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an SAI Global Company

ISO 9001:2000
464 Heritage Road
Southbury, CT 06488

What is ISO 9001:2000?

ISO 9001:2000 is an
standard for implementing a
quality management system
Why Use ISO 9001:2000?

ISO 9001:2000 sets out
how a company can
establish an effective
quality management
system to meet its
stakeholders’ needs
IS0 9000:2000 Series of

ISO 9000:2000 - Fundamentals and
 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
Eight Quality Management

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
Introduction to ISO 9000:2000

Management Customer
responsibility s

Customer Clause 5
Resource Clause 6 Clause analysis and Satisfaction
management 8 improvement

Clause 7

Input Product Output
Requirement Product
s realization

Value adding activities
Information flow
ISO 9001:2000

1. Scope
1.1 General

1.2 Application

2. Normative reference

3. Terms and definition
e.g., Supplier Organization
Permissible Exclusions

 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
4 Quality Management

 To meet the requirements you must:
 Document
 Implement
 Maintain
 Continually improve effectiveness
4 Quality Management

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
5.2 Customer focus
5.3 Quality policy
5.4 Planning
 Objectives

 Management system
5 Management Responsibility

5.5 Responsibility, authority and
 Top management emphasis
 Management representative
 Includes promotion of customer

requirements throughout the organization
 Internal communication

5.6 Management review
 Lists of inputs and outputs
 Recommendation for improvement
 Action items expected
 Records
6 Resource Management

6.1 Provision of resources to improve
processes and enhance customer
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
 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,
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
 Release, delivery and post delivery
 Validation of processes when no other
 Identification and traceability of product
and it’s status
 Care of customer property
7 Product Realization

7.6 Control of monitoring and measuring
 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
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
 Suppliers

8.5 Improvement
 Continually improve effectiveness
of the system
 Corrective action
 Preventive action
Next Steps

Phase I: Assess the present situation
Phase II: Plan the implementation /
Phase III: Implement plan
Phase IV: Assess and review
Phase V: Consolidate and improve
Phase VI: External assessment
Next Steps

Phase I: Assess the Present
I mplementation Transition
Assess existing Business Review:
System  Scope
I.D. Steering Team and  Existing documentation
Implementation Team  Assessment system
 Management review
Prepare and coach  Corrective and Preventive
teams Action Systems
 Senior management focus
 Performance since
 For compliance gaps
Next Steps
Phase II: Plan the
I mplementation Transition
Develop: Develop:
 Project Plan  Overall transition plan
 Documentation plan  Plan for those topics
 Training plan needing attention as a
 Communication plan result of the review
 Process mapping plan - Documentation
 Calibration plan (especially if existing
 Assessment plan system is not process
 Management review focused)
plan - Transition
 Measurement and  Plan to implement
Improvement plan processes to fulfill any
 Registrar selection plan system gaps
Next Steps

Phase III: Implement the Plan
I mplementation Transition
 Maintain project plan  Map processes is not
 Provide training identified already
 Process map the business  Measure processes
processes  Train assessors to assess
for business effectiveness
 Gather metrics data  Gather metrics data
 I.D. improvement issues  I.D. improvement issues
 Publish improvement  Publish improvement
Next Steps

Phase IV: Assess and Review
Assess Review
 Use internal assessment  Use internal assessment
to verify compliance and to verify compliance and
I.D. business I.D. business effectiveness
effectiveness issues issues
 Share information to gain  Share information to gain
improvement momentum improvement momentum
 Start management  Continue management
reviews reviews (revised)
Next Steps

Phase V: Consolidate and Improve
I mplementation Transition
 $ Improvement issues  $ Improvement issues
(process mapping, (process mapping,
assessments, customer assessments, customer
satisfaction) satisfaction)
 Change the processes  Change the processes

 Publish gains and  Publish gains and
success success
 Close gaps with  Close gaps with
compliance compliance
Next Steps

Phase VI: External Assessment
I mplementation Transition
 Optional pre-  On going
assessment surveillance
(increase scope)
 Registration  Upgrading the
assessment existing registration
 Business focus  Business focus

 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 competitive
 Improve cycle times
 Reduce costs
 Improve morale
an SAI Global Company

 Excel Partnership, Inc. provides a full range of
consulting, public 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
an SAI Global Company

Excel Partnership, Inc.
75 Glen Road
Sandy Hook, CT 06482