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ISO 9001 and ISO 140guidelin

in business manageme

QUALITY SYSTEM AND HACCPBanja Luka, May, 2003

Olga Martín-Bello

University of Lleid



Standardization = Systematization

A priority in management strategies

A safeguard of the performance of

policy, rules and requirements

A tool for continuous improvement



tegrated management systems advantag

Improve customer, society and personnel satisfaction.

Improve internal running and organizing systems. Saving costs.

Based on a recognized model internationally accepted.

Improve the external image of the organization.

Let open new markets.Standardize the performance of the regulations.

Define and improve processes.

Facilitate identification and solve real or potential problems.Let getting financial support from different Administrations.

Decrease the cost of insurance policy.



MANAGEMENT SYSTEMS

PLANMANAGEMENT RESPONSIBILITY

Policy Resources Representative Review

CHECK INTERNAL AUDITS

DO

ACTREVENTIVE &CORRECTIVE

ACTIONS

QUALITY SYSTEM

DOCUMENTS PERSONNE

ControlUp to date Training



Quality management process model

(ISO 9001:2000)

CONTINUAL IMPROVEMENT OF THE MANAGEMENT SYSTEM

Customer

Requirements

Customer

Satisfaction

Managementresponsibility

Product

realization

Resourcesmanagement

Measurement,analysis,

improvement

ProductOutput

Activities that add value

Flux of information

Input



Model of environmental manageme

system (ISO 14001)CONTINUOUS

IMPROVEMENT

ENVIRONMENTAL

POLICY

PLANNING

APPLICATION

CHECKING

MANAGEMENT

REVIEW



Environmental protection,

is it needed?



Objectives for environmental protectio

Sustainable management of natural resources

Integrated fight against pollution andreduction of wastes

Promotion of reuse and recycling

Rationalization of production and energy

consumption

Changing consumption behavior

Improving public health



Factors for promoting business

environmental policy Legal obligation

Pressure from society Image Improvement

Market exigency Improvement of profitability

Advantage from competitors Tax exemptions

Financial support and incentives

Avoiding punishments and sanctions



Common requirements on ISO 9001 and ISO14001 guidelines

Environ. manag. systemdocumentation

Control of documentsControl of records

4.4.4

4.4.54.5.3

4.2 cumentation

requirements

General requirements4.14.1neral requirementsEnviron. manag. syste44ality manag. system

Definitions33ms and definitions

Normative reference22rmative reference

Scope11pe

Introduction0oduction

RequirementChapter Chapter uirement

ISO 14001:1996ISO 9001:2000



Structure & responsibility 4.4.15anag. Responsibility

Management review 4.6 5.6 anagement review

General requirement Structure & responsibility

Communication

4.14.4.1

4.4.3

5.5 esponsibility, authority & communication

Planning4.35.4anning

Environmental policyStructure & responsibility

4.2 4.4.1

5.3uality policy

Environmental aspectsLegal & other requireme4.3.14.3.25.2 ustomer requirement

Environmental policyStructure & responsibility

4.2 4.4.1

5.1eneral requirement

RequirementChapter Chapter equirement

ISO 14001:1996ISO 9001:2000

Common requirements onISO 9001 and ISO 14001 guidelines



Training, awareness &competence

4.4.26.4rk environment

Structure & responsibility 4.4.16.3rastructure

Structure & responsibility Training, awareness &competence

4.4.14.4.26.16.2viding resourcesman resources

Structure & responsibility 4.4.16source management

RequirementChapter Chapter quirement

ISO 14001:1996ISO 9001:2000




Monitoring & measuremen4.5.17.6 ntrol of measuring &monitoring devices

Operational control4.4.67.5 duction & servicesoperations

Operational control4.4.67.4chasing Operational control4.4.67.3ign and development

