ISO 9001: 2015 QUALITY MANAGEMENT SYSTEMS

This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.

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
systemrequirements
lies within this
singleclause.
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
•Reactto 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
•Outputfrom management review
10.0 Improvement
Find opportunities for improvement and implement actions to meet customer requirements and
enhance customer satisfaction