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ISO 9001 : 2008(QMS AWARENESS)
BY : MR. JASMIN SUTHAR
SR. ENGINEER – Q.A.GALAXY SIVTEK PVT. LTD.
WHAT IS ISO 9001 : 2008
The International Organization for
Standardization (ISO) brought out in 1987 a set of
standards called ISO 9000 series of standards on
Quality Management System (QMS)
This standard was brought in for the purpose
of establishing a customer oriented quality discipline
in all functions. (Marketing, Design, Engineering,
Production, Procurement, Inspection. Etc.)
HISTORY & EVOLUTION OF ISO
In 1950s, after the world war US defence dept.
established the MIL-Q-9858 standard as contractual
specification for procurement.
In 1979, UK published quality system standard
BS 5750 (3 parts) & BS 5781
In 1987, ISO Geneva published a series of quality system
First amendment was taken in 1994 (ISO 9000 : 1994)
In Dec. 2000, the system was completely reviewed and
new standard ISO 9001 : 2000 series was released
In 2008, ISO 9001 : 2008 series was released (Only
introduced clarifications to the existing requirements of ISO
9001 : 2000 and some changes intended to improve
consistency with ISO 14001 : 2004.
WHY NEED OF ISO
Meet customer requirement
Ger more revenue and business from new
customers
Improve Company and Product Quality
Increase Customer Satisfaction with our Product.
Develop a Professional Culture and Better
Employee Morale
Improve the Consistency of our Operations
Improve Efficiency, Reduce Waste and Save
Money
5
Based on eight
quality
management
principles
Based on eight
quality
management
principles
2. Leadership
2. Leadership
4. Process
approach4. Process
approach
3. Involvement
of people
3. Involvement
of people
5.System
approach to
Management
5.System
approach to
Management6. Continual
improvement6. Continual
improvement
7. Factual
approach to
decision
making
7. Factual
approach to
decision
making
8. Mutual
beneficial
supplier
relationship
8. Mutual
beneficial
supplier
relationship
1. Customer
focus1. Customer
focus
Principles of ISO 9001 : 2008
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1. Customer focus To identify and understand customer needs To satisfy customer requirements To meet customer expectations
2. Leadership Leaders establish unity of purpose, direction of the organization Create and maintain the internal environment in which people can becomes fully involved in achieving the organization’s objective.
QMS PRINCIPLES
7
3. Involvement of People
Full involvement of people at all level enables their abilities to be used for the benefit of the organization.
4. Process approach
Activities and related resources are managed as a process to achieve desired goal
QMS PRINCIPLES Continue
8
5. System approach to Management
Identifying, understanding and managing a system of interrelated processes as a contribution to the organization’s effectiveness and efficiency.
6. Continual Improvement
Must become organization’s permanent objective
QMS PRINCIPLES Continue
9
7. Factual and documented approach to decision making
Effective decision are based on the analysis of data & information.
8. Mutually beneficial relationship with the suppliers
Allows both the organization to create value
QMS PRINCIPLES Continue
10
The Basics of ISOSay What You Do
This means document your systems so you will consistently do the job the same way every time. We must make sure we have appropriate documentation.
Do What You SayThis is what the auditors want to
see. Objective evidence that what you say you are doing in your documentation is what you are doing in practice.
System Requirements / Structure of the Standard
11
Provision of resources
Human resources
Infrastructures
Work environment
6 Resource Management
General requirements
Documentation Requirements
Planning
Customer related processes
Design & development
Purchasing
Production & service provision
Management Commitment
Customer focus
Quality policy
Planning
Responsibility, authority & communication
Management Reviews
5 Management Responsibility
8 Measurement Analysis & improvement
4 Quality Management System
7 Product Realization
General
Monitoring & measurement
Control of NCP
Analysis of data
Improvements
Control of monitoring & measuring equipment
12
4 - Quality management system
4.1 General requirements
1. Determine the processes required For QMS
2. Criteria and methods to ensure Operation & control
3. Availability of information & resources for operation & control
4. Monitoring and Measuring of Processes,Analysis the process
5. Implement action,Continual improvements
13
4 – Quality Management System
General• Documented statement & Quality policy• Quality Manual• Documented Procedure & records
General• Documented statement & Quality policy• Quality Manual• Documented Procedure & records
Quality ManualQuality Manual
Control of Documents• Approve doc. For adequacy• Legible and identifiable• Review and update
Control of Documents• Approve doc. For adequacy• Legible and identifiable• Review and update
Control of records• Identification, storage, protection, retrieval, retention & disposition• Provide evidence of conformity
Control of records• Identification, storage, protection, retrieval, retention & disposition• Provide evidence of conformity
4.2 Documentation requirement
4.2 Documentation requirement
14
5 - Management Responsibility
5.5 Responsibility authority & communicate
5.4 Planning
5.1 Management commitment
5.2 Customer focus
5.6 Management Review
5.3 Quality policy
Quality objectives
QMS planning
General
Review inputs
Review outputsInternal
communication
Management representative
Responsibility & authority
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Development, implementation and continually improvement of QMS
Development, implementation and continually improvement of QMS
Communication of importance of
