Insight Into The New

ISO 9001:2015

Indraprastha SystemCert Private Limited

Ghaziabad, Uttar Pradesh

Key perspectives
ISO 9001 needs to change, to:
adapt to a changing world
reflect the increasingly complex environments in
which organizations operate
provide a consistent foundation for the future
reflect the increasingly complex environments in
which organizations operate
ensure the new standard reflects the needs of all
relevant interested parties
Ensure alignment with other management
system standards

Key feature changes

10-clause structure and core text for all Management System
Standards (MSS)
More compatible with services and non-manufacturing users
Clearer understanding of the organizations context is required
one size doesnt fit all
Process approach strengthened/more explicit
Concept of preventive action now addressed throughout the
standard by risk identification and mitigation
The term documented information replaces the terms document
and record
Control of externally provided products and services replaces
purchasing/outsourcing
Increased emphasis on seeking opportunities for improvement

Module 1
Some common myths, truth and
lies about ISO 9002:2015

Myth , Truth or Lie ??

ISO means International

Sightseeing Organization Myth,
Truth Lie ??

LIE !!!
ISO = International Organization
for Standardization

Confederation of National Standards Bodies

Based in Geneva

BIS is the National Standards Body for

India
ANSI is the National Standards Body for
USA
BSI is National Standards Body for UKetc

ISO 9001:2005 will

revolutionize quality
management- Myth, Truth,
Lie ??

Myth !!
ISO 9001- evolution, not revolution !

ISO 9001:1987/1994

Prescriptive: clause - by clause

ISO 9001:2000/2008

Process approach less documentation

ISO 9001:2015

Performance- based
Process + Risk based thinking+ PDCA
Forecast life span till 2030 !!

ISO has a portfolio of almost

20,000 standards- Myth, Truth or
Lie ??

Truth !!
Collections of
19,777 ISO
standards

229 active TCs/

PCs
3483 technical
bodies
4518
documents
under
development

165 national
members
98% of world
GNI
97% or world
population

138 FTE

ISOs standards are written by

a bunch of bureaucrats in
Geneva-Myth, Truth or Lie ??

Lie !
Standards development work is done by Technical committees
comprising expert nominated by the national standards body
of liaison organization.
TC1 was the first Technical Committee (1948)Standardization
of screw threads
TC 176= Technical committee Number 176 for Management
and Quality Assurance.

TC 176/SC2 is the subcommittee responsible

for ISO 9001 9004 standards, among others

80 countries voted on ISO 9001:2015, 75 vote

in favor and 5 negative votes

ISO 9001 is ISOs biggest selling

standard of all time- Myth, Truth
or Lie ??

TRUTH !!
ISO 9001 is the top of the list !
Others in the top 10 include:

ISO 14001( Environmental Management)

ISO 9000 ( Quality Fundamentals &
Vocabulary)
ISO 9004 ( Using QMS for Sustained
Success)

ISO/IEC 17025 ( Laboratory requirements )

ISO/IEC 27001 ( Information Security)
ISO 19011 (Auditing management systems)

In Order to use ISO standards

you have to become certifiedMyth, Truth or Lie ??

LIE !!!!
ISO Mission:ISO develops high quality voluntary International
Standards which facilitate international exchange
of goods and services, support sustainable
and equitable economic growth, promote
innovation and protect health, safety and the
environment

ISO/TC176/SC2 Mission
To devolve, maintain and support a portfolio of
products that enable organization to improve
their performance and benefits from the
implementation of robust quality management
system
To establish generic quality management system
requirement that provides the foundation to
build confident in goods and services delivered
throughout the supply chain to organization and
people world wide
To provide guide and support where needed, to
ensure the continued credibility of our products

ISO 9001

Specifies quality management system requirement for

organization to:

Demonstrate its ability to consistently provide

product and services that meets customer and
applicable regulatory requirement
Enhance customer satisfaction..
An organization that demonstrate it is meeting
these requirements can than chose to be SO
9001 certified by an independent certification
body.

ISO 9001 has an important role to

play in sustainable developmentMyth, Truth or Lie ??

Truth !
ISO/TC176/SC2 Vision

SC2 is products are recognized and

respected worldwide, and used by
organizations as an integral
component of sustainable
development.

