Integrated Manag[1]. Systems Lecture 1 Fn

8/6/2019 Integrated Manag[1]. Systems Lecture 1 Fn

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INTEGRATEDMANAGEMENT SYSTEMS

LECTURE 1General presentation of integrated systems.Reasons to develop an integrated system

by

Prof. Liviu MOLDOVAN

Department of Technological and Managerial Engineering,³Petru Maior ́ University of Targu-Mures, Romania



Number of Credits: 4

Method of Delivery Face to face Lectures/Tutorials: 20 (10 x 2) hours

Laboratory sessions: 12 (3 x4) hours

C ompetences Acquired: This study unit

should provide the student with sufficient

knowledge and understanding of the

integrated management systems: quality,

environment, health and safety, especially the practical aspects applied in HT and SE

profile enterprises.



Syllabus: 10 LE C TURES:

1. General presentation of integrated systems. Reasonsto develop an integrated management system.

2. General presentation of the standards for quality(ISO9000), environment (ISO14000) and specificationsfor health and safety (OHSAS18001, 18002).

3. Process approach: parameters of processes, metricsfor processes, process objectives, indicators, processprocedures (flowchart).

4. Methods for analysis and evaluation of quality:

Ishikawa diagram, Pareto Diagram, Demeritsmethodology, Histograms, QFD (Quality FunctionDeployment), FME A (Failure Mode and Effects Analysis).

5. Statistical methods (analysis of capability and

stability), 6sigma.



6. Economical aspects of quality. The quality costsstructure: prevention costs, evaluating costs, defectingcosts (external, internal), demonstrating costs.

7. Environmental management: EU norms for Environmental management, processes with impact onenvironment, determination of processes with significantimpact on environment, operational control of processeswith significant impact on environment.

8. Health and safety: the calculus of risks in workspacewith HT and SE. Operational control of work places withhigh risk, processes/substances with high risk.

9. General procedures required by the integrated

systems: document control, registration control,treatment of unconformities, corrective actions,preventive actions.

10. Auditing of systems: documentation, techniques,methodology, reporting. The management of correctiveactions.



LECTURE 1:- General presentation of integrated systems.

- Reasons to develop an integratedmanagement system.

OBJECTIVES for lecture 1: To understand the scope of management systems ±

why is important to develop a management systems; Introduction in the ISO families 9000 and 14000;

Benefits of ISO 9001 and ISO 14001;

Quality system documentation ± the structure of

documentation: quality manual, operationalprocedures, working instructions, records;

Improvement and effectiveness in quality

management systems;

Certification, registration, accreditation.



Management systems

To be really efficient and effective, theorganization can manage its way of doingthings by systemizing it.

Nothing important is left out. Everyone is clear about who is

responsible for doing what, when, how, whyand where.

Management system standards provide theorganization with an international, state-of-the-art model to follow.



Management systems (cont.)

Large organizations, or ones withcomplicated processes, could not functionwell without management systems.

Companies in such fields as aerospace,automobiles, defence, or health care deviceshave been operating management systemsfor years.

The ISO 9001 and ISO 14001 management

system standards now make thesesuccessful practices available for allorganizations.



Why is this Important to (my)Organization?

Better management

Comprehensive and systematicapproach to target setting andimplementation of improvements

Clear picture of responsibilities androles of all actors in (and outside) of the

organization User friendly only one system and not

a handful



Success Factors (Pre-requisites) Know your organization, your processes, your

products and your customers and other interestedparties,

Decide where you want to go and how (vision andmission),

Specify by setting objectives and targets,

Clarify roles and responsibilities for action usingprocedures, instructions and action plans,

Measure progress (very) regularly and make revisionswhen needed,

Communicate internally and externally.



ISO 9001 and ISO 14001 in brief

ISO 9001 and ISO 14001 are among ISO's mostwell known standards ever.

They are implemented by some 887 770organizations in 161 countries.

ISO 9001 helps organizations to implement qualitymanagement.

ISO 14001 helps organizations to implementenvironmental management.



Generic standardsISO 9001 and ISO 14001 are generic

standards.

