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 organization’s context is required
“one size doesn’t 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 165 national

19,777 ISO members
standards 98% of world GNI
97% or world
population

229 active TC’s/

PC’s
3483 technical  138 FTE
bodies
4518 documents
under
development
ISO’s 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 ISO’s 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 certified- Myth,
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
“ÏSO 9001 certified” by an independent
certification body.
ISO 9001 has an important role to
play in sustainable development-
Myth, 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 Social
integrity 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 What to
improve do
next How to
time? do

Check Do
Did thing Do what
happen was
according planed?
to plan?
 Generic Process
“How to carry out Process”-Documented or not
Extent of planning depends on RISK

DESIRED
INPUTS Interrelated OUTPUT
CUSTOMER
Activities (Internal or External
PRODUCT
Other interested
•Effect on Product conformance parties
•Environmental Aspects/Impacts
•Health and safety Risk UNDESIRED OUTPUT
•Social Implications (“WASTE/POLLUTION”)
•Energy usage etc

MONITOR/ MEASURE ( also depend on risk)

 Generic Process
How to carry out Process”-Documented or not

A
Extent of planning depends on RISK
P
DESIRED
INPUT OUTPUT CUSTOMER

D
Interrelated
Activities (Internal or External)
PRODUCT

•Effect on Product conformance

•Environmental Aspects/Impacts Other interested
•Health and safety Risk parties

C
•Social Implications
•Energy usage etc

MONITOR/ MEASURE ( also depend on risk)

 System of Processes
E
E X
X T
T E
E A P A P
R
R N
N C DA C D A
P
A L
L C D
A P A P C
C U
U
C D C D T
T O
O M
M E
E R
R Interaction of Improvement of many PDCA cycle
ISO 9001 does not guarantee
business excellence- Myth, truth
lie ??
 Truth…. The Quality Journey
BUSINESS
Scientific and Technical EXECELLEN
excellence CE
Use of Appropriate MODELES
quality ISO 9004
Tool and methodology

ISO 9001
Disjointed
Quality
initiative
No thoughts
Of quality
Different Perspective

ISO 9004 perspective:

ISO 9004 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
sustainable
management TL 9000 event
ISO 20121
management
.
ISO 5001 Telecom
ISO/TS
16949
EMS ISO 18001 Automobile
ISO 14001 Requirement
OHSAS ISO27001
ISO 9001 IT Security
EMS
ISO 14004 Guideline QMS As 9100
Aerospace
ISO 14006 ISO 22000
ISO 3100
EMS ISO 14064 Food safety Risk
Guideline EMS Manageme
Eco system Greenhous nt
 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  Objective and plans to achieve
them
2. Normative references
7. Support
3. Term and definitions
 Resources
4. Context of the organization
 Competence
 Understanding the organization and its
context  Awareness
 Need and expectation of interested  Communication
parties
 Documented information
 Determining the scope
8. Operation
 Management system
 Operational planning and control
5. Leadership 9. Performance Evaluation
 Leadership and commitment  Monitoring, measurement, analysis &
evaluation
 Policy
 Internal audit
 Role responsibilities
 Management review
6. Planning
10. Improvement
 Action to address risks &
opportunities  Non conformity and corrective action
 Continual improvement
 The common structure and ISO 9001:2015 additions
4 Context of 9 Performance
5 Leadership 6 Planning 7 Support 8 Operation 10 Improvement
organization Evaluation

8.1 9.1 Monitoring,

4.1 5.1 6.1 7.1 Operational measurement, 10.1
Understanding Leadership and Risks and Resources planning and analysis and General
context commitment opportunities control evaluation

7.2 10.2
4.2
5.2 6.2 Competence 9.2 Nonconformity
Interested
Policy Planning Internal audit and corrective
parties
action
7.3
5.3 Awareness
4.3 Organizational 6.3 Planning of 9.3 10.3
Scope roles, changes Management Continual
responsibilities review improvement
and authorities 7.4
Communication
4.4 9.1.2 Customer
QMS satisfaction
7.5
Documented
information
9.1.3 Analysis
and evaluation
7.1.2 People
ISO/TC 176/SC 2/ N1282

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

42
 4 9
5 6 7 8 10
Context of Performance and
Leadership Planning Support Operation Improvement
organization Evaluation

8.1 Operational planning
and control
8.3 Design and 8.4 Control of externally 8.6 Release of products and
provided processes, 8.5 Production and
development of services
products and services service provision
products and services

8.5.1 Control of 8.7 Control of

8.2 Requirements for
8.3.1 General 8.4.1 General production and service nonconforming process
products and services
provision outputs

8.2.1 Customer 8.3.2 Design and 8.4.2 Type and extent of 8.5.2 Identification and
communication development planning control traceability

8.2.2 Determination of 8.5.3 Property belonging

8.3.3 Design and 8.4.3 Information for
requirements related to to customers or external
development Inputs external providers
products and services providers
ISO/TC 176/SC 2/ N1282

8.2.3 Review of 8.3.4 Design and

requirements related to development controls 8.5.4 Preservation
products and services

8.2.4 Changes to 8.5.5 Post-delivery

8.3.5 Design and activities
requirements for products
development outputs
and services
8.5.6 Control of
8.3.6 Design and changes
development changes

43
 New ”Matrix” structure of
Management System Standards
Core structure format and text ( “Annex SL)”

+
Quality (ISO 9001) +
Environmental (ISO
14001)
HSMS (ISO 45001) etc

+
Automobile Aerospace Telecom Oil & Gas etc

Vodafone Airtel Honda etc

ISO 9001 : 2015 is based on 7 Quality
Management Principles- Myth, Truth or Lie
??
 Truth !!
 7 ( Yes, now only SEVEN !!) “Quality Management Principles”

Customer focus
Leadership Details in ISO 9001:2015
and free brochure on
Engagement of people ISO website

Process approach
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 QMS- Myth,
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
Don’t 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 assessment-Myth, 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 organization’s 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