Chapter 34

ISO 9000 Quality Systems

Chapter Outline
34.1 Need for Quality 34.10 Mission Statement 479
Management Systems 472 34.10.1 Features of
34.2 International Organization Mission Statement 479
for Standardization 472 34.10.2 A Clear Mission
34.3 ISO 9000 Series of Quality Statement Would 480
Standards 472 34.10.3 Five Steps for
34.4 Evolution of ISO 9000 Drafting a Mission
Family of Standards 472 Statement 480
34.5 ISO/TS16949 474 34.11 Objectives, Goals, and
34.6 QS-9000 Series 474 Action Plans 480
34.7 Requirements as Specified 34.12 SOPStandard
by ISO 9000 475 Operating Procedures 481
34.8 Bureau of Indian Standards 477 34.13 Specific Features
34.9 Vision and Mission of ISO 9004 481
Statement 477 34.14 Steps to be Followed
34.9.1 Characteristics of for Getting ISO
a Vision Statement 478 Certification 482
34.9.2 General 34.15 Benefits of ISO 9001-2000
Guidelines in the and TS 16949 Quality
Formulation of a Systems 482
Vision Statement 478 34.16 ISO 9000:2005 483
34.9.3 Extracts From 34.17 2015 Revision of ISO 9000
Some of the Series 483
Vision Statements 34.18 The Six Stages of the
of Famous Release of the 2015
Companies Are Revision 484
Illustrated in the 34.19 Revision of ISO 9000
Following Section 479 in 2015 484
34.9.4 Seven Tips on 34.20 Conclusion 485
How to Write the Further Reading 485
Business Vision
Statement 479

Total Quality Management: Key Concepts and Case Studies. http://dx.doi.org/10.1016/B978-0-12-811035-5.00034-9

Copyright 2017 BSP Books Pvt. Ltd. Published by Elsevier Inc. All rights reserved. 471
472 Total Quality Management: Key Concepts and Case Studies

34.1 NEED FOR QUALITY MANAGEMENT SYSTEMS

Quality management has become a way of life in the manufacturing sector, in
fact, in every sector, whether service, logistic, road building, or any other sector,
and its importance is widely understood. This calls for a quality management
system for unified standards for evaluating the processes. Without a system in
place to establish procedure, monitor progress, and evaluate performance, it is
nearly impossible to consistently deliver a quality product to your customer. By
utilizing quality management systems, problems are identified and corrected as
they arise, allowing you to be proactive and minimize the likelihood of reoccur-
rence, which benefits all parties involved.

34.2 INTERNATIONAL ORGANIZATION

FOR STANDARDIZATION
The International Organization for Standardization (ISO), its central office
located in Geneva, is the worlds largest developer and publisher of interna-
tional standards. It forms a platform for several countries to establish quality
systems. It has a network of National Standards Institutes in 163 participating
countries, including the Bureau of Indian Standards (BIS) of India. ISO stan-
dards are constantly advancing to meet the needs of growing sectors within
the industry.
The vast majority of the ISO international standards are highly specific to
product, material, and process, ensuring regulation from start to finish.

34.3 ISO 9000 SERIES OF QUALITY STANDARDS

The ISO 9000 family addresses various aspects of quality management and
contains some of ISOs best known standards. The standards provide guidance
and tools for companies and organizations who want to ensure that their prod-
ucts and services meet customers requirements, and that quality is consistently
improved.

34.4 EVOLUTION OF ISO 9000 FAMILY OF STANDARDS

1926Formation of International Federation of the National Standardizing
Associations (ISA).
1944Formation of United Nations Standards Coordinating Committee
(UNSCC).
1947Birth of ISO on the basis of the above two Associations. 1959
United States Department of Defense drafts MIL-Q-9858 standard.
1969Revising the above into NATO AQAP series of standards.
1974British Standards Institute adapts these into BS 5179 series of guid-
ance standards.
 ISO 9000 Quality Systems Chapter | 34 473

