integrating q ms and ems

8/2/2019 Integrating q Ms and Ems

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Integrating QMS and EMS1

Integrating Q MS and EMS

Linking ISO 9000:2000/TS 16949:2002 based QMS and

ISO 14000 based EMS

North Shore

Management Systems In c.

AQSR Windsor

Presenters: Jeff Greaves and Branko Dimitrijevic


Quality and Environmental background for ISO

9000 and ISO 14000

Unders tanding needs for d if ferent management

systems,

Common requiremen ts between ISO/TS 16949 and

ISO 14000,

Implemen tation tips for developing combined

QMS and EMS,

Performing combined QM S and EMS audits.

Presentation Ob jectives


Qu ality Backgrou nd - History

Q CSPC

Q A

TQ C

TQ M

Prevention

Time1900 30 50-70 80 90

Management

Responsibility


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Qu ality Background of the ISO

9000 Standard s - TQM

TQM is:

the management ap proach of an organization

centered on quality, based on the

participation of all its members and aiming

at long-term success through customer

satisfaction, and benefits to all members of

the organization an d to society.


Pre-1970 Industrial revolution led to exploitation of natural resources and

technology to mass produce energy and m anufactured commod ities forhuman use

Generated waste materials were often discarded with little or no thoughtof environmental consequences

Millions of gallons and tonnes of gaseous, liquid and solid waste weredeposited into the air, ground an d wa ter bodies over a 75 to 100 yearperiod

La te 60s/Ea rly 70s

The United States enacts comprehensive air and water laws andregulations to help prevent further deterioration of air and water quality

The United States Environmental Protection Agency (USEPA) is createdto administer and enforce environmental laws/ regulations to safeguardthe environment

History of Environm ental

Awareness And Concern


Early 70s

Love Canal incident occurs in Niagara falls, New York - localresidents discover that their neighbourhoods (homes, schools, etc.)

are built on top of a toxic waste site

High incidents of cancer and other related illnesses are attributed tothe toxic waste

Both the public and government are shocked to discover the extent of

toxic chemicals and wastes that were d eposited into the ground

The area is subsequently evacuated, all buildings are demolished,

and the area is permanently quarantined

The area continues to remain quarantined - environmental testingand m onitoring will likely continue to occur over the n ext 100 years




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1980 The United States government recognizes that there are hundreds of

abandoned toxic waste sites, similar to Love Canal, throughout the U.S.

The USEPA identifies what are considered to be the most toxic abandonedhazardous w aste sites across the country and lists them on a registryentitled the National Priorities List (NPL)

The U.S. Congress enacts a strict new law for toxic waste sites (CERCLA)and sets aside $2.2 billion (referred to as the Superfund) for theinvestigation and cleanup of N PL sites

1986 The money in the Superfund is almost depleted due to the vast number of

NPL sites (also referred to as Superfund sites) and the costs associated withinvestigations and cleanups

The U.S. Congress enacts more strict environmental laws for polluters(SARA) and sets aside an additional $6.6 billion for the Superfund




Late 80s Directors and officers of large corporations recognize that they may be

personally liable for environmental offences committed by theirorganization

Environmental consultants are hired by directors to conduct compliancereviews/ audits of organizations to identify where environmental laws arebeing violated, and to recommend measures to correct the situations andachieve compliance

Early to Mid 90s Environmental compliance audits are completed for numerous

organizations - unfortunately, many of the recommenda tions to achievecompliance are ignored

There are no management systems in place to review, prioritize, implementand m onitor the effectiveness of the recommendations and investigate theinitial cause of noncompliance and implement m easures to prevent itsrecurrence




1996

The ISO 14000 Standards are published (final version) by theInternational Organization for Standardization

The standards stipulate requirements for the implementation ofenvironmental man agement systems designed to enable organizationsto control the environmental impacts a ssociated w ith their activities,

products and/ or services

Late 90s/Early 2000

OEMs obtain ISO 14001 registration and impose deadlines for all Tier 1suppliers to achieve ISO 14001 registration

OEMs threaten to remove non-registered suppliers (after the imposeddeadlines) from their approved su pplier lists




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ISO Stand ards

What does the ISO stand for?


ISO Stand ards

International

Organization for

Standardization

- Geneva, Switzerland


ISO 9000/QS-9000/TS 16949

History and Changes

1994 1995 1998 20061987 1999 2000 2003

ISO 9000:1994

ISO 9000:2000

QS-9000:1998

TS 16949:2002

2002


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Busin ess Stakehold ers

Who has an interest in your

business?

Who are the stakeholders of any

business?


Busin ess Stakehold ers

Customers/Clients

Public/Surrounding Community

Government/Regulatory Bodies

Insurers

Financial Institutions/Lenders

Shareholders

Management

Employees

Everyone!


