Smt N.C. Gandhi & B.V.

Gandhi
mahila arts & commerce college
Subject: ISO 9001:2008 & its 20 elements
By: Binisha Mehta

BMS -3 SEM-6
Roll no: 13
Guided by: Mr.Pradeep Gohil

Contents

Introduction
Definition
20 Elements
Principles of ISO 9001:2008
Benefits of ISO 9001:2008
Summary of ISO 9001:2008 in informal language
Review of the topic
Bibliography

Introduction
ISO 9001:2008 Quality management systems Requirements is a
document of approximately 30 pages which is available from the

national standards organization in each country. It is supplemented

by two other standards: ISO 9000:2005 Quality management
systems Fundamentals and vocabulary and ISO
9004:2009 Managing for the sustained success of an organization
A quality management approach. Only ISO 9001 is directly
audited against for third party assessment purposes. The other two
standards are supplementary and contain deeper information on
how to sustain and improve quality management systems; they are
therefore not used directly during third party assessment.

ISO 9001:2008 basically re-narrates ISO 9001:2000. The 2008

version only introduced clarifications to the existing
requirements of ISO 9001:2000 and some changes intended

to improve consistency with ISO 14001:2004. There were no

new requirements. For example, in ISO 9001:2008, a quality
management system being upgraded just needs to be checked

to see if it is following the clarifications introduced in the

amended version.

Definition

One of the standards developed by the International

Organization for Standardization (ISO). The purpose of this family of
standards is to increase customer satisfaction through the
deliverance of quality products and services.

ISO 9001 Definition: ISO 9001 is a set of internationally agreed

standards that provide guidelines for a Quality Management
System. If your organization meets ISO 9001-2008 then you can
become certified to the standard. Interestingly, ISO 9001-2008 can
apply to any type of organization. This includes manufacturing,
service, software or even non profit organizations

 ISO 9001:2008 is the International Standard for Quality

Management Systems (QMS).It provides your company with a
set of principles that ensure a common sense approach to the

management of your business activities to consistently

achieve customer satisfaction.

20 Elements
1. Management Responsibility
Top Management is required to:

1. develop a Quality Policy reflecting the organization's attitude to

quality and ensure it is communicated throughout the organization.
2. allocate appropriate resources and trained personnel to perform
the work.
3. appoint a management representative to monitor the Quality

System.
4. conduct regular management reviews to ensure the health of the
quality system .

2. Quality System
The system must:

1. be fully documented within the framework of ISO 9000.

2. satisfy customer's requirements and specifications.

3. be adapted to your organization.

4. define how quality requirements will be met.
5. demonstrate thorough planning to meet customer
requirements.

3. Contract Review
1. Sales must review the orders and contracts with the
customer.
2. Any change must be reviewed and agreed to with the
customer.

4. Design Control

All phases of product or service design (engineering) must

be controlled and conducted by qualified personnel. (This
pertains to ISO-9001 only.)

5. Document and Data Control

1. All documents and data used must be controlled and

authorized.
2. Obsolete documents must be removed form circulation;
latest issues must be located at appropriate areas
throughout the facility and available at the workplace.

3. Changes must be recorded and released in a controlled

manner.

6. Purchasing

1. Purchasing information must be complete and

accurate.
2. Suppliers must be qualified and selected based on

demonstrated quality.
3. Suppliers must be monitored continuously.

7. Control of Customer Supplied Product

If and when customers supply the materials for their

products, you must ensure that:

1. you report to the customers any discrepancy or damage to

their products.
2. their products can be identified easily.

3. their products are handled and stored accordingly.

8. Identification and Traceability

Products must be identified at all times and through all phases of
production.

9. Process Control
You are required to have a complete process, with appropriate
written procedures, to perform and monitor all production activities,
which affect quality.
10. Inspection

You are required to have documented verifications at all critical stages

of your process:
1. Receiving of raw material.
2. Work in process.
3. Final inspection.

11. Calibration

All inspection and measuring equipment (Gauges, thermometers,

scales , test software...) must be controlled and maintained in
calibration. You are required to:

1. provide unique identification and list of all inspection and

measuring equipment.
2. determine the required accuracy.

3. protect and maintain the equipment to ensure continuing accuracy.

4. calibrate each instrument on a pre-determined cycle to established
procedures.

12. Inspection and Test Status

The test status of all product must be identified through all

phases of production.
The test status indicates whether the product has passed or
failed inspection.

13. Control of Nonconforming Product

Any nonconforming product must be properly identified and

segregated (if practical) with a documented disposition.

