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1

Presents an Overview of the

ISO 9000:2000 Revisionsto the ISO 9000:1994 Standards

“ the Move from Conformance to Performance “

Presented by:

Date:


2

Outline

• Why Changes are Needed

• Principles and Approaches Driving the Changes

• Clause by Clause Review of New Requirements

• Transition Guidance

• Audit Implications


3

Current ISO 9000 Standards are Successful …

Why Change a Good Thing?

• ISO 9000 is the most successful standard in 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 of organizations

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.


4

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 to “performance excellence” models (like MBNQA) required by evolving user and customer needs)


5

“ One World …One Quality System”

• Current standards contain “loopholes”

Too many companies have only sought to meet “minimum requirements” and then only by “twisting the intent” of the existing standards

• There is a growing demand for “performance” excellence

ISO 9001:1994 does not require continual improvement

ISO 9001:2000 is process/performance oriented and does require continual improvement of the QMS, but by itself is not viewed as a “performance excellence” model


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ISO 9000:2000 is the foundation for

Performance Excellence

Competitive

Advantage

Efficient

Quality Management System

Effective

Quality Management System

Business Vision

Performance Excellence

Malcolm Baldrige Criteria

Performance Improvement

ISO 9004:2000

Baseline Performance:

ISO 9001:2000


7

EXERCISE #1

• List your organization’s three most significant challenges or business needs over the next 2-3 years (consider any external changes that will affect your organization):

1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

• What are your organization’s goals and objectives?1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

• How can you use ISO 9001:2000 to help deal with business needs and external challenges?

_________________________________________________________________________________________________________________________________________________________________________________


8

ISO 9000:2000 is based on Eight ISO 9000:2000 is based on Eight Quality Management PrinciplesQuality 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 FocusCustomer Focus

• Organizations depend on their customers and therefore should:

understand current and future customer needs,

meet customer requirements, and

strive to exceed customer expectations.


10

LeadershipLeadership

• Leaders should:

establish unity of purpose and direction of the organization, and

create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.


11

Involvement of PeopleInvolvement of People

• People at all levels are the essence of an organization, and

their full involvement enables their abilities to be used for the organization’s benefit.


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Process ApproachProcess Approach• Organizations need to do more than

simply monitor process outputs, (typically through inspection activities)

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

and, they must establish appropriate controls over the transformation activities (if desired results are to be achieved 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 transformation

activities consistently work, and the desired results are 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 ApproachSystem Approach

• Organizations must understand a system is a set of interrelated processes, and

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

It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective


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Continual ImprovementContinual Improvement

• Continual improvement of the organization’s overall performance should be a permanent objective:

improvement must be a planned activity if the organization desires to improve overall performance and capabilities.


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Plan Do

Act Check

QMS

Results

Baseline Performance

Improvement 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 for continuous improvement ...


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Factual Approach toFactual Approach toDecision MakingDecision Making

• Effective decisions are:

based on the analysis of data and information.


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Mutually BeneficialMutually BeneficialSupplier RelationshipsSupplier Relationships

• An organization and its suppliers are truly inter-dependent, and

a mutually beneficial relationship enhances the ability of both to create value.


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EXERCISE #2

• Pick one of the eight quality management principles and list three of the most important actions you think an organization should take in applying this principle.

1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

• How well does your organization do each of the actions identified above?

1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

• What can your organization do to more fully utilize the principle?

1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________


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The ISO 9000:2000 standards include 3 documents...

ISO 9000:2000Quality Management Systems -Fundamentals and Vocabulary

ISO 9004:2000Quality Management Systems -

Guidelines for Performance Improvements


Requirements


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ISO 9000:2000 standards replace 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 Performance Improvements

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


Requirements


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Other ISO documents are also being 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 European standard, for these standards:

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

only ISO/TS 16949 will be upgraded to ISO 9001:2000

however, ISO has granted permission for continued (indefinite) use of QS-9000

ISO/TS 16949International Automotive Standard -Quality System Requirements


25

Role of ISO 9000:2000

• Defines quality managementprinciplesterms and definitionsfundamentals:

