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, Commitment,
LEVEL 1
Organisation, Responsibilities

Quality System Procedures

Company Practices, Interfaces
LEVEL 2

Work Instructions
Written Instructions
LEVEL 3 to Control Tasks

Forms Quality
LEVEL 4
Records

Sales Design Purchasing Manufacturing Accounts Personnel After 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