Generic means that the same standards can

be applied: to any organization, large or small,

whatever its product or service,

in any sector of activity, and

whether it is a business enterprise, a publicadministration, or a government department.



Generic standards (cont.)

Generic also signifies that:

no matter what the organization's scope of

activity,

if it wants to establish a quality

management system, ISO 9001 gives the

essential features,

or if it wants to establish an environmentalmanagement system, ISO 14001 gives the

essential features.



Quality management ISO 9001 is for quality management.

Quality refers to all those features of aproduct (or service) which are required by thecustomer.

Quality management means what theorganization does to:

ensure that its products or services satisfy thecustomer's quality requirements, and

comply with any regulations applicable tothose products or services.



Quality management (cont.)

Quality management also means what

the organization does to:

enhance customer satisfaction, and

achieve continual improvement of its

performance.



The ISO 9000 family ISO 9001 is the standard that gives the

requirements for a quality managementsystem.

ISO 9001:2000 is the latest, improvedversion.

It is the only standard in the ISO 9000family that can be used for certification.

There are 14 other standards in the familythat can help an organization on specificaspects such as performance improvement,auditing, training«



Environmental management ISO 14001 is for environmental

management. This means what theorganization does to:

minimize harmful effects on theenvironment caused by its activities,

to conform to applicable regulatory

requirements, and to achieve continual improvement of its

environmental performance.



The ISO 14000 family ISO 14001 is the standard that gives the

requirements for an environmentalmanagement system.

ISO 14001:2004 is the latest, improvedversion.

It is the only standard in the ISO 14000family that can be used for certification.

The ISO 14000 family includes 21 other

standards that can help an organizationspecific aspects such as auditing,environmental labelling, life cycle analysis«



Processes, not products

Both ISO 9001 and ISO 14001 concernthe way an organization goes aboutits work.

They are not product standards.

They are not service standards.

They are process standards. They can be used by product

manufacturers and service providers.





Benefits

of ISO 9001 and ISO 14001

International, expert consensus on

state-of-the-art practices for qualityand environmental management,

Common language for dealing with

customers and suppliers worldwide,

Increase efficiency and effectiveness,

Model for continual improvement,



Benefits

of ISO 9001 and ISO 14001 (cont.)

Model for satisfying customers and

other stakeholders,

Build quality into products and services

from design onwards,

Address environmental concerns of

customers and public, and comply with

government regulations,

Integrate with global economy,



Benefits


Sustainable business,

Unifying base for industry sectors,

Qualify suppliers for global supply

chains,

Technical support for regulations,

Transfer of good practice to developing

countries,

Tools for new economic players,



Benefits


Regional integration,

Facilitate rise of services.

F or the customer:

Increase satisfaction and growth in

confidence.



WHY QUALIT Y S YSTEM -

ISO 9000 to satisfy customers through a quality

product,

to gain self confidence ± we get whatwe planned,

to achieve competitiveness in both the

local and overseas markets,

as a blueprint for efforts to improve

the quality system of the organization.



QUALIT Y S YSTEM = VEHICLE

QUALIT Y MANAGEMENT = DRIVER

QUALIT Y POLIC Y = ROAD MAP



THE QUALIT Y C YCLE

Inspection

Marketing

Service

MarketStudies

ProductDevelopment

Manufact.Engineering

Purchasing

Production

Vendors Customers



WHAT IS IT INTENDED FOR?

This International Standard specifiesquality system requirements for usewhere organization¶s capability to design

and supply conforming product needs tobe demonstrated.

The requirements specified are aimedprimarily at achieving customer

satisfaction by preventing nonconformityat all stages from design through toservicing.



ISO 9001:2000ISO 9001:2000 specifies requirements for a quality

management system where an organization:

� Needs to demonstrate its ability to consistentlyprovide product that meets customer andapplicable regulatory requirements, and

� Aims to enhance customer satisfaction through

the effective application of the system, including

processes for continual improvement of thesystem and the assurance of conformity to

customer and applicable regulatory requirements.



