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

C P CHANDRASEKARAN 2
 Structural Changes in clauses from
2008 to 2015
• 2008 • 2015
• 4. Quality Management • 4. Context of the
system Organisation
• 5. Management • 5. Leadership
responsibility • 6. Planning
• 6. Resource Management • 7. Support
• 7. Product Realisation • 8. Operation
• 8. Measurement , • 9. Performance
Analysis and evaluation
Improvement • 10. Improvement

C P CHANDRASEKARAN 3
 1. Standard is taking a view of your organisation
not as a set of departments but as a system
This is not a
physical
boundary
process process

process
system process

Multiple
processes can process
be identified process
within a system

C P CHANDRASEKARAN 4
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.

C P CHANDRASEKARAN 5
Articulate a Process within a system
with SINACOURE diagram

Process is the building block of Quality.

And can be mapped as in next slide

C P CHANDRASEKARAN 6
 Further detailing in terms of eight
Dimensions of the process
• Scope • Tick mark here whether each of
• Sequence these is described in your process
• People map. Then you will find the word
document or the flow chart
• Role becomes in adequate to capture
• Input these eight. Only way is to go to xl.
• Output
• Controls
• Measures

C P CHANDRASEKARAN 7
 A sample process map
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 Empl Busin
Stakeholders oyee 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
GIL SBU FunctionDept Mana Assoc Ex Control Rema
S No Sequence Corp Head Head Head ger iates Com doc measure Link from Link to rks
10
Release of BSC defining BSC Strategic
goals for the SBU goals from
SBU
Strategic
P 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
C P CHANDRASEKARAN 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.

C P CHANDRASEKARAN 9
 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.

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The 2008 standard had this picture

Compare and discuss the changes

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PDCA Cycle and the standard

How can
this be
done?

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 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?

C P CHANDRASEKARAN 13
 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.

C P CHANDRASEKARAN 14
 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.
C P CHANDRASEKARAN 15
 A risk assessment frame work
process Expecte In what What would What is the Risk
d ways the the probability assessment
outcom outcome economic that this = Impact *
e of the may not be impact may happen Probability
process achieved (1-10 )? ? (1-10)
Core processes
1 Stores of Safe Fire in stores 10 2 20
Inflammable working
materials in
factory
2
3

C P CHANDRASEKARAN 16
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 Avoidance Mitigation Acceptance of Responsibility
product of impact risk or sharing for actions
and probability is > of risk
20

Key People leaving Not Possible Keep one Back Communicate HR Manager
the project up trained for to the client
each role

C P CHANDRASEKARAN 18
 Role wise important clauses for HODs
Clause Finance HR Mktg Engineering Manufactu Quality Procureme Shipping Admin
title no CEO Head Head head Head ring Head Head nt Head Head 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
C P CHANDRASEKARAN 19
 Role wise important clauses
Claus Finance HR Mktg Engineering Manufactu Quality Procurem Shipping Admin service
title e no CEO Head Head head Head ring Head Head ent Head Head Head 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
C P CHANDRASEKARAN 20
 Dept wise important clauses for all employees
Clause Materia Executi Mech Innovati Service Manufact Shippin
title no ls on sales Engg on Admin s uring Quality Stores g
7.1.1.to
Support 7.17.1.1 7.1.1 7.1.3 7.1.6 7.1.3 7.1.4 7.1.5
7.2
7.3
7.4
7.5
Operati
on 8.1
8.2
8.3 8.3
8.4.1,.2,
8.4 .3 8.4.1

8.5 8.5.1,.5 8.5.1 8.5.4

8.6
8.7 C P CHANDRASEKARAN 21
Clause 2015 2008 Actions required for upgrade
no programme
Context 2
4.1 Understanding Internal Constantly evaluate the external
and external issues environment and internal system
affecting the organisation

4.2
Identifying the interested
Keep in touch with interested
parties and their New parties to know their requirements
requirements directly/indirectly

