Anura Senarathna
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ISO 9001 : 2000
Anura Senarathna
Objective Introduce the concept of new ISO 9001:2000 Standard
Highlight important areas and changes of the new standard
Briefly introduce the system requirements of the new standard
Important issues in implementations
What is ISO 9001: 2000 2nd revision of Quality Management System Requirement Standard from International Organization for Standards
Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994
Single standard (9001) for certification of all types of Organizations with possible permissible omissions of certain requirements
Introduced considerable conceptual changes From product centric to customer / business centric approach
New ISO 9001 Model Management Responsibility
Resource management
QMS
Measurement, analysis & improvements
Product Realization
Continual Improvement cycle
New ISO 9001 Model Continual Improvement of the QMS
Information
C U S T O M E R
R e q u i r e m e n t s
Resource Resource management Management
Input
Management Management Responsibility Responsibility
QMS
Product Product Realization Realization
Measurement, Measurement, analysis & Analysis improvements Improvements
Info
Product
S a t i s f a c t i o n
C U S T O M E R
Principles of the New Standard Customer focus Mutual beneficial supplier relationship
Factual approach to decision making Continual improvement
Leadership
Based and developed on eight quality management principles
System approach to Managemen t
Involvement of people
Process approach
Principles of the New Standard Customer focus
•Organization depends customers •Understand current & future customer needs. •Meet / exceed customer expectations
Leadership
•Leaders establish purpose & direction of the organization •Should create & maintain environment to achieve organization’s objectives
Involvement of People
•People of all levels are essence of an organization •Their full involvement for organization’s benefit
Process approach
Desired results are achieved more efficiently when activities and resources are managed as process
Principles of the New Standard System approach to Management
Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency
Continual improvements
Continual improvement of the organization’s overall performance should be a permanent objective of the organization
Factual approach to decision making
Effective decisions are based on the analysis of data and information
Mutually beneficial supplier relationships •An organization & its suppliers are interdependent •Mutually beneficial relationship enhances the ability of both to create value
Expectations of the New Standard Avoid the application of systems that are separate from the organization’s business process
Enable the development of a quality system that is fully integrated into the business operations of the organization
Enable continual improvements of the system for enhanced customer satisfaction
Enable compliance to statutory & regulatory requirements
Important Changes
Criteria
Previous versions
9001:2000
Main focus
Products
Customer satisfaction
Approach
20 quality elements
Value adding processes
Product requirements
Requirements specified by customer / organization
+ Statutory & regulatory requirements
Involvement of people
What to do, When, Whom & How to do
+ Why it is to be done
Improvements
Maintain the system requirements
Continual improvements should be achieved
Process Approach Process definition Set of interrelated and interacting activities which transforms inputs into outputs
Identify the processes
Identify the Inputs & outputs
Identify the Interaction s to other processes
Establish measuring criteria
Do it for all value adding processes
Ensure continual improvements
Process Approach E.g.: Manufacturing Process control •Process parameters •Inspection & testing •Calibration and maintenance of equipments
Inputs • • • •
Raw material Manufacturing formulations / Specs Equipments Manufacture /Testing Labour
Manufacturing Process
Interactions to Inspection & testing Warehousing Supply / Purchasing Sales Training
Output Finished product
Performance Measurement •Final testing •Conformance rate •Achieving of KPIs
Organizational processes are not in isolation Linked and interacting with other processes Manufacturing Process Purchasing Process
Sales Process
Warehousing process
Management review process
Product development process
QA process
Training & Development process Maintenance process
Out put of one process will be an input to another process
Process approach: - Continual improvement Understandings & meeting requirements PLAN
Processes in terms Of Added Value DO
PDCA Cycle
Measure results of process Performance and effectiveness - Objective Measurements CHECK
Continual improvements of Processes based on objective measurements ACTION
ISO 9001:2000 model Management Responsibility (ACTION)
General requirements
Resource Management (PLAN)
QMS
Measure, analysis improvements (CHECK)
Product Realization (DO)
Continual Improvement cycle
General requirements
ISO 9001:2000 System requirements
System Requirements 4
5
6
7
Quality Management System
Management Responsibility
Resource Management
Product Realization
General requirements
Management Commitment
Provision of resources
Planning
General
Documentation Requirements
Customer focus
Human resources
Customer related processes
Monitoring & measurement
