TERMINOLOGY OF ISO
9001:2000
By
KOESWIDIJONO
ISO
• ISO : THE INTERNATIONAL ORGANIZATION
FOR STANDARDIZATION IS A WORLDWIDE
FEDERATION OF NATIONAL STANDARDS
BODIES (ISO MEMBER BODIES)
• THE WORK OF PREPARING INTERNATIONAL
STANDARDS IS NORMALLY CARRIED OUT
THROUGH ISO TECHNICAL COMMITTEES
HISTORY
• THE TEXT OF ISO 9000:2000 HAS BEEN
PREPARED BY TECHNICAL
COMMITTEE IS0/TC 176 “QUALITY
MANAGEMENT AND QUALITY
ASSURANCE”
• THE EUROPEAN STANDARD
SUPERSEDES EN ISO 8402:1995
REFERENCE
•
•
•
•
EUROPEAN STANDARD
EN ISO 9000
ENGLISH VERSION
QUALITY MANAGEMENT SYSTEMS –
FUNDAMENTALS AND VOCABULARY
• IT WAS APPROVED ON 15 DEC 2000
• REF No.EN ISO 9000:2000 E
• FOR ACADEMIC PURPOSE ONLY.
HISTORY
• THE TEXT OF ISO 9000:2000 HAS BEEN
PREPARED BY TECHNICAL
COMMITTEE IS0/TC 176 “QUALITY
MANAGEMENT AND QUALITY
ASSURANCE”
• THE EUROPEAN STANDARD
SUPERSEDES EN ISO 8402:1995
ISO 9000 FAMILY
• ISO 9000 : FUNDAMENTALS OF
QUALITY MANAGEMENT SYSTEMS
(QMS)AND SPECIFIES THE
TERMINOLOGY FOR QMS.
• ISO 9001: REQUIREMENTS
• ISO 9004: IMPROVEMENT OF
PERFORMANCE
• ISO 19011: AUDITING QMS AND QMES
TERM AND DEFINITIONS
RELATING TO :
• 1.QUALITY
• 2.MANAGEMENT
• 3. ORGANIZATION
• 4. PROCESS AND PRODUCT
• 5.CHARACTERISTICS
• 6. CONFORMITY
TERM AND DEFINITIONS
RELATING TO:
• 7. DOCUMENTATION
• 8. EXAMINATION
• 9. AUDIT
• 10.QUALITY ASSURANCE FOR
MEASUREMENT PROCESSES
1. RELATING TO
QUALITY
1.QUALITY
DEGREE TO WHICH A SET OF
INHERENT CHARACTERISTICS
FULFILS REQUIREMENTS
2.REQUIREMENT
NEED OR EXPECTATION THAT IS
STATED, GENERALLY IMPLIED OR
OBLIGATORY
1. RELATING TO
QUALITY
3.CUSTOMER SATISFACTION
CUSTOMER’S PERCEPTION OF THE DEGREE
TO WHICH THE CUSTOMER’S
REQUIREMENTS HAVE BEEN FULFILLED
4.CAPABILITY
ABILITY OF AN ORGANIZATION, SYSTEM, OR
PROCESS TO REALIZE A PRODUCT THAT
WILL FULFIL THE REQUIREMENTS FOR THAT
PRODUCT
2. RELATING TO
MANAGEMENT
1.SYSTEM
SET OF INTERRELATED OR
INTERACTING ELEMENTS
2.MANAGEMENT SYSTEM
SYSTEM TO ESTABLISH POLICY AND
OBJECTIVES AND TO ACHIEV THOSE
OBJECTIVES
2. RELATING TO
MANAGEMENT
3.QUALITY MANAGEMENT SYSTEM
MANAGEMENT SYSTEM TO DIRECT
AND CONTROL AN ORGANIZATION
WITH REGARDS TO QUALITY
4.QUALITY POLICY
OVERALL INTENTIONS AND DIRECTION
OF AN ORGANIZATION RELATED TO
QUALITY AS FORMALLY EXPRESSED
BY TOP MANAGEMENT
2. RELATING TO
MANAGEMENT
5.QUALITY OBJECTIVE
SOMETHING SOUGHT, OR AIMED FOR,
RELATED TO QUALITY
6.MANAGEMENT
COORDINATED ACTIVITIES TO DIRECT
AND CONTROL AN ORGANIZATION
2. RELATING TO
MANAGEMENT
7.TOP MANAGEMENT
PERSON OR GROUP OF PEOPLE WHO
DIRECTS AND CONTROLS AN
ORGANIZATION AT THE HIGHEST
LEVEL
8.QUALITY MANAGEMENT
COORDINATED ACTIVITIES TO DIRECT
AND CONTROL AN ORGANIZATION
WITH REGARDS TO QUALITY
2. RELATING TO
MANAGEMENT
9. QUALITY ASSURANCE
PART OF QUALITY MANAGEMENT FOCUSED
ON PROVIDING CONFIDENCE THAT QUALITY
REQUIREMENTS WILL BE FULFILLED
10. QUALITY IMPROVEMENT
