ISO9001:2015 presentation

ISO 9001 : 2015
INTERPRETATION AND SUGGESTED
CHANGES TO SYSTEM
C P CHANDRASEKARAN 1

Agenda for the programme
• What are the new things in the standard
(2015 Edition as compared to 2008 Edition) ?
• What is the intent behind these changes?
• What should we do to address these new
provisions?
• Questions and Answers
• Total number of slides 40

Structural Changes in clauses from
2008 to 2015
• 2008
• 4. Quality Management
system
• 5. Management
responsibility
• 6. Resource Management
• 7. Product Realisation
• 8. Measurement ,
Analysis and
Improvement
• 2015
• 4. Context of the
Organisation
• 5. Leadership
• 6. Planning
• 7. Support
• 8. Operation
• 9. Performance
evaluation
• 10. Improvement

1. Standard is taking a view of your organisation
not as a set of departments but as a system
system
process
process
process
process
process
process
Multiple
processes can
be identified
within a system
This is not a
physical
boundary

Since system is built of processes, Describe
each process t understand the system
• A clear description of process is included in
ISO standard with the terminology as sources
of Inputs, Inputs, activities, Outputs and
Receiver of Outputs.
• The organisation may take note of this though
there is no explicit need to document this.

Articulate a Process within a system
with SINACOURE diagram
Process is the building block of Quality.
And can be mapped as in next slide

Further detailing in terms of eight
Dimensions of the process
• Scope
• Sequence
• People
• Role
• Input
• Output
• Controls
• Measures
• Tick mark here whether each of
these is described in your process
map. Then you will find the word
document or the flow chart
becomes in adequate to capture
these eight. Only way is to go to xl.

A sample process map
C P CHANDRASEKARAN
Process
PIP
Process Owner: Dr Sindhu
Scope of the process:
This process starts with the 3rd cycle SBU output GIL and includes the setting of goals at all levels of officers and ends with
the decision on reward and recognition and deciding the development of people in areas which will impact business goals.
Targeted
Stakeholders
Empl
oyee
Busin
ess
Outcome of the
process
1. Employee perception about fairness of the process 2. Capability improvement at individual level 3.Creation of a Learning
organisation
Objectives of the Process
Employee satisfaction on fair rewards : 75% of people should choose good or better. 2) Positive correlation between employee
payouts financial results of company
S No Sequence
GIL
Corp
SBU
Head
Function
Head
Dept
Head
Mana
ger
Assoc
iates
Ex
Com
Control
doc measure Link from Link to
Rema
rks
10
Release of BSC defining
goals for the SBU
P
BSC Strategic
goals from
SBU
Strategic
Planning
20
1st cycle (long term
qualitiative) meeting
Discussions on broad trends
affecting business while taking
into account the BSC. P
30
2nd cylce (long term
quantitative) meeting: Arriving
at specific numbers relevant to
each SBU
8

Install Process mapping in your
organisation with xl sheets
• A robust system of mapping the processes is
need to be introduced.
• Many make flow charts mechanically which
serves no purpose.
• The maps have to make all the dimensions of
the process explicit.
• These maps also should be easy to revise and
amend.

2. Standard defines the beneficiaries of
system as stakeholders/Interested parties
• As the standard expands it scope from
customer to interested parties inputs also
have been shown to be emanating from
interested parties.
• The second new arrow mark is for
organisation and its context which must
incorporate risks and opportunities.

The 2008 standard had this picture
Compare and discuss the changes

PDCA Cycle and the standard
How can
this be
done?

Collect needs and expectations of
stakeholders/interested parties
• A business can survive only if interested
parties willingly support. If any of the
interested parties starts working against the
business it will get destroyed in due course. So
standard now wants this to be done for
sustainability of your business.
• Who are the interested parties to your
business?
• What are their needs and expectations?

How system should be defined to
address this change
• A mechanism to review latest regulatory
requirements and market changes.
• Nomination of suitable agencies or managers
to identify the needs of interested parties
• After considering issues, needs of interested
parties, products and services of the
organisation the scope of QMS should be
defined/modified.

