Title: The ISO 9002 Quality Assurance Management System
1The ISO 9002 Quality Assurance Management System
2QUALITY EDUCATION
Whole Organization Involvement
Quality Service
3Output
Input
ORGANIZATION WITH LOUSY MANAGEMENT
Q
Resources
4Upgrading
- Service Quality
- Product Quality
- Personnel Quality
By...
5A Proven Successful Quality Assurance System
6ISO 9002 Certification
7A BRIEF INTRODUCTION TO ISO 9000
8QUALITY MANAGEMENT PRINCIPLES
- Customer focus
- Leadership
- Involvement of people
- Process approach
- System approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationships
9ISO 9000 is about QUALITY
- Quality is
- defined by customer needs
- defined in terms of fitness for purpose
- achieved through continuous improvement
- managed through prevention not detection
- getting it right at the first time
- measurable
10ISO stands for
- I nternational
- O rganization for
- S tandardization
11Self-manageableP-D-C-A
- Plan what you do
- Do what you planned record what you did
- Check the results
- Act on the difference
12ISO 9000 REQUIRES
- PLAN, DO, CHECK ACT
- with CONSISTENCY
- CUSTOMER SATISFACTION
- MANAGEMENT SUPPORTS
- RESOURCES MANAGEMENT
- PROCESS MANAGEMENT
- RESULTS ANALYSIS
- CONTINUOUS IMPROVEMENT
13THE CONTINUOUS IMPROVEMENT MECHANISM
14THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
15THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
- CAUSE INVESTIGATION
16THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
- CAUSE INVESTIGATION
- CORRECTIVE ACTION
17THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
- CAUSE INVESTIGATION
- CORRECTIVE ACTION
- PREVENTIVE ACTION
18THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
- CAUSE INVESTIGATION
- CORRECTIVE ACTION
- PREVENTIVE ACTION
- REVIEW
19THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
- CAUSE INVESTIGATION
- CORRECTIVE ACTION
- PREVENTIVE ACTION
- REVIEW
20THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
- CAUSE INVESTIGATION
- CORRECTIVE ACTION
- PREVENTIVE ACTION
- REVIEW
21THE CONTINUOUS IMPROVEMENT MECHANISM
- UNSATISFACTORY OUTCOME
- WORK IMPROVEMENT TEAM
- CAUSE INVESTIGATION
- CORRECTIVE ACTION
- PREVENTIVE ACTION
- REVIEW
21
22Quality Plan
Quality Manual
Q Procedures
Working Instruction Reference Document
23ISO 9000 - 20 Elements
- 4.1 Management Responsibility
- 4.2 Quality System
- 4.3 Contract Review
- 4.4 Design Control
- 4.5 Document Data Control
- 4.6 Purchasing
24ISO 9000 - 20 Elements
- 4.7 Control of Customer Supplied Product
- 4.8 Product Identification and Traceability
- 4.9 Process Control
- 4.10 Inspection and Test Status
- 4.11 Control of Inspection, Measuring and Test
Equipment.
25ISO 9000 - 20 Elements
- 4.12 Inspection and Test Status
- 4.13 Control of Nonconforming
Product - 4.14 Corrective Preventive Action
- 4.15 Handling , Storage, Packaging, Preservation
and Delivery - 4.16 Control of Quality Records
- 4.17 Quality Audits
26ISO 9000 - 20 Elements
- 4.18 Training
- 4.19 Servicing
- 4.20 Statistical Techniques
26
27Stages
- Setting up Steering Committee
- Design of Management System
- Training all Staff
- Setting up documentation system
- Implementation
- Monitoring Evaluation
27
28Stages
- Internal Audit Pre-assessment audit
- Certification Audit
- Registration
- Maintenance of the system
- Internal Q Audit
- Surveillance Visit
28
29Self-manageable
- Plan what you do
- Do what you planned
- Record what you did
- Check the results
- Act on the difference
30Standardized
- Clearly listed requirements / guidelines
- World-wide acceptance
31Systematic
- Inter-relationship of elements
- Comprehensive
- Team work
32Customer-oriented
- Needs defined by customer
- Stress on customer satisfaction
- Enhancement of quality culture
33Objectively assessed
- Internal audit (Self-assessment)
- Audit by 3rd party
- The management system governs
34Clearly Documented
- Data and record control
- Document process
35Human resources planning and control inISO
9001 QMS
365.1 Management commitment
- Top management shall provide evidence of its
commitment to the development and improvement of
the quality management system by - d) Ensuring the availability of necessary
resources
375.5.2 Responsibility and authority
- Functions and their interrelations within the
organization, including responsibilities and
authorities, shall be defined and communicated in
order to facilitate effective quality management.
385.5.4 Internal communication
- The organization shall ensure communication
between its various levels and functions
regarding the processes of the quality management
system and their effectiveness.
396.1 Provision of resources
- The organization shall determine and provide, in
a timely manner, the resources needed - To implement and improve the processes of the
quality management system, and - To address customer satisfaction.
406.2.1 Assignment of personnel
- Personnel who are assigned responsibilities
defined in the quality management system shall be
competent on the basis of applicable education,
training, skills and experience.
416.2.2 Training, awareness and competency
- The organization shall
- Identify competency needs for personnel
performing activities affecting quality - Provide training to satisfy these needs
- Evaluate the effectiveness of the training
provided
426.2.2 Training, awareness and competency
- d) Ensure that its employees are aware of he
relevance and importance of their activities and
how they contribute to the achievement of the
quality objective - e) Maintain appropriate records of education,
experience, training and qualifications.
437.4.1 Purchasing control
- The organization shall control its purchasing
processes to ensure purchased product conforms to
requirements. - The type and extent of control shall be dependent
upon the effect of subsequent realization
processes and their output.
447.4.1 Purchasing control
- The organization shall evaluate and select
suppliers based on their ability to supply
product in accordance with the organizations
requirements. - Criteria for selection on periodic evaluation
shall be defined. - The result of evaluations and follow-up actions
shall be recorded
457.4.2 Purchasing information
- Purchasing documents shall contain information
describing the product to be purchased, including
where appropriate - - personnel
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