ISO 9001:2000

ISO 9001
Made Easy
Mark Kaganov
Quality Works
mark@quality-works.com

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Instructor - introduction

Total 25 years experience in Quality

Management

10 years in medical device manufacturing –
QMS and R&D

8 years in certification business

Certified (IRCA) QMS Lead Auditor

Certified (RAB) EMS Lead Auditor

5 international patents

14 technical publications

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Objectives

You will learn:

The purpose of the standard

Benefits of a Quality Management System
(QMS)

Standard structure

Clause contents

Implementation approach

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Why do we need ISO 9001?

Enhanced relationship with clients and

suppliers

Improved awareness of company objectives

Consistent processes and product quality

Fewer rejects and returns

Improved utilization of time and resources

Establishes a process for continual
improvement

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What is ISO?

International Organization for Standardization

(Greek iso - equal)
http://www.iso.org/iso/en/ISOOnline.frontpage

Established in 1947

Geneva, Switzerland

Approximately 146 member bodies (2005)

Product and generic (system) standards

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What is ISO? (2)

2952 TCs, SCs, WGs

14,000+ standards

670,000 ISO 9001 registrations in 154
countries

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ISO Mission

“…to promote the development of

standardization to facilitate the
international exchange of goods and
services…”

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ISO 9000 Family of Standards

ISO 9001:2000, Quality management

systems – Requirements,

ISO 9000:2000, Quality management
systems – Fundamentals and vocabulary

ISO 9004:2000, Quality management
system – Guidelines for performance
improvements

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ISO 9001:2000

A compilation of system and process

requirements that an organization would
have to establish, document, implement
and maintain if the organization were to be
considered capable of meeting customer
requirements and sustaining continual
performance improvement

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ISO 9001:2000 Contents

1. Scope

2. Normative Reference

3. Terms and Definitions

4. Quality Management System

5. Management Responsibility

6. Resource Management

7. Product Realization

8. Measurement, Analysis and Improvement

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ISO 9001:2000 Appendices

Appendices that harmonize the numbering

systems of the 9001:1994 standard with
the 9001:2000 standard and with ISO
14001 (EMS)

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0.1 - General

Purpose: to demonstrate capability to

meet customer and applicable regulatory
requirements

Not all QMSs are alike

Documents your organization’s unique
processes

Complements technical product or
service requirements

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0.2 - Process approach

Continual improvement of the QMS

Management
responsibility

Measurement,
Resource
analysis and
management
improvement

Product Product,
realization output

Interested parties Requirements, input Satisfaction

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0.3 - Relationship with ISO 9004

ISO 9001 and ISO 9004 are developed as

a consistent pair of QMS Standards
 Similar structures

ISO 9001 focuses on effective QMS to
meet customer requirements

ISO 9004 covers wider range of objectives
to continually improve QMS
 Not intended for certification

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0.4 - Compatibility

Compatibility With Other Management

Systems

Requirements have been aligned with ISO
14001 for purposes of integration
 Does NOT address requirements of
environmental systems, OSHA, financial
management, or risk management
 These may be included in your QMS

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1 - Scope

1.1 General
 Addresses customer satisfaction through an
effective system, continual improvement, and
assurance of conformity to customer and
applicable regulatory requirements

1.2 Application
 Requirements are generic and intended to be
applicable to all organizations
 Requirements determined as non-applicable
may be considered for exclusion (only clause
7)

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2 – Normative references

ISO 9000:2000, Quality management

systems – Fundamentals and vocabulary

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3 - Terms and definitions

ISO 9000:2000 incorporates glossary

The section contains the standard’s use of
supply chain terminology

Supplier -> organization -> customer

Product is equivalent to service

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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 records

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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 communication
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5 - Management Responsibility

5.6 Management review

 5.6.1 General
 5.6.2 Review input
 5.6.3 Review output

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6 - Resource Management

6.1 Provision of resources

6.2 Human resources
 6.2.1 General
 6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

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7 - Product Realization

7.1 Planning of product realization

7.2 Customer-related processes
 7.2.1 Determination of requirements related to
the product
 7.2.2 Review of requirements related to the
product
 7.2.3 Customer communication

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7 - Product Realization

7.3 Design and development

 7.3.1 Planning
 7.3.2 Inputs
 7.3.3 Outputs
 7.3.4 Review
 7.3.5 Verification
 7.3.6 Validation
 7.3.7 Control of changes

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7 - Product Realization

7.4 Purchasing
 7.4.1 Purchasing process
 7.4.2 Purchasing information
 7.4.3 Verification of purchased product

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7 - Product Realization

7.5 Production and service provision

 7.5.1 Control of production and service
provision
 7.5.2 Validation of processes for production
and service provision
 7.5.3 Identification and traceability
 7.5.4 Customer property
 7.5.5 Preservation of product

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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 non-conforming product

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8 - Measurement, analysis and
improvement

8.4 Analysis of data

8.5 Improvement
 8.5.1 Continual improvement
 8.5.2 Corrective action
 8.5.3 Preventive action

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Implementation - considerations

Benefits / cost considerations

Commitment, commitment and commitment

Project management approach
 Tasks
 Responsibilities
 Timeframe
 Deliverables
 Periodic progress review
 Verification and validation

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Implementation - Resources

www.quality-works.com

ISO 9001:2000 - The Perfect Manual

ISO 9001:2000 - A Process Interaction
Matrix - A Case Study

ISO 9001:2000 - A Quality Manual for the
Transition and Beyond

Checklists - A Perfect Tool to Tune-up Your
Quality Manual

Keep Your Web Site Under Control

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Quiz

When ISO was established?

What elements can be
excluded from your QMS?

What are the official
languages of ISO?

ISO Mission?

Effective system needs…?

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Quiz - answers

1947

Clause 7 only

English, French and Russian

“…to promote the
development of
standardization to
facilitate the international
exchange of goods
and services…”

COMMITMENT!
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Did meet our objectives

We learned:

The purpose of the standard

Benefits of a Quality Management System
(QMS)

Standard structure

Clause contents

Implementation approach

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Questions

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Questions – Contact information

Mark Kaganov

Quality Works
Director of Operations

mark@quality-works.com

303-985-7942

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