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1

Quality Management

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2

What Is Quality?

Degree to which a set of inherent characteristicsfulfils requirements

ISO 9000:2000

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3

Quality Techniques & QMS Standards

Quality

Control

Quality

Assurance

Quality

Management

(Detection) (Prevention) (Direction)

BS 5750

1979-1987ISO

9001/2/3

1987-2000 ISO 9001

2000

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4

What Is A Quality Management System?

People

Processes

Materials

Equipment

Resources

Planned

Individually

System

Best Practice

Implemented

Collectively

DocumentedSystem

Describes how thishappens

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Why Document?

Communication Tool

Manage Change

Aids consistency

Record of Best Practice

Enables Effective Audit

ISO 9001 Pre-requisite

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6

Documented Q.M.S.

POLICY

QUALITY

MANUAL

PROCEDURES

LOCAL/WORK INSTRUCTIONS

RECORDS / FORMS

INTENT

WHAT?

PROOF

HOW?

WHY?

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ISO 9001:2000

The Structure:

ISO 9001 - Q.M.S. Requirements

ISO 9004 - Q.M.S. Guidelines on Performance Improvement

ISO 9000 - Q.M.S. Fundamentals & Vocabulary

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Do What theCustomer Wants

Managed

Measure

AnalyseImprove

GOOD

COMPANY

Policy

Customer FocusCommitted

ObjectivesDetermine & CommunicateAuthority & ResponsibilitiesReview

PeopleBuildings, Equipment,Machinery, etc

Environment

Planning

Provide Resources

CustomerSatisfaction

System

Processes

Product

Non-conformingProduct

Data & InfoCorrectiveAction

PreventiveAction

Control Our ProcessesControl Our Documentation

ISO

4.14.2

5.1

5.2

5.3 5.4

5.55.6

5.

6.2

6.3

6.4

6.

7.2

7.3

7.4

7.

7.1

7.5

7.6

8.2.1

8.2.2

8.

8.3

8.2.3

8.2.4

8.4

8.5.2

8.5.3

Selling

Purchasing

Designing

Calibrating

Production

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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 Relationships

ISO 9001:2000

Based on the 8 Quality Management

Principles:

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Quality Management Process Model

Continual improvement ofthe quality management system

Requirements

Satisfaction

Customers Customers

Resourcemanagement

Measurement,analysis andimprovement

ProductRealisation

ManagementResponsibility

Input Output

Product

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So the Quality Management System(ISO9001) defines what the organizationdoes to ensure that its products orservices satisfy the customer's qualityrequirements and comply with anyregulations applicable to those products

or services.ISO 14000is primarily concerned with"environmental management". In plainlanguage, this means what the

organization does to minimize harmfuleffects on the environment caused by itsactivities.

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ISO 14001 is an internationally recognisedstandard for environmental management systemwhich can be applied by any organisation. It hasmuch in common with ISO 9001, in particular thePLAN - DO - CHECK- ACT concept.

As a minimum, ISO 14001 requires a commitmentto legal compliance, continual improvement andpollution prevention. It involves the identificationand assessment of all environmental aspects andimpacts in order to determine which are

significant. These must then be managed so as tominimise harm to the environment.

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ISO 14001Fundamental requirements

Plan, Do, Check and Act to ensure:

prevention of pollution compliancewith environmental regulations (and RR

Standards) andcontinual improvementin environmental

performance

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Typical questionnaire for ISO14001

effectiveness:Have all employees received environmental

training and been briefed?

Are business/corporate objectives and targets

communicated to the workforce?Can you show progress towards the achievement

of objectives and are the relevant managers and

employees aware of their actions in this respect?

Is the site in a good general state ofhousekeeping?

Has the HS&E policy been reviewed and is the

updated copy available throughout the business?

Have any incidents been handled appropriately?

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Typical questionnaire for ISO14001

effectiveness (continued):

Have responsibilities been set for communications

with the regulatory bodies?

Has there been a test of the emergency plans?Was this documented and plans altered

accordingly?

Are all maintenance/calibration records fully up to

date?Has a management review been undertaken and

alterations made to the EMS as necessary?

Are all operational procedures up-to-date, readily

available and being worked to?

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Why bother Certificating?

External view from trained auditors helps focus attention on

the real issues.

Impending audits provide motivation to do things right.

Can be a necessary customer requirement in order to do

business.

Can give competitive advantage.