December 10
Awareness of ISO 9001 : 2008 (QMS) STAN STANDARD DARD Prepared By: Ashraf S. Youssef, Ph. D. QA & Ind. Methods Manager S.M. ASQ, L.A. BSI, M. ELI, M. EMS
اﻟﺘﻮﻋﻴﺔ ﺑﻨﻈﺎم إدارة اﻟﺠﻮدة واﻟﻤﻮاﺻﻔﺔ اﻟﻘﻴﺎﺳﻴﺔ اﻟﺪوﻟﻴﺔ ISO 9001 : 2008
June 27 27,, 2009
Training Approach
• Focu Focus s on Bas Basic ics s • Inte Intera ract ctiv ive e • Exer Exerci cise ses s • Case Case Stud Studie ies s • Role Role Play Plays s • Have Fun Fun !
Learning Objectives • Learn Learn about about Qual Quality ity Management and How it Applies to EEIC • Become Become Familiar Familiar with ISO equ rements rements • Desig Design n you yourr own own QMS QMS • Realize Realize the the Benefi Benefits ts of ISO at EEIC
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December 10
Agenda 1. Introduction Introduction to to Total Total Total Quality Quality Management 2. QMS Principles Princ Principle iples s & ISO 9001 Model 3. 3. ISO ISO 9001 Model & Clauses 4. Key Quality Quality Tools Tools Tools 5. 5. ISO ISO 9001 Certification Realization Process
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Why should my organization implement ISO 9001: 9001:2008 :2008 ?
To keep Customer comi ng again to you
To keep them satisfied for your product
Provide consistent direction to employee
Increase employee awareness of quality
Opportunity for continuous improvement
And that means consistently customer Growing Organiza Organization tion satisfaction & a Growing
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Exercise: What is Quality? • Use the Japan Japanese ese brain brainstor storming ming technique to answer the question. • After the the exercise exercise,, each group group reads reads out out .
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December 10
Dictionary Definitions
• “the degree of excellence which a
thing possesses” • “the feature that makes something
w a
s ”
• “superiority in kind”
Classical Definitions • “fitness for use” (Juran) • “conformance to requirements” (Crosby) • “the totality of features and
characteristics of a product or service that bear on its ability to satisfy given needs” (ASQ)
Quality Dimensions • Meaning Meaning of of quality quality cannot cannot be captured in a simple short statement • Let us us define define some some dimensi dimensions ons of quality for Product
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December 10
Quality Dimensions -- Product Conf Co Conformance nfor orma manc ncee
Dura Du Durability rabil bility ity
Reliability
Serviceability
Features
Aesthetic
Performance
Perceived Product
Source: Total quality and organization organization development development by by Lindsay and and Petrick
What is ISO 9000:2008 QMS?
• ISO = International Organization for Standards • 9000 = code code to denote denote QMS QMS Family Family • 2008 = year year of last last revisi revision on • Is a family family of standards standards for implem implementi enting ng a Quality Management System (QMS)
What is a QMS? • System System for managing managing quality quality System:
a set of logically related processes that turn input into output
Managing:
administering activities and resources to achieve an objective
Quality:
Input Input
customer/user satisfaction
Process
O Output utput
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December 10
ISO is not ... • a prod product uct label label • a produ product ct guara guarante ntee e • assessed assessed by by the ISO organ organizat ization, ion, but but b an inde endent auditor
Timeline • 1945
NATO 6-49
• 1959
MIL-Q-9858A
• 1975
BS 5179
• 1980s
TC 17 176 fo formed by by IS ISO
• 1987
ISO 9000
• 1994
revised IS ISO 9000:1994
• 2000
revised IS ISO 9000:2000
• 2008
revised ISO 9000:2008
ISO 9000 Family
ISO 9000 - fundamentals, fundamenta funda mentals, ls, vocabulary
ISO 9001 - requirements requir req uireme ements nts
ISO 9004 - continual contin con tinual ual improvement guidelines
ISO 19011 - auditing auditing guidelines guidelines guideline s
only ISO ISO 9001 can be used for certification purposes
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December 10
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Why ISO QMS? • Compe Competit titors ors have have it • Require Required d by customer customers s • Helps Helps manage manage compa company ny records records • Clarif arifiies auth uthorit rit & res res onsib nsibil ilit itiies • Improv Improves es perform performan ance ce • Can Can cut cut cost costs s • Global Global accept acceptanc ance e
ISO 9001:2008 QMS Principles 1. 2. 3. 4. . 6. 7.
