Iso 9001 2015

BACKGROUND
 ISO
 IS AN INTERNATIONAL ORGANISATION
FOR STANDARDIZATION
 CONFEDERATION OF NATIONAL
STANDARDS BODIES
 HAS HEAD QUARTERS AT GENEVA AND
 IS ENGAGED IN FORMULATION OF
INTERNATIONAL STANDARDS
 INDIA REPRESENTED BY BIS
05/04/2020 Bureau of Indian Standards 1
Inroduction
 There are three International Bodies, which

formulate standards at International level.
 (1) ISO - International Organisation for
Standardisation
 (2) IEC - International Electrotechnical
Commission
 (3) ITU – International Telecommunications
Union
Introduction
 BUREAU OF INDIAN STANDARDS

 Is the national standards body of India which
formulates standards at national level
 Till date, BIS had formulated about 19000
standards on various subjects
 Types of Standards: Products, test methods,
codes of practices, guidelines etc.

Introduction
Managing systems and processes
Leading and operating an organization successfully requires managing it in a

systematic and visible manner.
Success should result from implementing and maintaining a management

system that is designed to continually improve the effectiveness and
efficiency of the organization’s performance by considering the needs of
interested parties.
Managing an organization includes quality management, among other

management disciplines

Introduction
 To lead and operate an organization
successfully, it is necessary to manage it in a
systematic and visible manner.
 These principles have been developed for use by
top management in order to lead the

organization toward improved performance.

QUALITY
THE DEGREE TO WHICH A SET OF
INHERENT CHARECTERISITCS
FULFILS REQUIREMENTS

QUALITY MANAGEMENT SYSTEM
 SYSTEM – A SET OF INTERRELATED OR

INTERACTING ELEMENTS
 MANAGEMENT SYSTEM – SYSTEM TO
ESTABLISH POLICY AND OBJECTIVES AND
TO ACHIEVE THESE OBJECTIVES
 QUALITY MANAGEMENT SYSTEM
-MANAGEMENT SYSTEM TO DIRECT AND
CONTROL AN ORGANIZATION WITH
REGARD TO QUALITY

BUREAU OF INDIAN
STANDARDS
ISO 9001:2015
QUALITY MANAGEMENT SYSTEM
REQUIREMENTS

ORIGIN OF ISO 9000 SERIES
ISO PUBLISHED STANDARDS ON
QUALITY MANAGEMENT SYSTEMS
FIRST TIME IN 1987 as QUALITY SYSTEM

ISO 9001:2000 Outlines criteria for a good Quality Management System
(QMS) REVISED IN 2008 WITH MINOR TEXTUAL CHANGES.
05/04/2020
Bureau of Indian Standards 9
A SAYING
I KNOW YOU BELIEVE ,

YOU UNDERSTAND WHAT
YOU THINK YOU READ,
BUT I AM NOT SURE
YOU REALISE THAT
WHAT YOU READ IS NOT
WHAT COULD BE MEANT
REVISION HISTORY
ISO 9001
 First Edition : 1987
 Second Edition: 1994
 Third Edition: 2000

 Fourth Edition : 2008
 Fifth Edition : 2015

PURPOSE OF REVISION
1. Review every five years
2. Comments / Suggestions /proposals / feedback
(Last revision was mainly editorial in nature)
3. To align with other management standards
4. To provide more clarity /clarification on some
words used to make them more explicit
5. To give more weightage to SERVICES
6. To propagate concept of risk management
SOME BASIC CONCEPTS USED IN QMS
(Cl 0. INTRODUCTION)
 PDCA Cycle (0.1)

 QMS Principles (0.2)
 Process Approach (0.3 & 4.4)
 Risk and Opportunities (0.3.3)

QMS PRINCIPLES
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
Process approach-revisited
 A process consists of one or more activities
that transform inputs into outputs
 Inputs and outputs are generally products
that may be tangible and/or intangible.

