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