1979BS 5750 Part I, II, III series of requirement standards for system
control in all areas of management which directly or indirectly affect quality.
1987ISO 9000 family of Standards by ISO.
1988Bureau of Indian Standards IS 4000 series.
1994First Revision of ISO 9000 series.
In 1987, ISO released ISO 9000, which deals with the fundamentals
of quality management systems and also gives guidelines for selecting the
standards.
Subsequent standards in the 9000 series were released as follows:
l ISO 8402:1994Quality management and quality assurancevocabulary
l ISO 9001:1987Model for quality assurance in design, development, pro-
duction, installation, and servicing. This basically is for companies and or-
ganizations whose activities included the creation of new products.
l ISO 9002:1987Model for quality assurance in production, installation,

and servicing has basically the same material as ISO 9001, but without cov-
ering the creation of new products. This is applicable to the organizations
who manufacture, supply, and service products or services as per specifica-
tions given by the customer.
l ISO 9003:1987Model for quality assurance in final inspection and test.

This covers only the final inspection of finished product, with no concern for
how the product was produced.
l ISO 9004:2009Introduced in 2009, this focuses on how to make a quality

management system more efficient and effective. This has seven sections,
each giving guidelines on services, processed materials, quality improve-
ment, project management, quality plans, etc.
l ISO 19011:2011Introduced in 2011, this sets out guidance on internal and

external audits of quality management systems.

l ISO 10006Quality managementguidelines for quality management in
projects
l ISO 10007Quality managementguidelines for configuration
management
l ISO 10012Quality assurance requirements for measuring equipment
l ISO 10013Quality managementguidelines for developing quality

manuals
l ISO 10014Quality managementguidelines for economic effects of

quality
l ISO 10015Quality managementguidelines for continuing education
and training
These standards have been revised periodically, in 1994, 2000, and 2008.
The next revision was due in Dec. 2015.
It may be of interest that during mid-2015, American Society of Quality
(ASQ) had initiated a blog on the LinkedIn website, where several interested
474 Total Quality Management: Key Concepts and Case Studies

professionals, including this author, could contribute their opinions on this revi-
sion. ISO did revise this standard in November 2015, which is further detailed
in Section 34.17.

34.5 ISO/TS16949
The ISO/TS16949 is a process-oriented approach to the technical specification
aiming at the development of a quality management system that provides for
continual improvement, emphasizing prevention of defects and reduction of
variation and waste in the supply chain. It is based on the ISO9001, but de-
veloped by International Automotive Task Force (IATF) with the key require-
ment of fulfillment of customer-specific requirements, set up by the automotive
manufacturer in addition to the quality management system of their suppliers.

34.6 QS-9000 SERIES

QS-9000titled Quality System Requirements is similar to ISO-9000, International
Quality System Standard, interpreted by US automotive giants Chrysler and
Ford, applicable particularly to the US automotive industry, but now adapted
world over. QS-9000 is made up of all the three sections: an ISO-9000 based re-
quirement, a sector-specific requirement, and a customer-specific requirement.
These requirements ensure that each supplier procures a good quality product.
Furthermore, by developing QS-9000, we will be able to improve our product,
customer satisfaction, and supplier relations as well.
Similarly:
(a) AS 9000, TL 9000, and PS 9000, too, were adapted as industry specific
interpretation of the guidelines applicable for the aerospace, telecommuni-
cation, and pharmaceutical industries, respectively.
(b) ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000.
(c) ISO/TS 29001 are quality management system requirements for the design,
development, production, installation, and service of products for the petro-
leum, petrochemical, and natural gas industries.
The following table indicates the parameters covered by each of these two
series:
Quality System Requirements ISO 9001 QS 9000
Management responsibility X X
Quality system X X

Contract review X X
Design control X X

Document and data control X X

Purchasing X X
 ISO 9000 Quality Systems Chapter | 34 475

Control of customer-supplied product X X

Product identification and tractability X X

Process control
Inspection and testing
Control of inspection, measuring, and
test equipment
Inspection and test status
Control of nonconforming product
X X
X X
X X
X X
X X

Corrective and preventive action X X

Handling, storage, packaging,
preservation, and Delivery
Control of quality audits
Training
Servicing
Statistical techniques
Production parts approval process
X X
X X
X X
X X
X X
X