• Regulatory & statutory requirements• Meeting customer requirements• Quality Policy & Quality objectives• Responsibilities & authorities
Communication of importance of
• Regulatory & statutory requirements• Meeting customer requirements• Quality Policy & Quality objectives• Responsibilities & authorities
•Appointment of Management Representative
•Conducting Management Reviews
•Providing required resources
•Appointment of Management Representative
•Conducting Management Reviews
•Providing required resources
Establishment of
• Quality Policy
• Quality Objectives (measurable & consistent with Quality policy)
Ensuring the availability of resources
Establishment of
• Quality Policy
• Quality Objectives (measurable & consistent with Quality policy)
Ensuring the availability of resources
Identification of Customer requirements & satisfaction
Identification of Customer requirements & satisfaction
Top Management’s commitment
Top Management’s commitment
5 – MANAGEMENT RESPONSIBILITY
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Processes needed for QMS are established, implemented & maintained
Processes needed for QMS are established, implemented & maintained
MR(Responsibility
&Authority)
MR(Responsibility
&Authority)
5 – MANAGEMENT RESPONSIBILITY
Reporting to top management on the Performance of QMS
Reporting to top management on the Performance of QMS
Need for improvement for QMSNeed for improvement for QMS
Liaison with external partiesLiaison with external parties
17
6 - Resource Management
6.4 Work Environment
6.3 Infrastructures
6.2 Human Resources
General
Competence, awareness & training
6.1 Provision of resources
18
6 - Resource Management
Resources required toImplementing, monitoring & continual improvementsEnhance Customer satisfaction by meeting customer requirements
Resources required toImplementing, monitoring & continual improvementsEnhance Customer satisfaction by meeting customer requirements
Human ResourcesHuman Resources
InfrastructuresInfrastructures needed to achieve product conformity
InfrastructuresInfrastructures needed to achieve product conformity
Work environmentWork environment needed to achieve product conformity
Work environmentWork environment needed to achieve product conformity
Resource Management
Resource Management
19
Competent on the basis of appropriate education, skill and experience
Competent on the basis of appropriate education, skill and experience
Define competencies for people performing work affecting product quality
Define competencies for people performing work affecting product quality
Provide training or actionsProvide training or actions
Evaluate effectiveness of the training / actionsEvaluate effectiveness of the training / actions
Employees should aware importance of the activity being performed
Employees should aware importance of the activity being performed
6.2 Human Resources
6.2 Human Resources
6 - Resource Management
20
7 - Product Realization
7.6Control of monitoring & measuring equipment
Control
Preservation of product
Validation of processes
Identification & traceability
Customer property
7.5Production & service provision
Verification of purchased products
Purchasing process
Purchasing information
7.4Purchasing
D&D planning
D&D inputs
D&D outputs
D&D review
Control of D&D Changes
D&D validation
D&D verification
7.3Design and development
7.1Planning of product realization
Determination of requirement related to the product
Review of requirement related to the product
Customer communication
7.2 Customer related processes
21
7 - Product Realization
Quality objectives & requirement of Products
Quality objectives & requirement of Products
Processes, procedures, resources to realize product
Processes, procedures, resources to realize product
Verification, validation, monitoring, inspection and testing of product
Verification, validation, monitoring, inspection and testing of product
Record to demonstrate conformanceRecord to demonstrate conformance
7.1Planning of Product realization
7.1Planning of Product realization
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Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements
Review of requirements related product prior to acceptance / commitment to customers - ability to meet customer requirements
Effective communication with customer in relation to
• Product information• Enquiries, contracts or order handling, including
amendments• Customer feedback, including Customer complaints
Effective communication with customer in relation to
• Product information• Enquiries, contracts or order handling, including
amendments• Customer feedback, including Customer complaints
Identification of Customer / Market requirements
• Specified by customer• Requirements taken for granted• Statutory and regulatory requirements
Identification of Customer / Market requirements
• Specified by customer• Requirements taken for granted• Statutory and regulatory requirements
7.2Customer related processes – (Sales)
7.2Customer related processes – (Sales)
7 - Product Realization
23
Design inputs and outputsDesign inputs and outputs
Review and verification, validation and control of changes•Accuracy•Potential hazards & faults•Corrections•Evaluations against lessons learned
Review and verification, validation and control of changes•Accuracy•Potential hazards & faults•Corrections•Evaluations against lessons learned
Planning (Determine)• stages• review, verification, validation (each
stage)• Responsibility and authority
Planning (Determine)• stages• review, verification, validation (each
stage)• Responsibility and authority
7.3Design and Development
7.3Design and Development
7 - Product Realization
24
Supplier evaluationSupplier evaluation
Verification of purchased product – Inspection and testing
Verification of purchased product – Inspection and testing
