1

Quality Management

2

Why bother Certificating?

External view from trained auditors helps focus attention onthe real issues.

Impending audits provide “motivation” to do things right.

Can be a necessary customer requirement in order to dobusiness.

Can give competitive advantage.

3

What Is Quality?

Degree to which a set of inherent characteristicsfulfils requirements

ISO 9000:2000

4

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,amended

2008

5

What Is A Quality Management System?

People

Processes

Materials

Equipment

Resources

Planned

Individually

System

“Best Practice”

Implemented

Collectively

DocumentedSystem

Describes how thishappens

6

Why Document?

• Communication Tool

• Manage Change

• Aids consistency

• Record of Best Practice

• Enables Effective Audit

• ISO 9001 Pre-requisite

7

Documented Q.M.S.

POLICY

QUALITYMANUAL

PROCEDURES

LOCAL/WORK INSTRUCTIONS

RECORDS / FORMS

INTENT

WHAT?

PROOF

HOW?WHY?

8

ISO 9001:2008

The Structure:

ISO 9001 - Q.M.S. Requirements

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

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

9

Do What theCustomer Wants

Managed

MeasureAnalyseImprove

GOODCOMPANY

Policy

Customer Focus

Committed

ObjectivesDetermine & CommunicateAuthority & ResponsibilitiesReview

People

Buildings, Equipment,Machinery, etc

Environment

Planning

Provide Resources

CustomerSatisfaction

System

Processes

Product

Non-conformingProduct

Data & Info

CorrectiveAction

PreventiveAction

Control Our ProcessesControl Our Documentation

ISO

4.14.2

5.1

5.2

5.3 5.4

5.5

5.6

5.

6.2

6.3

6.4

6.

7.2

7.3

7.4

7.

7.1

7.5

7.6

8.2.1

8.2.28.

8.3

8.2.3

8.2.4

8.4

8.5.2

8.5.3

Selling

Purchasing

Designing

Calibrating

Production

10

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 9001:2008

Based on the 8 Quality ManagementPrinciples:

11

Quality Management Process Model

Continual improvement of

the quality management system

Continual improvement of

the quality management system

Requirements

Satisfaction

Customers Customers

Resourcemanagement

Resourcemanagement

Measurement,analysis andimprovement

Measurement,analysis andimprovement

ProductRealisation

ProductRealisation

ManagementResponsibility

ManagementResponsibility

Input Output

ProductProduct

12

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 productsor services.ISO 14000 is primarily concerned with"environmental management". In plainlanguage, this means what theorganization does to minimize harmfuleffects on the environment caused by itsactivities.

13

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 aresignificant. These must then be managed so as to

minimise harm to the environment.

14

ISO14001 - Environmental management system modelfor the international standard

Environmental Policy

Planning•Environmental aspects•Legal and other requirements•Objectives and targets•Environmental management

programmes

Implementation and Operation•Structure and responsibility•Training, awareness and competence•Communication•EMS documentation•Document control•Operational control•Emergency preparedness and response

Checking and Corrective Action•Monitoring and measurement•Non-conformance and corrective

and preventative action•Records•EMS audits

Continualimprovement

Management Review

15

ISO 14001Fundamental requirements

Plan, Do, Check and Act to ensure:

• prevention of pollution

• compliance with environmental regulations (and RRStandards)

• and continual improvement in environmentalperformance

16

Typical questionnaire for ISO14001effectiveness:

Have all employees received environmentaltraining and been briefed?Are business/corporate objectives and targetscommunicated to the workforce?Can you show progress towards the achievementof objectives and are the relevant managers andemployees 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 theupdated copy available throughout the business?Have any incidents been handled appropriately?

17

Typical questionnaire for ISO14001effectiveness (continued):

Have responsibilities been set for communicationswith the regulatory bodies?Has there been a test of the emergency plans?Was this documented and plans alteredaccordingly?Are all maintenance/calibration records fully up todate?Has a management review been undertaken andalterations made to the EMS as necessary?Are all operational procedures up-to-date, readilyavailable and being worked to?