Continuous improvement X

Manufacturing capability X
Customer-specific requirement X

34.7 REQUIREMENTS AS SPECIFIED BY ISO 9000

A. General
1. Scope and purpose of the standard
2. Nomenclature reference such as ISO 9000:2008
3. Terms and definitions, for all items referred in the QMS
4. Requirement specifications as indicated in the table above
5. Documentation:
(a) Statement of quality policy, vision, mission, and quality objectives
(b) Quality manuals
(c) Procedure manuals
(d) Control documents
(e) Control records
B. Management responsibility
(a) Commitment
(b) Customer focus
(c) Quality policy
(d) Organization
476 Total Quality Management: Key Concepts and Case Studies

(e) Responsibility and authority

(f) Communicationinternal and external
(g) Delegation of management responsibility, specifying the duties, respon-
sibilities, and authority
(h) Management review
C. Resource management
(a) Human resources
l General

l Competitive

l Awareness

l Training

(b) Infrastructure
(c) Work environment
D. Product realization
(a) Planning the product
(b) Planning the process
(c) Procedure followed for QFD
l Determination of requirement of procedure

l Review of requirement

l Customer communications

(d) Design and development

l Inputs outputs

l Review

l Verification

l Validation

l Control of design and development changes

(e) Purchasing
l Purchasing process

l Purchasing information

l Verification of purchased product

(f) Production and service provision

l Validation of the processes

l Identification and traceability

l Customer priority

E. Control of marking and measuring devises (measurement, analysis, and

improvement)
(a) Planning and measuring customer satisfaction
(b) Internal audit
(c) Marking and measuring the process parameters
(d) Marking and measuring the products and services
(e) Control of nonconforming products
(f) Analysis of the data
F. Contractual improvement.
 ISO 9000 Quality Systems Chapter | 34 477

Fig. 34.1 illustrates relationship among the quality management systems

(QMS) requirements as specified in ISO 9000.

Management
responsibility

QMS
Resource Measurement
continual
management and analysis
improvement

Customer
satisfaction

Input Product Output

measurement realization product

FIG. 34.1 Inter relationship among ISO requirement parameters.

34.8 BUREAU OF INDIAN STANDARDS

BIS was originally established in 1947 as Indian Standards Institution to fulfill
the role of standardization in gearing industry to competitive efficiency and
quality production. On Apr. 1, 1987, it became BIS as a statutory body. BIS
started the QMS certification as per ISO 90001.

34.9 VISION AND MISSION STATEMENT

In todays competitive environment, it is not enough for an enterprise just to be
a step ahead of others. They should advance by leaps and bounds. The first step
in this advancement is the vision statement.
Vision is the basic requirement for an enterprise. It is reflected by your
dream and creates a focus for the organization, inspires all stakeholders, and
transforms the purpose into actions and draws people into the process of
performance.
A vision statement helps the organization to focus on what is real as we
go about doing our daily work and dealing with the day-to-day hassles that
plague all organizations. Vision is set by the management with a foresight
into the future, and states not only what the company wants to be in the near
future, but also the avenues by which it aims to achieve this vision,
478 Total Quality Management: Key Concepts and Case Studies

generally in one sentence. A typical vision statement of an industrial orga-

nization can be cited as:
By the end of the decade, we shall be the industry leaders in the country, by dou-
bling our turnover every fifth year through new products, market penetration,
launching of new and contemporary products, and world-class customer service.

34.9.1 Characteristics of a Vision Statement

The characteristics of a vision statement are as follows:
1. It is based on what the organization shall strive for and achieve during the
next 510 years.
2. This acts as lodestar to all stakeholders, so that they can orient their perfor-
mance as a team toward achieving the vision.
3. It inspires and uplifts everyone involved in your effort.
4. It creates a commitment. Motivation and the drive for initiating the mission,
objectives, projects, and tasks needed to realize the vision.
5. It is broad enough to include a diverse variety of local perspectives for ex-
ample, but short enough to be easily understood and shared by members of
the community.
Before finalizing the vision statement, sufficient time shall be allowed for
brainstorming among participants and then categorizing the random thoughts
to ensure a comprehensive and realistic vision statement (Fig. 34.2).

FIG. 34.2 Characteristics of a vision statement.