ISO 9001 Revision 2000 been developed by

TC 176, after a great deal of research onEight Quality Management Principles:

1- Customer - focused organization

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 relationship



Continual improvement of the

Quality management system

Management

responsibility

Product

realization

Resource

management

Measurement,

analysis and

improvement

Customers

Requirements

Customers

Satisfaction

ProductOutputInput

Information flow

Value-adding activities



Principles of ISO 9000

ISO 9000 is a standard for a quality system, notproduct.

ISO 9000 is based on documentation and ispremised on the following:

- Document what you do;

- Do what your document;

- Prove it and improve it.

ISO 9000 emphasises prevention.

ISO 9000 is a universal standard; the focus is onwhat needs to be done and not on how it is to becarried out.



Quality Management System

Documentation The organization shall establish, document,

implement and maintain a quality management system andcontinually improve its effectiveness in accordance withthe requirements of this International Standard.

(Clause 4.1, ISO 9001:2000) Documentation is a set of documents, for example

specifications and records.

Document is information (meaningful data) and itssupporting medium.

Quality management system is a management system to

direct and control an organization with regard to quality. Quality manual is the document specifying the quality

management system of an organization.



A

Purchasing

Department

B

Production

Department

C

Personnel

Department

D

Quality

Control

E

Stores

FORMS,

LABEL,

RECORDS,ETC.

WORK INSTRUCTIONS

OPERATION

PROCEDURES

QUALITY/ POLICY

MANUAL

LEVEL 1

LEVEL 2

LEVEL 3

LEVEL 4

DOCUMENTATION PYRAMID

HIGH

LOW



LEVEL 1: QUALIT Y MANUAL

The quality manual is the highestlevel document, at the peak of the

pyramid, outlining the quality systemand acting as a directory for thedocuments and procedures below.

It outlines the company¶s policy andcommitment to quality.



WHY NEED QUALIT Y MANUAL?

Communicating the organization¶s quality policy,procedures and requirements;

Describing and implementing an effective qualitysystem;

Providing improved control of practices andfacilitating assurance activities;

Providing the documented bases for auditing thequality system;

Providing continuity of the quality system and itsrequirements during changing circumstances;

Training personnel;

Presenting quality system for external purposes;

Demonstrating compliance of the quality systemwith quality requirements.



Quality Policy

Clause 5.3

The overall quality intentions anddirection of an organization related toquality, as formally expressed by topmanagement





PROCEDURES

DEVELOPMENT Review current practice

Analyse current practice

Develop a draft procedure Release draft for comment

Review comments

Revise and issue procedure for acceptance

Obtain approval

Issue for use

Implement

Monitor and Review



SUGGESTED FORMAT

PURPOSE

APPLICATION/SCOPE REFERENCE DOCUMENT

DEFINITION

RESPONSIBILIT Y

PROCEDURE

RECORD

ATTACHMENT



LEVEL 3:

WORK INSTRUCTIONS

This third tier of work instructions

details the day-to-day operatinginstructions to provide control of

quality and being applied in the

manner laid down in operation

procedures.



WORK INSTRUCTIONS The written and /or spoken direction given with

regard to what is to be done, including theinformation given in training.

What is to be done?

How it should be done? Who should do it?

When it should be done?

Supplies, services & equipment to be used

Criteria to be satisfied Usually departmental, or specific to product

Frequently changed

In details



LEVEL 4:SUPPORTING DOCUMENTS

Relates to all the forms,

documents, records, labels, tickets, job cards, purchase orders, goods

inwards notes, registers, etc. that are

used to support the levels above.



Improvement and Effectiveness There are many examples andrequirements in ISO 9001:2000 thatrequire the organization to address theeffectiveness of its quality managementsystem.

Further requirements specify the need for

continual improvements to the qualitymanagement system ± not just sporadicquality campaigns.



Effectiveness ISO 9001 specifies requirements for a qualitymanagement system that can be used for internalapplication by organizations, or for certification, or for contractual purposes. It focuses on the effectivenessof the quality management system in meetingcustomer requirements.

ISO 9001: 2000 0.3

The effectiveness of the quality management systemin meeting both quality and/or business objectives islikely to be the key attribute that ensures the on-going

support and resource allocation to maintain the ISO9001:2000 quality management system within thecorporate environment.