PART OF QUALITY MANAGEMENT
FOCUSED ON INCREASING THE ABILITY
TO FULFIL QUALITY REQUIREMENTS
2. RELATING TO
MANAGEMENT
11. CONTINUAL IMPROVEMENT
RECURRING ACTIVITY TO
INCREASE THE ABILITY TO FULFIL
REQUIREMENTS
12. EFFECTIVENESS
EXTENT TO WHICH PLANNED
ACTIVITIES ARE REALIZED AND
PLANNED RESULTS ACHIEVED
2. RELATING TO
MANAGEMENT
13. EFFICIENCY
RELATIONSHIP BETWEEN THE
RESULT ACHIEVED AND THE
RESOURCES USED
3. RELATING TO
ORGANIZATION
1. ORGANIZATION
GROUP OF PEOPLE AND FACILITIES
WITH AN ARRANGEMENT OF
RESPONSIBILITIES, AUTHORITHIES
AND RELATIONSHIPS
2. CUSTOMER
ORGANIZATION OR PERSON THAT
RECEIVES A PRODUCT
3. RELATING TO
ORGANIZATION
3. SUPPLIER
ORGANIZATION OR PERSON THAT
PROVIDES A PRODUCT
4. RELATING TO
PROCESS AND PRODUCT
1.PROCESS
A SET OF INTERRELATED OR
INTERACTING ACTIVITIES WHICH
TRANSFORMS INPUTS INTO OUTPUTS
2. PRODUCT
RESULT OF A PROCESS
3. PROCEDURE
SPECIFIED WAY TO CARRY OUT AN
ACTIVITY OR A PROCESS
5. RELATING TO
CHARACTERISTICS
1.CHARACTERISTIC
DISTINGUISHING FEATURE
2.TRACEABILITY
ABILITY TO TRACE THE HISTORY,
APPLICATION OR LOCATION OF THAT
WHICH IS UNDER CONSIDERATION
6. RELATING TO
CONFORMITY
1.CONFORMITY
FULFILMENT OF A REQUIREMENT
2. NON-CONFIRMITY
NON-FULFILMENT OF A
REQUIREMENT
3. PREVENTIVE ACTION
ACTION TO ELIMINATE THE CAUSE OF
6. RELATING TO
CONFORMITY
3. PREVENTIVE ACTION
ACTION TO ELIMINATE THE CAUSE OF
A POTENTIAL NONCONFORMITY OR
OTHER UNDESIRABLE POTENTIAL
SITUATION
4.CORRECTIVE ACTION
ACTION TO ELIMINATE THE CAUSE OF
A DETECTED NONCONFIRMITY OR
OTHER UNDESIRABLE SITUATION
7. RELATING TO
DOCUMENTATION
1. DOCUMENT
INFORMATION AND ITS SUPPORTING
MEDIUM (PAPER, MAGNETIC,
ELECTRONIC OR OPTICAL
COMPUTER DISC, PHOTOGRAPH OR
AMSTER SAMPLE OR A
COMBINATION THEREOF.
7. RELATING TO
DOCUMENTATION
2.SPECIFICATION
DOCUMENT STATING REQUIREMENTS
3.QUALITY MANUAL
DOCUMENT SPECIFYING THE QUALITY
MANAGEMENT SYSTEM OF AN
ORGANIZATION
4. RECORD
DOCUMENT STATING RESULTS ACHIEVED
OR PROVIDING EVIDENCE OF ACTIVITY
PERFORMED
8. RELATING TO
EXAMINATION
4. OBJECTIVE EVIDENCE
DATA SUPPORTING THE EXISTENCE
OR VERIFY OF SOMETHING
5. VERIFICATION
CONFIRMATION, THROUGH THE
PROVISION OF OBJECTIVE EVIDENCE
THAT SPECIFIED REQUIREMENTS
HAVE BEEN FULFILLED
9. RELATING TO
AUDIT
1. AUDIT
SYSTEMATIC, INDEPENDENT AND
DOCUMENTED PROCESS FOR
OBTAINING AUDIT EVIDENCE AND
EVALUATING IT OBJECTIVELY TO
DETERMINE THE EXTENT TO WHICH
AUDIT CRITERIA ARE FULFILLED
9. RELATING TO
AUDIT
2. AUDITEE
ORGANIZATION BEING AUDITED
3. AUDITOR
PERSON WITH THE COMPETENCE TO
CONDUCT AN AUDIT
4. AUDITOR TEAM
ONE OR MORE AUDITORS
CONDUCTING AN AUDIT
10. RELATING TO
QUALITY ASSURANCE FOR
MEASUREMENT PROCESSES
1. MEASUREMENT EQUIPMENT
MEASURING INSTRUMENT,
SOFTWARE, MEASUREMENT
STANDARD, REFERENCE MATERIAL
OR AUXILARY APPARATUS OR
COMBINATION THEREOF
NECESSARY TO REALIZE A
MEASUREMENT PROCESS