Determining the scope of Determine the scope accordingly

4.3 the Quality Management
system

4.4 Define QMS in terms of its Install process approach

processes C P CHANDRASEKARAN 22
External issues
Clause no 4 Context

Define
Scope of
Internal issues
QMS

Define
Processes
Needs of
Interested Parties

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Clause 2015
no
Leadership
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
C P CHANDRASEKARAN
2008 Actions required for upgrade
programme
2
Restricted to Accountability of Top Management
communicating, needs to be understood as “Buck
establishing stops here” . Theoretically, any
policy, objectives lapse in QMS implementation now
etc 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.
24
Clause 2015 2008 Actions required for upgrade
no programme
Leadership
5.1.2 Scope of customer focus It was 5.2 Top Management should
enhanced to include Restricted to document all statutory and
especially ensuring regulatory requirements for the
a) customer, statutory and customer products and services in the
regulatory requirements requirements are markets they serve. Now this
are understood (D) met and cannot be left to a routine
b) Risks and enhancing departmental functionary.
customer As Risk management is new in the
opportunities in satisfaction standard, the risk assessment
products are exercise for the products and
determined and services should be led by top
management. The latest is the
addressed. Product Liability Law in developed
countries.

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.
C P CHANDRASEKARAN 25
Clause 2015 2008 Actions required for upgrade
no programme
Leadership
5.2.1 Establishing Quality policy It was 5.3 earlier Policy should support strategic
Addition direction-. This means that after
every strategic meeting the
Policy should
Management must review the
support its Quality policy (not just
periodically).
strategic direction New businesses, new services and
5.2.2 new collaborations may demand
change in the policy.
Just like EMS standard, ISO 9001
Addition also has asked the policy to be
Communication should not made available to interested
only be for employees but parties through website or through
the policy should be made news letters.
available to interested
parties also (D)

C P CHANDRASEKARAN 26
 Leadership
5.3 This clause now combines It was 5.5 earlier Management representative
what was earlier under post can be dissolved and can
Roles Management Representative. be replaced by Quality systems
and QMS planning is also
Manager assisted by a team.
responsi combined.
This team should have 4
bilities
Emphasis functions to enable that
processes will deliver the
a) Ensuring that processes intended outputs.
are delivering their 1) Quality Planning
intended outputs. 2) Quality system Audits
b) 3) Process Measurement and
analysis
4) Product Quality
measurement and analysis

C P CHANDRASEKARAN 27
 Clause 5 Leadership

Create Customer focus

Establish and communicate

Quality Policy

Determine roles and

Leadership responsibilities

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Clause 2015 2008 Actions required for upgrade programme
no
Planning
6.1 Determine risks and This was not In the context of the external issues and
opportunities which there internal challenges, a risk assessment frame
Actions would work should be developed which would
to a) Enhance evaluate the risks and opportunities.
address desirable effects A severity rating of 1-10 can also be defined so
risks b) Reduce that those who are of high risks can be
and undesirable selected. The counter measures for these risks
opportu effects (avoidance is the best) should be given so that
nities c) Achieve they can be followed.
improvement 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.

C P CHANDRASEKARAN 29
Clause no 2015 2008 Actions required for upgrade programme

Planning

6.2 Objectives shall be Earlier it was Objectives should be monitored and progress
Quality monitored and covered reported.
Objective updated. under 5.4.2 Similarly, the objectives shall be updated if the
s and Planning now has situation warrants.
planning been made clear
to with what, when,
achieve how etc (every
them function) (D)

C P CHANDRASEKARAN 30
Clause no 2015 2008 Actions required for upgrade programme

Planning
6.3 Planning of changes Somewhat Change Management should be now a defined
Planning covered process.
of Emphasis under 5.4.2
changes This will help proper implementation.
Allocation and
reallocation of
responsibilitie
s

C P CHANDRASEKARAN 31
Clause 6 Planning

Actions to address risks

and opportunities

Setting Quality Objectives

and planning to achieve
them

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Clause no 2015 2008 Actions required for upgrade
programme
Support 3
7.1 In 7.1.1 emphasis is on Similar to 6.1 Constant updation of position of
Resources Capabilities and resources and external providers is
7.1.1 constraints on internal needed.
resources and also
external providers
(D)

7.1.2 People Providing people for Similar to 6.2 --Emphasis from products to
processes (D) processes

7.1.3 Nothing much added (D) Similar to 6.3

Infrastructure
---
7.1.4 Only physical It is going to be a challenge to know
Environment
Social, how social and psychological
for the psychological and environment will be determined
operation of physical now and provided and maintained. This
processes C P CHANDRASEKARAN is the toughest clause in standard.
33
included (D)
Clause no 2015 2008 Actions required for upgrade
programme
Leadership
7.1.5 Resources should be Partly replaces Apart from calibration of
Monitoring provided for monitoring 7.6 for equipment and devices, the entire
and measuring and measurement. calibration monitoring of products and services
resources and also should be governed with proper
7.1.5.1 general traceability resources.
7.1.5.2 7.5.3 No extra requirement as far as the
Traceability Identification calibration is concerned.
and
traceability

