ISO 9000

Implementation
Imran Hussain
 ISO 9000: 1994 Clauses
1. Management Responsibility
2. Quality System
3. Contract Review
4. Design Control
5. Document Control
6. Purchasing
7. Purchaser Supplied Product
8. Product Identification and Traceability
9. Process Control
10. Inspection and Testing
 ISO 9000: 1994 Clauses
11. Inspection Measuring and Test Equipment
12. Inspection and Test Status
13. Control of Non-Conforming Product
14. Corrective Action
15. Handling, Storage, Packaging and Delivery
16. Quality Records
17. Internal Quality Audits
18. Training
19. Servicing
20. Statistical Techniques
 ISO 9000:2000 Clauses
1. Quality Management System
2. Resource Management
3. Product or Service Realization
4. Management Responsibility
5. Measurement, Analysis and
Improvement
 ISO 9000: 2000
Quality Management
System
 Quality Management
System
Documentation Standard
ISO 9000
Quality Manual
Policy Statement,
LEVEL 1
Commitment, Organisation,
Responsibilities

Quality System Procedures

Company Practices,
LEVEL 2
Interfaces

Work Instructions
Written
LEVEL 3 Instructions to
Control Tasks

Forms Quality
LEVEL 4 Records

Sales Desig Purchasi Manufactur Accounts Personn After

n ng ing el Sales
Why have a Quality
Policy?
 Need for Quality Policy
 All organizations have in mind some
principles, beliefs which are their broad
guides to managerial conduct
 These guides rest on a philosophical
and ethical base
 They concern important issues and are
intended to have a long life, i.e. to act
as a stabilizer
 Such principles and beliefs are referred
to as a Quality Policy
 Need for Quality Policy
 When organizations grow, there are
different managers working under which
various employees are working
 Things need to be defined at that stage as
things start becoming ambiguous
 As the unwelcome incidents accumulate,
there arises a growing urge to think
through, write out, and publish quality
policies to serve as guides to managerial
action
 Advantages of Policies
 It provides insiders and outsiders with a
new, superior form of predictability, i.e. a
written guide to managerial action
 It forces the organization to think about
quality problems to a depth never before
achieved. “before you write it down, you
must think it out”
 It establishes legitimacy and can be
communicated in an authoritative, uniform
manner
 It permits practices to be audited against
that policy
 Disadvantages of
Policies
 Major disadvantage is work involved
 Some managers think that written
policies tend to restrict innovation
and to narrow the range of action
available to adapt to changing
conditions
 Corporate Quality
Policies
 As a company grows, it becomes evident
that no one set of quality policies can fit all
company activities
 This problem is solved by creating several
levels of quality policy out of which one is
corporate policy which usually consists of
 The purpose of writing and publishing quality
policies
 A brief statement of corporate intent
 The minimal actions to be taken by the company
divisions with respect to quality
 Interdivisional relationships concerning quality
 Relationship of quality policies to other company
policies
 Corporate Quality
Policies
 A delegation of authority to subordinate
company organization units to establish
subsidiary quality policies appropriate to
their needs
 Summary statement
 It is the policy of the company to provide
products and services of a quality that meet the
initial and continuing needs and expectations of
customers in relation to the price paid and to
the nature of competitive offerings, and in doing
so, to be the leader in product quality reputation
 Corporate Quality
Policies
 Importance of quality
 Leadership in quality has top priority
 Quality shall be given equal priority to costs
and delivery
 Quality competitiveness
 Equal or exceed competitive quality
 Be of the highest quality
 Customer relations
 Provide customer satisfaction
 Meet customer perception of good quality
 Corporate Quality
Policies
 Internal Customers
 We regard the receivers of our work results as
“customers” whose needs are important to understand
and satisfy
 Work Force Involvement
 Our policy is to foster a spirit of pride among employees
regarding the company’s quality performance
 Quality improvement
 Resources will be allocated primarily to the prevention of
defects and corrective action will be focused on rot-cause
identification and elimination
 Divisional Quality
Policies
 The same design shall be used in all
factories making a specific product.
 Quality of design shall be used in all
factories making a specific product
 Quality Policies for
Functional Areas
 Many of the policies are prepared to provide
guidance to managers in specific functional
departments such as product development,
manufacturing and marketing
 New product introduction
 Design reviews shall be conducted with customer,
market and regulatory bodies in order to ensure
the compliance of the design for quality
 Suppliers
 We seek to establish long-term, open relations
with our suppliers
 Quality Policies for
Functional Areas
 Manufacturing
 Manufacturing process capability must be
verified during the product development cycle
 Production
 Involvement and a spirit of pride will be fostered
among employees by encouraging ideas and
resolutions regarding the company’s quality
performance
 Customer service
 Service operations shall be conducted so as to
minimize customers’ shutdowns
 Quality Objectives
 An objective is an aimed-at-target–
an achievement toward which effort
is extended.
 Quality objective is an aimed-at-
quality target
 Quality objectives should be
quantifiable in nature (measurable) -
SMART
Objectives vs. Policies
Objectives vs. Standards
 Implementing ISO
9000:2000
 Awareness Training
 Establish a Team
 Establish ISO 9000 Status
 Prepare Action Plan
 Track Action Plan
 Present Status of Action Plan
 ISO 9000 Readiness Assessment
 Contact Registrar (Certification Body)
 Official ISO 9000 Audit
 Continuous Improvement
 Celebrate!
 ISO 9000:2000 Clauses
1. Quality Management System
2. Resource Management
3. Product or Service Realization
4. Management Responsibility
5. Measurement, Analysis and
Improvement
 Quality Management
System (QMS)
 Concerned with the documentation
and management of the QMS
 Sub-clauses:
 Quality Manual
 Control of documents

 Control of records
 Management
Responsibility
 Concerned with the responsibility of
management in the implementation of the
quality system
 Sub-clauses:
 Management commitment
 Customer focus
 Quality policy
 Planning
 Responsibility, authority, and communication
 Management review
 Resource Management
 Concerned with the provision of
resources needed to implement the
QMS
 Sub-clauses:
 Provision of resources
 Human resources

 Infrastructure

 Work environment
 Product or Service
Realization
 Concerned with the provision of processes to implement
the product or service
 Sub-clauses:
 Planning of product realization
 Customer related processes
 Customer requirements
 Customer communication
 Design and development
 Control of changes
 Purchasing process
 Production and service provision
 Validation of processes
 Identification and traceability
 Customer property
 Preservation of product
 Control of measuring and monitoring devices
Measurement, Analysis and
Improvement
 Concerned with the establishment of a
measurement program to measure QMS
performance and to identify problems
 Sub-clauses:
 Measurement of customer satisfaction
 Internal audits
 Measurement and monitoring of processes
 Measurement and monitoring of product
 Control of nonconformity
 Analysis of data
 Continual improvement
 Corrective action
 Preventive action
 References
 Software Quality Management and
ISO 9001, by Michael Jenner, Ch. 1, 2
 A Practical Approach to Software
Quality, by Gerard O’Regan, Ch. 3