ISO 9001 PPT04

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Presents an Overview of the

ISO 9000:2000 Revisionsto the ISO 9000:1994 Standards

the Move from Conformance to Performance

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Outline

Why Changes are Needed

Principles and Approaches Driving the

Changes

Clause by Clause Review of NewRequirements

Transition Guidance

Audit Implications

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Current ISO 9000 Standards areSuccessful

Why Change a Good Thing?

ISO 9000 is the most successful standardin ISO history and is accepted world-wide

Nearly 400,000 registrations world-wide with

registrants in over 150 countries from all continents

Being applied in a wide variety oforganizations

Over 40 sectors or industry classifications

- led by: electrical/optical equipment, metal products,construction, machinery, wholesale/retail trade

- but growing in acceptance by many others, including:engineering, information technology, health/social work,

utilities, transportation, public administration, education,other services.

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Current ISO 9000Standards Need Revision ...

Bias Wording/terms biased towards manufacturing

Problems with the 20 element model

Difficult for small businesses to adapt

Flow incompatible with how companies do business

Incompatible with other models (ISO 14000 EMS e.g.)

Not sufficiently forward looking Does not smoothly facilitate the move from

baseline (effective) quality management toperformance excellence models (like MBNQA)required by evolving user and customer needs)

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One World One Quality System

Current standards contain loopholes

Too many companies have only sought to meetminimum requirements and then only by twistingthe intent of the existing standards

There is a growing demand forperformance excellence

ISO 9001:1994 does not require continual

improvement

ISO 9001:2000 is process/performance oriented anddoes require continual improvement of the QMS, butby itself is not viewed as a performance excellence

model

ISO 9000 2000 i h

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ISO 9000:2000 is thefoundation for

Performance Excellence

Competitive

Advantage

Efficient

Quality Management System

Effective


Business Vision

Performance Excellence

Malcolm Baldrige Criteria

Performance ImprovementISO 9004:2000

Baseline Performance:

ISO 9001:2000

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EXERCISE #1

List your organizations three most significant challengesor business needs over the next 2-3 years (consider anyexternal changes that will affect your organization):

1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

What are your organizations goals and objectives?1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

How can you use ISO 9001:2000 to help deal with

business needs and external challenges?___________________________________________________________

___________________________________________________________

___________________________________________________________

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ISO 9000:2000 is based on EightQuality Management Principles

Customer Focus

Leadership

Involvement of People

Process Approach

System Approach

Continual Improvement

Factual Approach to Decision Making

Mutually Beneficial Supplier Relationships

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Customer Focus

Organizations depend on theircustomers and therefore should:

understand current and future customerneeds,

meet customer requirements, and

strive to exceed customer expectations.

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Leadership

Leaders should:

establish unity of purpose and direction ofthe organization, and

create and maintain the internal

environment in which people can becomefully involved in achieving theorganizations objectives.

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Involvement of People

People at all levels are the essence

of an organization, and

their full involvement enables theirabilities to be used for the organizations

benefit.

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Process Approach

Organizations need to do more thansimply monitor process outputs,(typically through inspection activities)

they must also control all processinputs, (people, facilities/equipment,material and methods)

and, they must establish appropriatecontrols over the transformationactivities (if desired results are to beachieved consistently and efficiently)

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What is a Process?

Activity that transforms input into output

ActivityInput Output

Resources:

PeopleFacilities/EquipmentMaterialMethods

Results:

ProductsServicesPerformance

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How is a Process Managed?


Right Resources:

Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:

Quality ProductsQuality ServicesCustomer Satisfaction

Monitor & Measure the Processmake sure the inputs are right, the transformationactivities consistently work, and the desired resultsare achieved, then - improve the process as needed

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How is a Process Measured?


Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods

Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction

EfficientNo Waste

EffectiveDesired Results Achieved

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System Approach

Organizations must understand asystem is a set of interrelatedprocesses, and

the output of one process is the input toone or more subsequent processes, so ...

It is critical to manage the white space(or interface) between processes to ensurethat the overall system is effective

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Continual Improvement

Continual improvement of the

organizations overall performanceshould be a permanent objective:

improvement must be a planned activity ifthe organization desires to improve overallperformance and capabilities.

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Plan Do

Act CheckQMS

Results

Baseline PerformanceImprovement Objective

Improve Process

through PDCA Cycle

Measure/Monitor Results Against Objectives -

Improve Process and Change QMS as Needed

to Achieve and Sustain Desired Results

The QMS must be used forcontinuous improvement ...

