ISO – 9001 : 2000

OVERVIEW

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 WHY NEW STANDARDS?
 CUSTOMER PROBLEMS WITH 20 ELEMENT MODEL

* DIFFICULT FOR SMALL BUSINESSES

* ORIENTED TOWARDS MANUFACTURING

* PROLIFERATION OF GUIDELINE STANDARDS

* EMPHASIS ON COMPLIANCE ONLY NOT ORGANIZATIONAL PERFORMANCE

* IGNORES ENVIRONMENT, HEALTH AND SAFETY ASPECTS

 EVOLVING USER AND CUSTOMER NEEDS

 ISO MANDATED 5-YEAR STANDARDS REVIEW

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 GOALS OF THE ISO-
9000: 2000 CHANGES
 USABLE BY ALL SIZES OF ORGANIZATIONS

 USABLE BY ALL SECTORS

 SIMPLE AND EASY TO UNDERSTAND

 ENHANCED COMPATIBILITY WITH ISO 14001 ENVIRONMENTAL MANAGEMENT

SYSTEMS

 CONNECT QUALITY MANAGEMENT SYSTEM TO BUSINESS PROCESSES

 GREATER ORIENTATION TOWARDS CONTINUAL IMPROVEMENT AND

CUSTOMER SATISFACTION

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 OVERVIEW OF THE
NEW STANDARDS
 STANDARDS BASED UPON EIGHT QUALITY MANAGEMENT PRINCIPLES

 ISO 9000:2000 SERIES CONTAINS FOUR PRIMARY DOCUMENTS

--- ISO 9000 QUALITY MANAGEMENT SYSTEMS-FUNDAMENTALS AND

VOCABULARY

--- ISO 9001 QUALITY MANAGEMENT SYSTEMS-REQUIREMENTS

--- ISO 9004 QUALITY MANAGEMENT SYSTEMS-GUIDANCE FOR

PERFORMANCE IMPROVEMENT

--- ISO 19011 GUIDELINES FOR AUDITING QUALITY AND ENVIRONMENT

MANAGEMENT SYSTEMS

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 QUALITY MANAGEMENT
PRINCIPLES
A QUALITY MANAGEMENT PRINCIPLE IS A COMPREHENSIVE AND FUNDAMENTAL
RULE OR BELIEF, FOR LEADING AND OPERATING AN ORGANIZATION, AIMED AT
CONTINUALLY IMPROVING PERFORMANCE OVER THE LONG TERM BY FOCUSING
ON CUSTOMERS WHILE ADDRESSING THE NEEDS OF ALL THE OTHER
STAKEHOLDERS.

 CUSTOMER FOCUSED ORGANIZATION

 LEADERSHIP
 INVOLVEMENT OF PEOPLE
 PROCESS APPROACH
 SYSTEM APPROACH TO MANAGEMENT
 CONTINUAL IMPROVEMENT
 FACTUAL APPROACH TO DECISION MAKING
 MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

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 THE PROCESS
APPROACH
 THE PROCESS APPROACH

ORGANIZATIONS MUST IDENTIFY AND MANAGE NUMEROUS INTERLINKED

PROCESSES TO FUNCTION EFFECTIVELY

IDENTIFICATION AND MANAGEMENT OF PROCESSES WITHIN AN

ORGANIZATION ( INTERACTIONS BETWEEN PROCESSES ) IS THE “ PROCESS
APPROACH “

INPUT OUTPUT
PROCESS

A VALUE ADDING
TRANSFORMATION

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 ISO 9001:2000
FOREWORD
 FOREWORD

ISO 9001:2000 CARRIES A REVISED TITLE, WHICH NO LONGER

INCLUDES THE TERM QUALITY ASSURANCE

QUALITY MANAGEMENT SYSTEMS IS THE NEW TITLE, WHICH

ADDRESSES BOTH QUALITY ASSURANCE AND CUSTOMER
SATISFACTION

 INTRODUCTION

0.1 GENERAL

USE OF ISO 9001:2000 SHOULD BE A STRATEGIC DECISION, AND CAN

BE USED TO ADDRESS CUSTOMER, REGULATORY AND THE
ORGANIZATION’S OWN REQUIREMENTS

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 ISO 9001:2000
INTRODUCTION
0.2 PROCESS APPROACH

SYSTEMATIC IDENTIFICATION AND MANAGEMENT OF PROCESSES WITHIN AN

ORGANIZATION AND THE INTERACTIONS BETWEEN SUCH PROCESSES.

