SlideShare a Scribd company logo
1 of 16
TRUPTI. N. SHETE
International Organization
for Standardization
2
ORGANIZATION
WITH
LOUSY MANAGEMENT Q
Input
Output
Resources
Upgrading :
Service Quality
Product Quality
Personnel Quality
3
By...
A Proven Successful
Quality Assurance
System
ISO
9000
4
5
ISO 9002 Certification
ISO stands for
I nternational
O rganization for
S tandardization
6
It is located in Switzerland and established in
1947 to develop common international
standards.
ISO derived from Greek word ISOS means
equal , homogeneous or uniform.
Main idea behind the development of ISO –
9000 is to maintain uniformity in the existing
quality standards
ISO 9001 and ISO 14001 in
brief
 ISO 9001 and ISO 14001 are among ISO's most well
known standards ever.
 They are implemented by more than a million
organizations in some 175 countries.
 ISO 9001 helps organizations to implement quality
management.
 ISO 14001 helps organizations to implement
environmental management.
Quality management
 ISO 9001 is for quality management.
 Quality refers to all those features of a product (or
service) which are required by the customer.
 Quality management means what the organization does
to
 ensure that its products or services satisfy the customer's
quality requirements and
 comply with any regulations applicable to those products
or services.
 achieve continual improvement of its performance
Environmental management
 ISO 14001 is for environmental
management. This means what the
organization does to:
 minimize harmful effects on the
environment caused by its activities,
 to conform to applicable regulatory
requirements, and to
 achieve continual improvement of its
environmental performance.
Objectives of ISO 9000 Standards
 Achieve, maintain, and improve product
quality
 Improve quality of operations to
continually meet customers’ and
stakeholders’ needs
 Provide confidence to management,
employees, customers, and stakeholders
that quality requirements are fulfilled
11
Why adopt ISO 9000?
 To comply with customers who require
ISO 9000
 To sell in the European Union market
 To compete in domestic markets
 To improve the quality system
 To minimize repetitive auditing by similar
and different customers
IS 9000
Benefits of ISO 9001
Enable to foreign exchange
It enable the company to build customer confidence
Concession for import
To enhance quality image of the company & gives a
competitive edge over other company.
Helps in minimising the total cost of an organisation.
Helps in motivating an organisation.
Increase efficiency and effectiveness.
Ten Steps to ISO Registration
ISO 9000
2. Select the appropriate standard
1. Set the registration objective
3. Develop and implement the quality system
4. Select a third-party registrar and apply
5. Perform self-analysis audit
6. Submit quality manual for approval
7. Pre-assessment by registrar
8. Take corrective actions
9. Final assessment by registrar
10. Registration!
Problems with Certification
 Costs - application & maintenance
 Time - application & maintenance
 Level of internal expertise
 Executive commitment
 Selection of registration
15
Thank
You
Have a Good Day

More Related Content

What's hot

Process validation and its types
Process validation and its typesProcess validation and its types
Process validation and its typesAnjali9410
 
ISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-I
ISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-IISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-I
ISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-Isnigdharanibehera
 
Quality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsQuality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsVivek Jain
 
ICH GUIDELINE SPECIFIC WITH Q SERIES
ICH GUIDELINE SPECIFIC WITH Q SERIESICH GUIDELINE SPECIFIC WITH Q SERIES
ICH GUIDELINE SPECIFIC WITH Q SERIESHEALY LAD
 
In process & finished products quality control test for pharmaceuticals
In process & finished products quality control test for pharmaceuticalsIn process & finished products quality control test for pharmaceuticals
In process & finished products quality control test for pharmaceuticalsSuraj Ghorpade
 
Quality control test for packaging material ,qc test for glass,metal,rubber
Quality control test for packaging material ,qc test for glass,metal,rubberQuality control test for packaging material ,qc test for glass,metal,rubber
Quality control test for packaging material ,qc test for glass,metal,rubberKunalPatel257
 
ISO 9000
ISO 9000ISO 9000
ISO 900017somya
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)Swapnil Fernandes
 
Technology transfer from R&D to production
Technology transfer from R&D to productionTechnology transfer from R&D to production
Technology transfer from R&D to productionDeepak Shanbhag
 
