What is ISO 9000:2000 ?

• Three new standards to be published in Q4 ‘00– ISO9000:2000, ISO9001:2000, ISO9004:2000

• Nearly all standards in current ISO9000 series will be withdrawn• New ISO9001 and ISO9004 can be applied to any organisation & industry• Draft International Standard currently available (DIS)• Certification for ISO 9001:2000 can be issued once the final standard is

published (Q4 ‘00)

Fundamentals and Vocabulary; Requirements; Guidance for Improvements

What are the main changes?• A new process-oriented structure and a more logical sequence of the contents• Quality system requirements; 4 sections rather than 20• Reduction in documentation requirements• Emphasis on continual improvement and customer satisfaction• Increased emphasis on the role of top management• Establishment of measurable objectives at relevant functions and levels• Determination of Training Effectiveness

• Addition of the concept of organisational self-assessment as a driver for

improvement • Measurements extend to system, process and product• Analysis of collected data

5 Management Responsibility5.1 Management Commitment (4.1/ 4.1.2.2/4.2.1)5.2 Customer Focus5.3 Quality Policy (4.1.1)5.4 Planning (4.1.1/ 4.2.1/4.2.3)5.5 Administration (4.1.2/4.1.2.1/ 4.1.2.3/4.2.1/4.5/4.16)5.6 Management Review (4.1.3)

6 Resource management

6.1 Provision of resources (4.1.2.2)6.2 Human Resources (4.1.2.1/4.18)6.3 Facilities (4.9)6.4 Work Enviroment (4.9)

8 Measurement, Analysis &

Improvement

8.1 Planning (4.10/4.20)8.2 Measurement & Monitoring of product(4.10/4.17/4.20)8.3 Control of Nonconformity (4.13)8.4 Analysis of data (4.14/4.20)8.5 Improvement (4.1.3/4.9/4.14)

7 Product realization7.1 Planning of realization processes (4.2.3/4.9/4.10/

4.15/4.19)7.2 Customer related Process (4.3/4.7)7.3 Design and/or development (4.4)7.4 Purchasing (4.6)7.5 Production & Service Operation

(4.7/4.8/4.9/4.15/4.19)7.6 Control of measurement devices (4.11)

ISO9K:2K - 4 Sections ?

CD2 DIS FDIS

Translation Adoption

ISO 9001: 2000 Certification

NationalStandardisationBodies

AccreditationBodies

CertificationBodies

Trainers

Auditorupgrade

CertifiedOrganisations

End of 2000 End of 2001 End of 2003

NationalStandardsReleased

SectorSchemes

ISO2000

1994co-existence

International StandardEnd of 1999

New Standard Transition

Accreditation Update Transition

Certification Update Transition

Dec 1999

ISO 9000:2000 Timeline

ISO/DIS 9001::2000 ISO 9001:1994

1 Scope 1

1.1 General

1.2 Permissible exclusions

2 Normative references 2

3 Terms and definitions 3

4 Quality management system

4.1 General requirements 4.2.1

4.2 General documentation requirements 4.2.2

5 Management responsibility

5.1 Management commitment 4.1, 4.1.2.2, 4.2.1

5.2 Customer focus

5.3 Quality policy 4.1.1

5.4 Planning

5.4.1 Quality objectives 4.1.1 + 4.2.1

5.4.2 Quality planning 4.2.3

5.5 Administration

5.5.1 General

5.5.2 Responsibility and authority 4.1.2 + 4.1.2.1

5.5.3 Management representative 4.1.2.3

5.5.4 Internal communication

5.5.5 Quality Manual 4.2.1

5.5.6 Control of documents 4.5

5.5.7 Control of quality records 4.16

5.6 Management review 4.1.3

5.6.1 Review input 4.1.3

5.6.2 Review output 4.1.3

6 Resource management 4.1.2.2

6.1 Provision of resources 4.1.2.2

6.2 Human resources

6.2.1 Assignment of personnel 4.1.2.1

6.2.2 Training, awareness and competency 4.18

6.3 Facilities 4.9

6.4 Work environment 4.9

ISO/DIS 9001::2000 ISO 9001:1994

7 Product realization

7.1 Planning of realization processes 4.2.3, 4.9, 4.10, 4.15, 4.19

7.2 Customer-related processes

7.2.1 Identification of customer requirements

7.2.2 Review of product requirements 4.3

7.2.3 Customer communication

7.3 Design and/or development 4.4

7.3.1 Design and/or development planning 4.4.2 + 4.4.3

7.3.2 Design and/or development inputs 4.4.4

7.3.3 Design and/or development outputs 4.4.5

7.3.4 Design and/or development review 4.4.6

7.3.5 Design and/or development verification 4.4.7

7.3.6 Design and/or development validation 4.4.8

7.3.7 Control of design and/or development changes 4.4.9

7.4 Purchasing

7.4.1 Purchasing control 4.6

7.4.2 Purchasing information 4.6

7.4.3 Verification of purchased products 4.6

7.5 Production and service operations

7.5.1 Operations control 4.9, 4.10, 4.12, 4.19

7.5.2 Identification and traceability 4.8

7.5.3 Customer property 4.7

7.5.4 Preservation of product 4.15

7.5.5 Validation of processes 4.9

7.6 Control of measuring and monitoring devices 4.11

8 Measurement, analysis and improvement

8.1 Planning 4.10 + 4.20

8.2 Measurement and monitoring

8.2.1 Customer satisfaction

8.2.2 Internal audit 4.17

8.2.3 Measurement and monitoring of processes 4.20

8.2.4 Measurement and monitoring of product 4.10 + 4.20

8.3 Control of nonconformity 4.13

8.4 Analysis of data 4.14 + 4.20

8.5 Improvement

8.5.1 Planning for continual improvement 4.1.3 + 4.9

8.5.2 Corrective action 4.14

8.5.3 Preventive action 4.14

Correspondence

Transitioning from ISO 9002:1994 to ISO 9001:2000

The key areas to focus on are:

• Internal auditor training.

• Management awareness.

• General staff awareness programs.

• An understanding of process management and “permissible exclusions”

ISO2000 Vs 1994• Pros

– More modern approach to Quality System– Compatibility with other programs, data driven

decision making; continuous improvement; self assessment; customer focussed

• Cons– Still at Draft stage– New to industry