0.3 RELATIONSHIP WITH ISO 9004

STANDARDS INTENDED TO BE USED TOGETHER TO FOSTER IMPROVEMENT

OF THE QUALITY MANAGEMENT SYSTEM

0.4 COMPATIBILITY WITH OTHER MANAGEMENT SYSTEMS

DESIGNED TO BE COMPATIBLE WITH OTHER INTERNATIONALLY RECOGNIZED

MANAGEMENT SYSTEM STANDARDS SUCH AS ISO 14001, OCCUPATIONAL
HEALTH AND SAFETY

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 SCOPE
1.1 GENERAL

 ISO 9001:2000 IS AIMED AT

-- MEETING CUSTOMER AND REGULATORY REQUIREMENTS

-- ENHANCEMENT OF CUSTOMER SATISFACTION

-- CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

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 SCOPE
1.2 APPLICATION
REQUIREMENTS – GENERIC AND APPLICABLE TO ALL ORGANIZATIONS

-- EXCLUSION OF REQUIREMENTS
-- APPLICABLE TO SECTION 7 ONLY

COMMON REQUIREMENT EXCLUSIONS MAY INCLUDE :

7.3 DESIGN AND DEVELOPMENT

7.5.2 VALIDATION OF PROCESSES (SPECIAL PROCESSES)

7.5.4 CUSTOMER PROPERTY

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 SECTIONS 2,3 AND 4
2 NORMATIVE REFERENCE
ISO 9000:2000

3 TERMS AND DEFINITIONS

--- ISO 9000:2000

--- PRODUCT ALSO MEANS SERVICE

--- “SUB-CONTRACTOR” REPLACED BY “SUPPLIER”

--- “ SUPPLIER” REPLACED BY “ ORGANIZATION “

4 QUALITY MANAGEMENT SYSTEM

SECTION 4 IS INTENDED TO GUIDE THE ORGANIZATION IN DEVELOPING THE
OVERALL PLAN AND DOCUMENTATION ARCHITECTURE FOR THE QUALITY
MANAGEMENT SYSTEM

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 QUALITY MANAGEMENT
SYSTEM
4.1 GENERAL REQUIREMENTS

-- IDENTIFICATION OF PROCESSES FOR QMS

-- DETERMINE SEQUENCE AND INTERACTION OF THESE PROCESSES

-- CRITERIA AND METHODS FOR EFFECTIVE CONTROL OF PROCESSES

-- ENSURE AVAILABILITY OF RESOURCES

-- MONITOR, MEASURE AND ANALYZE THESE PROCESSES

-- ACTIONS FOR CONTINUAL IMPROVEMENTS

NOTE : IN CASE OF OUTSOURCING OF ANY PROCESS AFFECTING PRODUCT

CONFORMITY WITH REQUIREMENTS, THE ORGANIZATION SHALL ENSURE
CONTROL OVER SUCH PROCESSES.
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 OVERVIEW
ISO 9001:2000
 4 PROCESSES REPLACE 20 ELEMENTS

MANAGEMENT RESPONSIBILITY
e.g. POLICY, OBJECTIVES, PLANNING, QUALITY MANAGEMENT SYSTEM, REVIEW

RESOURCE MANAGEMENT
e.g.HUMAN RESOURCES, INFORMATION, FACILITIES

PRODUCT REALIZATION
e.g.CUSTOMER, DESIGN, PURCHASING, PRODUCTION

MEASUREMENT, ANALYSIS AND IMPROVEMENT

e.g. AUDIT, PROCESS/ PRODUCT CONTROL, IMPROVEMENT

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 QUALITY MANAGEMENT
SYSTEM
 4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL

QMS DOCUMENTATION SHALL INCLUDE :

-- DOCUMENTED QUALITY POLICY & OBJECTIVES

-- QUALITY MANUAL

-- DOCUMENTED PROCEDURES

-- DOCUMENTS NEEDED TO ENSURE EFFECTIVE PLANNING,

OPERATION & CONTROL OF PROCESS

-- QUALITY RECORDS

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 QUALITY MANAGEMENT
SYSTEM
4.2.2 QUALITY MANUAL SHALL INCLUDE

-- SCOPE OF QMS AND DETAILS OF JUSTIFICATION FOR ANY EXCLUSIONS

-- DOCUMENTED PROCEDURES FOR QMS OR REFERENCE TO THEM

-- DESCRIPTION OF INTERACTION BETWEEN THE PROCESSES OF QMS

4.2.3 CONTROL OF DOCUMENTS

-- DOCUMENTED PROCEDURES

4.2.4 CONTROL OF QUALITY RECORDS

-- DOCUMENTED PROCEDURES

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 MANAGEMENT
RESPONSIBILITY
 CLAUSE 5 FOCUSES ON MANAGEMENT’S ROLE AND THE NEED FOR THEM TO LEAD THE
ORGANIZATION, SET QUALITY POLICY AND OBJECTIVES, MAINTAIN CURRENT
PERFORMANCE AND ACHIEVE CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT
SYSTEM

5.1 MANAGEMENT COMMITMENT

-- EVIDENCES OF COMMITMENT TO QMS AND CONTINUALLY IMPROVING ITS

EFFECTIVENESS SHALL INCLUDE :

* COMMUNICATING THE IMPORTANCE OF MEETING CUSTOMER,

STATUTORY AND REGULATORY REQUIREMENTS

* ESTABLISHING QUALITY POLICY

* ESTABLISHING QUALITY OBJECTIVES

* CONDUCTING MANAGEMENT REVIEWS

* ENSURING AVAILABILITY OF RESOURCES

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 MANAGEMENT
RESPONSIBILITY
5.2 CUSTOMER FOCUS
-- MANAGEMENT TO ENSURE CUSTOMER REQUREMENTS ARE
DETERMINED AND FULFILLED
-- ENHANCING CUSTOMER SATISFACTION

5.3 QUALITY POLICY

-- APPROPRIATE TO THE PURPOSE OF THE ORGANIZATION

-- INCLUDES COMMITMENT TO COMPLY WITH REQUIREMENTS &

CONTINUALLY IMPROVE THE EFFECTIVENESS OF QMS

-- PROVIDES A FRAMEWORK FOR ESTABLISHING AND REVIEWING

QUALITY OBJECTIVES

-- IS COMMUNICATED AND UNDERSTOOD WITH IN THE ORGANIZATION

-- IS REVIEWED FOR CONTINUING SUITABILITY 17

 MANAGEMENT
RESPONSIBILITY
5.4 PLANNING
5.4.1 QUALITY OBJECTIVES
-- MEASURABLE AND CONSISTENT WITH QUALITY POLICY
5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1 RESPONSIBILITY AND AUTHORITY

-- DEFINE
-- COMMUNICATE WITHIN THE ORGANIZATION

5.5.2 MANAGEMENT REPRESENTATIVE

-- ESTABLISH, IMPLEMENT AND MAINTAIN PROCESSES FOR QMS
-- REPORTING TO TOP MANAGEMENT ON PERFORMANCE
-- PROMOTION OF AWARENESS OF CUSTOMER REQUIREMENTS
THROUGHOUT THE ORGANIZATION

5.5.3 INTERNAL COMMUNICATION

-- ON EFFECTIVENESS OF QMS

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 MANAGEMENT
RESPONSIBILITY
5.6 MANAGEMENT REVIEW

5.6.1 GENERAL
-- MANAGEMENT REVIEW TO ENSURE
* CONTINUING SUITABILITY
* ADEQUACY
* EFFECTIVENESS
* ASSESSING OPPORTUNITY FOR IMPROVEMENTS
* NEED FOR CHANGES TO QMS
* QUALITY POLICY AND OBJECTIVES