QMS and EMS

Definitions

Importance of definitions

ISO 9000:2000

QMS - Fundamenta ls and vocabulary

(replaces ISO 8402 )

ISO 14004

EMS General guidelines on principles, systemsand sup port ing techniques


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Importance of Definitions


Definitions

managementsystem

management

system

qualitymanagement system

quality

management

top management

quality policy

quality ob jectives

qualityimprovement

quality

control

qualityassurance

qualityplanning

effectiveness efficiency

continual improvement


Quality management system:

the part of the organizations management system that

focuses on the achievement of results, in relation to

the qu ality objectives, to satisfy th e needs,

expectations and requirem ents of interested parties, as

appropriate.

QM S Defin ition - ISO 9000


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Environmental management system:

the part of the overall management system th at

includes organizational structure, plann ing activities,

responsibilities, practices, p rocedures, p rocesses an d

resources for developing, implementing, achieving,

reviewing and maintaining the environmental policy.

EMS Definition - ISO 14001


ISO 9001:2000

0.4 Compatibility with oth er management systems

This International Standard (ISO 9000:2000) has been alignedwith ISO 14001:1996 in order to enhance the compatibility of the

two standard s for the benefit of the user community.

This International Standard does n ot include requirementsspecific to other management systems, such as those p articular to

environmental management, occupational health and safetymanagement, financial management or risk m anagement.However, this International Standard enables an organization to

align or integrate its own QMS w ith related management systemrequirements.

Management System Integration


ISO/TS 16949

8 QMS Principles

Customer focus

Leadership

Involvement of people

Process approach System approach to management

Continual improvement

Factual approach to decision making

Mutually b eneficial supp lier relationships


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ISO 14000

5 EMS Principles and Elements

Commitment and policy

Planning

Implementation

Measurement and evaluation

Review and Improvement


Continual Improvement Cycle

PDCA Cycle of Continual Im provement

P

DC

A


ISO 9000/TS 16949

ISO 9000:2000 - Major d ifference is Busin ess Process Mod el

5.0 Managemen tResponsibility

8.0 Measurem ent,

analysis andimprovement

7.0 Product

Realization

6.0 Resources

Management

4.0 QMS Continual Im provement

Customers

(and otherinterestedparties)

Reqnts

Customers(and other

interestedparties)

Satisfaction

Productinput ou t


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ISO 9000/TS 16949

20 clauses have become five major Sections : Quality Management System

(processes, documentation, control of documents & records )

Management Responsibility(commitment, customer focus, policy, objectives, mgmt. review, internalcommunication )

Resource Management(human resources, infrastructure, work environment)

Product Realization(planning, customer requirements, customer commu nication, design,purchasing, production, identification, calibration)

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


4.1 General requirements

4.2 Environmental policy

4.3 Planning4.3.1 Environmental aspects

4.3.2 Legal and other requirements

4.3.3 Objectives and targets4.3.4 Environmental managem entprogramme(s)

4.4 Implementation and operation4.4.1 Structure and responsibility

4.4.2 Training, awareness and competence4.4.3 Communication

4.4.4 EMS documentation

4.4.5 Document control4.4.6 Operational control

4.4.7 Emergency preparedness and response

ISO 14001 Elements

4.5 Checking and corrective action

4.5.1 Monitoring and measurement

4.5.2 Nonconformance and CA/PA

4.5.3 Records4.5.4 EMS audit

4.6 Management review


P

DC

A

Environmental PolicyManagement

ReviewAspects/Impacts

Legal Requirements

Objectives & TargetsEMPs

Implementation &

Operations

ResponsibilityTraining

CommunicationDocument Control

Operational ControlEmergency Response

Checking &

Corrective Action

Monitoring & MeasuringNonconformances

Records

Audit

Plan

Do

Check

Act

ISO 14001 Elements


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Common requirements between

ISO/ TS 16949 and ISO 14000

ISO 9001 / TS 16949 4.1 General requirements

Identifying QMS

Processes

4.2 Documentation

requirements

4.2.3 Control of documents

4.2.4 Control of records

ISO 14001 4.3 Pl an n in g

4.3.1 EnvironmentalAspects

4.3.2 Legal and otherrequirements

4.4.4 EMS Documentation

4.4.5 Documentation Control

4.5.3 Records




ISO 9001 / TS 16949

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

Appropriate

Commitment to complywith requirements and CI

Framework for objectives

Communicated andunderstood

Reviewed for continuing

suitability

ISO 14001

4.2 Environmental Policy

Appropriate

Commitment to CI andprevention of polution

Commitment to complywith legal and otherrequirements

Framework for objectives

Documented ,implemented, maintained,communicated

Available to public




ISO 9001 / TS 16949

5. 4 P la nn in g

5.4.1 Quality objectives

5.4.2 Quality managementsystem planning

Quality objectives

established at relevantfunctions and levels

Business Plan

ISO 14001

4.3.3 Objectives and Targets

Objectives and targetsshall be established,maintained anddocumented at each

relevant function andlevel within theorganization

4.3.4 EM Programme(s)

Responsibilities assigned

Means and time-frameestablished


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ISO 9001 / TS 16949 5.5 Responsibility, authority

