Quality Management System
Understanding our QMS for the achievement of organization and business success.
Objectives of the Orientation
To learn the benefits of implementing the requirements of the quality management system
The effect of not following the requirements.
ISO 9001:2008
Quality Management Systems
- a web of interconnected processes that are used to manage a business.
What is ISO?
ISO is not an acronym for International
Organization for Standardization
The organization’s short name was taken from the Greek word “isos”, meaning “equal”.
International Organization for Standardization
ISO 9001
1. CUSTOMER FOCUS
2. LEADERSHIP
3. INVOLVEMENT OF PEOPLE
4. PROCESS APPROACH
5. SYSTEM APPROACH
6. CONTINUAL IMPROVEMENT
7. FACTUAL APPROACH
8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
8 MANAGEMENT PRINCIPLES
When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach.
All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.
When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach.All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.
Contents
Scope 1.1 General
1.2 Application1
Terms and Definitions3
Normative Reference2
Quality Management System
4.1 General Requirements
4.2 Documentation Requirements4
Contents (cont.)
Management Responsibility
5.1 Management Commitment
5.2 Customer focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management Review
5
Resource Management 6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment
6
Contents (cont.)
Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8
Product Realization 7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
7
Section 1: Scope
Includes the design and construction of cleanroom, ventilation and air conditioning system, metal finishing system, environmental control system for automotive and other industrial or commercial applications.
Exclusion- Design and development validation …
1. Scope
2. Normative Reference
3. Definitions
4.1 Management responsibility
4.1.1 Quality Policy
4.1.2 Organization
4.1.2.1 Responsibility and authority
4.1.2.2 Resources
4.1.2.3 Management representative
4.1.3 Management review
4.2 Quality System
4.2.1 general
4.2.2 quality system procedures
4.2.3 quality planning
4.3 contract review
4.4 design control
4.5 document and data control
4.6 purchasing
4.7 control of customer-supplied product
4.8 product identification and traceability
4.9 process control
4.10 inspection and testing
4.11 Control of inspection, measuring and test equipment
4.12 Inspection and test status
4.13 Control of nonconforming product
4.14 Corrective and preventive action
4.15 Handling, storage, packaging, preservation and delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
ISO 9002:1994ISO 9001:2000 Elements1. Scope2. Normative Reference3. Terms and Definitions4. Quality Management System5. Management Responsibility6. Resource Management7. Product Realization8. Measurement, Analysis and Improvement
Section 2: Normative References
Processes, interaction, improvement The focus is on looking at:
What we do.
Who we are doing it for.
Improving how we provide service.
Section 4: General requirements
Documentation requirements
Control of document
Documents must show a control number, adoption and
revision dates, in order to ensure use of the most recent
information.
Control of records
Each record must be controlled in order to ensure uniform
quality.
Section 4: General requirements
2222
LEVEL 1 - QUALITY MANUAL
1. Quality Policy
2. Quality Objectives
3. Requirement Standard
4. Other Statutory and Regulatory Requirements
Section 4: General requirements
Documentation requirements
Quality manualThe quality manual describes our intent to establish a quality management
system with an emphasis on continual improvement.
Section 4: General requirements
The staff and management of ___ are committed to consistent provision of quality products and services
Quality Policy
that will satisfy the demands and expectations of customersby continual improvement of the QMS and conforming to local standards and prevailing codes of practice.
Section 4: General requirements
Current Objectives
Maintain good business relationship with the clients.
Deliver quality products and services to the
satisfaction of the clients
Effect efficiency in operations by continual
improvement of the Quality Management System.
Improve employee’s competence through periodic
evaluation and development of skills, knowledge and
abilities by providing appropriate training.