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Factual Approach toDecision Making

Effective decisions are:

based on the analysis of data andinformation.

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Mutually BeneficialSupplier Relationships

An organization and its suppliers are

truly inter-dependent, and

a mutually beneficial relationship enhancesthe ability of both to create value.

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EXERCISE #2

Pick one of the eight quality management principles andlist three of the most important actions you think anorganization should take in applying this principle.

1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

How well does your organization do each of the actionsidentified above?

1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

What can your organization do to more fully utilize theprinciple?

1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

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The ISO 9000:2000 standardsinclude 3 documents...

ISO 9000:2000Quality Management Systems -Fundamentals and Vocabulary

ISO 9004:2000Quality Management Systems -

Guidelines for Performance Improvements


Requirements

ISO 9000 2000 t d d

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ISO 9000:2000 standardsreplace many existing ISO

documents...

Revises/Replaces:- ISO 8402:1994

- ISO 9000-1:1994


Fundamentals and Vocabulary

Revises/Replaces:

- ISO 9004-1, 9004-2, 9004-3 and 9004-4

(all previous editions, 1994-1994)


Guidelines for PerformanceImprovements

Revises/Replaces:- ISO 9001:1994- ISO 9002-1994- ISO 9003:1994


Requirements

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Other ISO documents are alsobeing revised for consistency...

in Sep 2001 will likely replace:

- ISO 10011 (for QMS)- ISO 14011 (for EMS)

ISO 19011the Joint Working Group on

Auditing Document

with revisions due out after issuanceof ISO 9000:2000 include:

- Aerospace: AS 9100

- Telecommunications: TL 9000

Other sector specificQuality System

Requirements Documents

released in 4th quarter 1999 as a

harmonized US and Europeanstandard, for these standards:

- QS 9000 (US)- EAQF (France)- VDA6.1 (Germany)- AVSQ (Italy)

only ISO/TS 16949 will beupgraded to ISO 9001:2000

however, ISO has granted

permission for continued(indefinite) use of QS-9000

ISO/TS 16949International Automotive Standard -

Quality System Requirements

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Role of ISO 9000:2000

Defines quality managementprinciples

terms and definitions

fundamentals:- systems approach

- process approach

- continual improvement

ISO 9000:2000 is a normative reference(i.e. part of the requirements), andreplaces:

ISO 8402:1994 and ISO 9000-1:1994

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Specifies quality systemrequirements:

for achieving customer satisfaction

applicable to entire enterprise

note: permissible exclusions (like

design) are limited to requirements

within Clause 7 - Product Realization,

and your registrar must verify theyare not part of your business

ISO 9001:2000 replaces:ISO 9001/2/3:1994

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Provides guidelines for performanceimprovement, based on

quality management principles and approaches

defined in ISO 9000, and

continual improvement of the qualitymanagement system itself

note: however, ISO 9004 is NOT intended as a

guideline for implementing or assessingimplementation of ISO 9001 requirements

ISO 9004:2000 replaces:

ISO 9004-1, 9004-2, 9004-3 & 9004-4

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ISO 9001 and ISO 9004are the Consistent Pair

comprised of the following 8 clauses:1. Scope

2. Normative references (part of the requirements)

3. Terms and definitions4. Quality management system

5. Management responsibility

6. Resource management

7. Product (and/or service) realization

8. Measurement, analysis &

improvement

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Continual Improvement of the


The Process-Based Quality

Management System

ManagementResponsibility

Product

Realization

ResourceManagement

MeasurementAnalysis &

Improvement

C

US

T

OM

E

R

REQ

U

IR

E

ME

N

TS

C

US

T

OM

E

R

SAT

I

SF

A

CT

I

ON

Product

Input Output

i l

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ISO 9001:2000 implementsthe PDCA improvement cycle

PlanClause 5. Management responsibility -

everything flows from Management who definethe requirements for the system

Clause 6. Resource management - fromthese requirements the resources will beidentified and management must ensure they areprovided and applied within the system

Do

Clause 7. Product (and/or service)

realization - the necessary process are

established and carried out

SO 900 2000 i l

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ISO 9001:2000 implementsthe PDCA improvement cycle

CheckClause 8. Measurement, analysis and

improvement - processes and products will bemonitored and measured against policies,

objectives and requirements for the product andresults/opportunity for improvement reported