34.9.2 General Guidelines in the Formulation of a Vision

Statement
1. The vision statement should be short and realistic to the present situation.
2. It should project the growth of the organization.
 ISO 9000 Quality Systems Chapter | 34 479

3. The intention in achieving the goal should be highlighted in the statement.

4. It should also reflect the value system that would be adapted for growth.
5. Total employee involvement shall be highlighted in the statement.

34.9.3 Extracts From Some of the Vision Statements of

Famous Companies Are Illustrated in the Following Section
1. A computer on every deskMicrosoft.
2. To bring inspiration and innovation to every athlete in the worldNike.
3. A computer in the hands of everyday peopleApple.
4. Helping investors help themselvesCharles Schwab.
5. Make people happyDisney.
6. To provide access to the worlds information in one clickGoogle.

34.9.4 Seven Tips on How to Write the Business Vision

Statement
http://www.graystoneadvisors.com/7-ways-create-inspiring-vision-state- ment
suggests the following seven tips on how to write the business vision
statement
1. Define your future state
2. Make it powerfully memorable
3. Keep in synch
4. Gain consensus
5. Make it achievable
6. Make it visible
7. Align with your goals

34.10 MISSION STATEMENT

A mission statement is a written declaration of an organization's core purpose
and focus that normally remains unchanged over time (Business Dictionary).

34.10.1 Features of Mission Statement

A mission statement:
l Serves as filters to separate what is important from what is not,
l Clearly states which markets will be served and how,
l Communicates a sense of intended direction to the entire organization.
l Converts the broad dreams of your vision into more specific, action-
oriented terms.
480 Total Quality Management: Key Concepts and Case Studies

l Explains your goals to interested parties in a clear and concise manner.

l Enhances your organization's image as being competent and professional,
thus reassuring funding sources that their investment was (or would be!) a
smart choice.
A mission statement defines the companys goals, ethics, culture, and
norms for decision making. They highlight the companys goals in three
dimensions:
l what it does for its customers,
l what it does for its employees, and
l what it does for its owners.

A nonprofit mission is never static. Especially in the first years, an organiza-

tions mission shifts and changes as the organization develops.

34.10.2 A Clear Mission Statement Would

The process of writing your mission statement is much like that for developing
your vision statements. The same brainstorming process can help you develop
possibilities for your mission statement. Remember, though, that unlike with
vision statements, you will want to develop a single mission statement for your
work. After having brainstormed for possible statements, you will want to ask
of each one:
l Does it describe what your organization will do and why it will do it?
l Is it concise (one sentence)?
l Is it outcome-oriented?
l Is it inclusive of the goals and people who may become involved in the
organization?

34.10.3 Five Steps for Drafting a Mission Statement

The website of bplans.com indicates the following five steps in drafting a mis-
sion statement:
1. Start with a market-defining story
2. Define how your customers life is better because your business exists
3. Consider what your business does for employees
4. Add what the business does for its owners
5. Discuss, digest, cut, polish, review, and revise

34.11 OBJECTIVES, GOALS, AND ACTION PLANS

Vision and mission statements are followed by the statement of objectives, goals,
targets, and action plans as illustrated in the Fig. 34.3 given in the following
section.
 ISO 9000 Quality Systems Chapter | 34 481

FIG. 34.3 Vision based activities per ISO 9001.

34.12 SOPSTANDARD OPERATING PROCEDURES

Standard operating procedures (SOP) are the instructions that cover operational
parts. Initially, an SOP is based on army-wide publications and then modified to
use local operating conditions and command policies as a guideline. The scope
of SOP is extensive and varies. It provides the major instructions for all division
elements of operational features.
In general, there are two formats for an SOP to follow:
lA format that publishes all comprising documents which details the function
and the responsibilities of subordinate units.
l A format that is published as a basic document which includes general in-

structions to all units. This kind of format has specific instructions for each
individual unit. It is more detailed and easier to use.