PROCERSS APPROACH
PROCESS – Set of interrelated or interacting
activities that use input to deliver an
intended result
Note: intended result may be called output,
product or service
OUTPUT
INPUT PROCESS

EXAMPLE OF A PROCESS
MATERIALS
PLANT/EQUIPMENT PRODUCTS
PEOPLE
TRAINING SERVICES
SKILL
KNOWLEDGE
PROCESS
PROCEDURES RECORDS
INFORMATION
ENERGY INFORMATION
WORK ENVIRONMENT
INPUTS OUTPUTS
TYPICAL PROCESSES
1. Quality Management Process,
2. Regulatory Research Process,
3. Understanding organization and context process,
4. Risk assessment and monitoring process,
5. Customer Needs Assessment Process,
6. Communication Process,
7. Complaint Handling Process,
8. Customer Feedback Process,
9. Product / service Design Process,
10. External providers assessing and control Process
11. Production/ service provision Process
12. Equipment Maintenance Process
13. Product / service Delivery/ Post-delivery Process
14. Measuring Equipment Calibration and Maintenance

PROCESS ANALYSIS
Should be analyzed for their components- example:
 Objectives
 Owner of the process
 Customer(s) of the process (sequence of processes)
 Inputs (incl. Resources/control)
 Activity / activities
 Output(s)
 Analysis, Monitoring, Measurements, acceptance criteria, risk
and opportunities
 Changes and Improvement
 Retaining Documented information, if any
This can be converted to tabular form, if so desired

Act Plan
•How to improve •What to do?
next time? •How to do it?
Check Do
• Did things happen •Do what was
according to plan? planned

PDCA Cycle
 Plan: establish the objectives and processes necessary to
deliver results in accordance with customer
requirements and the organization's policies;
 Do: implement the processes
 Check: monitor and measure processes and product
against policies, objectives and requirements for the
product and report the results;
 Act: take actions to continually improve process
performance;"

Representation of the structure of ISO
9001:2015 Standard in the PDCA cycle
Quality Management System (4)
Organization
and its context Support &
(4) Operation
(7,8)
Plan Customer
Do satisfaction
Performance Results of
Customer Planning Leadership
requirements
evaluation (9) the QMS
(6) (5)
Products and
Act Check services
Improvement
Needs and (10)
expectations of
relevant
Intersted parties Reference: ISO 9001:2015 Figure 2
(4)
ISO 9001:2015
1. SCOPE
2. NORMATIVE REFERENCE
3. TERMS AND DEFINITIONS
4. CONTEXT OF THE ORGANIZATION
5. LEADERSHIP
6. PLANNING
7. SUPPORT
8. OPERATION
9. PERFORMANCE EVALUATION
10. IMPROVEMENT
1 . SCOPE
Covers QMS requirements
• For meeting product /service requirements
consistently
(Customers, statutory & regulatory)
-Pertaining to intended product or service only
(Not unintended product, health, environment,
safety etc.)
Aims:
a) Enhance customer satisfaction
b) Improvement
2.NORMATIVE REFERENCES &
3.TERMS AND DEFINITIONS
 Refers to ISO 9000 :2015
 “shall” indicates a requirement;
 “should” indicates a recommendation;
 “may” indicates a permission;
 “can” indicates a possibility or a capability.
 Information marked as “NOTE” is for
guidance in understanding or clarifying the
associated requirement.
TERMS FOR SUPPLY CHAIN
EXTERNAL PROVIDER
ORGANIZATION
CUSTOMER
TERMS FOR SUPPLY CHAIN
 External provider
-Supplier , Seller, Stockist , Dealer,
Distributor, Retailer
-Vendor, Contractor , Sub-contractor
-Associated Company etc
 Organization
-Entity which wants to implement QMS
 Customer (some of these can be categorized as interested
parties)
-Purchaser ; Buyer
-Intermediary (dealer , Distributor,
Retailer etc.)
-Client; Recipient
4.1 Understanding the organization
and its context
 For the purpose of planning, organization
needs to understand:
 Its purpose and status,


 What it wants to achieve
Issues affecting it
 05/04/2020 Bureau of Indian Standards 28
CONTEXT
 DETERMINE external and internal ISSUES
 Determine: establish or find out with certainty by
research, examination or calculation
 Issues: important topics for the organization,

problems for debate and discussion or changing
circumstances-
-Could refer to factors, points, elements that
influence, values, beliefs, culture, principles,
corporation image, historic background, challenges
CONTEXT
 Organization charter
 MOU
 MOA
 Purpose for which organization is set up
 Vision
 Mission
 “Business environment”, “Organizational
environment”, “Operating environment” or
“Ecosystem of an organization”
CONTEXT
 External context includes: P E S T analysis

 Political
 Economical
 Social
 Technical

CONTEXT
 Internal context can include: 7 S Framework
 Strategy,
 Structure,
 Systems,
 Shared Values,
 Skills,
 Style,
 Staff.
CONTEXT
 External context includes:
 Cultural, social, political, legal, financial,
technological, economic, natural and competitive
environment
 Relationship with and perception/ values of
interested parties
 Internal context includes:
 Corporate culture, governance, organization
structure, roles and accountabilities, policies,
objectives, resources, information system, decision
making
05/04/2020
processes (Taken from ISO 31000)
context
Which issues?
 Which are relevant to its purpose,
 Relevant to its strategic direction, and
 that affect its ability to achieve desired

results.
context
What to do once these are determined?
 The organization would need to monitor and
review the information about these issues.

