality Management System (QMS). Often,
the market is the driving factor. However, once an ISO 9000 QMS is in place companies realize that there
are internal benefits that are as important as the external benefits.

When you start the implementation process you should start to see the following benefits:

Process Improvements: as you implement the system, you have the opportunity to improve your processes.
You will outline the current process, add the requirements of the Standard and then optimize the process
with input from the process users.

Increased Quality Awareness: as the system is implemented, quality awareness will increase because all
staff must be regularly trained on ISO 9000 and company’s processes.

After certification you should see the following benefits:

Market Advantages: surveys of registered companies show that 41% were asked by a client to obtain
certification. When a client requests a vendor to seek ISO registration, it can take up to 6 months or more to
obtain the certification. Therefore, the vendor who has already taken ISO certification has a distinct
advantage. This can be used as a strong marketing tool. ISO is becoming a requirement to do business in
many markets. Certified companies currently have an advantage over their competition.

Internal advantages: once certified, companies often find the greatest payoffs are internal as processes
experience continual improvement. A survey of 100 registered firms reported the average improvement in
operating margin at 5% of sales. Firms also report improvements in order turnaround time, scrap, and
overtime. The QMS has built-in systems to report on key quality indicators: Correction and Preventive
Action, Internal Audits and Management Review. Management is required to take action based on this
information. These built-in systems also contribute to continual improvement by significantly reducing the
reoccurrence of problems. Corrective actions issued must be addressed, the root cause determined, and
action taken to prevent reoccurrence. Follow-up will make sure the action was effective. Internal audits will
evaluate the effectiveness of the system, and identify opportunities for improvements.

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Nonconformity identified in internal audits must be addressed. Internal auditors are also able to make
observations and suggestions. Management Review is a chance for management to evaluate the
performance of the QMS using information provided from the implementation of QMS.

The operation will run more smoothly, with fewer crises. The QMS promotes consistency in how work is
done and recorded. It helps employees learn more easily and quickly what should be done. It reduces
misunderstandings with customers. When a problem occurs, it is corrected at the root cause. It does not
have to be "fixed" again next week by someone else, and next month by another person. There is a strong
Quality Culture due to the QMS. Internal Audits, Corrective Action and Training result in "Top of Mind"
awareness of the QMS. Increased confidence in workmanship results in a more confident staff. Systems in
place allow staff to address problems. Staff recognizes problems as systems or process issues. Problems are
solved, not blamed on someone.

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