Professional Documents
Culture Documents
ISO 9001:2000
Tutor’s Introduction
Course Objectives
ISO14
001
ISO 9000
International SA8 0
00
z SUPPORTING STANDARDS
z ISO 10005:1995 Guidelines for Quality Plans
z ISO 10006:1997 Guidelines for Project Management
z ISO 10007:1995 Guidelines for Configuration Mgt
z ISO 10011-1, -2, -3 on Auditing
z ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt.
z ISO 10013:1995 Guidelines for Quality manuals
ISO 9000:2000 Family of
Standards
2. New Structure
z 20 clauses abandoned
z Now 8 sections
QMS
Quality
Management System
A System of coordinated activities which
is meant to “direct” and “control” an
organization with regard to quality.
or
(satisfying your customer by managing your resources,
through a standardized system)
Corrective &
Preventive
Actions Production &
Design Control Process Controls
Management
Material, Equipment
Human Resource &
Controls Records, Facility Controls
Documents, &
Change Controls
QUALITY MANAGEMENT
PRINCIPLES
What are they?
Quality Management
Principles
Principles of new Standard
r
CCuussto meer
tom p
us
foccus
fo LLeeaaddeerrsshhi ip
l
MMuutu tuaal
bbeenneefifciciaial l eenntt
vo lvlveem
ssuupppplileierr hhtt
In
In vo m
ship s e d o n n eig
e ig ooffppeeoopplele
tionnship
rreelalatio a
BBased o
qquuaaliltityy
a n a g eem m eenntt
mman plesa g
FFaacctu l
tuaal incci iples
pprrin
to
aapppprrooaacchh to
ionn
ddeeccisisio PPrroocceessss
king aapppprrooaacchh
mmaaking
SSyysstetemm
al
tinuual t
CCoonntin ch to
aapppprrooaach to
rroovveem eennt nt
im
impp m MMaannaaggeem meent
PRINCIPLE 1
CUSTOMER-FOCUSED
ORGANISATION
z Continual improvement
should be a permanent
objective of the
organization.
PRINCIPLE 7
FACTUAL APPROACH
TO DECISION MAKING
z Effective decisions are based on the
analysis of data and information.
PRINCIPLE 8
MUTUAL BENEFICIAL
SUPPLIER RELATIONSHIPS
z An organization and its
suppliers are
interdependent, and a
mutually beneficial
relationship enhances the
ability of both to create
value.
Process
Any activity that takes “inputs”
and converts them to “outputs”
Process Approach
Performance
PerformanceMeasurements
Measurements
•Delivery
•Deliverystatus
status––On-time,
On-time,On
Onspec,
spec,
etc
etc
•Supplier
•Supplierevaluation
evaluation
Process Approach Model
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM
C R
e Management C S
a
U q
responsibility U
t
i
u
S i
S s
r Measurement, f
T e Resource
analysis and T a
c
O m management improvement
e O t
M n
t M
i
o
Input
E s Service Output
E
n
R realization Product
R
Important changes
•More emphasis on customer satisfaction
•Commitment to comply with legal and statutory requirements
•Need to review suitability of quality policy
•Need to define quantified and measurable quality objective at
different functions and levels
•More emphasis on human resource management
•Re-evaluation of suppliers on the basis of their performance
•Analysis of data for continual improvement
•Need to maintain suitable work environment
•Term “Subcontractor” replaced with “Supplier” and “Supplier”
replaced with “organization”
•Exclusions defined
The Structure
0 Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 Quality management system
requirements
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
System Requirements /
Structure of the Standard
4 Quality 5 Management 6 Resource 7 Product 8
Management Responsibility Management Realization Measurement
System Analysis &
improvement
Management
General Provision of Planning(7.1)
Commitment(5. General (8.1)
requirements (4.1) resources(6.1)
1)
Customer
Documentation Customer focus related
Requirements(4.2) (5.2) Human Monitoring &
processes(7.2
resources(6.2) measurement(8.2)
)
Quality Design &
policy(5.3) development(7.3)
Infrastructures(6.3 Control of NCP(8.3)
)
Planning(5.4)
Purchasing(7.4)
Work
Analysis of data(8.4)
environment(6.4)
Responsibility,
Production &
authority &
service
communication(
provision(7.5) Improvements(8.5)
5.5)
z customer requirements
z Exclusions must:
z Not affect ability to provide conforming
product
z Be limited to clause 7
4 Quality Management
System
4.1 General Requirements
z Establish, document, implement,
maintain and continually improve QMS in
accordance with the standard.
4.2 General
Requirements
z To implement the QMS the Organization shall
z 7.4 Purchasing
z REPORTING
z INVESTIGATION
z ACTION
z FOLLOWUP
z CLOSING
EXPECTED BENEFITS
Transparency in working at all level
Data availability : Hidden Factors are open
Creates Accountability
Planning & scheduling improved
Rework & Rejection are known and being
controlled
Customer feedback through regular
surveys
Employees Participation enhanced
Continuos Improvements Program launched
Market Reputation
Thank
You