Act

Clause 8. Measurement, analysis andimprovement - acting upon data reported in thecheck cycle, improvement actions can be taken -directly, or as an output of the Management

Review process (Clause 5.6)

Cl 4 Q li

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Clause 4 - Qualitymanagement system

4.1 General requirements - New: must defineprocesses to be managed (including out-sourcedprocesses - which typically include design, training,calibration, heat treat, etc.); determine the sequenceand interaction of these processes; determine the

criteria and methods needed to ensure theseprocesses are effective; and take actions to improvethese processes

4.2 Documentation requirements - New:

documentation requirements less prescriptive;however, at a minimum must include a quality manualand the following six documented procedures: Control ofDocuments (Clause 4.2.3), Control of Quality Records (Clause 4.2.4), Internal Audits(Clause 8.2.2), Control of Nonconforming Product (Clause 8.3), Corrective Action(Clause 8.5.2), and Preventive Action (Clause 8.5.3).

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Clause 5 - Managementresponsibility

5.1 Management commitment - New: topmanagement must demonstrate commitment todevelopment and implementation of the quality

system and continually improving its effectiveness

5.2 Customer focus - New: customerrequirements (identified per Clause 7.2.1) must be metwith the aim of enhancing customer satisfaction (a

perception that must be measured per Clause 8.2.1)

5.3 Quality policy - New: quality policy mustinclude commitment to meeting requirements andcontinual improvement of the effectiveness of theQMS, provide a framework for establishing/reviewingmeasurable quality objectives; and, quality policy

must be periodically reviewed for continuing suitability

Cl 5 M t

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5.4 Planning - New: establish measurablequality objectives at relevant functions and levelsin the organization needed to meet productrequirements (identified per Clause 7.1 a); andidentify and plan quality system processes (identified

per Clause 4.1)

5.5 Responsibility, authority andcommunication - New: managementrepresentative must promote awareness of

customer requirements throughout theorganization; internal communications regarding theeffectiveness of the quality system must beestablished

Cl 5 M t

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5.6 Management review - New: evaluate theneed for changes to the quality system (includingpolicy and objectives) by reviewing specified inputs(improvement opportunities)and reporting specifiedoutputs(related management actions and resource

needs)

Cl 6 R

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Clause 6 - Resourcemanagement

6.1 Provision of resources - New: determine

and provide resources needed to implement andimprove the QMS and address customersatisfaction

6.2 Human resources - New: determine

needed competencies, evaluate effectiveness ofactions taken to satisfy competency needs; andensure employees are aware of the importance oftheir activities and how they contribute to achievingquality objectives

6.3 Infrastructure and 6.4 WorkEnvironment - New: determine and manage theinfrastructure (buildings, workspace, utilities, equipmentand support services), as well as the work

environment needed to achieve product conformance

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Clause 7 - Product realization

7.1 Planning of product realization - New:determine measurable quality objectives forcontracts, projects and products

7.2 Customer-related processes - New: define

the processes for communicating with thecustomer with regards to product information;inquiries, contracts or order handling, and customerfeedback, including complaints

7.3 Design and development resources -New: design output to include appropriate informationfor purchasing, production and for service provision

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Clause 7 - Product realization

7.4 Purchasing - New: establish criteria forsupplier evaluation and selection, and periodic re-evaluation

7.5 Production and service provision - New:Nothing, essentially the same as requirementscontained in Elements 4.7, 4.8, 4.9, 4.15, and 4.19 ofISO 9001:1994

7.6 Control of measuring and monitoring

devices - New: validate software used to verifyproduct

Cl 8 M t

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Clause 8 - Measurement,analysis and improvement

8.1 General - New: plan and implementmonitoring, measurement, analysis andimprovement processes

8.2 Monitoring and measurement - New:

must measure and monitor customersatisfaction(note: customer satisfaction is anyinformation relating to the customers perception ofthe organizations ability to meet customer

requirements); internal auditors must now be

objective and impartial (vice independent); andprocesses used to manage the quality system mustbe measured/monitored to the degree necessary todemonstrate they achieved planned results

Cl 8 M t

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Clause 8 - Measurement,analysis and improvement

8.3 Control of nonconforming product -New: Nothing, essentially the same as requirementscontained in Clause 4.13 of ISO 9001:1994)

8.4 Analysis of data - New: analyze data to

determine quality system effectiveness and toprovide information on customer satisfaction,supplier performance, product conformance, andprocess/product characteristics and trends used toidentify opportunities for preventive action