34.13 SPECIFIC FEATURES OF ISO 9004

ISO 9004:2009 is a guidance document for the sustained success of an organiza-
tion with a quality management approach. It emphasizes the effectiveness and
efficiency of a quality management system, and consequently the potential for
improvement of the performance of an organization. The objectives of customer
satisfaction and product quality are extended to include the satisfaction of inter-
ested parties and the performance of the organization. It spells out the benefits
482 Total Quality Management: Key Concepts and Case Studies

of ISO 9004 to self-assessment. In short, this standard provides the basic under-
standing of total quality management principles.

34.14 STEPS TO BE FOLLOWED FOR GETTING ISO

CERTIFICATION
1. Preparatory work
(a) We must know the complete details of the work we are doing
(b) We must know our work Procedures in detail
(c) Our workplace must be neat and clean
(d) Everything must be attached with a label/tag/color along with its sta-
tus, ie, for inspection/accepted/rejected/for rework, etc.
(e) All the inspection, measuring, and test equipment must be calibrated
(f) We must maintain records, wherever written in the work procedures
2. Study the standard and select the right standard
3. Define quality policy and quality objectives. Display at various locations,
explain meaning/intent to all
4. Give training to each and every employee
5. Write work procedures giving details of all activities
6. Make changes in work practices wherever necessary
7. Conduct Internal Audits to find out whether work is carried out as per
written procedures
8. Implement suggestions/observations of internal audit
9. Conduct an audit by external auditors
10. Implement suggestions received from them
11. For certification audit, call world-famous, well-known auditors for audit
12. Implement their suggestions
13. Achieve certification

34.15 BENEFITS OF ISO 9001-2000 AND TS 16949

QUALITY SYSTEMS
1. Improved communication at all levels.
2. Decreasing trend in rejections, reworks, and customer complaints.
3. Decreasing trend in inventories
l Raw materials

l W.I.P.

l Finished goods

l Lead time reduction

4. Customer relation improvement. Trust/confidence enhancement.

5. Subcontractor relations improvement. Long-term association.
6. Improved housekeeping.
7. Improved contacts with overseas buyers.
8. People development.
 ISO 9000 Quality Systems Chapter | 34 483

9. Improved health of people.

10. Reduced rejection/rework.
11. Improved housekeeping.
12. Increased morale of the company.
13. Ensured quality and after sales service to customers.
14. Improved team work.
15. It saves cost by:
l avoiding repetition of work

l avoiding unnecessary records

l monitoring processes

16. Opportunities for export market.

17. Due to increased confidence of customers in you, you get more and more
orders.
18. Improved discipline in the organization.
19. Increased credit in the market.

34.16 ISO 9000:2005

ISO 9000:2005 defines eight quality management principles in the quality man-
agement approach for the sustained success of an organization
Principle 1customer focus
Principle 2leadership
Principle 3involvement of people
Principle 4process approach
Principle 5system approach to management
Principle 6continual improvement
Principle 7factual approach to decision making
Principle 8mutually beneficial supplier relationships

34.17 2015 REVISION OF ISO 9000 SERIES

Subsequent to the publication of ISO 9001:2008 and ISO 9004: 2009, ISO's Technical
Committee TC 176/TC has been developing new standards and periodically releas-
ing the supporting documents, giving guidelines to the users. All ISO standards are
reviewed every five years to establish if a revision is required to keep it current and
relevant for the marketplace. ISO 9001:2015 is designed to respond to the latest
trends and be compatible with other management systems, such as ISO 14001.
Accordingly, ISO had now revised the ISO 9000 Quality Management
Systems, the world's leading quality management standard, which was last re-
vised in 2008.
It may be noted that the ASQ initiated discussions on ISO 2015 on its Twitter
and LinkedIn, ASQ during the mid-2015, when several professionals, includ-
ing this author participated and discussed the benefits and limitations of the
20125 revision, a reference to which would yield several interesting criticisms.
484 Total Quality Management: Key Concepts and Case Studies

Wikipedia records that the number of standards released in this series increased
from 409,421 in 2001 to 1,138,155 in 2014. While Chands is first with 297,037
certificates issued in 2010, India stands eighth with 33,250, and the United
States stands ninth with 25,101 certificates.

