1
Overview of ISO 9001:2015 with focus on
Risk Based Thinking
Naresh Chawla
Principal Consultant – TQM & Operational Excellence
Visiting Professor – Punjab Engineering College (deemed to be University)
Outline of Session 2
Session Topic
1 ISO 9001-2015 standard – Key
Changes
2 Risk Assessment overview
3 Tools, Techniques & Methodologies
for risk assessment
4 Defining Measurable Quality
Objectives
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Evolution of ISO 9001 3
ISO ISO
ISO ISO
ISO 9001:2000 9001:2010
9001:1994 9001:2015
9001:1987
Process Process
Preventive Risk and
Procedures Approach & Approach &
Actions opportunity
PDCA Cycle PDCA Cycle
Naresh Chawla,
Principal Consultant- Transformation & Operational Excellence
ISO 9001: 2015- Key changes 4
The term “product” has been changed to “Product and
Services”
The term “purchased product” has been replaced with
“externally provided products and services”.
The new standard does not make any reference to the
exclusions. To be justified in scope.
The term “work environment” used in ISO 9001:2008
has been replaced with “Environment for the
operation of processes”.
The term record has been replaced with “documented
information”
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
ISO 9001: 2015- Key changes 5
The term "continual improvement" has been
replaced with "improvement"
New language such as ‘‘context of the
organization’ risk based thinking’ introduced.
Two new clauses related to the context of the
organization have been added (4.1 & 4.2)
Risk based approach which has replaced
preventive action
The requirement to use process approach has been
made more explicit by adding a new clause (4.4.2)
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Quality Management principles 6
ISO 9000:2008 ISO 9000:2015
1. Customer Focus 1. Customer Focus
2. Leadership 2. Leadership
3. Involvement of people 3. Engagement of people
4. Process Approach 4. Process Approach
5. System Approach to Management
6. Continual Improvement 5. Improvement
6. Evidence based decision making
7. Factual Approach to Decision Making
8. Mutually Beneficial Relationship 7. Relationship Management
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Differences between ISO 7
9001:2008 and ISO 9001:2015
ISO 9001:2008 ISO 9001:2015
0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative reference 2. Normative reference
3. Terms and definitions 3. Terms and definitions
4. Quality management system 4. Context of the organisation
5. Leadership
5. Management responsibility
6. Planning
6. Resource management 7. Support
7. Product realisation 8. Operation
8. Measurement, analysis and 9. Performance evaluation
improvement 10. Improvement
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
ISO 9001:2015 8
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
9
Risk based thinking
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Some of our daily activities….
10
What are our common
responses?
Naresh Chawla,
Principal Consultant- Transformation & Operational Excellence
11
All these situations are
process of verification
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
12
Are these of same
significance?
Methods of inspection and verification varied
from person to person.
Governing Factors : Risk
What is risk: proportional to likely hood of
occurrence and impact of the event
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Risk Based Thinking 13
Risk based thinking can help you
prevent losses
capture opportunities and
improve communication
throughout the organization.
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Risk Based Thinking 14
Problems cost money; The sooner a potential
problem or error is anticipated and resolved, the
less it will ultimately cost an organization. This
includes direct costs like warranty claims and
recalls, and in more serious terms, the long-term
costs associated with lost business and damage to
a company’s reputation.
Naresh Chawla,
Principal Consultant- Transformation & Operational Excellence
Risk Based Thinking 15
Quality is not simply a theoretical idea about how
to cut costs and make better products and
services. Quality is about anticipating the
consequences of errors, carelessness, and
inefficiency, and putting processes in place to
ensure they don’t occur.
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
6.1 Actions to address risk &
opportunities 16
Risk v/s Opportunity
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
6.1 Actions to address risk &
opportunities 17
Risk v/s Opportunity
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
6.1 Actions to address risk &
opportunities 18
Implementing risk based thinking
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Risk Based Thinking and Process 19
Approach
Define the process (what, where, when & how)
Assign a Process Owner (who)
Identify the inputs and outputs
Define measures of effectiveness and efficiency
Measure the process v/s criteria (measures)
Take corrective actions if things are wrong
Identify risks and opportunities
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Risk Based Thinking and Process 20
Approach
Manpower
Materials Measures
(Training/Skills)
RISK!
Suppliers Customer
(By whom)
Inputs PROCESS Outputs
(For Whom)
Methods Machine Environment
(How) (With what) (Conditions)
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Tools for Risk Based Thinking 21
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Tools for Risk Based Thinking 22
Checklists
Process Decision Program Chart (PDPC)
Failure Mode & Effect Analysis
Impact-effort Matrix
Mistake prevention/proofing
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
Defining Measurable Objectives 23
Objective Measures Actions/Initiatives
Safety Accidents Near Accidents finding, Essential Safety
Design
Productivity OEE Defect Tag, OPL, PM-Analysis, RCM
New Product Ratio Co-development with Customers, FMEA,FTA
Quality Claim, Quality Quality of Modules, Supplier Assessment,
QFD
Cost Cost reduction KAIZEN, New Material Evaluation, etc.
Delivery Lead Time “MAKIGAMI” （Process Step Reduction), VSM
Environment Energy Energy Conservation, Wastes Reduction
Moral Skill Management Seminar, Qualification, Certification
Naresh Chawla,
Principal Consultant- TQM & Operational Excellence
24
Any Question please!!!!!!!!
Prof Naresh Chawla
Visiting Professor
Principal Consultant – TQM & Operational Excellence