Improvement and Effectiveness Top Management shall ensure that the quality policy

includes a commitment to comply with requirementsand continually improve the effectiveness of the

quality management system. ISO 9001: 2000 5.3

The organization shall continually improve theeffectiveness of the quality management systemthrough the use of the quality policy, qualityobjectives, audit results, analysis of data, correctiveand preventive actions and management review.

ISO 9001: 2000 8.5



Analysis of Data

Organizational

Objectives

Customer

requirements

Statutory &

regulatory

requirements

Defect rate and

customer returns

QMS controls

Purchasing

Examples of

objectives set bythe Organization



Analysis of Data

Examples of

results recordedby the

Organization

Organizational

Results

Customer

satisfactionStatutory & regulato

compliance

Quality system

metrics

Inspection and te

Supplier

performance

Organizational

Objectives

Customer

requirements

Statutory &

regulatory

requirements

Defect rate and

customer returns

QMS controls

Purchasing



Effectiveness of the QMS

Organizational

ObjectivesOrganizationa

Results

0 0

100 100

The gap measures the lack of effectiveness of the quality

management system.

The narrower the gap, the more

effective the QMS.

Things are looking good!




Organizational

ObjectivesOrganizationa

Results

0 0

100 100

Management should get a wake

up warning!

The gap measures the lack of

effectiveness of the quality

management system.




Organizational

ObjectivesOrganizational

Results

The Organization is in trouble!

The gap measures the lack of

effectiveness of the quality

management system.



Improvement in the QMS

Organizational

ObjectivesOrganizational

Results

% 100 75 50 25 0

Improvement can also be

measured





Organizational

Objectives

Organizational

Results

Customer Focus

Corrective Action

Procurement

Improvement

Initiatives

These actions may cause

the organization to

revise its objectives.



Management Review

Organizational

Objectives

Organizational

Results

0 0

100 100

Customer Focus

Corrective Action

Procurement

Improvement

Initiatives

Management

Review

The improvement

processes are also

evaluated duringmanagement review

meetings and

appropriate action

taken.Which may cause the

organization to again

revise its objectives.



Certification and registration

Certification is known in some countries as

registration.

It means that an independent, external bodyhas audited an organization's management

system and verified that it conforms to the

requirements specified in the standard (ISO

9001 or ISO 14001). ISO does not carry out certification and

does not issue or approve certificates.



Accreditation

Accreditation is like certification of the certificationbody.

It means the formal approval by a specialized body -an accreditation body - that a certification body iscompetent to carry out ISO 9001:2000 or ISO 14001:2004 certification in specified businesssectors.

Certificates issued by accredited certification bodies -and known as accredited certificates - may beperceived on the market as having increased

credibility. ISO does not carry out or approve accreditations.



Certification not a requirement Certification is not a requirement of ISO

90001 or ISO 14001.

The organization can implement and benefitfrom an ISO 9001 or ISO 14001 system

without having it certified.

The organization can implement them for the

internal benefits without spending money ona certification programme.



Certification is a business

decision Certification is a decision to be taken for

business reasons:

if it is a contractual, regulatory, or marketrequirement,

If it meets customer preferences,

it is part of a risk management programme, or

if it will motivate staff by setting a clear goal.



ISO does not certify

ISO does not carry out ISO 9001 or ISO 14001 certification.

ISO does not issue certificates.

ISO does not accredit, approve or control the certification bodies.

ISO develops standards and guides toencourage good practice inaccreditation and certification.



The ISO Survey



The ISO Survey (cont.)

The worldwide total of certificates toISO 9001:2000 at the end of 2005 was776 608.

This was increase of 18 % over 2004when the total was 660 132 certificates.

Certificates had been issued in 161

countries compared to 154 the previousyear.



The ISO Survey (cont.)



The ISO Survey (cont.) The worldwide total of ISO 14001

certificates at the end of 2005 was 111

162. This was an increase of 24 % over

2004 when the total was 89 937.

Certificates had been issued in 138

countries compared to 127 the year before.

Documents

Integrated Manag[1]. Systems Lecture 1 Fn