3.Risk based thinking
• In every process which is followed, there are
inherent risks. They could be due to changes in
materials, changes in people, customer or source
of power etc. which suddenly impact on the
process.(differentiate between systemic failures
and risks)
• Are these considered while implementing the
standard?
• If so, what are the counter measures proposed?
• Again, there is no requirement for documentation
of this exercise.

A risk assessment frame work
process Expecte
d
outcom
e of the
process
In what
ways the
outcome
may not be
achieved
What would
the
economic
impact
(1-10 )?
What is the
probability
that this
may happen
? (1-10)
Risk
assessment
= Impact *
Probability
Core processes
1 Stores of
Inflammable
materials
Safe
working
in
factory
Fire in stores 10 2 20
2
3

NOTE 1 Options to address risks can include
1. avoiding risk,: example stop using nickel
2. taking risk in order to pursue an opportunity,: example export
equipment to Europe with tough laws
3. eliminating the risk source, : example stop importing leather from an
illegal source
4. changing the likelihood or consequences : example increase post
supply monitoring
5. sharing the risk : example use a service contractor for repair
6. or retaining risk by informed decision : example an airbag may not
open in the event of collision and insurer should be aware of it.
NOTE 2
Opportunities can lead to the adoption of new practices,
launching new products, opening new markets, addressing
new customers, building partnerships, using new technology
example export of ayurvedic products to health conscious
Americans C P CHANDRASEKARAN 17

Planning of counter measures
Risks where the
product of impact
and probability is >
20
Avoidance Mitigation Acceptance of
risk or sharing
of risk
Responsibility
for actions
Key People leaving
the project
Not Possible Keep one Back
up trained for
each role
Communicate
to the client
HR Manager

Role wise important clauses for HODs
title
Clause
no CEO
Finance
Head
HR
Head
Mktg
head
Engineering
Head
Manufactu
ring Head
Quality
Head
Procureme
nt Head
Shipping
Head
Admin
Head services
Context 4.1
4.2
4.3
4.4
Leadership 5.1
5.2
5.3
Planning 6.1
6.2
6.3
Support 7.1 7.1.3 7.1.2 7.1.4 7.1.5 7.1.3
7.1.6 7.1.5.2 7.1.5.2
7.2
7.3
7.4

Role wise important clauses
title
Claus
e no CEO
Finance
Head
HR
Head
Mktg
head
Engineering
Head
Manufactu
ring Head
Quality
Head
Procurem
ent Head
Shipping
Head
Admin
Head
service
s
Operation 8.1
8.2
8.3
8.4
8.5 8.5.3
8.6
8.7
Evaluation 9.1
9.2
9.3
Improveme
nt 10.1
10.2
10.3

Dept wise important clauses for all employees
title
Clause
no
Materia
ls
Executi
on sales
Mech
Engg
Innovati
on Admin
Service
s
Manufact
uring Quality Stores
Shippin
g
Support 7.17.1.1 7.1.1 7.1.3 7.1.6 7.1.3
7.1.1.to
7.1.4 7.1.5
7.2
7.3
7.4
7.5
Operati
on 8.1
8.2
8.3 8.3
8.4
8.4.1,.2,
.3 8.4.1
8.5 8.5.1,.5 8.5.1 8.5.4
8.6
8.7

Clause
no
2015 2008 Actions required for upgrade
programme
4.1
4.2
4.3
4.4
Understanding Internal
and external issues
affecting the organisation
Identifying the interested
parties and their
requirements
Determining the scope of
the Quality Management
system
Define QMS in terms of its
processes
New
Constantly evaluate the external
environment and internal system
Keep in touch with interested
parties to know their requirements
directly/indirectly
Determine the scope accordingly
Install process approach
Context
2

External issues
Internal issues
Needs of
Interested Parties
Define
Scope of
QMS
Define
Processes
Clause no 4 Context