Quality policy Planning Responsibility, authority & communication Management Reviews
Infrastructures Work environment
Design & development
8 Measurement, Analysis & improvement
Control of NCP Analysis of data
Purchasing Improvements Production & service provision
4 – Quality management system Identification Continual
of processes
improvements
required
4.1 General requirements
Criteria and
Monitoring and
methods to ensure
Measuring of
Operation & control
processes Availability of information & resources for operation & control
4 – Quality management system 4.2 Document requirements Quality Policy Quality Objectives – Company objectives & Departmental objectives Quality Manual Procedures required by the Standard – (6 procedures) Procedures required for planning, operation & control of Organization activities
Records
5 – Management responsibility 5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.6
Quality objectives
Responsibility & authority
Responsibilit y authority & communicate
5.7 Management Review
General Review inputs
QMS planning
Management representative Internal communication
Review outputs
5 – Management responsibility Development, implementation and continually improvement of QMS Establishment of •Quality Policy •Quality Objectives
Top Management’ s commitment
Identification of Customer requirements
Communication of importance of
•Management Representative •Conducting Management Reviews •Providing required resources
•Regulatory & statutory requirements •Meeting customer requirements •Quality Policy & Quality objectives •Responsibilities & authorities
5 – Management responsibility
Evidence must be provided to show that the Management is committed to the above requirements
Auditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management system
New Development
6 – Resource management 6.1
6.2
Provision of resources
Human Resources
General
Competence, awareness & training
6.3 Infrastructures
6.4 Work Environment
6 – Resource management Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements
Human Resources Resource Managemen t
Infrastructures Infrastructures needed to achieve product conformity
Work environment Work environment needed to achieve product conformity
6 – Human resources
Enhanced
Competent on the basis of appropriate education, skill and experience
Define competencies for people performing work affecting product quality
6.2 Human Resources
Provide training or actions
Evaluate effectiveness of the training / actions
Employees should aware importance of the activity being performed
7 – Product realization 7.1
7.2
7.3
7.4
7.5
7.6
Planning of product realization
Customer related processes
Design and development
Purchasing
Production & service provision
Control of monitoring measuring devices
Identification of customer requirement
Design planning
Purchasing process
Control
Design inputs
Review of customer requirement
Design outputs
Customer communication
Design verification
Design review
Design validation
Design Changes
Purchasing information
Verification of purchased products
Validation of processes Identification & traceability Customer property Preservation of product
7 – Product realization Quality objectives of Products – Specs
Processes, procedures to realize product
7.1 Planning of Product realization
Verification, validation, monitoring, inspection and testing of product
Record to demonstrate conformance
7 – Product realization Identification of Customer / Market requirements •Specified by customer •Requirements taken for granted •Statutory / Regulatory requirements
7.2 Customer related processes – (Sales)
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 •Sales order handling •Customer feedback •Customer complaints
7 – Product realization Planning •Effective & efficient •Expectations of interested parties •EHS
7.3 Design and Development – (Product)
Design inputs and outputs
Review and verification, validation and control of changes •Accuracy •Potential hazards & faults •Corrections •Evaluations against lessons learned
7 – Product realization Degree of control depends on effects of subsequent processes and effect on final product 7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements
Supplier evaluation
Verification of purchased product – Inspection and testing
7 – Product realization Product characteristics (Specs)
Procedures and work instructions
Suitable equipments to manufacture. Monitoring and inspection & testing
7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product
Product release, delivery and post delivery
Process validation
Identification and traceability
Customers property Material supplied by customers – e.g.. 3rd party blending
7 – Product realization 7.6 Control of monitoring and measuring devices Control and Calibration of equipments used for monitoring, inspection and testing
8 – Measurements, analysis & improvements 8.1
8.2
General
Monitoring & measurements
8.3 Control of non conforming product
8.4
8.5
Analysis of data
Improvement
Customer satisfaction
Continual improvements
Internal audits
Corrective action
Measurement of processes Measurement of product
Preventive action
8 – Measurements, analysis & improvements To demonstrate 8.1 - To demonstrate •Conformity of the product •Conformity to QMS requirements •Continually improvements and the effectiveness of the system
8.2 - Monitoring and Measurements •Customer satisfaction / perception •Internal audits - conformity planned arrangements of QMS and ISO9001 •Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results