 Assess those issues, and if not mitigated,
which could prevent the success of quality

management system implementation
 Take these issues into account while
planning QMS , including the wording of

QMS scope
4.2 Understanding the needs and
expectations of interested parties
 Parties that provide significant risk to the
organisational sustainability if their needs
and expectations are not met.
 Risk= Effect of uncertainty
 Organizations attract, capture and retain the
support of relevant interested parties they
depend on for their success
 Interested parties are some times known as
“stake holders”.
INTERESTED PARTIES
 Customer,
 Owners,
 Employees,
 Supplier,
 Regulatory authorities,
 Society at large

INTERESTED PARTIES
Others interested parties could be:
 Parent organizations,
 Bankers,
 Trade associations,
 Trade union,
 Media, Community groups, neighbourers,
 Some NGOs, consumer organizations
 Competitors
INTERESTED PARTIES
 interested parties that are relevant

to the quality management
system;
 requirements of these interested
parties that are relevant to the

quality management system.
4.3 Determining the scope of the quality
management system
 4.1+4.2+ products and services
 Boundaries and applicability-must be

clear to customers /other interested
parties as to what is “in”, what is “out”

scope of the quality management
system
 Claim non-applicability of any requirement
only if it does not affect ability and capability
and provide justification, if non-applicability
claimed
 Non-applicability, if claimed and accepted will
be part of scope.
 So, documented information about scope has
to be a bit elaborate.

5. LEADERSHIP
5.1.1 Leadership is required to:
 take accountability for the effectiveness of the quality
management system
 ensure the quality policy and quality objectives are
compatible with the context and strategic direction of the
organization
 ensure the integration of the QMS requirements into the
organization’s business processes(just not an “add on”)
 promote the use of the process approach and risk-based
thinking
 ensure that the QMS achieves its intended results
 engage, direct and support persons to contribute to the
effectiveness of the QMS
 05/04/2020
promote improvement; support relevant management roles
5.1.2 Customer focus:
Top management needs to ensure customer

satisfaction through:
 customer and applicable statutory and
regulatory requirements being determined and

met
 risk and opportunities are being addressed
 the focus on enhancing customer satisfaction
is maintained
5.2 Policy
 Appropriate to purpose and context of
organization and its strategic direction
 Provides framework for objectives
 Commitments : a)satisfy applicable
requirements b) continual improvement of QMS
 Policy is required to be documented,
communicated, understood and applied within
organization and be available to relevant
interested parties
(can be put on web-site or made available “on
request”)
5.3 organizational roles, responsibilities
and authorities
 Assign organizational roles, responsibilities
and authorities.
 Responsibilities enumerated can be:
- discharged by top management itself
or
-allocated to one person
or
-distributed to different persons.
6 . PLANNING
Planning-risk and opportunities (6.1)
Context(4.1) Interested
parties(4.2)
6 . PLANNING
 IF YOU FAIL TO PLAN,
YOU PLAN TO FAIL

6.1 RISK AND OPPRTUNITIES
 This clause requires the determination of risks
and opportunities which need to be addressed,
actions to be taken and evaluation of the
effectiveness of these actions
 Though risk management is not mandatory,
some risk assessment would be required.

 Organization should be able to explain how
they address this clause (6.1) and Cl 9.3.2e).

Should it be found wanting, a non-conformity
05/04/2020would be in order.
RISK BASED THINKING
New concept
to replace
Preventive Action
RISK BASED THINKING
 Risk = effect of uncertainty

 Any such uncertainty can have positive or
negative effects. A positive deviation arising
from a risk can provide an opportunity
 Risk-based thinking is something we all do
automatically and often sub-consciously to get
the best result
 The concept of risk has always been implicit in
ISO 9001 – this edition makes it more explicit
What is risk-based thinking?
 Risk-based thinking is something we all do
automatically and often sub-consciously to get the
best result
 The concept of risk has always been implicit in

ISO 9001 – this edition makes it more explicit and
builds it into the whole management system
Risk is considered from the beginning and

throughout to determine factors that could cause its
processes and QMS to deviate from the planned
results
51
SUMMARY /CONCLUSIONS
Risk-based thinking:
 is not new
 is something you probably do already
 is ongoing
 ensures greater knowledge of risks and
improves preparedness
 increases the probability of meeting objectives
 reduces the probability of negative results
 makes prevention a habit

