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ISO 9001 : 2000ISO 9001 : 2000ISO 9004 : 2000ISO 9004 : 2000
AgustiniWest Coast University
(ISO : International Organization for Standardization’s)
ISO 9001 and ISO 9004 in brief
ISO 9001 and ISO 9004 are among ISO's most well known standards ever.
ISO 9001 helps organizations to implement quality management systems-requirements.
ISO 9004 helps organizations to implement quality management systems- guidelines for performance improvements.
Future ISO 9000 Family(Subject to Ballot)
ISO9000 Core
Standards
Brochures
9000 9001 900419011
10012
Withdrawor transfer
to otherTC
9000-39000-49004-29004-39004-410005
OtherISO9000
Standards
TechnicalReports
10006**10007**100131001410015**10017
** Document status TR to be considered at next revision
•QMP•Sel & Use•Small Bus Handbook
TS16949
Technical Specs
EXPECTED QUALITY
by the Customer
PLANNED QUALITY
by the Company
PRODUCED QUALITY
by the Company
PERCEIVEDQUALITY
by the Customer
Measurement of the Performance of the Company
Measurement of theClient’s satisfaction
The ISO 9000:2000 requirementsThe ISO 9000:2000 requirements
“A COHERENT PAIR”:
•ISO 9001:2000 – Quality Management Systems: REQUIREMENTS (WHAT ?)ISO 9001 oriented effectiveness and certification,
•ISO 9004:2000 - Quality Management Systems: GUIDELINES FOR PERFORMANCE IMPROVEMENTS(HOW ...?)
ISO 9004 oriented effectiveness and efficiency
Presentation of ISO 9000:2000
Relationship ISO 9001/ISO 9004 2 stand-alone standards, each being part of a
“consistent pair” Common structure based on “Process
Approach” Harmonized terminology Based on 8 “Quality Management Principles”
previously endorsed by ISO/TC176
TC :Technical Committee
The eight Quality Management Principles (ISO 9000 Principles) :1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. Systems Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually beneficial supplier relationship
Process-based structure
Management responsibility Policy, objectives, planning, system, review
Resource management Human resources, information, facilities
Product realization Customer, design, purchasing, production, calibration
Measurement, analysis and improvement Audit, process/product control, improvement
Basic process model
MANAGEMENT
ACTIVITIES
ENABLERS
CUSTOMER
INPUTS
CUSTOMERSATISFACTION
DESIRED
OUTPUTS
The 9 criteria of the EFQM Model
The percentages were established following a wide ranging survey to collect views
We acknowledge here the key role of leadership, policy and strategy, the management of people and the management of partnerships and resources.
EFQM : European Foundation for Quality Management
The percentages were established following a wide ranging survey to collect views
We acknowledge here the key role of leadership, policy and strategy, the management of people and the management of partnerships and resources.
EFQM : European Foundation for Quality Management
Leadership100 points
(10%)
Leadership100 points
(10%)
Processes140 points
(14%)
Processes140 points
(14%)
Key Performance
Results150 points
(15%)
Key Performance
Results150 points
(15%)
People90 points (9%)
People90 points (9%)
Policy and Strategy
80 points (8%)
Partnerships &Resources
90 points (9%)
Partnerships &Resources
90 points (9%)
People Results90 points (9%)
People Results90 points (9%)
CustomerResults
200 points (20%)
CustomerResults
200 points (20%)
Society Results60 points (6%)
Society Results60 points (6%)
Capacity 500 points (50%) Results 500 points (50%)
ResultsEnablers
Management
responsibility
Measurement ,
analysis ,
improvement
Resource
management
QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT OF
C
u
s
t
o
m
e
r
Requ
ir
ements
C
u
s
t
o
m
e
rProduct
realizationInput Output
Product
S
atisfaction
Process Model (ISO 9001:2000)
Management
responsibility
Measurement ,
analysis ,improvement
Resource
management
QUALITY MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT OF
Requirements
Productrealization
Input OutputProduct
Satisfaction
Interested
Parties
Interested
Parties
Process Model (ISO 9004:2000)
Development process for
ISO 9001 and ISO 9004 User surveys Specifications Project approach
Review of comments received Verification process Validation pilot studies
Extensive use of electronic communications
“To provide confidence, as a result of demonstration, in product conformance to
established requirements”
ISO 9001:2000 - ISO 9001:2000 - RequirementsRequirements
Understand the role of ISO 9001 standard: Product and/or service quality oriented Confidence to own management Confidence to customers ‘Established requirements’ Customer satisfaction
“Benefits for all interested parties through sustained customer
satisfaction”
ISO 9004:2000 - Guidelines
ISO 9004:2000
ISO 9004 completely re-written Revised terminology, harmonized with ISO
9001 Annex on self-assessment added Includes the requirements from ISO 9001 (in
clearly delineated boxes). More “user-friendly” Benefits “For all interested parties”
Think Performance Improvement… Think ISO 9004!! Increase profits
leadership and customer focus
clear objectives
increased efficiency
improved employee performance
employee and customer satisfaction
efficient use of resources
Potential Benefits Potential Benefits and Opportunities for and Opportunities for
OrganizationsOrganizations
What the new standard What the new standard means for your means for your organisationorganisation Customer focus
Need to stop and think: “Who are my customers?” “What do they really want?” “What are my key processes to be sure they get what
they want?” “Does that tie in with what I want??”