7.1.6 Surprisingly, Knowledge New

organisational is separate clause under Knowledge management via
knowledge 7.1 resources and Libraries, standards, technical
competence is separate. bulletins and web sites (intra
company) are required to preserve
and spread knowledge as a
resource.
C P CHANDRASEKARAN 34
Clause no 2015 2008 Actions required for upgrade
programme
People
7.2 By and large same with Earlier 6.2.2 Competence should be
Competence determination of but that time determined not only for those
competence required it was only for affecting product quality but also
and ensuring that the product. for all activities concerned with
competence is QMS. This will expand the
maintained. requirement of competence for
Except that now it says areas like Admin, Vendor
“ performance and development and HR.
effectiveness of Quality
Management system”
instead of product. (D)
7.3 awareness Specifically highlighted Earlier part of Nothing much added.
for quality policy and 6.2.2
objectives.

7.4 Internal and external Internal was New system needs to be

communication communication (D) 5.5.3 developed for external
C P CHANDRASEKARAN communication 35
Clause no 2015 2008 Actions required for upgrade
programme
Information
7. 5 All types of documents Unification of the treatment for all
Documented namely procedures, Earlier 4.2.1 documented information would be
Information documents and records required. The debate on what is a
are covered record and want is a document is no
more relevant.
7.5.1 general Quality Manual is no
more mandated.

7.5.2 Creating Pretty much the same Earlier 4.2.3

and updating

7.5.3 Control Protection of documents The clause now embraces electronic

of and access control is now 4.2.3 and versions more than paper versions
documented included in the control. 4.2.4 and hence it is needed to switch
information Mention of obsolete over the implementation to
documents is deleted. electronic documents.

C P CHANDRASEKARAN 36
 Clause no 7 support

Organisational
People, Knowledge, Communication Knowledge
competence, awareness

Infrastructure Environment
C P CHANDRASEKARAN
Measuring resources 37
Clause no 2015 2008 Actions required for upgrade
Operation programme
8 Determine how to Link to higher Operational plan has to be in
8.1 control the processes in level plan was alignment with the plan for the QMS
Operational line with planning done absent. or business.
Planning and in clause no 6. Outsourced Operational planning extends to
control Criteria for both processes was processes and products which
processes and products not covered. means those processes which are
mentioned. not linked an output like a product
Documented information but which are essential for QMS like
necessary to the extent Training are also covered now.
of creating confidence
that processes have been
carried out and for
conformity of products.
It covers outsourced
processes also. (D)

C P CHANDRASEKARAN 38
Clause no 2015 2008 Actions required for upgrade
Operation programme
8.2 Earlier 7.2.1
Requirements 7.2.2 and This is for sales to get the
for Products and 7.2.3 information
services

8.2.1 customer Customer property now merged

communication in this clause. Establishing
contingency actions is new. What are contingency
8.2.2 actions?
Determining
requirements No addition
8.2.3
Review of
requirements No addition

8.2.4 changes to Changes should be intimated to

requirements all Change notification to be
strengthened
C P CHANDRASEKARAN 39
Clause no 2015 2008 Actions required for upgrade
programme
operation
8.3 Design and 7.3
development of
products and
services
8.3.1 General
8.3.2 Design and Involvement of customers and 7.3.1 System to involve users and
Development users in the design process customers to be
planning mentioned strengthened
8.3.3 Design and
Development No additional requirement 7.3.2
Inputs
8.3.4 Design and
Development The requirements in Design are ---
Controls consolidated and explained in one
8.3.5 Design and clause (D)
Development
outputs
C P CHANDRASEKARAN 40
Clause no 2015 2008 Actions required for upgrade
programme
Operation

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

C P CHANDRASEKARAN 41
Clause no 2015 2008 Actions required for upgrade
operation programme
8.4 Control of Expanded to 7.4
Externally provided
processes , products
externally provided
and services processes instead of
8.4.1 General limiting to
8.4.2 type and This needs efforts to bring
extent of control
purchasing activity outsourced processes within the
ambit of QMS.
8.4.3 information External process should
for external remain within control of 7.4.2 Consolidated review is required to
providers QMS be done to cover the
communication to vendors
No significant addition