DEAMING OF A SUSTAINABLE
FUTURE !
Economic
growth

Sustainable
Development
Environmental
integrity

Social
responsibly

.BUT SIMPLY DREAMING

IS NOT ENOUGH !!!

In words of Dr. W. Edwards Deming

How

could there be life without aims and hopes ?

Everyone has aims, hopes plans. But a goal that
lies beyond the means of accomplishment will
lead to discouragement, frustration,
demoralization

In other words, there must be a method to achieve an aim.

BY WHAT METHOD ??

The Method.

Management system

Set of interrelated or interacting elements of an

organization to establish policy and objective and to
achieve those objectives( ISO 9000:2015 definition)
In other words RESULTS FOCUSED.

ISO 9001- Consistent conforming products

ISO 14001- Prevention of pollution
ISO 45001- Safe working conditions
ISO 50001- Efficient energy usage
ISO 22000- Safe food
Etc

ISO 9001 promotes

documentation and inhabits
innovation- Myth, truth or lie??

Myth !
Management system
A documented system- NOT a system of
documents
IMPORTANT:

System should not be carved in stone

Should allow flexibility and agility

To seize opportunities as they arise

Adapt to the risk posed by the ever-changing

business context

ISO 9001:2015 has abandoned

the Process approach-Myth,
truth or lie ??

Lie !
3 Core concept for ISO 9001:2015.
Identify the processes needed to achieve the
planed results
Continually monitor the risks (Risk-based
thinking)
Understanding the Cause and effects
Manage the processes and the system using
PDCA

PDCA
.

Act

Plan

How to
improve
next
time?

What to
do
How to
do

Check

Do

Did thing
happen
according
to plan?

Do what
was
planed?

Generic Process
How to carry out Process-Documented or not
Extent of planning depends on RISK

INPUTS

Interrelated
Activities

DESIRED
OUTPUT
PRODUCT

CUSTOMER
(Internal or External
Other interested
parties

Effect on Product
conformance
UNDESIRED OUTPUT
Environmental
(WASTE/POLLUTION)
Aspects/Impacts
Health and safety Risk
Social Implications
Energy
usage MEASURE
etc
MONITOR/
( also depend on risk)

Generic Process

How to carry out Process-Documented or not

Extent of planning depends on RISK

INPUT

Interrelated
Activities

DESIRED
OUTPUT
CUSTOMER

Effect on Product conformance

Environmental Aspects/Impacts
Health and safety Risk
Social Implications
Energy usage etc

(Internal or Externa
PRODUCT

Other interested
parties

MONITOR/ MEASURE ( also depend on risk)

System of Processes
E
X
T
E
R
N
A
L

DA

E
X
T
E
R
N
A
L

C
C
U
U
T
D
C
D
C
T
O
O
M
M
E
E
R
RInteraction of Improvement of many PDCA cycle

ISO 9001 does not guarantee

business excellence- Myth, truth
lie ??

Truth. The Quality

Journey
BUSINESS
Scientific and
Technical
excellence
Use of Appropriate
quality
Tool and
methodology

ISO 9004

ISO 9001
Disjointed
Quality
initiative
No
thoughts
Of quality

ing
s
rea ity
c
In tur
Ma

S
M
Q

EXECELLE
NCE
MODELES

Different
Perspective
ISO 9004

ISO 9004 perspective:

confidence in the
organization

ISO 9001 perspective :

ISO 9001
Confidence in the organization produc

ISO 9004
Provide Guideline for achieving sustained
(Long-term) success using the Quality
management system.
Focus on efficiency. includes topics such as:
Financial resources and results

Use of natural resources

Competence and motivation

Allow for self-assessments ( Maturity model)

Not for certification
Work on new revision begins Nov 2015

Every management system

standards is written in a different
way- Myth, truth or lie ??

Currently true:
Becoming Lie !
Energy
management

ISO
20121

.
ISO 5001

ISO
14001

EMS
Requiremen
t

sustainable
event
management

TL 9000
Telecom

ISO
18001
OHSAS

ISO/TS
16949
Automobile
ISO27001
IT Security

ISO 9001
ISO
14004

EMS
Guideline

QMS
ISO
22000

ISO
14006
EMS
Guideline
Eco system

ISO
14064

Food safety

EMS
Greenhous

As 9100
Aerospace
ISO 3100

Risk
Managemen
t

Alignment of Management
system standards !

