ISO 9001 is an international standard outlining requirements for a Quality Management System (QMS) aimed at improving organizational processes and efficiency while fostering continual improvement. The 2015 version emphasizes leadership, customer satisfaction, and risk management, integrating a structured approach to planning, support, operation, performance evaluation, and improvement. The goal is to enhance product quality, reduce non-conformities, and meet customer needs effectively.

1. PREPARED BY:
SUBHNEDU DATTA
MBA CPM, B.E. Civil
RICS School of Built Environment

2.  WHAT IS ISO 9001 ?
It is the international standard that specifies requirements for QMS.
 PURPOSE ?
Organizations of all types and sizes find that using the ISO 9001 standard helps
them:
 Organize processes
 Improve the efficiency of processes
 Continually improve
 ISO 9001:2015 Forecast schedules

3. 1. Scope
2. Nominative References
3. Terms & Definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance Evaluation
10. Improvement
PLAN
DO
CHECK
ACT

5. • Internal issues
• External issues
4.1 Understanding the organization and its context.
• Requirement of interested parties
4.2 Understanding the needs and expectations of the interested parties.
• Determine the Boundaries & Applicability of the QMS
4.3 Determining the scope of QMS.
• Design the target Process
4.4 Quality Management System and its processes.

6. • Accountability for
Effectiveness
• Quality Policy & Quality
objectives
• Integration of QMS
• Promoting
• Resource needed for Quality
• Communicating the
Importance
• Conforming the Requirements
• Intended Results
• Improvement
• Support
Top Management
wrt.
“QMS”
“Having a unified direction or
mission that comes from strong
leadership is essential to ensure
that everyone in the
organization understands what
you are trying to achieve.”
• Requirements
• Risk & Opportunities
• Focus on Customer
Satisfaction
Customer Focus
wrt.
QMS

7. • Appropriate
purpose
• Strategic direction
• Framework
• Commitment
• Continual
Improvement
• Documented
• Communicated
• Available to
interested Parties
Policy
Developing
&
Communicate
• Assigned
understood and
communicated
• Reporting
• Implemented as
per the plan
ORG. Roles
Responsibilities
Authorities
So, Top management should
• Demonstrate leadership & Commitment
• Focus on customer
• Developing & Implementing Quality Policy
• Assign roles, responsibilities & authorities.
Leads to Customer Satisfaction

8. • Enlist Risks &
Opportunities
• Evaluate the effectives
• Enhance Desirable
Effects
• Prevent or Reduce
undesirable effects
• Improvements
Address Risk
&
Opportunities
• At relevant functions,
levels & processes
• Measurable
• Consistent
• Monitored
• Communicated
• Updated
• Relevant Conformity of
product
• Resources required
• Evaluated
Objectives
& Planning for
them
“Taking Decisions for future
actions in order to achieve pre-
determined objectives by
optimum utilization of available
resources in a limited time
frame.”
• Planning for Changes
• Purpose & its potential
• Integrity
• Availability of resources
• Allocation or Reallocation of
responsibilities

9. Support
Resources
Competence
Awareness
Communication
Doc.
Information

10. Operation
Planning & Control
Determination
Design &
Development of
Product/Service
Control of
Externally Provided
Product/Services
Product & Service
Provision
Release of Product
& Service
Control over Non-
Conformity
 The bulk of the
management
system requirements
lies within this
single clause.
 It has 7 sub clauses

11. 9.0 Performance Evaluation
Performance evaluation is the critical Check step in the Plan-Do-Check-Act (PDCA) cycle that ISO 9001 is
based on.
• Analyze
(Desired
outcomes,
Statistical tools)
• Internal Audit
• Management
Review
• How & When to
measure
• Determine
Processes that
need to be
monitored
Monitor Measurement
AnalysisEvaluate
Customer Satisfaction is Critical Performance Indicator which will govern benchmark to be set in each Process.

12. Input
• Criteria for selection, evaluation, and re-evaluation shall be established
• Each individual organization can set the supplier criteria
Why?
• Cost
• Compliance
• Financial stability
• Quality & lead time
How?
• Evaluating number of suppliers
• Equal opportunity for all
• Must use “Risk –based thinking” in process
Output
• Decreased cost
• Increased competence
• Better quality
• Shorter delivery time
Evaluation of Supplier Performance

13. Include
• Products and services- meet requirements and address future needs and expectations;
• Correcting undesired effects;
• Improving performance and effectiveness of the QMS
Non
Conformities
• React to the nonconformity
• Evaluate the need for action to eliminate the cause(s) of the nonconformity,
• Implement any action needed;
• Review the effectiveness of any corrective action taken;
• Make changes to the quality management system, if necessary
Continual
improvement
• Improve the suitability
• Adequacy
• Effectiveness
• Output from management review
10.0 Improvement
Find opportunities for improvement and implement actions to meet customer requirements and
enhance customer satisfaction