8.5 Improvement - New: must improveeffectiveness of the quality managementsystem(note: accomplish through the use of qualitypolicy, objectives, audit results, analysis of data,corrective/preventive actions, and management review)

ISO 9000 2000 t d d

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ISO 9000:2000 standardsreleased December 2000

The final International Standard (IS)was released 15 December 2000 andis available now

Sector specific schemes are underreview and ISO 9000:2000 basedrevisions will be issued soon:

Automotive: ISO/TS 16949

Aerospace: AS 9100

Telecommunications: TL 9000

Essentially youll have 3

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Essentially, you ll have 3years to transition to the

new standards

Accredited registrations to ISO9001/2/3:1994 may continue for up to3 years (through 12/03)

Allows transition time for those in progress

Both new registrations andcontinuations of current registrations

based on 1994 standards will expireon or before the end of CY 2003

Allows time for accredited organizations, registrars,and training activities/consultants

So what should

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So what shouldorganizations do NOW?

Obtain assistance from qualified sources Obtain/conduct Management and Employee Awareness

Training, Internal Auditor Training, and ProcessManagement Training

Obtain/conduct a Gap Analysis

Obtain guidance from your Registrar

Obtain their transition plan, including provisions related to

any sector specific schemes applicable to yourorganization (QS 9000 e.g.)

Develop/implement your transition plan

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Answers to FAQs ...

Do I have to change my system?Not at the moment HOWEVER, it would be

beneficial to look at the new standards as soon aspossible so you can get an idea of what new

requirements are forthcoming

Do I have to re-write my documents?

NO HOWEVER, at a minimum, someadjustments will have to be made to address newrequirements and cross reference quality systemdocumentation to ISO 9001:2000

Answers to FAQs

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Answers to FAQs(continued) ...

Will the changes affect my currentregistration / certification?

Yes. A transition plan will need to be approved byyour registrar and incorporated into their regular audit

routine

I am not yet registered. Should Ipursue registration to the 1994

standards first?Only if timing is an issue either way your

system design should be based on the new standards consult with your Registrar to discuss options

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The Role of Internal

Audits has shifted...

ISO9001

1994

Internal auditEffectivenessassessed in

audit report

Managementreview

ISO90012000

Customersatisfaction

Managementdetermines

effectiveness byanalyzing allavailable data

and information

Managementreview

Internal audit

Other data

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Audit Methodologies ...

Audit Planning

Evaluating QMS Documentation

Conducting Process Audits

Using Internal Audits to:

Verify QMS Effectiveness

Identify Opportunities for Improvement

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Audit Planning

The Shift to Process Audits

Element Audits, or Departmental Audits should giveway to process audits - i.e. audit (from start to finish)key processes the organization has defined as critical tomeeting the overall objectives of the organization

Note: The processes selected, as well as their sequence andinterrelation, must make sense to the organization; however, theymust address all requirements of ISO 9001:2000 and the policyand objectives of the organization.

Use Internal Audits for Improvement Audit scope should clearly state if/when the purpose of

the internal audit will go beyond compliance audits andbe used to identify additional opportunities forimprovement

Evaluating QMS

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Evaluating QMSDocumentation

Documentation requirements are lessprescriptive

ISO 9001:2000 only requires a handful of documentedprocedures be in place

All QMS processes, however, must be controlled by eithera documented procedure or well defined system

Evaluating System Adequacy

Assess organizations compliance with documentedprocedures and/or other well defined responsibilitiesassociated with the process under review (conformance)

Verify that the system is achieving the desired results(performance)

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Conducting Process Audits

Identify QMS Process Owners

Tools like Deployment Flowcharts can be invaluablein defining the sequence, interrelationship andresponsibilities associated with QMS Processes

Evaluate Conformance Tools like our Checklist and Audit Guide can be

invaluable in verifying that the documented procedureor process complies with ISO 9001:2000 requirements

Evaluate Performance

Verify that the organization is collecting and usingprocess performance data to monitor, measure andimprove processes

Conducting Top

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Conducting TopManagement Interviews

The expanded role of top managementrequires more time be spent withthem during internal audits to collectevidence of their commitment to:

Communicating importance of meeting requirements,

Establishing quality policy and objectives,

Conducting management reviews, and

Ensuring availability of necessary resources.