Quality control on secondary packaging materials
Quality control on secondary packaging materialsQuality control on secondary packaging materials
Quality control on secondary packaging materialsAnupriyaNR
 
THE ROLE OF QA IN PHARMACEUTICALS
THE ROLE OF QA IN PHARMACEUTICALSTHE ROLE OF QA IN PHARMACEUTICALS
THE ROLE OF QA IN PHARMACEUTICALSKostas Skopelitis
 
Quality Management System
Quality Management SystemQuality Management System
Quality Management SystemSumit Bansal
 
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )JAYACHANDRA AKUTHOTA
 
Out of specification shravan
Out of specification shravanOut of specification shravan
Out of specification shravanshravan dubey
 
Iso (International organization for standardization)
Iso (International organization for standardization)Iso (International organization for standardization)
Iso (International organization for standardization)Shreya Jain
 
Ich guidelines for stability studies 1
Ich guidelines for stability studies 1Ich guidelines for stability studies 1
Ich guidelines for stability studies 1priyanka odela
 

What's hot (20)

Process validation and its types
Process validation and its typesProcess validation and its types
Process validation and its types
 
ISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-I
ISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-IISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-I
ISO9000 & ISO14000, B.PHARMACY, 6TH SEM,PHARMACEUTICAL QUALITY ASSURANCE, UNIT-I
 
Quality Assurance and Quality Management Concepts
Quality Assurance and Quality Management ConceptsQuality Assurance and Quality Management Concepts
Quality Assurance and Quality Management Concepts
 
ICH GUIDELINE SPECIFIC WITH Q SERIES
ICH GUIDELINE SPECIFIC WITH Q SERIESICH GUIDELINE SPECIFIC WITH Q SERIES
ICH GUIDELINE SPECIFIC WITH Q SERIES
 
In process & finished products quality control test for pharmaceuticals
In process & finished products quality control test for pharmaceuticalsIn process & finished products quality control test for pharmaceuticals
In process & finished products quality control test for pharmaceuticals
 
ISO 9000
ISO 9000ISO 9000
ISO 9000
 
Quality control test for packaging material ,qc test for glass,metal,rubber
Quality control test for packaging material ,qc test for glass,metal,rubberQuality control test for packaging material ,qc test for glass,metal,rubber
Quality control test for packaging material ,qc test for glass,metal,rubber
 
ISO 9000
ISO 9000ISO 9000
ISO 9000
 
Validation master plan
Validation master planValidation master plan
Validation master plan
 
Common Technical Document (CTD)
Common Technical Document (CTD)Common Technical Document (CTD)
Common Technical Document (CTD)
 
Technology transfer from R&D to production
Technology transfer from R&D to productionTechnology transfer from R&D to production
Technology transfer from R&D to production
 
Quality control on secondary packaging materials
Quality control on secondary packaging materialsQuality control on secondary packaging materials
Quality control on secondary packaging materials
 
ISO 14000
ISO 14000ISO 14000
ISO 14000
 
THE ROLE OF QA IN PHARMACEUTICALS
THE ROLE OF QA IN PHARMACEUTICALSTHE ROLE OF QA IN PHARMACEUTICALS
THE ROLE OF QA IN PHARMACEUTICALS
 
Quality Management System
Quality Management SystemQuality Management System
Quality Management System
 
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
 
Out of specification shravan
Out of specification shravanOut of specification shravan
Out of specification shravan
 
Iso (International organization for standardization)
Iso (International organization for standardization)Iso (International organization for standardization)
Iso (International organization for standardization)
 
Ich guidelines for stability studies 1
Ich guidelines for stability studies 1Ich guidelines for stability studies 1
Ich guidelines for stability studies 1
 
ISO 9000 & ISO 14000
ISO 9000 & ISO 14000ISO 9000 & ISO 14000
ISO 9000 & ISO 14000
 

Similar to iso-9000 (20)

Iso9000 &iso14000
Iso9000 &iso14000Iso9000 &iso14000
Iso9000 &iso14000
 
Quality standards as per iso
Quality  standards  as  per  isoQuality  standards  as  per  iso
Quality standards as per iso
 