•Monitoring and measurements of product – Conformity to product requirements
8.3 - Control of NCP •To assure that NCP products are identified and controlled
to prevent unintended use / delivery
8 – Measurements, analysis & improvements 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 •Trends of processes and products • Opportunities for preventive actions •Suppliers
8 – Measurements, analysis & improvements 8.5 - Improvements Continual Improvements •QMS needed to be continually improved
Corrective action •Actions to prevent recurrence of NCP, NCR etc •Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records
Preventive action •Actions against potential non conformities to avoid their occurrence •Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records
Criteria for measurements
System performance requirements
Process performance requirementrs
Product performance requirements
Criteria for measurements –Satisfaction surveys for customers and other interested parties •Feedback on products •Customer & market requirements
System performanc e
–Financial measurements •Prevention cost •Non conforming / failure cost •Lifecycle cost Self assessment
–Internal audits •Effectiveness & efficiency of processes •Opportunities for improvements •Use of data / information •Effective & efficient use of resources •Adequacy, accuracy and performance of measurements •Relationships with customers/ suppliers/ other interested parties
Criteria for measurements Processe s
–Process capability / process validation –Reaction time –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction –Conformance rate –On time delivery
Products
–Inspection and testing of incoming, in process and final product –Product verification –Product validation
Pros & Cons More business oriented. Less procedure oriented
Company wide involvement Mutual benefit to all interested parties Customer focus than product focus Continual improvements Less emphasis on documentation
More resource demanding ??
Challenges in implementation Management Support Encouragement / commitment
Resources QA System
Communication
Other employee Support
Summing up Introduce the concept of new ISO 9001:2000 Standard
Highlight important areas and changes of the new standard
ISO 9001:2000 system requirements in brief
Important issues in implementations
Thank You
Anura Senarathna
Objective Introduce the concept of new ISO 9001:2000 Standard
Highlight important areas and changes of the new standard
Briefly introduce the system requirements of the new standard
Important issues in implementations
What is ISO 9001: 2000 2nd revision of Quality Management System Requirement Standard from International Organization for Standards
Replacement for previous ISO 9001 / 9002 and 9003 standards of 1994
Single standard (9001) for certification of all types of Organizations with possible permissible omissions of certain requirements
Introduced considerable conceptual changes From product centric to customer / business centric approach
New ISO 9001 Model Management Responsibility
Resource management
QMS
Measurement, analysis & improvements
Product Realization
Continual Improvement cycle
New ISO 9001 Model Continual Improvement of the QMS
Information
C U S T O M E R
R e q u i r e m e n t s
Resource Resource management Management
Input
Management Management Responsibility Responsibility
QMS
Product Product Realization Realization
Measurement, Measurement, analysis & Analysis improvements Improvements
Info
Product
S a t i s f a c t i o n
C U S T O M E R
Principles of the New Standard Customer focus Mutual beneficial supplier relationship
Factual approach to decision making Continual improvement
Leadership
Based and developed on eight quality management principles
System approach to Managemen t
Involvement of people
Process approach
Principles of the New Standard Customer focus
•Organization depends customers •Understand current & future customer needs. •Meet / exceed customer expectations
Leadership
•Leaders establish purpose & direction of the organization •Should create & maintain environment to achieve organization’s objectives
Involvement of People
•People of all levels are essence of an organization •Their full involvement for organization’s benefit
Process approach
Desired results are achieved more efficiently when activities and resources are managed as process
Principles of the New Standard System approach to Management
Identifying, understanding and managing interrelated process as a system contributes to the organization’s effectiveness & efficiency
Continual improvements
Continual improvement of the organization’s overall performance should be a permanent objective of the organization
Factual approach to decision making
Effective decisions are based on the analysis of data and information
Mutually beneficial supplier relationships •An organization & its suppliers are interdependent •Mutually beneficial relationship enhances the ability of both to create value
Expectations of the New Standard Avoid the application of systems that are separate from the organization’s business process
Enable the development of a quality system that is fully integrated into the business operations of the organization
Enable continual improvements of the system for enhanced customer satisfaction
Enable compliance to statutory & regulatory requirements