Clause
no
programme
5.1.1 Scope of commitment
enhanced to include
especially
a) accountability for
effectiveness of QMS
b) integration of QMS into
business processes
c) promoting the use of
process approach and risk
based thinking
d) promoting
improvement
e) supporting other
management roles
Restricted to
communicating,
establishing
policy, objectives
etc
Accountability of Top Management
needs to be understood as “Buck
stops here” . Theoretically, any
lapse in QMS implementation now
can be attributed to management .
Top management people need to
get visibly involved in QMS and
ensure integration of QMS and day
to day activities.
Since there is no MR, CEO should
now function as de facto MR and
encourage a team to supervise
QMS not on an audit to audit basis
but on daily basis.
Leadership
2

Clause
no
programme
5.1.2 Scope of customer focus
enhanced to include
especially
a) customer, statutory and
regulatory requirements
are understood (D)
b) Risks and
opportunities in
products are
determined and
addressed.
It was 5.2
Restricted to
ensuring
customer
requirements are
met and
enhancing
customer
satisfaction
Top Management should
document all statutory and
regulatory requirements for the
products and services in the
markets they serve. Now this
cannot be left to a routine
departmental functionary.
As Risk management is new in the
standard, the risk assessment
exercise for the products and
services should be led by top
management. The latest is the
Product Liability Law in developed
countries.
Leadership
When the business is small, the risks are quite low. When it grows, the risks due to failure of
products or services can be huge.

Clause
no
programme
5.2.1
5.2.2
Establishing Quality policy
Addition
Policy should
support its
strategic direction
Addition
Communication should not
only be for employees but
the policy should be made
available to interested
parties also (D)
It was 5.3 earlier Policy should support strategic
direction-. This means that after
every strategic meeting the
Management must review the
Quality policy (not just
periodically).
New businesses, new services and
new collaborations may demand
change in the policy.
Just like EMS standard, ISO 9001
also has asked the policy to be
made available to interested
parties through website or through
news letters.
Leadership

5.3
Roles
and
responsi
bilities
This clause now combines
what was earlier under
Management Representative.
QMS planning is also
combined.
Emphasis
a) Ensuring that processes
are delivering their
intended outputs.
b)
It was 5.5 earlier Management representative
post can be dissolved and can
be replaced by Quality systems
Manager assisted by a team.
This team should have 4
functions to enable that
processes will deliver the
intended outputs.
1) Quality Planning
2) Quality system Audits
3) Process Measurement and
analysis
4) Product Quality
measurement and analysis
Leadership

Clause 5 Leadership
Create Customer focus
Establish and communicate
Quality Policy
Determine roles and
responsibilitiesLeadership

Clause
no
2015 2008 Actions required for upgrade programme
6.1
Actions
to
address
risks
and
opportu
nities
Determine risks and
opportunities which
would
a) Enhance
desirable effects
b) Reduce
undesirable
effects
c) Achieve
improvement
This was not
there
In the context of the external issues and
internal challenges, a risk assessment frame
work should be developed which would
evaluate the risks and opportunities.
A severity rating of 1-10 can also be defined so
that those who are of high risks can be
selected. The counter measures for these risks
(avoidance is the best) should be given so that
they can be followed.
Example
Diesel cars to be banned – counter measure
divert the plant capacity for diesel generator
production.
It would require intense work to work on
opportunities in the horizon. Note 1 and Note 2
given in the standard can help.
Planning

Clause no 2015 2008 Actions required for upgrade programme
6.2
Quality
Objective
s and
planning
to
achieve
them
Objectives shall be
monitored and
updated.
Planning now has
been made clear
with what, when,
how etc (every
function) (D)
Earlier it was
covered
under 5.4.2
Objectives should be monitored and progress
reported.
Similarly, the objectives shall be updated if the
situation warrants.
Planning

Clause no 2015 2008 Actions required for upgrade programme
6.3
Planning
of
changes
Planning of changes
Emphasis
Allocation and
reallocation of
responsibilitie
s
Somewhat
covered
under 5.4.2
Change Management should be now a defined
process.
This will help proper implementation.
Planning

Clause 6 Planning
Actions to address risks
and opportunities
Setting Quality Objectives
and planning to achieve
them