Cust Custom omer er focu focus s Lead Leader ersh ship ip Invol Involvem vement ent of people people Proc Proces ess s appr approa oach ch
Contin Continua uall imp improv roveme ement nt Factua Factuall approa approach ch to decis decision ion making 8. Mutually Mutually beneficia beneficiall supplier supplier’s ’s relationship
ISO 9000 ISO 9000: :2008 2008
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December 10
QMS Principles & ISO 9001 Model Continual Improvement of the QMS S T N E M E R I U Q E R R E M O T S U C
info. flow
management responsibility
resource management
1.
meas., analysis improvement
product realization
Input Input value adding activities
N O I T C A F I T A S R E M O T S U C
QMS
info. flow
product
O Output utput
value adding activities
Customer Fo Focus
• Organiza Organization tions s depend depend on their customer customers; s; S T N E M E R I U Q E R R E M O T S U C
therefore they should Know
their current and future needs
ee
e r requrem requremen en s
Exceed Get
2.
their expectations
their feedback
N O I T C A F S I T A S R E M O T S U C
Leadership
• Leaders Leaders create create commo common n purpose purpose
management responsibility
and direction; therefore they should Maintain
a healthy internal environment
Inspire
workforce to excel
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December 10
3. Invo Involv lvem emen entt of of Peo Peopl ple e resource management
• People People are are the essence essence of of an organization; organization; therefore They
should be fully involved
Their
abilities should be used for
organization benefits
4. Process Proc Proces esss Approach App Apprroach oach
Manage activities and related resources as a PROCESS
Review Purchase Order
Product
4. Process Proc Proces esss Approach App Apprroach oach S T N E M E R I U Q R R E M O T S U C
Input value adding activities
product realization
product
Output value adding activities
N O I T C A F S I T A S R E M O T S U C
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December 10
5.
Syst System em Appr Approa oach ch to to Man Manag agem emen entt
• Managing Managing interre interrelate lated d processes processes as a system helps the organization in achieving its objectives in an effective and efficient manner
5. System Syst System em Approach Appr Approa oach ch S T N E M E R I U E R R E M O T S U C
N O I T C A F S I
management responsibility
resource management
Input Input value adding activities
6.
meas., analysis improvement
product realization
product
O Output utput value adding activities
A S R E M O T S U C
Cont Contin inua uall Imp Impro rov vemen ementt
• A permanent permanent objecti objective ve of an organizat organization ion should be to grow and improve over time
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December 10
6.
Continual Continu Cont Contin inua ual all Impr Im Improvemen Impro prov ovem vement: emen ent: t: PDCA Cycle Cycle Continual Improvement of the QMS
management responsibility
Plan
resource management
Act
meas., analysis improvement
Check
Do product realization
7.
Factua Factuall Appr Approac oach h to to Decisi Decisionon-Mak Making ing
• Effective Effective decis decisions ions are are based based on the the analysis of data and information S T N E M E R I U Q E R R E M O T S U C
info. flow
management responsibility
meas., analysis improvement
product realization
8.
info. flow
N O I T C A F I T A S R E M O T S U C
Mutual Mutually ly Benefi Beneficia ciall Supp Supplier lier Relati Relations onship hip
• Inte Interr rrel elat ated ed • WinWin-Wi Win n Supplier
product realization
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December 10
ISO 9001 Model & Clauses Continual Improvement of the QMS S T N E M E R I U Q E R R E M O T S U C
info. flow
management responsibility
clause 4 clause QMS
clause 5 clause clause 6 clause resource management
clause 8 clause meas., analysis improvement
clause 7 clause product realization
Input value adding activities
info. flow
Output
product
value adding activities
N O I T C A F S I A S R E M O T S U C
Clauses/Requirements Clause 4. Quality Management System Clause 5. Management Responsibility Clause 6. Resource Management . Clause 8. Measurement, Analysis and Improvement Count the number of requirement categories.
Clause 4: Quality Management System 4.1 Genera Generall requir requirem ement ents s 4.2 Docume Documenta ntatio tion n require requireme ments nts 1. General 2. Quality manual 3. Control of documents 4. Control of records
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December 10
Clause 5: Management Responsibility 5.1 Manag Manageme ement nt commit commitmen mentt 5.2 5.2 Cust Custom omer er foc focus us 5.3 5.3 Qual Qualit ity y pol polic icy y 5.4 Planning 1. Quality objectives 2. QMS planning
Clause 5: Management Responsibility (Cont.)
