2000 Rev Overview - Rev 3-1-03

Presents an Overview of the

ISO 9000:2000 Revisions

to the ISO 9000:1994 Standards

“ the Move from Conformance to Performance

“

Presented by:

Date:

Your Company

Outline

• Why Changes are Needed

• Principles and Approaches Driving the

Changes

• Clause by Clause Review of New

Requirements

• Transition Guidance

• Audit Implications

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

 Over 500,000 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.

Current ISO 9000

Standards 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)

“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

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

# 1

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?

___________________________________________________________
___________________________________________________________
___________________________________________________________

ISO 9000:2000 is based on Eight

Quality Management Principles

• Customer Focus
• Leadership
• Involvement of People
• Process Approach
• System Approach
• Continual Improvement
• Factual Approach to Decision Making
• Mutually Beneficial Supplier Relationships

Customer Focus

• Organizations depend on their

customers and therefore should:

 understand current and future customer

needs,

 meet customer requirements, and

 strive to exceed customer expectations.

Leadership

• 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.

Process 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)

What is a Process?

Activity that transforms input into output

Activity

Input

Output

Resources:

People
Facilities/Equipment
Material
Methods

Results:

Products
Services
Performance

How is a Process Managed?

Activity

Input

Output

Right Resources:

Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods

Desired Results:

Quality Products
Quality Services
Customer Satisfaction

Monitor & Measure the Process

make sure the inputs are right, the transformation

activities consistently work, and the desired results
are achieved, then - improve the process as needed

How is a Process Measured?

Activity

Input

Output

Right Resources:

Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods

Desired Results:

Quality Products
Quality Services
Customer Satisfaction

Efficient

No Waste

Effective

Desired Results Achieved

System 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

Continual 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.

Plan
Do

Act
Check

QM
S

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 ...

Mutually Beneficial

Supplier Relationships

• An organization and its suppliers are

truly inter-dependent, and

 a mutually beneficial relationship enhances

the ability of both to create value.

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. __________________________________________________________

The ISO 9000:2000 standards

include 3 documents...

ISO 9000:2000

Quality Management Systems -

Fundamentals and Vocabulary

ISO 9004:2000

Quality Management Systems -

Guidelines for Performance Improvements

ISO 9001:2000

Quality Management Systems -

Requirements

ISO 9000:2000 standards

replace many existing ISO

documents...

Revises/Replaces:

- ISO 8402:1994
- ISO 9000-1:1994

ISO 9000:2000

Quality Management Systems -

Fundamentals and

Vocabulary

Revises/Replaces:

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

9004-4 (all previous editions, 1994-
1994)

ISO 9004:2000

Quality Management Systems -

Guidelines for

Performance

Improvements

Revises/Replaces:

-  ISO 9001:1994
-  ISO 9002-1994
-  ISO 9003:1994

ISO 9001:2000

Quality Management Systems -

Requirements

Other ISO documents are also

being revised for consistency...

replaces:

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

ISO 19011

the Joint Working Group on

Auditing Document

with revisions due out after issuance
of ISO 9000:2000 include:

- Aerospace: AS 9100
- Telecommunications: TL 9000

Other sector specific

Quality System

Requirements Documents

released in 2002 to
“harmonize” and replace US
and European these
automotive QMS standards:

- QS 9000 (US)
- EAQF (France)
- VDA6.1

(Germany)

- AVSQ (Italy)

ISO/TS 16949:2000
includes all ISO
9001:2000 requirements

and is to be taken in
conjunction with applicable
customer specified
requirements and guidance

ISO/TS 16949:2002

International Automotive

Standard -

Quality System

Requirements

Role of ISO 9000:2000

• Defines quality management

principles
terms and definitions
fundamentals:

-  systems approach
-  process 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

Role of ISO 9001:2000

• Specifies quality system

requirements:

 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 they
are not part of your business

• ISO 9001:2000 replaces:

ISO 9001/2/3:1994

Role of ISO 9004:2000

• 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 a
guideline for implementing or assessing
implementation of ISO 9001 requirements

• ISO 9004:2000 replaces:

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

ISO 9001 and ISO 9004

are the “Consistent Pair”

comprised of the following 8 clauses:

Scope

Normative references

(part of the requirements)

Terms and definitions

Quality management system

Management responsibility

Resource management

Product

(and/or service)

realization

Measurement, analysis &

improvement

Continual Improvement of the

Quality Management System

The Process-Based Quality

Management System

Management

Responsibility

Product

Realization

Resource

Management

Measurement

Analysis &

Improvement

C
U

A
C

Product

Input

Output

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

• Do

Clause 7. Product (and/or service)

realization - the necessary process are
established and carried out

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

• Act

Clause 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)

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).

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

“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

Clause 5 - Management

responsibility

• 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

Clause 5 - Management

responsibility

• 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)

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

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

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

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

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)

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 based on

ISO 9000:2000 and applicable sector
specific requirements applicable to:

 Automotive: ISO/TS 16949:2002
 Aerospace: AS 9100
 Telecommunications: TL 9000

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

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

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

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

The Role of Internal

Audits has shifted...

ISO

900
119

Internal

audit

Effectiveness

assessed in

audit report

Management

review

ISO
900
120
00

Customer

satisfaction

Management

determines

effectiveness

by analyzing

all available

data and

information

Management

review

Internal

audit

Other data

Audit Methodologies ...

• Audit Planning

• Evaluating QMS Documentation

• Conducting Process Audits

• Using Internal Audits to:

 Verify QMS Effectiveness

 Identify Opportunities for Improvement

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 (usually ‘production’ processes, 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

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)

Conducting Process Audits

• Identify QMS Process “Owners”

 “Deployment Flowcharts” can be invaluable in defining

the sequence, interrelationship and responsibilities
associated with QMS Processes

• Evaluate “Conformance”

 “Checklists” 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

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.

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 process
sequence and interrelationships are known
and interfaces are effectively managed to
achieve the desired objectives.

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

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. __________________________________________________________

ISO 9001:2000 to ISO 9001:1994

Mapping

ISO 9001:2000

ISO 9001:1994

1. Scope

1.1 General

1.2 Permissible Exclusions

2. Normative Reference

3. Terms and Definitions

4. 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 to ISO 9001:1994

Mapping

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 to ISO 9001:1994

Mapping

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

4.18

6.3 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

ISO 9001:2000 to ISO 9001:1994

Mapping

ISO 9001:2000

ISO 9001:1994

7.3 Design and Development

7.3.1 Design and Development Planning

4.4.2, 4.4.3, 4.4.6,
4.4.7, 4.4.8

7.3.2 Design and Development Inputs

4.4.4

7.3.3 Design and Development Outputs

4.4.5

7.3.4 Design and Development Review

4.4.6

7.3.5 Design and Development Verification

4.4.7

7.3.6 Design and Development Validation

4.4.8

7.3.7 Design and Development Changes

4.4.9

7.4 Purchasing

7.4.1 Purchasing Process

4.6.1, 4.6.2

7.4.2 Purchasing Information

4.6.3

7.4.3 Verification of Purchased Products

4.6.4, 4.10.2

ISO 9001:2000 to ISO 9001:1994

Mapping

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, 4.12

7.5.4 Customer Property

4.7

7.5.5 Preservation of Product

4.15

7.6 Control of Monitoring and Measuring Devices

4.11

ISO 9001:2000 to ISO 9001:1994

Mapping

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

4.17

8.2.3 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

information?

• 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: isoqual@bellsouth.net
or call (502) 299-6122

Document Outline