Iso 9000 and 14000
Iso 9000 and 14000Iso 9000 and 14000
Iso 9000 and 14000
 
iso info
iso infoiso info
iso info
 
6. ISO.pptx
6. ISO.pptx6. ISO.pptx
6. ISO.pptx
 
ISO 9001: 2008 QMS Awareness PPT
ISO 9001: 2008 QMS Awareness PPTISO 9001: 2008 QMS Awareness PPT
ISO 9001: 2008 QMS Awareness PPT
 
Iso 9000 (2)
Iso 9000 (2)Iso 9000 (2)
Iso 9000 (2)
 
Iso new
Iso newIso new
Iso new
 
ISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATIONISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ISO INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
 
QUALITY STANDARDS
QUALITY STANDARDSQUALITY STANDARDS
QUALITY STANDARDS
 
iso 9001 &14001
iso 9001 &14001iso 9001 &14001
iso 9001 &14001
 
Iso
IsoIso
Iso
 
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION(ISO)
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION(ISO)INTERNATIONAL ORGANIZATION FOR STANDARDIZATION(ISO)
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION(ISO)
 
ISO Standards
ISO StandardsISO Standards
ISO Standards
 
Iso shz
Iso shzIso shz
Iso shz
 
Iso
IsoIso
Iso
 
Iso 9001 2008
Iso 9001 2008Iso 9001 2008
Iso 9001 2008
 
BIS and ISO
BIS and ISOBIS and ISO
BIS and ISO
 
ISO 9001 2000
ISO 9001 2000ISO 9001 2000
ISO 9001 2000
 
Management of ISO Quality
Management of ISO QualityManagement of ISO Quality
Management of ISO Quality
 

iso-9000

  • 1. TRUPTI. N. SHETE International Organization for Standardization
  • 3. Upgrading : Service Quality Product Quality Personnel Quality 3 By...
  • 4. A Proven Successful Quality Assurance System ISO 9000 4
  • 6. ISO stands for I nternational O rganization for S tandardization 6
  • 7. It is located in Switzerland and established in 1947 to develop common international standards. ISO derived from Greek word ISOS means equal , homogeneous or uniform. Main idea behind the development of ISO – 9000 is to maintain uniformity in the existing quality standards
  • 8. ISO 9001 and ISO 14001 in brief  ISO 9001 and ISO 14001 are among ISO's most well known standards ever.  They are implemented by more than a million organizations in some 175 countries.  ISO 9001 helps organizations to implement quality management.  ISO 14001 helps organizations to implement environmental management.
  • 9. Quality management  ISO 9001 is for quality management.  Quality refers to all those features of a product (or service) which are required by the customer.  Quality management means what the organization does to  ensure that its products or services satisfy the customer's quality requirements and  comply with any regulations applicable to those products or services.  achieve continual improvement of its performance
  • 10. Environmental management  ISO 14001 is for environmental management. This means what the organization does to:  minimize harmful effects on the environment caused by its activities,  to conform to applicable regulatory requirements, and to  achieve continual improvement of its environmental performance.
  • 11. Objectives of ISO 9000 Standards  Achieve, maintain, and improve product quality  Improve quality of operations to continually meet customers’ and stakeholders’ needs  Provide confidence to management, employees, customers, and stakeholders that quality requirements are fulfilled 11
  • 12. Why adopt ISO 9000?  To comply with customers who require ISO 9000  To sell in the European Union market  To compete in domestic markets  To improve the quality system  To minimize repetitive auditing by similar and different customers IS 9000
  • 13. Benefits of ISO 9001 Enable to foreign exchange It enable the company to build customer confidence Concession for import To enhance quality image of the company & gives a competitive edge over other company. Helps in minimising the total cost of an organisation. Helps in motivating an organisation. Increase efficiency and effectiveness.
  • 14. Ten Steps to ISO Registration ISO 9000 2. Select the appropriate standard 1. Set the registration objective 3. Develop and implement the quality system 4. Select a third-party registrar and apply 5. Perform self-analysis audit 6. Submit quality manual for approval 7. Pre-assessment by registrar 8. Take corrective actions 9. Final assessment by registrar 10. Registration!
  • 15. Problems with Certification  Costs - application & maintenance  Time - application & maintenance  Level of internal expertise  Executive commitment  Selection of registration 15