Interviewing

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InterviewingProcess Owners

Other managers (i.e. Process Owners)should be interviewed to collect evidencethat:

Processes and improvement objectives are

documented and planned, Processes and needed resources are deployed,

Processes are monitored and measured, and

Actions are taken, as warranted by analysis of

process data.

Note: Auditors should look for evidence that process

sequence and interrelationships are known

and interfaces are effectively managed to

achieve the desired objectives.

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Implications for Auditors

Opportunities Find the holes as process linkages

Follow the way the business actually works

Value-addedauditing

Challenges Process Audits versus Element Audits

Fewer procedures

Less prescriptive requirements for realizationprocesses

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EXERCISE #3

What are the three most significant changes included inISO 9001:2000?1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

What are the benefits of using internal audit results to aidin assessing effectiveness and the need for improvement?

1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

How can you use internal audits to enhance employeeawareness and involvement in quality management?

1. __________________________________________________________

2. __________________________________________________________

3. __________________________________________________________

ISO 9001 2000 t ISO 9001 1994

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ISO 9001:2000 to ISO 9001:1994Mapping

ISO 9001:2000 ISO 9001:1994

1. Scope 1

1.1 General -

1.2 Permissible Exclusions -

2. Normative Reference 2

3. Terms and Definitions 34. Quality Management System -

4.1 General Requirements 4.2.1

4.2 Documentation Requirements -

4.2.1 General 4.5.2, 4.5.3

4.2.2 Quality Manual 4.2.1

4.2.3 Control of Documents 4.5

4.2.4 Control of Quality Records 4.16

ISO 9001 2000 t ISO 9001 1994

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ISO 9001:2000 ISO 9001:1994

5. Management Responsibility -

5.1 Management Commitment 4.1, 4.1.2.2, 4.2.1

5.2 Customer Focus 4.3.2

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 Management System Planning 4.2.3

5.5 Responsibility, Authority, and Communication -

5.5.1 Responsibility and Authority 4.1.2.1

5.5.2 Management Representative 4.1.2.3

5.5.3 Internal Communications -

5.6 Management Review 4.1.3

5.6.1 General 4.1.3

5.6.2 Review Input 4.1.3

5.6.3 Review Output 4.1.3

ISO 9001 2000 t ISO 9001 1994

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ISO 9001:2000 ISO 9001:1994

6. Resource Management -

6.1 Provision of Resources 4.1.2.2

6.2 Human Resources -

6.2.1 Assignment of Personnel 4.1.2.2, 4.2.3, 4.18

6.2.2 Competence, Awareness, and Training 4.186.3 Infrastructure 4.1.2.2, 4.9

6.4 Work Environment 4.9

7. Product Realization -

7.1 Planning of Product Realization 4.2.3, 4.9, 4.10.1

7.2 Customer-Related Processes -

7.2.1 Determination of Product Requirements 4.3.2, 4.4.4

7.2.2 Review of Product Requirements 4.3

7.2.3 Customer Communication 4.3.2

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ISO 9001 2000 t ISO 9001 1994

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ISO 9001:2000 ISO 9001:1994

7.5 Production and Service Provision -

7.5.1 Control of Production and Service Provision 4.9, 4.10.3,

4.15.6, 4.19

7.5.2 Validation of Special Processes 4.9

7.5.3 Identification and Traceability 4.8, 4.10.5, 4.127.5.4 Customer Property 4.7

7.5.5 Preservation of Product 4.15

7.6 Control of Monitoring and Measuring Devices 4.11

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ISO 9001:2000 ISO 9001:1994

8. Measurement, Analysis, and Improvement -

8.1 General 4.10, 4.20.1

8.2 Monitoring and Measurement -

8.2.1 Customer Satisfaction -

8.2.2 Internal Audit 4.178.2.3 Monitoring and Measurement of Processes 4.9, 4.20.1

8.2.4 Monitoring and Measurement of Product 4.10, 4.20

8.3 Control of Nonconforming Product 4.13

8.4 Analysis of Data 4.14, 4.20

8.5 Improvement -

8.5.1 Continual Improvement 4.1.3

8.5.2 Corrective Action 4.14.1, 4.14.2

8.5.3 Preventive Action 4.14.1, 4.14.3

Where can I obtain more

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Where can I obtain moreinformation?

On the world-wide web:ISO web site www.iso.ch

TC 176 web site www.bsi.org.uk/iso-176-sc2

ASQ web site www.asq.org

ISO-ONLINE web site www.isoqual.net

Other questions?ISO-ONLINE Email: [email protected]

or call (502) 244-6183