Important Changes
Criteria
Previous versions
9001:2000
Main focus
Products
Customer satisfaction
Approach
20 quality elements
Value adding processes
Product requirements
Requirements specified by customer / organization
+ Statutory & regulatory requirements
Involvement of people
What to do, When, Whom & How to do
+ Why it is to be done
Improvements
Maintain the system requirements
Continual improvements should be achieved
Process Approach Process definition Set of interrelated and interacting activities which transforms inputs into outputs
Identify the processes
Identify the Inputs & outputs
Identify the Interaction s to other processes
Establish measuring criteria
Do it for all value adding processes
Ensure continual improvements
Process Approach E.g.: Manufacturing Process control •Process parameters •Inspection & testing •Calibration and maintenance of equipments
Inputs • • • •
Raw material Manufacturing formulations / Specs Equipments Manufacture /Testing Labour
Manufacturing Process
Interactions to Inspection & testing Warehousing Supply / Purchasing Sales Training
Output Finished product
Performance Measurement •Final testing •Conformance rate •Achieving of KPIs
Organizational processes are not in isolation Linked and interacting with other processes Manufacturing Process Purchasing Process
Sales Process
Warehousing process
Management review process
Product development process
QA process
Training & Development process Maintenance process
Out put of one process will be an input to another process
Process approach: - Continual improvement Understandings & meeting requirements PLAN
Processes in terms Of Added Value DO
PDCA Cycle
Measure results of process Performance and effectiveness - Objective Measurements CHECK
Continual improvements of Processes based on objective measurements ACTION
ISO 9001:2000 model Management Responsibility (ACTION)
General requirements
Resource Management (PLAN)
QMS
Measure, analysis improvements (CHECK)
Product Realization (DO)
Continual Improvement cycle
General requirements
ISO 9001:2000 System requirements
System Requirements 4
5
6
7
Quality Management System
Management Responsibility
Resource Management
Product Realization
General requirements
Management Commitment
Provision of resources
Planning
General
Documentation Requirements
Customer focus
Human resources
Customer related processes
Monitoring & measurement
Quality policy Planning Responsibility, authority & communication Management Reviews
Infrastructures Work environment
Design & development
8 Measurement, Analysis & improvement
Control of NCP Analysis of data
Purchasing Improvements Production & service provision
4 – Quality management system Identification Continual
of processes
improvements
required
4.1 General requirements
Criteria and
Monitoring and
methods to ensure
Measuring of
Operation & control
processes Availability of information & resources for operation & control
4 – Quality management system 4.2 Document requirements Quality Policy Quality Objectives – Company objectives & Departmental objectives Quality Manual Procedures required by the Standard – (6 procedures) Procedures required for planning, operation & control of Organization activities
Records
5 – Management responsibility 5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.6
Quality objectives
Responsibility & authority
Responsibilit y authority & communicate
5.7 Management Review
General Review inputs
QMS planning
Management representative Internal communication
Review outputs
5 – Management responsibility Development, implementation and continually improvement of QMS Establishment of •Quality Policy •Quality Objectives
Top Management’ s commitment
Identification of Customer requirements
Communication of importance of
•Management Representative •Conducting Management Reviews •Providing required resources
•Regulatory & statutory requirements •Meeting customer requirements •Quality Policy & Quality objectives •Responsibilities & authorities
5 – Management responsibility
Evidence must be provided to show that the Management is committed to the above requirements
Auditors could speak to and audit Top Management (E.g. MD / Directors) to establish their commitment to the management system
New Development
6 – Resource management 6.1
6.2
Provision of resources
Human Resources
General
Competence, awareness & training
6.3 Infrastructures
6.4 Work Environment
6 – Resource management Resources required to Implementing, monitoring & continual improvements Enhance Customer satisfaction by meeting customer requirements
Human Resources Resource Managemen t
Infrastructures Infrastructures needed to achieve product conformity
Work environment Work environment needed to achieve product conformity
6 – Human resources
Enhanced
Competent on the basis of appropriate education, skill and experience
Define competencies for people performing work affecting product quality
6.2 Human Resources
Provide training or actions
Evaluate effectiveness of the training / actions
Employees should aware importance of the activity being performed
7 – Product realization 7.1
7.2
7.3
7.4
7.5
7.6
Planning of product realization
Customer related processes
Design and development
Purchasing
Production & service provision
Control of monitoring measuring devices
Identification of customer requirement
Design planning
Purchasing process
Control
Design inputs
Review of customer requirement