- systems approachprocess approach- continual improvement

• ISO 9000:2000 is a “normative reference” (i.e. part of the requirements), and replaces:

ISO 8402:1994 and ISO 9000-1:1994


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• Specifies quality system requirements:

for achieving customer satisfaction applicable to entire enterprise

note: “permissible exclusions” (likedesign) are limited to

requirementswithin 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 performance improvement, based on

quality management principles and approaches defined in ISO 9000, and

continual improvement of the quality management system itself

note: however, ISO 9004 is NOT intended as aguideline 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 definitions

4. 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 theQuality Management System

The Process-Based QualityManagement System

ManagementResponsibility

ProductRealization

ResourceManagement

MeasurementAnalysis &

Improvement

CUSTOMER

REQUIREMENTS

CUSTOMER

SATISFACTION

Product

Input Output


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ISO 9001:2000 implements the PDCA improvement cycle• Plan

Clause 5. Management responsibility - everything flows from Management who define the requirements for the system

Clause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system

• DoClause 7. Product (and/or service)

realization - the necessary process are established and carried out


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ISO 9001:2000 implements the PDCA improvement cycle• Check

Clause 8. Measurement, analysis and improvement - processes and products will be monitored and measured against policies, objectives and requirements for the product and results/opportunity for improvement reported

• ActClause 8. Measurement, analysis and

improvement - acting upon data reported in the check cycle, improvement actions can be taken - directly, or as an output of the Management Review process (Clause 5.6)


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Clause 4 - Quality management system

• 4.1 General requirements - New: must define processes to be managed (including out-sourced processes - which typically include design, training, calibration, heat treat, etc.); determine the sequence and interaction of these processes; determine the criteria and methods needed to ensure these processes are effective; and take actions to improve these processes

• 4.2 Documentation requirements - New: documentation requirements less prescriptive; however, at a minimum must include a quality manual and the following six documented procedures: Control of Documents (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 - Management responsibility

• 5.1 Management commitment - New: top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness

• 5.2 Customer focus - New: customer requirements (identified per Clause 7.2.1) must be met with the aim of enhancing customer satisfaction (a “perception” that must be measured per Clause 8.2.1)

• 5.3 Quality policy - New: quality policy must include commitment to meeting requirements and continual improvement of the effectiveness of the QMS, provide a framework for establishing/reviewing measurable quality objectives; and, quality policy must be periodically reviewed for continuing suitability


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• 5.4 Planning - New: establish measurable quality objectives at relevant functions and levels in the organization needed to meet product requirements (identified per Clause 7.1 a); and identify and plan quality system processes (identified per Clause 4.1)

• 5.5 Responsibility, authority and communication - New: management representative must promote awareness of customer requirements throughout the organization; internal communications regarding the effectiveness of the quality system must be established


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• 5.6 Management review - New: evaluate the need for changes to the quality system (including policy and objectives) by reviewing specified inputs (improvement opportunities) and reporting specified outputs (related management actions and resource needs)


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Clause 6 - Resource management

• 6.1 Provision of resources - New: determine and provide resources needed to implement and improve the QMS and address customer satisfaction

• 6.2 Human resources - New: determine needed competencies, evaluate effectiveness of actions taken to satisfy competency needs; and ensure employees are aware of the importance of their activities and how they contribute to achieving quality objectives

• 6.3 Infrastructure and 6.4 Work Environment - New: determine and manage the infrastructure (buildings, workspace, utilities, equipment and 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 for contracts, projects and products

• 7.2 Customer-related processes - New: define the processes for communicating with the customer with regards to product information; inquiries, contracts or order handling, and customer feedback, including complaints

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


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Clause 7 - Product realization

• 7.4 Purchasing - New: establish criteria for supplier evaluation and selection, and periodic re-evaluation

• 7.5 Production and service provision - New: Nothing, essentially the same as requirements contained in Elements 4.7, 4.8, 4.9, 4.15, and 4.19 of ISO 9001:1994

• 7.6 Control of measuring and monitoring devices - New: validate software used to verify product


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Clause 8 - Measurement, analysis and improvement

• 8.1 General - New: plan and implement monitoring, measurement, analysis and improvement processes

