Presents an Overview of the

ISO 9000:2000 Revisions

to the ISO 9000:1994 Standards the Move from Conformance to Performance

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
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.

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

Business Vision

Performance Excellence

Competitive

Malcolm Baldrige Criteria

Advantage

Performance Improvement ISO 9004:2000

Efficient

Quality Management System

Baseline Performance: ISO 9001:2000

Effective Quality Management System

EXERCISE #1
List your organizations 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 organizations 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 organizations objectives.

Involvement of People

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

their full involvement enables their abilities to be used for the organizations benefit.

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

Input Resources:

Activity

Output Results:
Products Services Performance

People Facilities/Equipment Material Methods

How is a Process Managed?

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

Input

Activity

Output

Right Resources:
Qualified People Right Facilities/Equipment Correct Materials Proven Methods

Desired Results:
Quality Products Quality Services Customer Satisfaction

How is a Process Measured?

Efficient
No Waste Desired Results Achieved

Effective

Input

Activity

Output
Desired Results:
Quality Products Quality Services Customer Satisfaction

Right Resources:
Qualified People Right Facilities/Equipment Correct Materials Proven Methods

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 organizations overall performance should be a permanent objective:

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

The QMS must be used for continuous improvement ...

Improve Process through PDCA Cycle

Plan Act
QMS

Do Check

Results

Measure/Monitor Results Against Objectives Improve Process and Change QMS as Needed to Achieve and Sustain Desired Results

Improvement Objective Baseline Performance

Factual Approach to Decision Making

Effective decisions are:

based on the analysis of data and information.

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...

Quality Management Systems Fundamentals and Vocabulary

ISO 9000:2000

Quality Management Systems Requirements

ISO 9001:2000

Quality Management Systems Guidelines for Performance Improvements

ISO 9004:2000

ISO 9000:2000 standards replace many existing ISO documents...

ISO 9000:2000
Quality Management Systems -

ISO 9001:2000
Quality Management Systems -

Fundamentals and Vocabulary

Revises/Replaces:

Requirements
Revises/Replaces:

- ISO 8402:1994 - ISO 9000-1:1994 ISO 9004:2000

Quality Management Systems -

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

Guidelines for Performance Improvements

Revises/Replaces:

- ISO 9004-1, 9004-2, 9004-3 and 9004-4 (all previous editions, 1994-1994)

Other ISO documents are also being revised for consistency...

ISO 19011
the Joint Working Group on

ISO/TS 16949
International Automotive Standard -

Auditing Document
in Sep 2001 will likely replace:

Quality System Requirements

released in 4th quarter 1999 as a harmonized US and European standard, for these standards:

- ISO 10011 (for QMS) - ISO 14011 (for EMS) Other sector specific
Quality System

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

- 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

- Aerospace: AS 9100 - Telecommunications: TL 9000

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: 1. Scope
2. Normative references
3. Terms and definitions 4. Quality management system 5. Management responsibility 6. Resource management
(part of the requirements)

7. Product (and/or service) realization

8. Measurement, analysis &

improvement

C U S T O M E R R E Q U I R E M E N T S

Continual Improvement of the Quality Management System

Management Responsibility

C U S T O M E R S A T I S F A C T I O N

Resource Management

Measurement Analysis & Improvement

Product Realization
Input

Product Output

The Process-Based Quality Management System

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 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)

5.2 Customer focus - New: customer

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 reevaluation Nothing, essentially the same as requirements contained in Elements 4.7, 4.8, 4.9, 4.15, and 4.19 of ISO 9001:1994

7.5 Production and service provision - New:

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 customers perception of the organizations 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) 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

8.4 Analysis of data - New: analyze data to

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 under review and ISO 9000:2000 based revisions will be issued soon:
Automotive: ISO/TS 16949 Aerospace: AS 9100 Telecommunications: TL 9000

Essentially, youll 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 9001 1994 Internal audit Effectiveness assessed in audit report Management review

Internal audit ISO 9001 2000 Customer satisfaction Other data

Management determines effectiveness by analyzing all available data and information

Management review

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, 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 organizations 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
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

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-addedauditing

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 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 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Quality Records ISO 9001:1994 1 2 3 4.2.1 4.5.2, 4.5.3 4.2.1 4.5 4.16

ISO 9001:2000 to ISO 9001:1994 Mapping

ISO 9001:2000 5. Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning 5.5 Responsibility, Authority, and Communication 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communications 5.6 Management Review 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output ISO 9001:1994 4.1, 4.1.2.2, 4.2.1 4.3.2 4.1.1 4.1.1, 4.2.1 4.2.3 4.1.2.1 4.1.2.3 4.1.3 4.1.3 4.1.3 4.1.3

ISO 9001:2000 to ISO 9001:1994 Mapping

ISO 9001:2000 6. Resource Management 6.1 Provision of Resources 6.2 Human Resources 6.2.1 Assignment of Personnel 6.2.2 Competence, Awareness, and Training 6.3 Infrastructure 6.4 Work Environment 7. Product Realization 7.1 Planning of Product Realization 7.2 Customer-Related Processes 7.2.1 Determination of Product Requirements 7.2.2 Review of Product Requirements 7.2.3 Customer Communication ISO 9001:1994 4.1.2.2 4.1.2.2, 4.2.3, 4.18 4.18 4.1.2.2, 4.9 4.9 4.2.3, 4.9, 4.10.1 4.3.2, 4.4.4 4.3 4.3.2

ISO 9001:2000 to ISO 9001:1994 Mapping

ISO 9001:2000 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 Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Products ISO 9001:1994 4.4.2, 4.4.3, 4.4.6, 4.4.7, 4.4.8 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9 4.6.1, 4.6.2 4.6.3 4.6.4, 4.10.2

ISO 9001:2000 to ISO 9001:1994 Mapping

ISO 9001:2000 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Special Processes 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product 7.6 Control of Monitoring and Measuring Devices ISO 9001:1994 4.9, 4.10.3, 4.15.6, 4.19 4.9 4.8, 4.10.5, 4.12 4.7 4.15 4.11

ISO 9001:2000 to ISO 9001:1994 Mapping

ISO 9001:2000 8. Measurement, Analysis, and Improvement 8.1 General 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action ISO 9001:1994 4.10, 4.20.1 4.17 4.9, 4.20.1 4.10, 4.20 4.13 4.14, 4.20 4.1.3 4.14.1, 4.14.2 4.14.1, 4.14.3

Where can I obtain more information?

On the world-wide web:
ISO web site TC 176 web site ASQ web site ISO-ONLINE web site www.iso.ch www.bsi.org.uk/iso-176-sc2 www.asq.org www.isoqual.net

Other questions?
ISO-ONLINE Email: isoqual@isoqual.net or call (502) 244-6183