Environmental aspectsLegal & other requirementOperational controlCommunication

4.3.14.3.24.4.64.4.3

7.2 tomer-related processes

Operational control4.4.67.1nning

Implementation & operat 4.47duct realization


ISO 14001:1996ISO 9001:2000




Environmental policy

Environ. manag. programNon-conformance, correctiv preventive action

4.2

4.3.44.5.2

8.5 rovement

Monitoring & measurement4.5.18.4ta analysis

Non-conformance, correctivpreventive action

Emergency plan & response

4.5.2

4.4.7

8.3ntrol of nonconformity

Monitoring & measurementEnviron. manag. Syst. Audit

4.5.14.5.4

8.2 asurement &monitoring

Monitoring & measurement4.5.18.1neral requirements

Checking & correct. Actio4.5 8asurement, analysis &improvement


ISO 14001:1996ISO 9001:2000




ISO 9001

Customer contract

Quality of product

Customer satisfaction

Differences between ISO 9001 and

ISO 14001

ISO 14001

Regulatory compliance

Emergency system

Environmental impact



Integrated quality and

environmental management systemQuality

management

system

Environmentalmanagement

systemINTEGRATEDSYSTEM

SYNERGY

ISO 9001Qualitymanagement

systemcertification

ISO 14001Environmentalmanagement

systemcertification



Integrated quality and

environmental management systemeneral principles

Compromise of the

whole organization

Preventive character PDCA Methodology

Elements

Requirements

Procedures

Measurement index

Main difficulties:

No-Training Non-Awareness

M i t f lit i t l d



Main aspects of quality, environmental and

integrated management systems

Resourceoptimization

Better organizationBetter coordination

A jointsystem

grated

ISO140

199

Improveefficiency- Answer to societydemands

- Avoiding fines

Compliancelegal and

internal

requirement

Environm.respectironment

ISO

900

200

Improve sales- Association to

providers- Fidelity

- Customer

satisfaction- Competitiveness

improvement

Compliance

consumers

requirement

Customer

satisfactionlity

GuiSaving

costs

AdvantagesDefinitionObjectiveagement

tem



rocess for an integrated management progr

DiagnosticRequirement identification Definition of strategic objectives

Definition of processes mapEstablishment of efficacy indexes

Documental developmentQuality and Environmental planning processes

ont. improvement programMeas. customer satisfaction

uto evaluation and improvement

management

System implantationPersonnel formationFollowing efficacy indexes

Internal audit

Integrated system certification

I d



Integrated management system.

Manual of the management system

Chapter 1. Management system

Chapter 2. Management policy

Chapter 3. Organization & responsibility

Chapter 4. Documentation control

Chapter 5. Internal audits

Chapter 6. Record of the management system

Chapter 7. Training

Chapter 8. Preventive and corrective actions

Chapter 1. Management system

Chapter 2. Management policy

Chapter 3. Organization & responsibility

Chapter 4. Documentation control

Chapter 5. Internal audits

Chapter 6. Record of the management system

Chapter 7. Training

Chapter 8. Preventive and corrective actions



Integrated management system.

Quality management manual (ISO 9001)

Chapter 4. Quality management system

Chapter 5. Responsibility of the manager

Chapter 6. Resources management

Chapter 7. Product realization

Chapter 8. Measurement, analysis & improvemen

Chapter 4. Quality management system

Chapter 5. Responsibility of the manager

Chapter 6. Resources management

Chapter 7. Product realizationChapter 8. Measurement, analysis & improvemen

I t t d t t



Chapter 1. General requirementsChapter 2. Environmental policy

Chapter 3. PlanningChapter 4. Implantation and operating

Chapter 5. Checking and corrective actionsChapter 6. Manager review

Chapter 1. General requirementsChapter 2. Environmental policy

Chapter 3. PlanningChapter 4. Implantation and operating

Chapter 5. Checking and corrective actionsChapter 6. Manager review

Integrated management system.vironmental management manual (ISO 1400



Principles of ISO 19011

Related to auditorsEthic behavior

Clarity of communication

Right mind

Related to audits Independency

Objectivity

Feasible

conclusions



Chapters of ISO-19011

Scope

Normative reference

Terms and definitions

Principles of audit

Management of an audit program

Audit activities

Competency and evaluation of auditors.



Competency of auditors

Environment

Specific knowledgeon quality

(7.3.3)

GeneralGeneralknowledgeknowledge(7.3.1, 7.3.2)(7.3.1, 7.3.2)

Specific knowledgeon environment

(7.3.4)

Quality

EducationWork

experience

Audit

experience

Specific training as

auditor (7.4)

Personal capabilities(7.2)

ISO 9001 and ISO 14001 for



ISO 9001 and ISO 14001 for

satisfied and healthy consumers



H V A L A !

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