• 8.2 Monitoring and measurement - New: must measure and monitor customer satisfaction (note: customer satisfaction is any information relating to the customer’s “perception” of the organization’s ability to meet customer requirements); internal auditors must now be objective and impartial (vice “independent); and processes used to manage the quality system must be measured/monitored to the degree necessary to demonstrate they achieved planned results


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Clause 8 - Measurement, analysis and improvement

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

• 8.4 Analysis of data - New: analyze data to determine quality system effectiveness and to provide information on customer satisfaction, supplier performance, product conformance, and process/product characteristics and trends used to identify opportunities for preventive action

• 8.5 Improvement - New: must improve effectiveness of the quality management system (note: accomplish through the use of quality policy, objectives, audit results, analysis of data, corrective/preventive actions, and management review)


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ISO 9000:2000 standards released December 2000

• The final International Standard (IS) was released 15 December 2000 and is available now

• Sector specific schemes are under review and ISO 9000:2000 based revisions will be issued soon:

Automotive: ISO/TS 16949 Aerospace: AS 9100 Telecommunications: TL 9000


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Essentially, you’ll have 3 years to transition to the

new standards

• Accredited registrations to ISO 9001/2/3:1994 may continue for up to 3 years (through 12/03)

Allows transition time for those “in progress”

• Both new registrations and continuations of current registrations based on 1994 standards will expire on or before the end of CY 2003

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


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So … what should organizations do NOW?

• Obtain assistance from qualified sources

Obtain/conduct Management and Employee Awareness Training, Internal Auditor Training, and Process Management 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 your organization (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 as possible 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, some adjustments will have to be made to address new requirements and cross reference quality system documentation to ISO 9001:2000


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Answers to FAQs (continued) ...

• Will the changes affect my current registration / certification?

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

• I am not yet registered. Should I pursue 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 The Role of Internal Audits has shifted...Audits has shifted...

ISO 90011994

Internal auditEffectiveness assessed in audit report

Management review

ISO 90012000

Customer satisfaction

Management determines

effectiveness by analyzing all

available data and information

Management review

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


48

Audit Planning• The Shift to Process Audits “Element” Audits, or Departmental Audits should give

way to process audits - i.e. audit (from start to finish) key processes the organization has defined as critical to meeting the overall objectives of the organization

Note: The processes selected, as well as their sequence and interrelation, must make sense to the organization; however, they must address all requirements of ISO 9001:2000 and the policy and 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” and be used to identify additional opportunities for improvement


49

Evaluating QMS Documentation

• Documentation requirements are less prescriptive

ISO 9001:2000 only “requires” a handful of “documented procedures” be in place

All QMS processes, however, must be controlled by either a documented procedure or well defined “system”

• Evaluating System Adequacy Assess organization’s compliance with documented

procedures and/or other well defined responsibilities associated with the process under review (conformance)

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


50

Conducting Process Audits• Identify QMS Process “Owners”

Tools like “Deployment Flowcharts” can be invaluable in defining the sequence, interrelationship and responsibilities associated with QMS Processes

• Evaluate “Conformance”

Tools like our “Checklist and Audit Guide” can be invaluable in verifying that the documented procedure or process complies with ISO 9001:2000 requirements

• Evaluate “Performance”

Verify that the organization is collecting and using process performance data to monitor, measure and improve processes


51

Conducting Top Management Interviews

• The expanded role of top management requires more time be spent with them during internal audits to collect evidence of their commitment to:

Communicating importance of meeting requirements,

Establishing quality policy and objectives,

Conducting management reviews, and

Ensuring availability of necessary resources.


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Interviewing “Process Owners”

• Other managers (i.e. “Process Owners”) should be interviewed to collect evidence that:

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 processsequence and interrelationships are knownand interfaces are effectively managed toachieve 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-added”auditing

• Challenges Process Audits versus Element Audits Fewer procedures Less prescriptive requirements for realization

processes


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EXERCISE #3

• What are the three most significant changes included in ISO 9001:2000?

1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

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

1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________

• How can you use internal audits to enhance employee awareness and involvement in quality management?