C P CHANDRASEKARAN 42
 Types of External providers
Incorporated in
to product or
External providers service given
of products and to customer
services
QMS of the
company

customer
External providers
of process

External providers
of products and
services

C P CHANDRASEKARAN 43
Clause no 2015 2008 Actions required for upgrade
Operation programme
8.5 production 7.5
and service
provision

8.5.1 control of Implementation of 7.5.1 Poka Yoke to be started

production and
service
actions to prevent
provision human error added
8.5.2 Identify all products and keep 7.5.3
Identification traceability when needed
and traceability No additional requirement
(D)
8.5.3 Property
belonging to Protect property of customer 7.5.4
customers and if damaged inform the
customer (D)
No additional requirement

C P CHANDRASEKARAN 44
Clause no 2015 2008 Actions required for upgrade
operation programme

8.5.4 No additional requirement 7.5.5

Preservation

8.5.5 Post Ne requirements explicitly stated now System for warranty provision
Delivery that the company should carry out exists however system for
activities post delivery activities as agreed or as recycling and disposal need to
required by regulatory requirements. be developed.

8.5.6 Control Obvious requirement stated for Changes not only in design but
of changes emphasis. in production documents need
to be regulated

8.6 Release of No addition 8.2.4

products and Keep record of the releases
services

C P CHANDRASEKARAN 45
Clause no 2015 2008 Actions required for upgrade
operation programme
8.7 Control of 8.3
non
conforming
products

8.7.1 Terminological change done

as Suitable changes need to be done in
Correction, segregation, documents
containment informing the
customer and obtaining
permission

8.7.2 Retain documented

information about the non 8.3
conformity and resolution of
the same (D)

C P CHANDRASEKARAN 46
 Clause no 8 Operation

Control on
External
Customer providers
requirements

Production Preservation

Design and
Development Release of
product and
post delivery
activities
C P CHANDRASEKARAN 47
Clause no 2015 2008 Actions required for upgrade
Performance
programme
Evaluation
9 Performance
evaluation
9.1 Monitoring ,
measurement,
analysis and
evaluation
9.1.1 General Language simpler and more 8.1 Quality plans can be synchronised
clear to indicate the way with the requirement. Those having
measurement needs to be Control plans may not require any
organised. action.

9.1.2 Customer No additional requirement 8.2.1

satisfaction

9.1.3 Analysis and Language made clear about 8.4 Statistical techniques mentioned
evaluation analysis

C P CHANDRASEKARAN 48
Clause no 2015 2008 Actions required for upgrade
Performance programme
Evaluation
9.2 Internal
audit
9.2.1 No significant addition 8.2.2

9.2.2 No significant addition

9.3
Management
review 5.6
9.3.1
9.3.2 Inputs Effectiveness of actions taken to As a logical step management
address risks and opportunities review needs to review status of
counter measures to risks
9.3.3 outputs No addition

C P CHANDRASEKARAN 49
 Clause no 9 Performance Evaluation

Customer satisfaction
survey

Internal audit Analysis and Management

evaluation review

Day to day monitoring

and measurement

C P CHANDRASEKARAN 50
Clause no 2015 2008 Actions required for upgrade
Improvement programme

10 Improvement
10.1 General
10.1.1 Preventing and reducing 8.5.1
undesired effects added
10.2.1 Non
conformity and Corrective action explained
corrective action clearly

10.2.2
Documentation

10.3 Continual The intent behind this clause
improvement is not clear. Earlier the
preventive action was clear
but now we need to debate
and find suitable way to
implement the clause.
C P CHANDRASEKARAN
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
51
 Clause 10 Improvement

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

C P CHANDRASEKARAN 52
• 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
Documented
• Evaluation of external providers information
• Traceability Required
• 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

C P CHANDRASEKARAN 53
 End of the Programme

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C P CHANDRASEKARAN 54
ANNEXURES

C P CHANDRASEKARAN 55
 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

C P CHANDRASEKARAN 56
 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.

C P CHANDRASEKARAN 57
 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

C P CHANDRASEKARAN 58
 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

C P CHANDRASEKARAN 59
 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

C P CHANDRASEKARAN 60
 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

C P CHANDRASEKARAN 61