Degree of control depends on effects of subsequent processes and effect on final product
Degree of control depends on effects of subsequent processes and effect on final product
7.4Purchasing
Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements
7.4Purchasing
Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements
7 - Product Realization
25
Product characteristics (Specs)
Product characteristics (Specs)
Procedures and work instructionsProcedures and work instructions
Suitable equipments to manufacture. Monitoring and inspection & testing
Suitable equipments to manufacture. Monitoring and inspection & testing
Product release, delivery and post deliveryProduct release, delivery and post delivery
Process validationProcess validation
Identification and traceability Identification and traceability
• Customers property (Identify, verify, protect and safeguard)• Preservation of product (during processing, storage, Handling,
delivery)
• Customers property (Identify, verify, protect and safeguard)• Preservation of product (during processing, storage, Handling,
delivery)
7.5Production and service provisionManufacturing / service provision under controlled condition to ensure conformity of product
7.5Production and service provisionManufacturing / service provision under controlled condition to ensure conformity of product
7 - Product Realization
26
• Calibrate and validate at specific interval• traceable to international measurement standard
• Calibrate and validate at specific interval• traceable to international measurement standard
7.6 Control of monitoring
and measuring equipment
7.6 Control of monitoring
and measuring equipment
7 - Product Realization
• Adjusted or re-adjusted as necessary• Protect from damage and deterioration during handling, maintenance and storage
• Adjusted or re-adjusted as necessary• Protect from damage and deterioration during handling, maintenance and storage
Identification in order to determine its calibration status
Identification in order to determine its calibration status
27
8 - Measurement, analysis and improvement
8.2Monitoring & measurement
8.4Analysis of data
8.5Improvement
8.3 Control of non conforming product
Monitoring &Measurement of product
Internal audits
Customer satisfaction
Monitoring &Measurement of processes
Corrective action
Preventive action
Continual improvements
8.1General
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8 - Measurement, analysis & improvement
To demonstrate•Conformity of the product•Conformity to QMS requirements•Continually improvements and the effectiveness of the system
To demonstrate•Conformity of the product•Conformity to QMS requirements•Continually improvements and the effectiveness of the system
8.2 - Monitoring and Measurements•Measure Customer satisfaction / perception•Conduct Internal audits •Monitoring and measurements of processes – to demonstrate ability to meet planned results•Monitoring and measurements of product – Conformity to product requirements
8.2 - Monitoring and Measurements•Measure Customer satisfaction / perception•Conduct Internal audits •Monitoring and measurements of processes – to demonstrate ability to meet planned results•Monitoring and measurements of product – Conformity to product requirements
8.3 - Control of NCP (Non Conforming Products)•To assure that NCP products are identified and controlled to prevent unintended use / delivery
8.3 - Control of NCP (Non Conforming Products)•To assure that NCP products are identified and controlled to prevent unintended use / delivery
8.1 - To demonstrate•Plan & carried out inspection, testing, measurement, analysis & improvement processes.•Demonstrate that products & services meet defined requirements.•Continually improve the effectiveness of the QMS
8.1 - To demonstrate•Plan & carried out inspection, testing, measurement, analysis & improvement processes.•Demonstrate that products & services meet defined requirements.•Continually improve the effectiveness of the QMS
29
8.4 - Analysis of data
Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system
8.4 - Analysis of data
Collection and analysis of data generated through QMS activities to verify suitability, effectiveness and continual improvement of the system
Analysis shall provide information related to
• Customer satisfaction / perception• Conformity to specs, requirements• Process data & product trends• Opportunities for preventive actions• Suppliers data
8 - Measurement, analysis & improvement
30
8.5 - ImprovementsContinual Improvements
• QMS needed to be continually improved
8.5 - ImprovementsContinual Improvements
• QMS needed to be continually improved
Corrective action• Resolve complaints and nonconformities.• Investigate causes of nonconformities• Record results of investigation.• Corrective action is determined, carried out, effective & reviewed.
Corrective action• Resolve complaints and nonconformities.• Investigate causes of nonconformities• Record results of investigation.• Corrective action is determined, carried out, effective & reviewed.
Preventive action• Use information from many sources to detect, analyze &
eliminate potential causes.• Identify steps needed to prevent problems• Ensure preventive action is effective• Action taken are recorded and reviewed.
Preventive action• Use information from many sources to detect, analyze &
eliminate potential causes.• Identify steps needed to prevent problems• Ensure preventive action is effective• Action taken are recorded and reviewed.
8 - Measurement, analysis & improvement
31
MissionPurpose for which we are working?
VisionWhat we would like to be?
Policy Which path we need to adopt?
ObjectivesWhat we should achieve?
32
ISO 9000 Reminders
• Does NOT define quality• Is NOT a one-time process• Is NOT easy• Requires commitment• Requires resources
33
BY : MR. JASMIN SUTHAR
SR. ENGINEER – Q.A.
GALAXY SIVTEK PVT. LTD.