Clause no 2015 2008 Actions required for upgrade
programme
7.1
Resources
7.1.1
7.1.2 People
7.1.3
Infrastructure
7.1.4
Environment
for the
operation of
processes
In 7.1.1 emphasis is on
Capabilities and
constraints on internal
resources and also
external providers
(D)
Providing people for
processes (D)
Nothing much added (D)
Social,
psychological and
physical now
included (D)
Similar to 6.1
Similar to 6.2
Similar to 6.3
Only physical
Constant updation of position of
resources and external providers is
needed.
--Emphasis from products to
processes
---
It is going to be a challenge to know
how social and psychological
environment will be determined
and provided and maintained. This
is the toughest clause in standard.
Support
3

programme
7.1.5
Monitoring
and measuring
resources
7.1.5.1 general
7.1.5.2
Traceability
7.1.6
organisational
knowledge
Resources should be
provided for monitoring
and measurement.
Surprisingly, Knowledge
is separate clause under
7.1 resources and
competence is separate.
Partly replaces
7.6 for
calibration
and also
traceability
7.5.3
Identification
and
traceability
New
Apart from calibration of
equipment and devices, the entire
monitoring of products and services
should be governed with proper
resources.
No extra requirement as far as the
calibration is concerned.
Knowledge management via
Libraries, standards, technical
bulletins and web sites (intra
company) are required to preserve
and spread knowledge as a
resource.
Leadership

programme
7.2
Competence
7.3 awareness
7.4
communication
By and large same with
determination of
competence required
and ensuring that the
competence is
maintained.
Except that now it says
“ performance and
effectiveness of Quality
Management system”
instead of product. (D)
Specifically highlighted
for quality policy and
objectives.
Internal and external
communication (D)
Earlier 6.2.2
but that time
it was only for
product.
Earlier part of
6.2.2
Internal was
5.5.3
Competence should be
determined not only for those
affecting product quality but also
for all activities concerned with
QMS. This will expand the
requirement of competence for
areas like Admin, Vendor
development and HR.
Nothing much added.
New system needs to be
developed for external
communication
People

programme
7. 5
Documented
Information
7.5.1 general
7.5.2 Creating
and updating
7.5.3 Control
of
documented
information
All types of documents
namely procedures,
documents and records
are covered
Quality Manual is no
more mandated.
Pretty much the same
Protection of documents
and access control is now
included in the control.
Mention of obsolete
documents is deleted.
Earlier 4.2.1
Earlier 4.2.3
4.2.3 and
4.2.4
Unification of the treatment for all
documented information would be
required. The debate on what is a
record and want is a document is no
more relevant.
The clause now embraces electronic
versions more than paper versions
and hence it is needed to switch
over the implementation to
electronic documents.
Information

Clause no 7 support
People, Knowledge,
competence, awareness
Infrastructure Environment Measuring resources
Organisational
KnowledgeCommunication

programme
8
8.1
Operational
Planning and
control
Determine how to
control the processes in
line with planning done
in clause no 6.
Criteria for both
processes and products
mentioned.
Documented information
necessary to the extent
of creating confidence
that processes have been
carried out and for
conformity of products.
It covers outsourced
processes also. (D)
Link to higher
level plan was
absent.
Outsourced
processes was
not covered.
Operational plan has to be in
alignment with the plan for the QMS
or business.
Operational planning extends to
processes and products which
means those processes which are
not linked an output like a product
but which are essential for QMS like
Training are also covered now.
Operation

programme
8.2
Requirements
for Products and
services
8.2.1 customer
communication
8.2.2
Determining
requirements
8.2.3
Review of
requirements
8.2.4 changes to
requirements
Customer property now merged
in this clause. Establishing
contingency actions is new.
No addition
No addition
Changes should be intimated to
all
Earlier 7.2.1
7.2.2 and
7.2.3
This is for sales to get the
information
What are contingency
actions?
Change notification to be
strengthened
Operation