For revision
Section 4: General requirements
LEVEL 2 - QUALITY PROCEDURES
1. Control of Documents
2. Control of Records
3. Internal Quality Audits
4. Control of Non-conforming Products
5. Corrective Action
6. Preventive Action
2626
Section 4: General requirements
2727
LEVEL 3 - QUALITY PLAN
1. Incoming Inspection Plan
2. In-Process Inspection Plan
3. Final Test Report/ Inspection Plan
4. Work Instruction
Section 4: General requirements
2828
LEVEL 4 - FORMS / FORMATS/RECORDS
1. Testing Report forms
2. Commissioning Report Forms
3. Inspection forms
4. Check Sheets/Check List
5. Miscellaneous Documentation Forms
Section 4: General requirements
23 MANDATORY RECORDS
1. Management Review
2. Competence, Training and Awareness
3. Planning and Production
4. Review of Requirement Related to Product
5. Design and Development Input
2929
Section 4: General requirements
3030
23 MANDATORY RECORDS (cont’n)
6. Design and Development Output
7. Design and Development Review
8. Design and Development Verification
9. Design and Development Validation
10. Control of Design and Development Changes
Section 4: General requirements
3131
23 MANDATORY RECORDS (cont’n)11. Purchasing Process12. Availability of Monitoring and Measuring Equipment13. Preservation of Product14. Customer Property15. Control of Monitoring and Measuring Equipment16. Standards used for Calibrating Monitoring and Measuring
Equipment
Section 4: General requirements
3232
23 MANDATORY RECORDS (cont’n)17. Identify and Enable Calibration18. Result of Calibration and Verification19. Internal Audit20. Monitoring and Measurement of Product21. Control of Non-conforming Product22. Corrective Action23. Preventive Action
Section 4: General requirements
Summary of Section 5
Management Responsibility Commitment Focus Policy Objectives Planning
These correspond to the following principles:• Customer focus• Leadership
Summary of Section 6
Resource Management Provide quality resources Provide quality personnel Provide quality infrastructure Provide quality environment
This corresponds to the following principle:• Involvement of People
7.1 Plan and develop the processes Include product objectives, relevant processes and resource,
appropriate test and validation
7.2 Customer related processes Customer requirement - stated and implied Statutory and regulatory Product requirements and changes Organization ability Communication with customers
Section 7: Product Realization
Section 7: Product Realization
7.3 Design and development Planning, inputs, outputs, systematic reviews, verification and
validation, control of changes
7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product
Section 7: Product Realization
7.5 Production and service provision Controlled conditions including product characteristics, work
instructions, suitable equipment, measuring devices, and system Release, delivery and post delivery activities Validation of processes when no other method Identification and traceability of product and it’s status Care of customer property Preservation of product
Includes constituent parts
Section 7: Product Realization
7.6 Control of monitoring and measuring devices
Calibrated where necessary
Adjusted and readjusted
Identifies status
Safeguarded from invalid adjustment
Protected from damage or deterioration
Summary of Section 7
Control of the following process
realization planning customer communication product development purchasing function operation monitoring
These correspond to:• Get the facts before you
decide• Focus on customers• Use a process approach• Work with your suppliers
CONTINUAL IMPROVEMENT OF THE QUALITY MANGEMENT SYSTEM
Section 8: Measurement, Analysis & Improvement
GeneralMeasurement and monitoring processes
To demonstrate product conformity, system conformity and
continually improve the Quality Management System.
Customer satisfaction Perception of fulfillment.
Section 8: Measurement, Analysis & Improvement
Monitoring and Measurement
Internal planned audit, etc. Process Auditors, independent of their own work will audit department
process.
Processes Demonstrate achievement of planned results.
Section 8: Measurement, Analysis & Improvement
Monitoring and Measurement
• Product Monitor and measure characteristics. Conformity with acceptance criteria. Waivers / concessions.
• Nonconforming process/product
• Elimination or correction of nonconforming processes.
Section 8: Measurement, Analysis & Improvement
Analysis of data Customer satisfaction Product and process requirements and trends
Suppliers
Section 8: Measurement, Analysis & Improvement
Improvement Continually improve effectiveness
of the system
Corrective action
Preventive action
Section 8: Measurement, Analysis & Improvement
Summary of Section 8
Measurement, Analysis and ImprovementPerform remedial processes
Monitor and measure quality
Control nonconforming products
Analyze quality information
Make quality improvements
This corresponds to:• Get the facts before you decide• Encourage continual improvement
What do you do when accepting a task?
(Answerable by Yes or No)
1. Before accepting an assignment, do you make sure you understand completely what you are supposed to do?
2. Are the deadlines clear? 3. Is it clear how much responsibility and authority
you have in the project?4. Do you know which tasks you can perform on your
own. Without reporting back to your boss?5. Do you let your boss know if a new assignment
makes it difficult for you to do your other jobs?
What do you do when accepting a task (Continuation)
6. Do you make suggestions to make priorities on how much time you will allow the project?
7. Do you get the information and background material you need to do the job properly?
8. Do you try to imagine all the problems and obstacles that could arise while you are doing the job – then plan accordingly?
9. Is it clear who makes decisions when your boss is not available?10. If a problem arises that you can’t handle, do you talk to your boss about the
situation?
Are You Quality-Conscious?(Answerable by True or False)
1. When it comes to quality, there’s always room for improvement.
2. Nobody can be aware of quality needs all the time.
3. Customers pay little attention to quality.
4. A quality program must mesh with the organization’s goals and profit plans.
5. Quality means conformance to standards.
Are You Quality-Conscious? (Continuation)
6. Quality should operate in all parts of a business
7. Personal quality standards and business quality standards have little in common.
8. Quality requires commitment.
9. Quality relates to the process as much as to the goal.
10. People who talk about quality are mostly idealists.