6. iso 9000 - implementation.ppt
TRANSCRIPT
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ISO 9000
ImplementationImran Hussain
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ISO 9000: 1994 Clauses
1. Management Responsibility
2. Quality System
3. Contract Review
4. Design Control5. Document Control
6. Purchasing
7. Purchaser Supplied Product
8. Product Identification and Traceability9. Process Control
10. Inspection and Testing
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ISO 9000: 1994 Clauses
11. Inspection Measuring and Test Equipment
12. Inspection and Test Status
13. Control of Non-Conforming Product
14. Corrective Action15. Handling, Storage, Packaging and Delivery
16. Quality Records
17. Internal Quality Audits
18. Training19. Servicing
20. Statistical Techniques
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ISO 9000:2000 Clauses
1. Quality Management System
2. Resource Management
3. Product or Service Realization4. Management Responsibility
5. Measurement, Analysis and Improvement
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ISO 9000: 2000
Quality Management System
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Quality Management System
DocumentationStandard
ISO 9000
Quality Manual
Quality System Procedures
Work Instructions
Forms
LEVEL 1
LEVEL 2
LEVEL 3
LEVEL 4
Policy Statement, Commitment,
Organisation, Responsibilities
Company Practices, Interfaces
Written Instructions
to Control Tasks
Quality
Records
Sales Design Purchasing Manufacturing Accounts Personnel After Sales
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Why have a Quality Policy?
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Need for Quality Policy
All organizations have in mind some principles,beliefs which are their broad guides tomanagerial conduct
These guides rest on a philosophical and ethicalbase
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
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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
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Advantages of Policies
It provides insiders and outsiders with a new, superiorform of predictability, i.e. a written guide to managerialaction
It forces the organization to think about quality
problems to a depth never before achieved. before youwrite it down, you must think it out
It establishes legitimacy and can be communicated in anauthoritative, uniform manner
It permits practices to be audited against that policy
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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
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Corporate Quality Policies
As a company grows, it becomes evident that no oneset of quality policies can fit all company activities
This problem is solved by creating several levels ofquality 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 divisionswith respect to quality
Interdivisional relationships concerning quality
Relationship of quality policies to other company policies
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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, tobe the leader in product quality reputation
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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
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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 companys 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
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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
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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
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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
companys quality performance
Customer service Service operations shall be conducted so as to minimize
customers shutdowns
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Quality Objectives
An objective is an aimed-at-targetan
achievement toward which effort is extended.
Quality objective is an aimed-at-quality target
Quality objectives should be quantifiable in
nature (measurable) - SMART
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Objectives vs. Policies
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Objectives vs. Standards
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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!
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ISO 9000:2000 Clauses
1. Quality Management System
2. Resource Management
3. Product or Service Realization4. Management Responsibility
5. Measurement, Analysis and Improvement
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Quality Management System (QMS)
Concerned with the documentation and
management of the QMS
Sub-clauses:
Quality Manual
Control of documents
Control of records
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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
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Resource Management
Concerned with the provision of resources
needed to implement the QMS
Sub-clauses:
Provision of resources
Human resources
Infrastructure
Work environment
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Product or Service Realization
Concerned with the provision of processes to implement the product orservice
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
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Measurement, Analysis and
Improvement
Concerned with the establishment of a measurement program tomeasure 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
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References
Software Quality Management and ISO 9001, by
Michael Jenner, Ch. 1, 2
A Practical Approach to Software Quality, by
Gerard ORegan, Ch. 3