ISO 9001 : 2000
Anura Senarathna
Objective
Introduce the concept of new ISO 9001:2000 Standard
Highlight important areas and changes of the new standard
Briefly introduce the system requirements of the new standard
Important issues in implementations
What is ISO 9001: 2000
2nd revision of Quality Management System Requirement Standard
from International Organization for Standards
Replacement for previous ISO 9001 / 9002 and 9003 standards of
1994
Single standard (9001) for certification of all types of Organizations
with possible permissible omissions of certain requirements
Introduced considerable conceptual changes
From product centric to customer / business centric approach
New ISO 9001 Model
Management
Responsibility
Measurement,
Resource
analysis &
management QMS improvements
Product
Realization
Continual Improvement cycle
New ISO 9001 Model
Continual Improvement of the QMS
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
System approach to Management
Identifying, understanding and managing interrelated process as a system
contributes to the organization’s effectiveness & efficiency
Continual improvements
Continual improvement of the organization’s overall performance should be a
permanent objective of the organization
Factual approach to decision making
Effective decisions are based on the analysis of data and information
Mutually beneficial supplier relationships
•An organization & its suppliers are interdependent
•Mutually beneficial relationship enhances the ability of both to create
value
Expectations of the New Standard
Avoid the application of systems that are separate from the
organization’s business process
Enable the development of a quality system that is fully integrated
into the business operations of the organization
Enable continual improvements of the system for enhanced
customer satisfaction
Enable compliance to statutory & regulatory requirements
Important Changes
Criteria Previous versions 9001:2000
Main focus Products Customer satisfaction
Approach 20 quality elements Value adding processes
Product Requirements specified by + Statutory & regulatory
requirements customer / organization requirements
Involvement of What to do, When, Whom & + Why it is to be done
people How to do
Improvements Maintain the system Continual improvements
requirements should be achieved
Process Approach
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
Do it for all value adding processes
Process Approach
E.g.: Manufacturing
Process control
•Process parameters
•Inspection & testing
•Calibration and
maintenance of
equipments
Inputs
• Raw material
Output
• Manufacturing Manufacturing Finished product
formulations / Specs
• Equipments
Process
Manufacture /Testing
• Labour
Interactions to Performance Measurement
Inspection & testing
Warehousing •Final testing
Supply / Purchasing •Conformance rate
Sales
Training •Achieving of KPIs
Organizational processes are not in isolation
Linked and interacting with other processes
Manufacturing
Process
Purchasing
Sales Process
Process
Warehousing Management
QA process
process review process
Product development Training & Development
process process
Maintenance
process
Out put of one process will be an input to another process
Process approach: - Continual improvement
Understandings &
meeting requirements
PLAN
Continual improvements
Processes in terms
of Processes based on
Of Added Value PDCA Cycle
objective measurements
DO
ACTION
Measure results of process
Performance and effectiveness
- Objective Measurements
CHECK
ISO 9001:2000 model
Management
Responsibility
(ACTION)
Resource Measure, analysis
General General
Management improvements
requirements (PLAN)
QMS (CHECK)
requirements
Product
Realization
(DO)
Continual Improvement cycle
ISO 9001:2000
System requirements
System Requirements
4 5 6 7 8
Quality Measurement,
Management Resource Product
Management Analysis &
System Responsibility Management Realization
improvement
General Management Provision of Planning General
requirements Commitment resources
Customer Monitoring &
Documentation Customer focus Human related measurement
Requirements resources processes
Quality policy Control of NCP
Infrastructures Design &
development
Planning Analysis of data
Work
environment Purchasing
Responsibility, Improvements
authority &
communication Production &
service
provision
Management
Reviews
4 – Quality management system
Identification
Continual of processes
improvements required
4.1 General
requirements Criteria and
Monitoring and methods to ensure
Measuring of Operation & control
processes
Availability of
information &
resources for
operation & control
4 – Quality management system
4.2 Document requirements
Quality Policy
Quality Objectives – Company objectives & Departmental objectives
Quality Manual
Procedures required by the Standard – (6 procedures)
Procedures required for planning, operation & control of Organization activities
Records
5 – Management responsibility
5.1 5.2 5.3 5.4 5.6 5.7
Management Customer Quality Planning Responsibilit Management
commitment focus policy y authority & Review
communicate
Quality Responsibility & General
objectives authority
Review inputs
QMS planning Management
representative
Review
Internal outputs
communication
5 – Management responsibility
Development, implementation and
continually improvement of QMS
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
Evidence must be provided to show that the Management is committed
