Professional Documents
Culture Documents
Iso9001 2000
Iso9001 2000
Anura Senarathna
Objective
Management
Responsibility
Measurement,
Resource
analysis &
management QMS improvements
Product
Realization
S
Information Management
Management a
Responsibility
Responsibility t
C i C
R
s
U e f U
S q Measurement,
Measurement, a S
Resource
Resource
u QMS Analysis
analysis & Info c
T management
Management improvements
T
i Improvements t
O r i O
M e o M
E m n E
R e Product
Product R
n Input Realization Product
Realization
t
s
Principles of the New Standard
Customer
focus
Leadership
Mutual
beneficial
supplier
relationship Based and
Involvement
developed on
of people
eight quality
Factual management
approach to principles
decision
making
Process
approach
Continual System
improvement approach to
Managemen
t
Principles of the New Standard
Customer focus
•Organization depends customers
•Understand current & future customer needs.
•Meet / exceed customer expectations
Leadership
•Leaders establish purpose & direction of the organization
•Should create & maintain environment to achieve organization’s
objectives
Involvement of People
•People of all levels are essence of an organization
•Their full involvement for organization’s benefit
Process approach
Desired results are achieved more efficiently when activities and resources
are managed as process
Principles of the New Standard
Continual improvements
Continual improvement of the organization’s overall performance should be a
permanent objective of the organization
Process definition
Set of interrelated and interacting activities which transforms
inputs into outputs
Identify
Identify Identify the Establish Ensure
the the Inputs Interaction measuring continual
processes & outputs s to other criteria improvements
processes
Inputs
• Raw material
Output
• Manufacturing Manufacturing Finished product
formulations / Specs
• Equipments
Process
Manufacture /Testing
• Labour
Manufacturing
Process
Purchasing
Sales Process
Process
Warehousing Management
QA process
process review process
Maintenance
process
Understandings &
meeting requirements
PLAN
Continual improvements
Processes in terms
of Processes based on
Of Added Value PDCA Cycle
objective measurements
DO
ACTION
Management
Responsibility
(ACTION)
Product
Realization
(DO)
4 5 6 7 8
Quality Measurement,
Management Resource Product
Management Analysis &
System Responsibility Management Realization
improvement
Identification
Continual of processes
improvements required
4.1 General
requirements Criteria and
processes
Availability of
information &
resources for
operation & control
4 – Quality management system
Quality Policy
Quality Manual
Records
5 – Management responsibility
Establishment of
•Quality Policy
•Quality Objectives
Top
Management’
Identification of Customer requirements
s commitment
Communication of importance of
•Regulatory & statutory requirements
•Meeting customer requirements
•Management Representative •Quality Policy & Quality objectives
•Responsibilities & authorities
•Conducting Management Reviews
•Providing required resources
5 – Management responsibility
New
Development
6 – Resource management
General
Competence,
awareness &
training
6 – Resource management
Resources required to
Implementing, monitoring & continual
improvements
Enhance Customer satisfaction by meeting
customer requirements
Human Resources
Resource
Managemen
t Infrastructures
Infrastructures needed to achieve product
conformity
Work environment
Work environment needed to achieve product
conformity
6 – Human resources Enhanced
6.2
Human Provide training or actions
Resources
Design Changes
7 – Product realization
Planning
•Effective & efficient
•Expectations of interested parties
•EHS
7.3
Design and
Development –
(Product) Design inputs and outputs
7.4
Purchasing
Purchasing is done in
controlled manner to Supplier evaluation
ensure that
purchased products
conforms to specific
requirements
Customers property
Material supplied by customers – e.g.. 3rd party blending
7 – Product realization
Customer Continual
satisfaction improvements
Measurement of
processes Preventive
action
Measurement of
product
8 – Measurements, analysis & improvements
To demonstrate
8.1 - To demonstrate
•Conformity of the product
•Conformity to QMS requirements
•Continually improvements and the effectiveness of the system
8.5 - Improvements
Continual Improvements
•QMS needed to be continually improved
Corrective action
•Actions to prevent recurrence of NCP, NCR etc
•Includes reviews, determination of causes, need of action,
implementation of action, review of action and maintenance of
relevant records
Preventive action
•Actions against potential non conformities to avoid their occurrence
•Includes identification of potential non conformities, cause, need for
action, implementation of action, review of action and maintenance of
records
Criteria for measurements
–Financial measurements
•Prevention cost
System •Non conforming / failure cost
performanc •Lifecycle cost
e
Self assessment
–Internal audits
•Effectiveness & efficiency of processes
•Opportunities for improvements
•Use of data / information
•Effective & efficient use of resources
•Adequacy, accuracy and performance of measurements
•Relationships with customers/ suppliers/ other interested parties
Criteria for measurements
–Process capability / process validation
–Reaction time
Processe –Cycle time / throughput (Capacity)
s –Utilization of technology
–Waste reduction
–Cost reduction
–Conformance rate
–On time delivery
Products
Continual improvements
Management Support
Encouragement / commitment
Resources
QA System
Communication