Design outputs
Customer communication
Design verification
Design review
Design validation
Design Changes
Purchasing information
Verification of purchased products
Validation of processes Identification & traceability Customer property Preservation of product
7 – Product realization Quality objectives of Products – Specs
Processes, procedures to realize product
7.1 Planning of Product realization
Verification, validation, monitoring, inspection and testing of product
Record to demonstrate conformance
7 – Product realization Identification of Customer / Market requirements •Specified by customer •Requirements taken for granted •Statutory / Regulatory requirements
7.2 Customer related processes – (Sales)
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 •Sales order handling •Customer feedback •Customer complaints
7 – Product realization Planning •Effective & efficient •Expectations of interested parties •EHS
7.3 Design and Development – (Product)
Design inputs and outputs
Review and verification, validation and control of changes •Accuracy •Potential hazards & faults •Corrections •Evaluations against lessons learned
7 – Product realization Degree of control depends on effects of subsequent processes and effect on final product 7.4 Purchasing Purchasing is done in controlled manner to ensure that purchased products conforms to specific requirements
Supplier evaluation
Verification of purchased product – Inspection and testing
7 – Product realization Product characteristics (Specs)
Procedures and work instructions
Suitable equipments to manufacture. Monitoring and inspection & testing
7.5 Production and service provision Manufacturing / service provision under controlled condition to ensure conformity of product
Product release, delivery and post delivery
Process validation
Identification and traceability
Customers property Material supplied by customers – e.g.. 3rd party blending
7 – Product realization 7.6 Control of monitoring and measuring devices Control and Calibration of equipments used for monitoring, inspection and testing
8 – Measurements, analysis & improvements 8.1
8.2
General
Monitoring & measurements
8.3 Control of non conforming product
8.4
8.5
Analysis of data
Improvement
Customer satisfaction
Continual improvements
Internal audits
Corrective action
Measurement of processes Measurement of product
Preventive action
8 – Measurements, analysis & improvements To demonstrate 8.1 - To demonstrate •Conformity of the product •Conformity to QMS requirements •Continually improvements and the effectiveness of the system
8.2 - Monitoring and Measurements •Customer satisfaction / perception •Internal audits - conformity planned arrangements of QMS and ISO9001 •Monitoring and measurements of processes – to determine / demonstrate ability of processes to achieve required results
•Monitoring and measurements of product – Conformity to product requirements
8.3 - Control of NCP •To assure that NCP products are identified and controlled
to prevent unintended use / delivery
8 – Measurements, analysis & improvements 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 •Trends of processes and products • Opportunities for preventive actions •Suppliers
8 – Measurements, analysis & improvements 8.5 - Improvements Continual Improvements •QMS needed to be continually improved
Corrective action •Actions to prevent recurrence of NCP, NCR etc •Includes reviews, determination of causes, need of action, implementation of action, review of action and maintenance of relevant records
Preventive action •Actions against potential non conformities to avoid their occurrence •Includes identification of potential non conformities, cause, need for action, implementation of action, review of action and maintenance of records
Criteria for measurements
System performance requirements
Process performance requirementrs
Product performance requirements
Criteria for measurements –Satisfaction surveys for customers and other interested parties •Feedback on products •Customer & market requirements
System performanc e
–Financial measurements •Prevention cost •Non conforming / failure cost •Lifecycle cost Self assessment
–Internal audits •Effectiveness & efficiency of processes •Opportunities for improvements •Use of data / information •Effective & efficient use of resources •Adequacy, accuracy and performance of measurements •Relationships with customers/ suppliers/ other interested parties
Criteria for measurements Processe s
–Process capability / process validation –Reaction time –Cycle time / throughput (Capacity) –Utilization of technology –Waste reduction –Cost reduction –Conformance rate –On time delivery
Products
–Inspection and testing of incoming, in process and final product –Product verification –Product validation
Pros & Cons More business oriented. Less procedure oriented
Company wide involvement Mutual benefit to all interested parties Customer focus than product focus Continual improvements Less emphasis on documentation
More resource demanding ??
Challenges in implementation Management Support Encouragement / commitment
Resources QA System
Communication
Other employee Support
Summing up Introduce the concept of new ISO 9001:2000 Standard
Highlight important areas and changes of the new standard
ISO 9001:2000 system requirements in brief
Important issues in implementations
Thank You
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