5.6.2 REVIEW INPUT

-- BACKUP DATA

5.6.3 REVIEW OUTPUT SHALL INCLUDE DECISIONS RELATED TO

-- IMPROVEMENT OF THE EFFECTIVENESS OF QMS & ITS PROCESSES

-- IMPROVEMENT OF PRODUCT RELATED TO CUSTOMER REQUIREMENTS
-- RESOURCE NEEDS

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 RESOURCE
MANAGEMENT
CLAUSE 6 FOCUSES ON MANAGEMENT’S ROLE IN STAFFING THE ORGANIZATION
WITH APPROPRIATE HUMAN RESOURCES, AND SUPPORTING THEM WITH
ADEQUATE FACILITIES, EQUIPMENT, AND A SUITABLE WORKING ENVIRONMENT.

6.1 PROVISION OF RESOURCES

-- FOR IMPLEMENTATION OF QMS
-- FOR ENHANCING CUSTOMER SATISFACTION

6.2 HUMAN RESOURCES

6.2.1 GENERAL
( TRAINING CLAUSE )

--- COMPETENCY

--- SKILLS ADDED TO APPROPRIATE EDUCATION, TRAINING AND EXPERIENCE

FOR COMPETENCY OF PEROSNNEL.

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 RESOURCE
MANAGEMENT
6.2 HUMAN RESOURCES

6.2.2 COMPETENCE, AWARENESS AND TRAINING

-- DETERMINE NECESSARY COMPETENCY
-- PROVIDE TRAINING
-- EVALUATE THE EFFECTIVENESS OF ACTIONS
-- AWARENESS OF THE RELEVENCE AND IMPORTANCE OF THEIR
ACTIVITIES IN ACHIEVEMENT OF QUALITY OBJECTIVES

6.3 INFRASTRUCTURE
-- BUILDINGS, WORKSPACE & UTILITIES
-- PROCESS EQUIPMENT ( HARDWARE AND SOFTWARE )
-- SUPPORTING SERVICES ( TRANSPORT AND COMMUNICATION )

6.4 WORK ENVIRONMENT

-- DETERMINE AND MANAGE TO ACHIEVE PRODUCT CONFORMITY TO
PRODUCT REQUIREMENTS

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PRODUCT REALIZATION
CLAUSE 7 DEALS WITH THE NEED TO PLAN, IMPLEMENT AND CONTROL WORK
PROCESSES TO SATISFY CUSTOMER REQUIREMENTS ( APQP CONCEPTS )

7.1 PLANNING OF PRODUCT REALIZATION

-- PROCESS FLOW
-- QUALITY PLAN

7.2 CUSTOMER RELATED PROCESSES

7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT

-- CUSTOMER SPECIFICATIONS, DELIVERY REQUIREMENTS, POST
DELIVERY ACTIVITIES
-- INTENDED USE
-- STATUTORY & REGULATORY REQUIREMENTS
-- ADDITIONAL REQUIREMENTS AS DETERMINED BY THE ORGANIZATION

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

-- PRIOR TO COMMITMENT TO SUPPLY

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PRODUCT REALIZATION
7.2.3 CUSTOMER COMMUNICATION

-- PRODUCT INFORMATION
-- ENQUIRIES, ORDERS AND AMENDMENTS
-- CUSTOMER FEEDBACK INCLUDING COMPLAINTS

7.3 DESIGN AND DEVELOPMENT

7.3.1 DESIGN AND DEVELOPMENT PLANNING

7.3.2 DESIGN AND DEVELOPMENT INPUTS
7.3.3 DESIGN AND DEVELOPMENT OUTPUTS
7.3.4 DESIGN AND DEVELOPMENT REVIEW
7.3.5 DESIGN AND DEVELOPMENT VERIFICATION
7.3.6 DESIGN AND DEVELOPMENT VALIDATION
7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES

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PRODUCT REALIZATION
7.4 PURCHASING

