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ISO 9001:2008ISO 9001:2008

Practical Guidance toPractical Guidance to

By: Andy Hofmann, President

International Certification Services Inc.

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Presentation ObjectivesPresentation Objectives

Overview of ISO 9001:2008

Commitment Required by Organization

Keys to successful implementation

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ISO 9001:2008ISO 9001:2008

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Business Process FlowBusiness Process Flow

C

URe

C

U

SMeasurement,Anal sis,

Satisf

ManagementResponsibility

Resource

Quality Management System

Continual ImprovementContinuous

ImprovementCycle

A P

C D

ST

O

M

E

R

uiremen

ts

Input Productand/or ServiceRealization

O

M

E

R

Output

Improvement

a

ction

Quality Management System

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Structure of ISO 9001Structure of ISO 9001Based on a Plan-Do-Check-Act Business ProcessModel Organized into Five Major Clauses: 4.0 Quality Management System (general requirements,

documentation requirements, quality manual, control ofdocuments and records)

5.0 Management Responsibility (policy, objectives,planning, customer focus, QMS, management review)

6.0 Resource Management (human resources, facilities,work environment)

7.0 Product and/or Service Realization (contract, design,

purchasing, production, calibration)

8.0 Measurement, Analysis and Improvement(monitoring, audit, control of NC, continual improvement,customer satisfaction)

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Summary ofSummary of RequirementsRequirementsItems that your QMS must document: Policy

Control of Documents Control of Records

Internal Audits Nonconformance Control

Corrective Action Preventive Action Processes and Procedures required to control work

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ISO 9001:2008ISO 9001:2008

Imp ementat onImp ementat on omm tmentomm tment

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Implementation CommitmentImplementation Commitment Full support by Top Management

Implementation is planned, consistently communicatedand appropriate training provided

Regular review of progress - audit

Successes are identified and celebrated

Maximum use is made of existing methods

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Implementation CommitmentImplementation Commitment Establishment of organizational direction through policy

Setting of objectives and targets

Definition of metrics

Provision of resources and removal of road blocks

Assessment of customer risk

Consistent reinforcement of positives

Resources to resolve nonconformances

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Implementation CommitmentImplementation Commitment

Establishment of direction through policy

- Strategic framework for the organization

- Commitment to customer and stakeholders

-

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Implementation CommitmentImplementation Commitment

Setting of Objectives and Targets

- Linked to customer needs

- Measurable and Meaningful

- Risk Based

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Implementation CommitmentImplementation Commitment

Metrics

- Monitoring direct measurables- Monitoring of audits of processes

- Monitoring of customer indicators

- Action when different from plan

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Implementation CommitmentImplementation Commitment

Resources

- Adjustment where metrics indicate

- Recognition and removal of road blocksto improvement

-

- Review of Strategy for continued fit

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Implementation CommitmentImplementation Commitment

Assessment of Customer Risk

- Identification of key needs, past and future

- Review of delivery systems and personnel

- Optimization of resources to consistently deliver against

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ISO 9001:2008ISO 9001:2008Ke sKe s to Successto Success

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Keys to SuccessKeys to Success

Map your processes

Maximum use of existing systems Assign ownership of process steps

Identif sub- rocesses and

controls/procedures Obtain management direction for policy,

goals, targets and metrics

Training, Training, Training

React to measures

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Keys to SuccessKeys to Success

A time line for activities usually six to 18months

A focus point, someone responsible toencourage each stakeholder

egu ar s a us mee ngs w en orManagement

Regular communication on progress toeveryone

An external resource to assist withinterpretations

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Keys to SuccessKeys to Success

Have Fun

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Keys to SuccessKeys to Success

Quotation:

You do not have to do this;

Survival is not compulsory !

Dr. W. Edwards Deming