14. Corrective and Preventive Action

You are required to have a formal process to correct and

prevent problems form occurring. The process will insure that:

1. root cause is investigated

2. corrective and/or preventive action is taken
3. the effectiveness of corrective and/or preventive is verified

15. Handling, Storage, Packaging, Preservation and Delivery

You are required to have documented procedures for:

1. Handling
2. Storage

3. Packaging
4. Preservation

5. Delivery

16. Control of Quality Records

Records which demonstrate compliance to procedures and
ISO-9000 must be:

1. identified
2. legible
3. accurate
4. filed and indexed properly
5. easily retrievable
6. retained for a specified period of time

17. Internal Quality Audits

You are required to conduct formal internal audits to examine
all activities affecting quality, and evaluate their compliance
to:
1. documented procedures.
2. ISO 9000 requirements.
18. Training

1.
2.
3.
4.

You are required to:

identify training needs.
provide appropriate training.
document training activities.
ensure only trained people carry activities affecting product
quality.

19. Servicing
If you provide "servicing" as part of the contract, you are
required to control:
1.
2.
3.
4.

the design and use of the service equipment.

use trained and qualified personnel.
ensure product and parts availability.
document working procedures and methods.

20. Statistical Techniques

Any data analysis, sampling methods, and SPC used must be
based on established procedures and sound statistical
techniques.

Principles of ISO 9001:2008

When fully adopted, these principles can help improve your
organizational performance:

Customer focus: organizations depends on their customers,

and therefore need to shape activities around the fulfillment
of market need
Leadership: is needed to provide unity of purpose and
direction
Involvement of people: creates an environment where
people become fully involved in achieving the organization's
objectives

 Process approach: to achieve organizational objectives,

resources and activities need to be managed as processes, with
an understanding of how the outputs of one process affects the

inputs of another
System approach to management: the effectiveness and
efficiency of the organization depends on a systemized
approach to work activities
Continual improvement: adopting this as a part of everyday

culture is a key objective for an organization

 Fact based decision-making: effective decisions are

based on the logical and intuitive analysis of data and

factual information
Mutually beneficial supplier relationships: such

relationships will enhance the ability to create value.

What are the benefits of registration?

1. Customer satisfaction - through delivery of products that
consistently meet customer requirements
2. Reduced operating costs - through continual improvement of
processes and resulting operational efficiencies

3. Improved stakeholder relationships - including staff,

customers and suppliers
4. Legal compliance - by understanding how statutory and
regulatory requirements impact on the organization and its
your customers

5. Improved risk management - through greater consistency

and traceability of products and services

6. Proven business credentials(That which entitles one to

confidence, credit, or authority) - through independent

verification against recognized standards

7. Ability to win more business - particularly where

procurement specifications require certification as a
condition to supply

8. Involves Top management in the improvement of the Quality

management System
Facilitates the organization to become a customer-focused

organization.
9. Ensures sustained customer satisfaction by producing,
delivering services and providing support functions that
meet customer's needs and expectations.
10. Increases the effectiveness and efficiency of the organization

through continual improvement in systems and products

/services quality

Summary of ISO 9001:2008 in informal

language
The quality policy is a formal statement from management, closely
linked to the business and marketing plan and to customer needs.
The quality policy is understood and followed at all levels and by all
employees. Each employee works towards measurable objectives.

The business makes decisions about the quality system based on

recorded data.
The quality system is regularly audited and evaluated for
conformance and effectiveness.

 Records show how and where raw materials and products were
processed to allow products and problems to be traced to the
source.

The business determines customer requirements.

The business has created systems for communicating with
customers about product information, inquiries, contracts,
orders, feedback, and complaints.
When developing new products, the business plans the stages of
development, with appropriate testing at each stage. It tests and
documents whether the product meets design requirements,
regulatory requirements, and user needs.

 The business regularly reviews performance through internal

audits and meetings. The business determines whether the
quality system is working and what improvements can be

made. It has a documented procedure for internal audits.

The business deals with past problems and potential
problems. It keeps records of these activities and the resulting
decisions, and monitors their effectiveness.

 The business has documented procedures for dealing with

actual and potential nonconformance's (problems involving
suppliers, customers, or internal problems).

The business:
makes sure no one uses a bad product,
determines what to do with a bad product,
deals with the root cause of problems, and
keeps records to use as a tool to improve the system.

Review of the topic

Introduction
Definition
20 Elements
Principles of ISO 9001:2008
Benefits of ISO 9001:2008
Summary of ISO 9001:2008 in informal language
Bibliography

Bibliography
Productivity and quality management
Yogesh Zaveri
Sheth publishers
Production and Operation Management
K. Ashwathappa
K. Shridhara Bhatt
Himalaya publishing house
Productivity Management
A practical handbook,
Oxford & IBH publishing co. pvt ltd Joseph
Prokopenko