52
6.2 QUALITY OBJECTIVES
 Objectives shall be:
 established for processes relevant to the QMS
 Consistent with quality policy, measureable

and take into account applicable requirements
 must be relevant to conformity of product/
services, and customer satisfaction.
 monitored, communicated & updated
 Objectives are required to be documented
 Requirements for objectives have been

enhanced
 What will be done?
 Who is responsible?
 When will it be completed?
 How the results will be evaluated?
 Resources etc.
 Objectives should be :
S
M
A
R
T
6 . 3 PLANNING OF CHANGES
 Changes to the QMS shall be carried out in a

planned manner
 Purpose of changes and their potential
consequences
 Integrity of QMS
 Availability of resources
 Allocation / reallocation of res and auth.

7 . SUPPORT
 7.1 Resources
 7.1.1 General – assess internal resources, add
from external providers, if needed

 7.1.2 People- necessary for implementation
 7.1.3 Infrastructure
 7.1.4 Environment for the operation of
processes
( can be combination of human and physical
factors, examples of which have been given in
the note)
7 . 1 RESOURCES
 7.1.5 Monitoring and measuring resources
 Term “equipment” changed to “resources’
 (wider implication)
 Suitability & fitness(maintenance) of
resources
+
 Calibration of measuring equipment

7 . 1 RESOURCES
 7.1.6 Organizational knowledge
 Determine, maintain, make available
 Additional knowledge and updates, if
required when addressing changing needs

and trends
 Examples of internal and external sources on
which knowledge can be based are given

 Can include information, such as intellectual
property and lessons learnt

7. SUPPORT
 7.2 Competence
Appropriate education, training or experience
Examples of actions to fill competence gap:
training, mentoring, reassignment, getting

competent persons from outside
 7.3 Awareness
policy, relevant objectives,
contribution to effectiveness of QMS,
improved performance,
 implication of not conforming to QMS
7. SUPPORT
 7.4 Communication
Both internal and external
What, when, with whom, how, who
 7.5 Documented information

 Elaborate requirement for the creation,
updating and control of documented
information
(ref separate session on documentation)
8 . OPERATION
 8.1 Operational planning and control

 Planning for provision of products and
services taking into account of actions
planned in Cl 6.
 Control planned changes ; review

consequences of unintended changes; action
to mitigate adverse effects
 Control of outsourced processes (ref 8.4)
8.2 Requirements for products and services
 8.2.1 Customer communication includes:
 reference to customer property,
 establishing requirements for contingency
actions
 8.2.2 Organization to ensure it can meet
claims made for products and services
 Auditors may also check sources of claim,
such as advertisement (“puffing”),
web-site etc for claims made
 8.2.3 Contract review
8.3 Design and development of products
and services
 8.3.2 Elaborate planning, including need for
involvement of customer / user
 8.3.3 Inputs include standards, code of
practices, potential consequences of failure

 8.3.4Control includes review, verification and
validation
 8.3.5 Output to ensure also adequacy for
subsequent processes
 8.3.6 Design & Development changes –record
also authorization
05/04/2020 ofof changes
Bureau Indian Standards 64
8.4 Control of externally provided
processes, products and services
 8.4.1 Includes:
- out-sourced processes, and
-products/services directly provided to customer
by external provider (new reference)
 8.4.2 Controls on external provider and resulting

output
 8.4.3 Information for external provider has been

enhanced
8. 5.1 control of production and service
provision
 A) Monitoring, measuring, acceptance
criteria brought under this clause (see
also 9.1)
 B) Added reference to:
1. infrastructure,
2. environment,
3. appointment of competent persons; and
4. action to prevent human error
8. OPERATION
 8.5.2 The identification and traceability focus
on ‘outputs’ (includes intermediate products
and services also) rather than on ‘product’
 8.5.3 Apart from customer property, external
provider’s property is also to be taken care of
 8.5.4 preservation of “outputs” rather than
“product”
 8.5.5 Post-delivery activities have been
elaborated through a separate sub-clause
8. OPERATION
 8.5.6 Control of changes to include

reference to person authorizing changes.
 8.6 Traceability of person(s) authorizing

release

8.7 CONTROL OF
NONCONFORMING PRODUCT
 Alternatives (options) for disposal of non-

conforming outputs
 Elaborate documented information is

required to be retained, including
identifying the authority deciding action in
respect of non-conformity

9.1 Monitoring, measurement,
analysis and evaluation
 9.1.1 General-what , how, when measurements/
analysis to be carried out
 9.1.2 Customer satisfaction
(needs and expectations, not only requirements)

 9.1.3 Analysis and evaluation
(Items for analysis are stipulated--

-the more the analysis, the less the uncertainty)
-Also includes effectiveness of action taken to
address risk and opportunities
ANALYSIS OF DATA
 Data is like garbage.