7.4.1 PURCHASING PROCESS

-- EXTENT OF CONTROL APPLIED TO THE SUPPLIER AND THE

PURCHASED PRODUCT
-- SELECTION, EVALUATION & RE-EVALUATION CRITERIA TO BE
ESTABLISHED

7.4.2 PURCHASING INFORMATION

-- APPROVAL OF PRODUCT/PROCEDURES
-- QUALIFICATION OF PERSONNELS
-- QMS REQUIREMENTS

7.4.3 VERIFICATION OF PURCHASED PRODUCT

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PRODUCT REALIZATION
7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

-- PRODUCT CHARACTERISTICS
-- WORK INSTRUCTIONS
-- SUITABLE EQUIPMENTS
-- MONITORING & MEASURING DEVICES

7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICES

PROVISION ( APPLICABLE FOR SPECIAL PROCESSES )

-- CRITERIA FOR REVIEW AND APPROVAL

-- EQUIPMENT AND PERSONNEL APPROVAL
-- SPECIFIC METHOD & PROCEDURES
-- REQUIREMENTS FOR RECORDS
-- REVALIDATION

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 PRODUCT REALIZATION
7.5.3 IDENTIFICATION & TRACEABILITY

IDENTIFICATIION – WHERE APPROPRIATE FOR PRODUCT STATUS WITH

RESPECT MONITORING MEASUREMENT
REQUIREMENTS

TRACEABILITY – WHERE REQUIRED

7.5.4 CUSTOMER PROPERTY

-- IDENTIFY AND SAFEGUARD

-- INCLUDES INTELLECTUAL PROPERTY( CUSTOMER STD./DRGS.)

7.5.5 PRESERVATION OF PRODUCT

-- IDENTIFICATION, HANDLING, PACKAGING, STORAGE & PROTECTION

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PRODUCT REALIZATION
7.6 CONTROL OF MONITORING AND MEASURING DEVICES
( EQUIVALENT TO CLAUSE 4.11 OF ISO 9001 : 1994 )

--- REQUIREMENTS ARE SAME INTENT WISE

--- COMPUTER SOFTWARE FOR MONITORING AND MEASUREMENT,

CONFIRMATION OF INTENDED APPLICATION PRIOR TO INITIAL USE AND
RECONFIRMED

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MEASUREMENT, ANALYSIS
AND IMPROVEMENT
CLAUSE 8 FOCUSES ON THE PLANNING AND IMPLEMENTATION OF SYSTEMS USED
TO MEASURE , ANALYZE AND IMPROVE THE PRODUCT, PROCESS AND QUALITY
MANAGEMENT SYSTEM
( CLAUSE 4.1+ 4.17+ 4.20+ 4.9+ 4.13+ 4.14 OF ISO 9001 : 1994

8.1 GENERAL
PLAN AND IMPLEMENT MONITORING, MEASUREMENT, ANALYZING AND
IMPROVEMENT PROCESSES FOR :

-- DEMONSTRATING CONFORMITY OF THE PRODUCT

-- ENSURING CONFORMITY OF QMS
-- CONTINUALLY IMPROVE THE EFFECTIVENESS OF QMS

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MEASUREMENT, ANALYSIS
AND IMPROVEMENT
8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION

-- MONITORING INFO RELATING TO CUSTOMER PERCEPTION

-- THE METHOD FOR OBTAINING & USING THE ABOVE INFO
SHALL BE DETERMINED

8.2.2 INTERNAL AUDIT

-- DOCUMENTED PROCEDURE
-- INTENT IS SAME AS IN ISO 9001 : 1994

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 MEASUREMENT, ANALYSIS
AND IMPROVEMENT
8.2.3 MONITORING AND MEASUREMENT OF PROCESSES

-- SUITABLE METHODS FOR MONITORING OF QMS PROCESSES

-- METHODS SHALL BE SUITABLE FOR DEMONSTRATING ABILITY TO
ACHIEVE THE PLANNED RESULTS
-- CORRECTION AND CORRECTIVE ACTION WHEN PLANNED RESULTS
ARE NOT ACHIEVED

