ISO 9001:2000 The 5 Phase Plan to
Implementation
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Sterling, VA703-801-3673
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
Website: http://www.tnaqconsulting.com
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