 You better be sure what you are going to do
with it before you collect it.
Data interpretation
ANALYSE

9.2 INTERNAL AUDIT
 Internal audit (overall) programme includes

frequency, methods, responsibility, planning
requirements and reporting, whereas audit
criteria and scope is required to be defined
for each audit.
 Select auditors to ensure objectivity and
impartiality of audit
 Take correction and corrective action on the
reported results of audit
9.2 INTERNAL AUDIT
 Internal audit programme now has to take

into account “changes affecting the
organization” also.
 An auditor is required to be impartial

9.3 MANAGEMENT REVIEW
 At planned intervals to ensure its continuing

suitability, adequacy, effectiveness and
alignment with strategic direction of the
organization
 Management review items for inputs and
outputs are given, including:

- Internal and external issues;
-Extent to which objectives have been met;
-Address risk and opportunities
10. IMPROVEMENT
10.1 General
 Implication wider than continual
improvement
-can include :
 correction,
 Corrective Action,
 Breakthrough change,
 Innovation etc.
10. IMPROVEMENT
 Includes enhancing customer satisfaction
Improve what?
 Products and services
 Controlling undesired effects
 Performance and effectiveness of QMS

10. IMPROVEMENT
10.2 Nonconformity and corrective action
(For entire QMS, not only products and
services)
 Determine if similar NCs exist or could
potential occur (PNCs)
 Update risk and opportunities, if

necessary
10. IMPROVEMENT
10.3 Continual improvement

 For effectiveness of QMS
Consider:
 Analysis,
 Evaluation and results of management
review output


Iso 9001 2015

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Iso 9001 2015

Uploaded by

Copyright:

Available Formats

BACKGROUND

 There are three International Bodies, which

 BUREAU OF INDIAN STANDARDS

05/04/2020 Bureau of Indian Standards 3

Leading and operating an organization successfully requires managing it in a

Success should result from implementing and maintaining a management

Managing an organization includes quality management, among other

05/04/2020 Bureau of Indian Standards 4

top management in order to lead the

05/04/2020 Bureau of Indian Standards 5

05/04/2020 Bureau of Indian Standards 6

 SYSTEM – A SET OF INTERRELATED OR

05/04/2020 Bureau of Indian Standards 7

QUALITY MANAGEMENT SYSTEM

05/04/2020 Bureau of Indian Standards 8

QUALITY MANAGEMENT SYSTEMS

FIRST TIME IN 1987 as QUALITY SYSTEM

I KNOW YOU BELIEVE ,

 Third Edition: 2000

 Fifth Edition : 2015

05/04/2020 Bureau of Indian Standards 11

 PDCA Cycle (0.1)

 Process Approach (0.3 & 4.4)

 Risk and Opportunities (0.3.3)

05/04/2020 Bureau of Indian Standards 13

05/04/2020 Bureau of Indian Standards 15

05/04/2020 Bureau of Indian Standards 16

05/04/2020 Bureau of Indian Standards 18

 Owner of the process

 Customer(s) of the process (sequence of processes)

 Inputs (incl. Resources/control)

 Analysis, Monitoring, Measurements, acceptance criteria, risk

 Retaining Documented information, if any

This can be converted to tabular form, if so desired

05/04/2020 Bureau of Indian Standards 19

05/04/2020 Bureau of Indian Standards 20

05/04/2020 Bureau of Indian Standards 21

 Its purpose and status,

 What it wants to achieve

 Issues: important topics for the organization,

 External context includes: P E S T analysis

05/04/2020 Bureau of Indian Standards 31

 Which are relevant to its purpose,

 Relevant to its strategic direction, and

 that affect its ability to achieve desired

review the information about these issues.

which could prevent the success of quality

planning QMS , including the wording of

05/04/2020 Bureau of Indian Standards 37

 interested parties that are relevant

parties that are relevant to the

 4.1+4.2+ products and services

 Boundaries and applicability-must be

05/04/2020 Bureau of Indian Standards 40

05/04/2020 Bureau of Indian Standards 41

Top management needs to ensure customer

regulatory requirements being determined and

 the focus on enhancing customer satisfaction

Planning-risk and opportunities (6.1)

 IF YOU FAIL TO PLAN,

YOU PLAN TO FAIL

05/04/2020 Bureau of Indian Standards 47