1. __________________________________________________________2. __________________________________________________________3. __________________________________________________________


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ISO 9001:2000 to ISO 9001:1994 Mapping

ISO 9001:2000 ISO 9001:19941. Scope 11.1 General -1.2 Permissible Exclusions -2. Normative Reference 23. Terms and Definitions 34. Quality Management System -4.1 General Requirements 4.2.14.2 Documentation Requirements -4.2.1 General 4.5.2, 4.5.34.2.2 Quality Manual 4.2.14.2.3 Control of Documents 4.54.2.4 Control of Quality Records 4.16


56


ISO 9001:2000 ISO 9001:19945. Management Responsibility -5.1 Management Commitment 4.1, 4.1.2.2, 4.2.15.2 Customer Focus 4.3.25.3 Quality Policy 4.1.15.4 Planning -5.4.1 Quality Objectives 4.1.1, 4.2.15.4.2 Quality Management System Planning 4.2.35.5 Responsibility, Authority, and Communication -5.5.1 Responsibility and Authority 4.1.2.15.5.2 Management Representative 4.1.2.35.5.3 Internal Communications -5.6 Management Review 4.1.35.6.1 General 4.1.35.6.2 Review Input 4.1.35.6.3 Review Output 4.1.3


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ISO 9001:2000 ISO 9001:19946. Resource Management -6.1 Provision of Resources 4.1.2.26.2 Human Resources -6.2.1 Assignment of Personnel 4.1.2.2, 4.2.3, 4.186.2.2 Competence, Awareness, and Training 4.186.3 Infrastructure 4.1.2.2, 4.96.4 Work Environment 4.97. Product Realization -7.1 Planning of Product Realization 4.2.3, 4.9, 4.10.17.2 Customer-Related Processes -7.2.1 Determination of Product Requirements 4.3.2, 4.4.47.2.2 Review of Product Requirements 4.37.2.3 Customer Communication 4.3.2


58


ISO 9001:2000 ISO 9001:19947.3 Design and Development -7.3.1 Design and Development Planning 4.4.2, 4.4.3, 4.4.6,

4.4.7, 4.4.87.3.2 Design and Development Inputs 4.4.47.3.3 Design and Development Outputs 4.4.57.3.4 Design and Development Review 4.4.67.3.5 Design and Development Verification 4.4.77.3.6 Design and Development Validation 4.4.87.3.7 Design and Development Changes 4.4.97.4 Purchasing -7.4.1 Purchasing Process 4.6.1, 4.6.27.4.2 Purchasing Information 4.6.37.4.3 Verification of Purchased Products 4.6.4, 4.10.2


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ISO 9001:2000 ISO 9001:19947.5 Production and Service Provision -7.5.1 Control of Production and Service Provision 4.9, 4.10.3,

4.15.6, 4.197.5.2 Validation of Special Processes 4.97.5.3 Identification and Traceability 4.8, 4.10.5, 4.127.5.4 Customer Property 4.77.5.5 Preservation of Product 4.157.6 Control of Monitoring and Measuring Devices 4.11


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ISO 9001:2000 ISO 9001:19948. Measurement, Analysis, and Improvement -8.1 General 4.10, 4.20.18.2 Monitoring and Measurement -8.2.1 Customer Satisfaction -8.2.2 Internal Audit 4.178.2.3 Monitoring and Measurement of Processes4.9, 4.20.18.2.4 Monitoring and Measurement of Product 4.10, 4.208.3 Control of Nonconforming Product 4.138.4 Analysis of Data 4.14, 4.208.5 Improvement -8.5.1 Continual Improvement 4.1.38.5.2 Corrective Action 4.14.1, 4.14.28.5.3 Preventive Action 4.14.1, 4.14.3


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Where can I obtain more information?

• On the world-wide web:ISO web site www.iso.chTC 176 web site www.bsi.org.uk/iso-176-sc2ASQ web site www.asq.orgISO-ONLINE web site www.isoqual.net

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

or call (502) 244-6183

visit us at for more great products 1 presents an overview of the iso 9000:2000 revisions to the...

Documents

great products iso

great products current

models iso

iso history

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baseline performance

metal products

performance excellenceiso