34.18 THE SIX STAGES OF THE RELEASE OF THE 2015

REVISION
In 2012, its silver jubilee year, ISO 9001 decided to create a new QMS model
for the next 25 years, starting with the new QM principles. The revised standard
ISO 9001:2015 was published by ISO on Sep. 23, 2015 in the stages as indi-
cated in the following section:
1. The proposal stage commenced in May-Jun. 2012
2. The preparation stage commenced in Jun.-Oct. 2012
3. The Committee discussion commenced in Jun.-Sep. 2013
4. The enquiry and discussions stages went on until May-Oct. 2014
5. It was approved in Jul. 2015
6. Final standard text was released in Sep. 2015

34.19 REVISION OF ISO 9000 IN 2015

The new version follows a new, higher-level structure to make it easier to use
in conjunction with other management system standards, with increased im-
portance given to risk. More information about the changes can be found in the
news area. It is specifically intended to ensure that ISO continues to adapt to the
changing environments in which the organizations operate.
More importantly, the structure and core terms were modified to allow the
standard to integrate more easily with other international management systems
standards.
The 2015 revision focuses on performance by combining the process ap-
proach with Plan-Do-Check-Act and risk-based thinking such as failure mode
and effect analysis (FMEA), which are described more earlier chapters and
other safety standards, such as ISO 13485 on Food Safety, or Aerospace.
We can summarize the key changes as:
1. Greater emphasis on building a management system suited to each organi-
zations particular needs.
2. A major focus is given on achieving value for the organization and its customers.
3. Revisions allow ISO 9001 to be more applicable by service-based
organizations.
4. A requirement that those at the top of an organization be involved and ac-
countable, aligning quality with wider business strategy.
5. Risk-based thinking throughout the standard, emphasizing the use
of FMEA, and safety standards such as ISO 13485, makes the whole
 ISO 9000 Quality Systems Chapter | 34 485

management system a preventive tool and encourages continuous im-

provement. Identification of risk and risk control is now a requirement.
6. Addresses supply chain management more effectively.
7. Less prescriptive requirements for documentation: The organization can
now decide what documented information it needs and what format it
should be in.
8. Alignment with other key management system standards through the use
of a common structure and core text.
9. Is more user-friendly for service and knowledge-based organizations.
10. Use of simplified language and a common structure of terminology by
standardizing core text, structure, and definitions, to help organizations
using multiple management systems, such as those for the environment,
health and safety, or business continuity.

34.20 CONCLUSION
ISO 9000 deals with the fundamentals of quality management systems, includ-
ing the eight management principles. Over one million global organizations are
independently certified for ISO standards, making ISO 9001 one of the most
widely-used management tools in the world today. However, ISO itself does not
certify organizations. The third-party certification bodies provide independent
confirmation that organizations meet the requirements of ISO 9001. The spe-
cific point of interest with ISO is the periodic revisions made in the standards,
the latest being of ISO 9000 in 2015, as discussed earlier.

On the Lighter Side

He is bragging, he is lying, and he is giving three measures.
During the 1962 Tamilnadu elections, DMK party's election
campaign was to give three measures (each measure
equals 1.4 kg) of rice per rupee. The counter campaign of
the Congress party was Arukkaraan, puzhukkaran,
moondru padi kudukkuraan which in Tamil means He is
bragging, he is lying, and he is giving three measures.

FURTHER READING
[1] Hoyle D. ISO 9000 quality systems handbook. Butterworth and Heinemann; 2001.
[2] Indian Standard on Quality Management SystemsGuidelines for Performance improve-
ments (IS/ISO 9004: 2000Bureau of Indian Standards2000).
[3] www.bsigroup.com/en-IN/ISO-9001.
[4] www.lrqa.in/ISO9001.
[5] http://www.asrworldwide.com.
[6] www.iso.org/iso/catalogue.
486 Total Quality Management: Key Concepts and Case Studies

[7] http://www.iso.org/iso/iso_9001_-_moving_from_2008_to_2015.pdf.
[8] http://asq.org/learn-about-quality/iso-9000/iso-9001-2015.
[9] ASQs twitter discussions in Linked-in.
[10] http://en.wikipedia.org/wiki/ISO_9000.
[11] http://www.iso.org/iso/survey2008.pdf.
[12] http://the9000store.com/what-is-iso-9004.aspx.