to the above requirements
Auditors could speak to and audit Top Management (E.g. MD /
Directors) to establish their commitment to the management system
New
Development
6 – Resource management
6.1 6.2 6.3 6.4
Infrastructures
Provision of Human Work
resources Resources Environment
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
Competent on the basis of appropriate
education, skill and experience
Define competencies for people performing
work affecting product quality
6.2
Human Provide training or actions
Resources
Evaluate effectiveness of the training / actions
Employees should aware importance of the
activity being performed
7 – Product realization
7.1 7.2 7.3 7.4 7.5 7.6
Planning of Customer Design and Purchasing Production Control of
related development & service monitoring
product measuring
realization processes provision
devices
Identification of Design planning Purchasing Control
customer process
requirement
Design inputs Validation of
Purchasing processes
Review of Design outputs information
customer
Identification
requirement
Design review Verification of & traceability
purchased
products
Customer Design verification Customer
communication property
Design validation Preservation
of product
Design Changes
7 – Product realization
Quality objectives of Products – Specs
Processes, procedures to realize
product
7.1
Planning of Product
realization Verification, validation, monitoring,
inspection and testing of product
Record to demonstrate conformance
7 – Product realization
Identification of Customer / Market
requirements
•Specified by customer
•Requirements taken for granted
•Statutory / Regulatory requirements
7.2
Customer related
processes – (Sales) Review of requirements related
product prior to acceptance /
commitment to customers - ability to
meet customer requirements
Effective communication with customer in relation to
•Product information
•Sales order handling
•Customer feedback
•Customer complaints
7 – Product realization
Planning
•Effective & efficient
•Expectations of interested parties
•EHS
7.3
Design and
Development –
(Product) Design inputs and outputs
Review and verification, validation and control of changes
•Accuracy
•Potential hazards & faults
•Corrections
•Evaluations against lessons learned
7 – Product realization
Degree of control depends on effects of
subsequent processes and effect on final
product
7.4
Purchasing
Purchasing is done in
controlled manner to Supplier evaluation
ensure that
purchased products
conforms to specific
requirements
Verification of purchased product – Inspection
and testing
7 – Product realization
Product characteristics
(Specs) Procedures and work instructions
Suitable equipments to manufacture.
7.5 Monitoring and inspection & testing
Production and
service provision
Product release, delivery and post delivery
Manufacturing / service
provision under
controlled condition to
Process validation
ensure conformity of
product
Identification and traceability
Customers property
Material supplied by customers – e.g.. 3rd party blending
7 – Product realization
7.6 Control of monitoring and measuring devices
Control and Calibration of equipments used for monitoring, inspection and
testing
8 – Measurements, analysis & improvements
8.1 8.2 8.3 Control of 8.4 8.5
non
General Monitoring & Analysis of Improvement
conforming
measurements data
product
Customer Continual
satisfaction improvements
Internal audits Corrective
action
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
8.2 - Monitoring and Measurements
•Customer satisfaction / perception
•Internal audits - conformity planned arrangements of QMS and ISO9001
•Monitoring and measurements of processes – to determine /
demonstrate ability of processes to achieve required results
•Monitoring and measurements of product – Conformity to product
requirements
8.3 - Control of NCP
•To assure that NCP products are identified and controlled
to prevent unintended use / delivery
8 – Measurements, analysis & improvements
8.4 - Analysis of data
Collection and analysis of data generated through QMS
activities to verify suitability, effectiveness and continual
improvement of the system
Analysis shall provide information related to
•Customer satisfaction / perception
•Conformity to specs, requirements
•Trends of processes and products
• Opportunities for preventive actions
•Suppliers
8 – Measurements, analysis & improvements
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
System performance requirements
Process performance requirementrs
Product performance requirements
Criteria for measurements
–Satisfaction surveys for customers and other interested
parties
•Feedback on products
•Customer & market requirements
–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
–Inspection and testing of incoming, in process and final product
–Product verification
–Product validation
Pros & Cons
More business oriented. Less procedure oriented
Company wide involvement
Mutual benefit to all interested parties
Customer focus than product focus
Continual improvements
Less emphasis on documentation
More resource demanding ??
Challenges in implementation
Management Support
Encouragement / commitment
Resources
QA System
Communication
Other employee Support
Summing up
Introduce the concept of new ISO 9001:2000 Standard
Highlight important areas and changes of the new standard
ISO 9001:2000 system requirements in brief
Important issues in implementations
Thank You