5.5 Respon Responsib sibili ility ty,, autho authorit rity y and communication 1. Responsibility and authority 2. Management representative 3. Internal communication
5.6 5.6
Mana Manage geme ment nt revie review w 1. General 2. Review input 3. Review output
Clause 6: Resource Management 6.1 Provis Provision ion of resour resources ces 6.2 6.2 Huma Human n reso resour urce ces s 1. General 2. Competence, awareness and training
6.3 6.3 Infr Infras astr truc uctu ture re 6.4 6.4 Work Work envi enviro ronm nmen entt
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December 10
Clause 7: Product Realization 7.1 Plann Planning ing of of produ product ct realiz realizati ation on 7.2 Custom Customerer-rel relate ated d proces processes ses 1. Determination of requirements related to the product 2. Review of requirements related to the product 3. Customer communication
Clause 7: Product Realization (Cont.) 7.3 7.3
Desi Design gn and and dev devel elop opme ment nt 1. Design and development planning 2. Design and development inputs 3. Design and development outputs . 5. Design and development verification 6. Design and development validation 7. Control of design and development changes
Clause 7: Product Realization (Cont.) 7.4 7.4
Purc Purch hasing sing 1. Purchasing process 2. Purchasing information 3. Verification of purchased product
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December 10
Clause 7: Product Realization (Cont.) 7.5 Produc Productio tion n and serv service ice prov provisi ision on 1. Control of production and service provision 2. Validation of processes for production and service provision 3. Identification and traceability 4. Customer property 5. Preservation of product
7.6
Control Control of of monitor monitoring ing and measuring measuring devices devices
Clause 8: Measurement, Analysis, and Improvement
8.1 General 8.2 Monito Monitorin ring g and meas measure uremen mentt 1. Customer satisfaction 2. Internal audit . processes 4. Monitoring and measurement of product
Clause 8: Measurement, Analysis, and Improvement (Cont.) 8.3 Contro Controll of noncon nonconfor formin ming g product product 8.4 8.4 Anal Analys ysis is of data data 8.5 8.5 Impr Improv ovem emen entt 1. Continu Continual al im rovemen rovementt 2. Corrective action 3. Preventive action
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December 10
Key Quality Tools
Documentation Documentation
A Auditing uditing
Why Document? Document for ARCA: Accuracy Repeatability Consistency Accountability
From Standards to Quality Manual
Organization
ISO 9001 Standard
Quality Manual
shall shall shall shall shall sh al all
shall sh al all
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December 10
ISO 9001 Documentation Documentation Structure Policies
The Quality Manual
Procedures (Department) Work Instructions (Job/Task) Quality Records External Documents
ISO 9001 Documentation Documentation Cross Referencing Policies
Level I
Procedures (Department)
Level II
Work Instructions (Job/Task) Quality Records External Documents
Level III
Level IV
Why Audit? The organization shall continually improve the effectiveness of the QMS through the use of the: quality audit
policy and objectives
results
analysis
of data
corrective
and preventive actions
management
review Clause 8.5.1
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December 10
Types of Audits
1st party - audit within your organization
2nd party - auditing your suppliers
3rd party part pa rty y - audit by regulators & registrars
ISO 9001 Certificate Realization Process
Identify Gap
Plan
Document
QM Implement
Evidence Certificate
Register
Gap Analysis Identify Gap
ISO 9001 Standard
Organization
shall shall shall shall shall sha ll sh
shall sh al all
Plan
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December 10
From Standards to Quality Manual
Identify Gap
Document
Organization
ISO 9001 Standard
Quality Manual
shall shall shall shall shall sh al l
shall sh al l
Identify Gap Gap
Implementing Documentation
Document Document
Implement
ISO 9001 an ar
Organization
Implementing Quality Manual
shall shall shall shall shall sh al l
shall sh al l
Getting the Certificate
Identify Gap Gap
Document Document
Implement
Organization
ISO 9001 Standard shall shall shall shall sh al sh al l
Implementing Quality Manual Register
shall shall s ha ha ll ll
Certificate
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December 10
ISO is a Documented System ٥٥
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