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ISO 9001:2000
Tutor’s Introduction
Course Objectives
Planning
to implement the
requirements of the standard
Course Structure
Lecturesand value
added discussions on
each topic.
Workshops to enable
delegates to increase
their understanding
regarding ISO 9001:2000
version and to
experience Quality
ISO
ISO14
001
ISO 9000
International SA80
00
Organization OHSAS1
8001
9
4
169
TS
for IS O /
Standardizatio
n
1
INTRODUCTION
Origin
ISO 9000:87
ISO 9000:94
ISO 9001:2000
BS5750
1979
AQAP1
(NATO)
1970’s
MIL-STD-9858
(1940’s)
What is ISO?
International Organization for Standardization
Develops standards do not certify companies
SUPPORTING STANDARDS
ISO 10005:1995 Guidelines for Quality Plans
ISO 10006:1997 Guidelines for Project Management
ISO 10007:1995 Guidelines for Configuration Mgt
ISO 10011-1, -2, -3 on Auditing
ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt.
ISO 10013:1995 Guidelines for Quality manuals
ISO 9000:2000 Family of
Standards
ISO/TR 10014:1998 Guidelines for
managing economics of quality
ISO 10015 Guidelines for Training
2. New Structure
20clauses abandoned
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?
Mutual
beneficial nt
supplier Involveme
ip d o n eight of people
relationsh B a se
quality
ent
managem
Factual principles
to
approach
decision Process
making approach
System
to
Continual approach
en
improvem
ent Managem
t
PRINCIPLE 1
CUSTOMER-FOCUSED
ORGANISATION
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
i
M n
t M 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)
customer requirements
Exclusions must:
7.4 Purchasing
tangible / intangible
7.5.5 Preservation of Product
Preserve conformity of product during
internal processing and final delivery to
intended destination
Include identification, handling, packaging,
storage and protection
This applies to constituent parts of product
7.6 Control of monitoring &
measuring devices
Calibrate & adjust measuring and monitoring
devices at specified intervals as prior to use
Traceability to international or national
standards. Where no such standard exist record
the basis
Safeguard MMD from adjustments invalidating
calibration
Protect MMD from damage or deterioration
during handling, maintenance or storage
Record results of calibration
Assess validity of previous results when devices
found to be out of calibration
1 Measurement, Analysis
and Improvement
8.1 General 8.3 Control of non-
8.2 Monitoring & conforming product
Measurement 8.4 Analysis of data
8.2.1 Customer 8.5 Improvement
satisfaction
8.5.1 Continual
8.2.2 Internal audit
improvement
8.2.3 Monitoring and
8.5.2 Corrective action
Identification
of major non-conformance.
Large number of minor non-conformities.
Customer Complaints.
REPORTING
INVESTIGATION
ACTION
FOLLOWUP
CLOSING
EXPECTED BENEFITS
Transparency in working at all level
Data availability : Hidden Factors are open
Creates Accountability
Planning & scheduling improved