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT

-- MONITOR AND MEASURE CHARACTERISTICS OF PRODUCT AT

APPROPRIATE STAGES OF PRODUCT REALIZATION PROCESS
-- EVIDENCE OF CONFORMITY WITH ACCEPTANCE CRITERIA
-- RECORDS TO INDICATE PERSON AUTHORIZING RELEASE OF
PRODUCT
-- HOLD THE PRODUCT UNTIL PLANNED ARRANGEMENTS
COMPLETED/MET, UNLESS OTHERWISE APPROVED BY A RELEVENT
AUTHORITY, AND WHERE APPLICABLE BY THE CUSTOMER

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MEASUREMENT, ANALYSIS
AND IMPROVEMENT
8.3 CONTROL OF NONCONFORMING PRODUCT

--- DOCUMENTED PROCEDURE ( 4.13 OF ISO 9001 : 1994 )

8.4 ANALYSIS OF DATA

IT SHALL PROVIDE INFO RELATED TO –

-- CUSTOMER SATISFACTION
-- CONFORMANCE TO PRODUCT REQUIREMENTS
-- CHARACTERISTICS & TRENDS OF PROCESSES AND PRODUCTS
INCLUDING OPPORTUNITIES FOR PREVENTIVE ACTIONS
-- SUPPLIERS INFORMATION

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MEASUREMENT, ANALYSIS
AND IMPROVEMENT
8.5 IMPROVEMENT

8.5.1 CONTINUAL IMPROVEMENT

-- THROUGH THE USE OF QUALITY POLICY,OBJECTIVES,AUDIT
RESULTS,ANALYSIS OF DATA,CAPA,MANAGEMENT REVIEW

8.5.2 CORRECTIVE ACTION

-- ACTION TO ELIMINATE THE CAUSE OF NCs IN ORDER TO PREVENT

RECURRENCE
-- DOCUMENTED PROCEDURES

8.5.3 PREVENTIVE ACTION

-- ACTION TO ELIMINATE THE CAUSES OF POTENTIAL NCs IN ORDER TO

PREVENT OCCRUNCE
-- DOCUMENTED PROCEDURES

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MANDATORY DOCUMENTED
PROCEDURES
 CONTROL OF DOCUMENTS

 CONTROL OF RECORDS

 CONTROL OF NONCONFORMITY

 INTERNAL AUDIT

 CORRECTIVE ACTIONS

 PREVENTIVE ACTIONS

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 REQUIRED QUALITY
RECORDS
 MANAGEMENT REVIEW RECORDS
 RECORDS OF EDUCATION, TRAINING, SKILLS AND EXPERIENCE
 RECORDS FOR EVIDENCES THAT PROCESSES AND RESULTING PRODUCTS
FULFILL REQUIREMENT
 CONTRACT REVIEW RECORDS ALONG WITH ACTIONS REQUIRED FROM THE
REVIEWS
 DESIGN AND DEVELOPMENT RECORDS

-- PRODUCT REQUIREMENTS AND INPUTS

-- REVIEW RECORDS ALONG WITH ( ACTION NECESSARY )
-- VERIFICATION RECORDS AND NECESSARY ACTIONS
-- VALIDATION RECORDS AND NECESSARY ACTIONS
-- RECORDS OF CHANGES TO DESIGN AND DEVELOPMENT AND
NECESSARY ACTIONS

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 REQUIRED QUALITY
RECORDS
 RECORDS OF EVALUATION OF SUPPLIERS

 RECORDS OF VALIDATION OF PROCESSES

 TRACEABILITY ( WHEREVER IT IS REQUIREMENT )

 RECORDS OF CUSTOMER PROPERTY LOSS/ DAMAGE/ OTHERWISE FOUND UNSUITABLE

 RESULTS OF CALIBRATION AND VERIFICATION

 INTERNAL AUDIT RECORDS

 RECORDS OF RELEASE OF PRODUCT AND AUTHORITY RESPONSIBLE

 NATURE OF NON-CONFORMITIES AND ACTIONS TAKEN INCLUDING CONCESSIONS OBTAINED

 RESULTS OF CORRECTIVE ACTION

 RESULT OF PREVENTIVE ACTION

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