programme
8.3 Design and
development of
products and
services
8.3.1 General
8.3.2 Design and
Development
planning
8.3.3 Design and
Development
Inputs
8.3.4 Design and
Development
Controls
8.3.5 Design and
Development
outputs
Involvement of customers and
users in the design process
mentioned
No additional requirement
The requirements in Design are
consolidated and explained in one
clause (D)
7.3
7.3.1
7.3.2
---
System to involve users and
customers to be
strengthened
operation

programme
8.3.5 Design and
Development
outputs
8.3.6 Design and
development
changes
“include monitoring and
measuring requirements for
products and services” added
instead of only acceptance
criteria
No addition
Actions taken to adverse
impacts added explicitly
7.3.3
7.3.7
Acceptance criteria was only for
product whereas monitoring
and measuring will encompass
Operation

programme
8.4 Control of
Externally provided
processes , products
and services
8.4.1 General
8.4.2 type and
extent of control
8.4.3 information
for external
providers
Expanded to
externally provided
processes instead of
limiting to
purchasing activity
External process should
remain within control of
QMS
No significant addition
7.4
7.4.2
This needs efforts to bring
outsourced processes within the
ambit of QMS.
Consolidated review is required to
be done to cover the
communication to vendors
operation

Types of External providers
QMS of the
company
External providers
of products and
services
Incorporated in
to product or
service given
to customer
External providers
of products and
services
customer
External providers
of process

programme
8.5 production
and service
provision
8.5.1 control of
production and
service
provision
8.5.2
Identification
and traceability
8.5.3 Property
belonging to
customers
Implementation of
actions to prevent
human error added
Identify all products and keep
traceability when needed
(D)
Protect property of customer
and if damaged inform the
customer (D)
7.5
7.5.1
7.5.3
7.5.4
Poka Yoke to be started
Operation

programme
8.5.4
Preservation
8.5.5 Post
Delivery
activities
8.5.6 Control
of changes
8.6 Release of
products and
services
Ne requirements explicitly stated now
that the company should carry out
post delivery activities as agreed or as
required by regulatory requirements.
Obvious requirement stated for
emphasis.
No addition
Keep record of the releases
7.5.5
8.2.4
System for warranty provision
exists however system for
recycling and disposal need to
be developed.
Changes not only in design but
in production documents need
to be regulated
operation

programme
8.7 Control of
non
conforming
products
8.7.1
8.7.2
Terminological change done
as
Correction, segregation,
containment informing the
customer and obtaining
permission
Retain documented
information about the non
conformity and resolution of
the same (D)
8.3
8.3
Suitable changes need to be done in
documents
operation

Customer
requirements
Design and
Development
Control on
External
providers
Production Preservation
Release of
product and
post delivery
activities
Clause no 8 Operation

programme
9 Performance
evaluation
9.1 Monitoring ,
measurement,
analysis and
evaluation
9.1.1 General
9.1.2 Customer
satisfaction
9.1.3 Analysis and
evaluation
Language simpler and more
clear to indicate the way
measurement needs to be
organised.
Language made clear about
analysis
8.1
8.2.1
8.4
Quality plans can be synchronised
with the requirement. Those having
Control plans may not require any
action.
Statistical techniques mentioned
Performance
Evaluation

programme
9.2 Internal
audit
9.2.1
9.2.2
9.3
Management
review
9.3.1
9.3.2 Inputs
9.3.3 outputs
Effectiveness of actions taken to
address risks and opportunities
No addition
8.2.2
5.6
As a logical step management
review needs to review status of
counter measures to risks
Performance
Evaluation

Clause no 9 Performance Evaluation
Customer satisfaction
survey
Internal audit
Day to day monitoring
and measurement
Analysis and
evaluation
Management
review

programme
10 Improvement
10.1 General
10.1.1
10.2.1 Non
conformity and
corrective action
10.2.2
Documentation
10.3 Continual
improvement
Preventing and reducing
undesired effects added
Corrective action explained
clearly
The intent behind this clause
is not clear. Earlier the
preventive action was clear
but now we need to debate
and find suitable way to
implement the clause.
8.5.1
Some take a view that since the
risks are already identified, the
preventive action clause is no ore
needed. Then the preventive
action can be maintained under
10.3
Improvement

