ISO 9001:2000 The 5 Phase Plan to

Implementation

www.tnaqconsutling.com

Sterling, VA703-801-3673

rterry@tnaqconsulting.com

Terry & Associates Quality Consulting, LLC

What is ISO 9001:2000?

ISO 9001:2000 is an international

standard for implementing a quality management system

ISO 9001:2000 sets out how a company can

establish an effective quality management system to meet its

stakeholders’ needs

ISO 9001:2000 sets out how a company can

establish an effective quality management system to meet its

stakeholders’ needs

Why Use ISO 9001:2000?

ISO 9000:2000 - Fundamentals and Vocabulary

Provides an introduction to Quality Management Systems (QMS) and vocabulary

ISO 9001:2000 - Requirements Specifies requirements for a QMS where

capability to provide product that meets customer and regulatory requirements needs to be demonstrated

ISO 9004:2000 - Guidelines for Performance Improvement

Provides guidance on using an established QMS to further enhance customer satisfaction and product/service quality

IS0 9000:2000 Series of Standards

1. Customer focus

2. Leadership

3. Involvement of people

4. Process approach

5. System approach to management

6. Continual improvement

7. Factual approach to decision making

8. Mutually beneficial supplier relationship

Eight Quality Management Principles

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Measurement, analysis and improvement

Measurement, analysis and improvement

ProductProductInput Output

Management responsibility

Resource management

Resource management

Clause 5

Clause 6 Clause 8

Clause 7

Customers

Requirements

Product

realization

Customers

Satisfaction

Value adding activitiesInformation flow

Introduction to ISO 9000:2000

1. Scope

1.1 General

1.2 Application

2. Normative reference

3. Terms and definitione.g., Supplier Organization Customer

ISO 9001:2000 Requirements

Possibility to reduce scope

No 9002 or 9003

Can reduce the scope of requirements related to “product realization”

May not exclude any requirement that affects ability to provide product and/or service that meets customer and regulatory requirements

Permissible Exclusions

To meet the requirements you must: Document Implement Maintain Continually improve effectiveness

4 Quality Management System

4 Quality Management System

4.1 General requirements Processes, interaction, improvement

4.2 Documentation requirements General Quality manual Control of document Control of records

5 Management Responsibility

5.1 Management commitment

5.2 Customer focus5.3 Quality policy5.4 Planning

Objectives Management system

5.5 Responsibility, authority and communication

Top management emphasis Management representative

Includes promotion of customer requirements throughout the organization

Internal communication5.6 Management review

Lists of inputs and outputs Recommendation for improvement Action items expected Records

5 Management Responsibility

6 Resource Management

6.1 Provision of resources to improve processes and enhance customer satisfaction

6.2 Human resource Determine competence Provide training or other action Evaluate effectiveness of action

6.3 Infrastructure Buildings, workspace, utilities Process equipment Support services

6.4 Work environment Manage conditions of environment to

achieve product requirement conformance

7 Product Realization

7.1 Plan and develop the processes Include product objectives, relevant

processes and resource, appropriate test and validation

7.2 Customer related processes Customer requirement - stated and

implied Statutory and regulatory Product requirements and changes Organization ability Communication with customers

7.3 Design and development Planning, inputs, outputs, systematic

reviews, verification and validation, control of changes

7 Product Realization

7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product

7.5 Production and service provision Controlled conditions including product

characteristics, work instructions, suitable equipment, measuring devices, and system

Release, delivery and post delivery activities

Validation of processes when no other method

Identification and traceability of product and it’s status

Care of customer property Preservation of product

Includes constituent parts

7 Product Realization

7.6 Control of monitoring and measuring devices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration

8 Measurement, Analysis, and Improvement

8.1 General Plan and implement Measurement and monitoring processes

To demonstrate product conformity, system conformity and continually improve the QMS

8.2 Monitoring and measurement Customer satisfaction

Perception of fulfillment Internal planned audit, etc.

Auditors independent of their own work Processes

Demonstrate achievement of planned results Product

Monitor and measure characteristics Conformity with acceptance criteria Waivers / concessions

8 Measurement, Analysis, and Improvement

8.3 Control of nonconforming product Elimination, concession, preclude

intended use

8.4 Analysis of data Customer satisfaction Product and process requirements and

trends Suppliers

8.5 Improvement Continually improve effectiveness

of the system Corrective action Preventive action

Next Steps

Phase I: Assess the present situationPhase II: Plan the implementation /

transitionPhase III: Implement planPhase IV: Assess and reviewPhase V: Consolidate and improvePhase VI: External assessment

Next Steps

Implementation Transition Assess existing Business System

Review: Scope

I.D. Steering Team and Implementation Team

Existing documentation Assessment system Management review

Prepare and coach teams

Corrective and Preventive Action Systems

Senior management focus Performance since

registration For compliance gaps

Phase I: Assess the Present Situation

Next Steps

Implementation TransitionDevelop:

Project PlanDevelop:

Overall transition plan Documentation plan Training plan Communication plan Process mapping plan Calibration plan Assessment plan Management review

plan

Plan for those topicsneeding attention as aresult of the review

- Documentation(especially if existingsystem is not processfocused)

- Transition Measurement and

Improvement plan Registrar selection plan

Plan to implementprocesses to fulfill anysystem gaps

Phase II: Plan the Implementation/Transition

Next Steps

Implementation Transition Maintain project plan Provide training identified Process map the business

processes Gather metrics data I.D. improvement issues Publish improvement

Map processes if not already documented

Measure processes Train assessors to assess

for business effectiveness Gather metrics data I.D. improvement issues Publish improvement

Phase III: Implement the Plan

Next Steps

Assess Review Use internal assessment

to verify compliance andI.D. businesseffectiveness issues

Use internal assessmentto verify compliance andI.D. business effectivenessissues

Share information to gainimprovement momentum

Share information to gainimprovement momentum

Start managementreviews

Continue managementreviews (revised)

Phase IV: Assess and Review

Next Steps

Implementation Transition $ Improvement issues

(process mapping,assessments, customersatisfaction)

$ Improvement issues(process mapping,assessments, customersatisfaction)

Change the processes Change the processes

Publish gains andsuccess

Publish gains andsuccess

Close gaps withcompliance

Close gaps withcompliance

Phase V: Consolidate and Improve

Next Steps

Implementation Transition Optional pre-assessment

On goingsurveillance(increase scope)

Registrationassessment

Upgrading theexisting registration

Business focus Business focus

Phase VI: External Assessment

Summary

ISO 9001:2000 is much more project driven Top management have greater accountability The organization is required to measure

business performance against objectives If implemented correctly, it will help the

organization to:Be more competitiveImprove cycle timesReduce costsImprove morale

Terry & Associates Quality Consulting, LLC

Terry & Assoc. provides a full range of consulting, and in-house training in international standards, regulatory requirements, and process improvement techniques which maximizes performance and profitability for your company.

Contact us or visit our website for ways in which we can help support your organization’s ISO 9001:2000 implementation or transition or other business process improvement activities.

Terry & Associates Quality Consulting, LLC

Terry & Associates Quality Consulting,

LLC

Sterling, VA703-801-3673

rterry@tnaqconsulting.com

Website: http://www.tnaqconsulting.com