ISO Joint Technical Coordination Group (JTCG)

Joint vision for management system standards

High level structure for all ISO management
system standards
Identical sub clause titles under the high level
structure
Generic core vocabulary for management
system standards
Aim is to make life easier for those who wish to have a Single
management system

ISO Directives Annex

SL

Incorporates the recommendation of the JTCG work

Defines the common structure and format for all new
ISO management system standards and revision to
existing standards
Common text ( approx 30% or more of each standard
will be identical text)
Significant impact on revisions of ISO 9001 and ISO
14001

Annexure SL High Level

Structure

1.

Scope

2.

Normative references

3.

Term and definitions

4.

Context of the organization

Understanding the organization and its context

Need and expectation of interested parties

Determining the scope

Management system

5.

Leadership

Leadership and commitment

Policy

Role responsibilities

6. Planning

Action to address risks & opportunities

Objective and plans to achieve them

7.

Support

Resources

Competence

Awareness

Communication

Documented information

8.

Operation

Operational planning and control

9.

Performance Evaluation

Monitoring, measurement, analysis & evaluation

Internal audit

Management review

10. Improvement

Non conformity and corrective action

Continual improvement

The common structure and ISO 9001:2015

additions
4 Context of
organization

5 Leadership

6 Planning

7 Support

8 Operation

9 Performance
Evaluation

4.1
Understanding
context

5.1
Leadership and
commitment

6.1
Risks and
opportunities

7.1
Resources

8.1
Operational
planning and
control

9.1 Monitoring,
measurement,
analysis and
evaluation

4.2
Interested
parties

5.2
Policy

6.2
Planning

4.3
Scope

5.3
Organizational
roles,
responsibilities
and authorities

6.3 Planning of
changes

7.2
Competence

7.3
Awareness

10.2
Nonconformity
and corrective
action

9.3
Management
review

10.3
Continual
improvement

9.1.2 Customer
satisfaction
7.5
Documented
information

ISO/TC 176/SC 2/ N1282

9.1.3 Analysis
and evaluation
7.1.2 People

7.1.3
Infrastructure

7.1.4
Environment for
the operation of
processes
7.1.5 Monitoring
and measuring
resources
7.1.6
Organizational
knowledge

10.1
General

9.2
Internal audit

7.4
Communication

4.4
QMS

10 Improvement

4
Context of
organization

5
Leadership

7
Support

8
Operation

9
Performance and
Evaluation

10
Improvement

8.3 Design and

development of
products and services

8.4 Control of externally

provided processes,
products and services

8.5 Production and

service provision

8.6 Release of products

and services

8.2 Requirements for

products and services

8.3.1 General

8.4.1 General

8.5.1 Control of
production and
service provision

8.7 Control of
nonconforming process
outputs

8.2.1 Customer
communication

8.3.2 Design and

development planning

8.4.2 Type and extent of

control

8.5.2 Identification
and traceability

8.2.2 Determination of
requirements related to
products and services

8.3.3 Design and

development Inputs

8.4.3 Information for

external providers

8.5.3 Property belonging

to customers or external
providers

8.2.3 Review of
requirements related to
products and services

8.3.4 Design and

development controls

8.2.4 Changes to
requirements for
products and services

8.3.5 Design and

development outputs

8.1 Operational planning

and control

ISO/TC 176/SC 2/ N1282

6
Planning

8.3.6 Design and

development changes

8.5.4 Preservation
8.5.5 Post-delivery
activities
8.5.6 Control of
changes

New Matrix structure of

Management System Standards
Core structure format and text ( Annex SL)

Quality (ISO 9001)

Automobile

Vodafone

+
Environmental (ISO
+
14001)
+

Aerospace

Airtel

Telecom

Honda

HSMS (ISO
45001)

etc

Oil & Gas

etc

etc

ISO 9001 : 2015 is based on 7

Quality Management PrinciplesMyth, Truth or Lie ??

Truth !!

7 ( Yes, now only SEVEN !!) Quality Management Principles

Customer focus
Leadership
Engagement of people
Process approach

Details in ISO
9001:2015 and free
brochure on ISO
website

Improvement
Evidence-based decision making
Relationship Management

Industry sectors are abandoning

ISO 9001 and will decouple
their standards- Myth, Truth or
Lie??