Non conformity
from monitoring
and measurement
and complaints
Clause 10 Improvement
React to the non
conformity and
correct it
Eliminate the
causes for non
conformity to
prevent
recurrence

• Scope of QMS
• Quality Policy
• Quality Objectives
• Training of personnel
• Monitoring and measurement resources
• Competence
• Customer’s requirements
• Design and development inputs
• Design and Development outputs
• Evaluation of external providers
• Traceability
• Changes to Production Provision
• Release of product
• Non conformity review
• Measurement and evaluation of QMS
• Internal audits
• Corrective actions on non conformity
• Management Review outputs
Documented
information
Required

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ANNEXURES

0.3 Risk based thinking
Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management
system. The concept of risk-based thinking has been implicit in previous editions of this
International Standard including, for example, carrying out preventive action to eliminate
potential nonconformities, analysing any nonconformities that do occur, and taking action to
prevent recurrence that is appropriate for the effects of the nonconformity. To conform to the
requirements of this International Standard, an organization needs to plan and implement
actions to address risks and opportunities. Addressing both risks and opportunities establishes a
basis for increasing the effectiveness of the quality management system, achieving improved
results and preventing negative effects. Opportunities can arise as a result of a situation
favourable to achieving an intended result, for example, a set of circumstances that allow the
organization to attract customers, develop new products and services, reduce waste or improve
productivity. Actions to address opportunities can also include consideration of associated risks.
Risk is the effect

7.1.4
7.1.4 Environment for the operation of processes The organization shall determine,
provide and maintain the environment necessary for the operation of its processes
and to achieve conformity of products and services. NOTE A suitable environment
can be a combination of human and physical factors, such as: a) social (e.g. non-
discriminatory, calm, non-confrontational); b) psychological (e.g. stress-reducing,
burnout prevention, emotionally protective); c) physical (e.g. temperature, heat,
humidity, light, airflow, hygiene, noise). These factors can differ substantially
depending on the products and services provided.

7.1.6
7.1.6 Organizational knowledge The organization shall determine the knowledge
necessary for the operation of its processes and to achieve conformity of products and
services. This knowledge shall be maintained and be made available to the extent
necessary. When addressing changing needs and trends, the organization shall consider
its current knowledge and determine how to acquire or access any necessary additional
knowledge and required updates. NOTE 1 Organizational knowledge is knowledge
specific to the organization; it is generally gained by experience. It is information that is
used and shared to achieve the organization’s objectives. NOTE 2 Organizational
knowledge can be based on: a) internal sources (e.g. intellectual property; knowledge
gained from experience; lessons learned from failures and successful projects;
capturing and sharing undocumented knowledge and experience; the results of
improvements in processes, products and services); b) external sources (e.g. standards

8.4
The organization shall ensure that externally provided processes, products and services
conform to requirements. The organization shall determine the controls to be applied to
externally provided processes, products and services when: a) products and services
from external providers are intended for incorporation into the organization’s own
products and services;b) products and services are provided directly to the customer(s)
by external providers on behalf of the organization;c) a process, or part of a process, is
provided by an external provider as a result of a decision by the organization. The
organization shall determine and apply criteria for the evaluation, selection, monitoring
of performance, and re-evaluation of external providers, based on their ability

8.5.5
8.5.5 Post-delivery activities The organization shall meet requirements for post-
delivery activities associated with the products and services. In determining the extent
of post-delivery activities that are required, the organization shall consider: a)
statutory and regulatory requirements; b) the potential undesired consequences
associated with its products and services; c) the nature, use and intended lifetime of
its products and services; d) customer requirements; e) customer feedback. NOTE
Post-delivery activities can include actions under warranty provisions, contractual

10.3
10.3 Continual improvement The organization shall continually improve the
suitability, adequacy and effectiveness of the quality
10.3 Continual improvement The organization shall continually improve the
suitability, adequacy and effectiveness of the quality

ISO9001:2015 presentation

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