More emphasis on defining objectives Providing leadership
Better integration of Better integration of QMSQMS
Better integration of QMS into the Day-to-Day running of the Business
Need to define and understand key processes Inputs Outputs Measurements
Quality Management StyleQuality Management Style
Focus on the entire system Customer is main concern Communication at all levels Continuous Improvement Responsibility assigned
Why Implement a Why Implement a QMS?QMS?(ISO 9000)(ISO 9000) Ensure Customer Satisfaction Improve Quality System Enhance Control of Resources Improve Suppliers Performance
Analysis of Data
OrganizationalObjectives
Customer requirements
Statutory & regulatory
requirements
Defect rate and customer returns
QMS controls
Purchasing
Examples of objectives set by the Organization
Analysis of Data
Examples of results
recorded by the
Organization
OrganizationalResults
Customer satisfaction
Statutory & regulatory compliance
Quality system metrics
Inspection and test
Supplier performance
OrganizationalObjectivesCustomer
requirements
Statutory & regulatory
requirements
Defect rate and customer returns
QMS controls
Purchasing
Effectiveness of the QMS
OrganizationalObjectives
OrganizationalResults
0 0
100 100
The gap measures the lack of effectiveness of the quality management system.
The narrower the gap, the more effective the QMS.
Things are looking good!
Effectiveness of the QMS
OrganizationalObjectives
OrganizationalResults
0 0
100 100
Management should get a wake up warning!
The gap measures the lack of effectiveness of the quality management system.
Effectiveness of the QMS
OrganizationalObjectives
OrganizationalResults
The Organization is in trouble!
The gap measures the lack of effectiveness of the quality management system.
Improvement in the QMS
OrganizationalObjectives
OrganizationalResults
% 100 75 50 25 0
Improvement can also be measured
Improvement in the QMS
Improvement in the QMS
OrganizationalObjectives
OrganizationalResults
Customer Focus
Corrective Action
Procurement
Improvement Initiatives
These actions may cause the organization to revise its objectives.
Management ReviewManagement Review
OrganizationalObjectives
OrganizationalResults
0 0
100 100
Customer Focus
Corrective Action
Procurement
Improvement Initiatives
Management Review
The improvement processes are also evaluated during management review meetings and appropriate action taken.
Which may cause the organization to again revise its objectives.
OpportunitiesOpportunities
“Use the QMS as a useful MANAGEMENT tool, not just “to show the auditor”
Better understanding of customer needs Beyond “Compliance” towards “Excellence” Beyond “Effectiveness” towards “Efficiency”
Conclusion:Conclusion:
The eight Quality Management Principles are the foundation of a Quality Management System.
Stepping stone to performance improvement.
Stepping-Stone to Stepping-Stone to ExcellenceExcellence
Alignment ISO 9001 and ISO 9004 ISO 9004 for self-assessment of maturity Focus on improvement in performance Compatibility with Quality Awards
Thank YouThank You