Lie !!
All the major sectors are adapting their own
standards to align with ISO 9001:2015

Telecom (TL-9000)
Aerospace (AS-9100)
Automobile (TS-16949)

ISO 9001:2015 gives

organizations a lot more
flexibility about how to
implement their QMSMyth, Truth or Lie ??

Truth !!
Some examples
No specific requirement for Quality manual
No specific documented procedure
Context of the organization
What are the internal and external factors that affect the organization
ability to achieve planned results
Every organization is different

Identification of Interested parties

Relevant needs and expectation of relevant interested parties.
Customer continue to be the primary ( but not the only) interested
party

Action to address risks and opportunity

Not all processes have the same impact
Dont all need the same level of planning and control

Organization will need to THINK more !!

ISO 9001:2015 no Longer

requires preventive action-Myth,
Truth or Lie??

Myth !!
ISO 9001:2015 no longer require uses of term
Preventive action and there is no longer a
separate clause in the standard.
BUT
The concept still remains, and is actually reinforced
throughout the standard ( by addressing RISK)

Chang in Focus
Old (Wrong !!)
A in the PDCA cycle

Correction

Corrective action

Preventive action

New ( Correct !!)

P of the PDCA cycle:
Risk identification and treatment/Mitigation ( Prevention)

A of the PDCA cycle:

Containment

Correction

Corrective action 9 to prevent recurrence)

Improvement ( includes Kaizen, but also breakthrough

improvements innovation etc.)

ISO 9001:2015 will require

organizations to conduct
formal risk assessmentMyth, Truth or Lie ??

Myth !!
ISO 9001:2015 Annex A4 explains..
Although Clause 6.1 specifies that the
organization shall plan actions to address
risks, there is no requirement for formal
methods for risk management or a
documented risk management process

Organizations can decide whether or not to

develop a more extensive risk management
methodology than is required by ISO
9001:2015, e.g. Through the application of
other guidance or standards

ISO is preparing guidance on

the implementation of ISO
9001:2015- Myth, Truth or
LIE??

Truth !!
ISO 9001 Annex A provides clarification of new
structure, terminology and concept for ISO 9001:2015.
Work is underway to develop generic implementation
guidance for ISO 9001:2015
Numbered as ISO/TS 9002
DTS ( Draft Technical Specification ) due out soon

ISO/TC 176 Small Business Handbook is also being

updated/
Plus a lot of free guidance on the ISO website
www.iso.org

MODULE 2
A walk
through some of
the changes
introduced in ISO
9001:2015

Annex A
Clarification of new structure, terminology and
concepts for ISO 9001:2015

There is a lot of good , useful

guidance and explanations in
Annex A
Many examples of what ISO
9001:2015 does not require
I recommend to start here !!

Beneficial changes to ISO

9001
Enhanced leadership involvement in the
management system
Risk-based thinking
Simplified language, common structure
and terms
Aligning QMS policy and objectives with
the strategy of the organization

Potential benefits
to the user

Focus on achieving planned results

Flexibility for documented information
Improved risk control
Better process control leading to
improved results
Improved customer satisfaction
Customer retention and loyalty
Improved image and reputation
Greater credibility

Key benefits of the common

clause structure
A new common format has been developed
All ISO management systems standards
will look the same with the same structure
(some deviations)

More efficient to address multiple

management system requirements
Provides the option of integrating
management systems
Standardized core definitions

A sneaky word in ISO 9001:2015

DETERMINE
Determine Establish or find out with certainty by research
examination or calculation
ISODTS 9002:

Based on what is to be determined and the completely critically or inherent risk , the
result may need to be maintained or retained as documented information

It is the option of the organization to determine when documented information is

needed unless a specific documented information requirement is identified in ISO
9001( or other relevant standards)

Auditors need to take care not be OBLIGE organization to keep

recorded, there may be other ways of obtaining objective evidence

Remember- it is the organizations responsibly to provide objective evidence of

conformity

Objective evidence- Data supporting the existence or verity of

something (ISO 9001:2015)

Note 1: Objective evidence can be obtained by observation, measurement, test or other

means

Note 2: Objective evidence for the purpose of audit generally consist of records,
statements of facts or other information which are relevant to the audit criteria verified