and communication

5.5.1 Responsibility andauthority

5.5.1.1 Responsibility forquality

5.5.2 Management rep.

5.5.2.1 Customer rep.

5.5.3 Internal communication

ISO 14001 4.4.1 Structure and

responsibility

Roles defined ,documented andcommunicated

Resources provided

EMS ManagementRepresentative

4.4.3 Communication




ISO 9001 / TS 16949

5.6 Management review

5.6.1 General

5.6.1.1 Quality managementsystem performance

5.6.2 Review input

5.6.2.1 Review input

Supplemental

5.6.3 Review output

ISO 14001

4.6 Management Review




ISO 9001 / TS 16949

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness

and training 6.2.2.1 Product design skills

6.2.2.2 Training

6.2.2.3 Training on the job

6.2.2.4 Employee motivation andempowerment

ISO 14001

4.4.2 Training, Awarenessand Competence

Employees aware of

importance of conforming

with env. policy andprocedures and

requirements of the EMS

significant environmentalimpacts,

their roles andresponsibilities in

potential consequences


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ISO 9001 / TS 16949 6.3 Infrastructure

6.3.1 Plant, facility andequipment planning

6.3.2 Contingency plans

6.4 Work environment

6.4.1 Personnel safety to

achieve product quality

6.4.2 Cleanliness of premises

ISO 14001 4.4.1 Structure and

Responsibility

Resources provided

4.4.7 Emergencypreparedness and response




ISO 9001 / TS 16949

7 Product Realization

7.1 Planning / APQP

7.2 Determining andReviewing CustomerReqs

7.3 Product and ProcessDesign

7.4 Purchasing

7.5 Production andService Pr ovision

7.6 Control of Measuringand monitoring devices

ISO 14001

4.4.6 Operational Control

Identify operations thatare associated w ithsignificant aspects

Plan these activitiesincluding documentingprocedures, stipulatingoperating criteria,communication tosuppliers andsubcontractors

4.5.1 Monitoring andMeasurement




ISO 9001 / TS 16949

8 .1 General

8.1.1 Identification of

statistical tools

8.1.2 Knowledge of basic

statistical concepts

8.2 Monitoring andmeasurement

8.2.1 Customer satisfaction

ISO 14001




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ISO 9001 / TS 16949 8 .2 .2 In ternal aud it

8.2.2.1 Quality managementsystem audit

8.2.2.2 Manufacturingprocess audit

8.2.2.3 Product audit

8.2.2.4 Internal audit plans

8.2.2.5 Internal auditorqualification

ISO 14001 4.5.4 EMS Audit




ISO 9001 / TS 16949

8.2.3 Monitoring andmeasurement of p rocesses

8.2.3.1 Monitoring andmeasurement ofmanufacturing processes

8.2.4 Monitoring andmeasurement of product

8.2.4.1 Layout inspectionand functional testing

8.2.4.2 Appearance items

ISO 14001






ISO 9001 / TS 16949

8.3 Control of nonconformingproduct

8.4 Analysis of data

8 .5 Improvement 8.5.1 Continual

improvement

8.5.2 Corrective action

8.5.2 Preventive action

ISO 14001


4.5.2 Nonconformance andcorrective and preventive

action



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Policy

Management Review

CI Structure

Internal Audit

CA/PA

Operational Control

Comm on activities/ docum entation

between EMS and QMS


ISO/TS 16949

Documentation

Job or Work

Level 1

Level 2

Level 3

Level 4

Quality (Policy) Manu al

Procedures

inst ruct ions

External Docs.

FormsDrawings

Regulat ions

Business Processes

Sales D esign Purchasing M an ufactu rin g


Integrating

EMS and QM S Benefits

Facilitate Plannin g

Allocation of resources

Definition of complementary objectives

Evaluation of the overall effectiveness


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Integrating

EMS and QM S Audit

ISO 19011:2002 Guidelin es for q uality an d/orenvironmental management systems auditing

ISO /TS 16949 Customer Oriented Processes

Support Processes

Use of Turtle diagrams


Integrating

EMS and QM S Audit

Use of Turtle diagrams

Process

Equipment People

Methods Measurables

input output


Integrating

EMS and QM S Audit

Integrated external audits


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Integrating EMS and QM S

Jeff Greaves

jg re aves@aqs r.co m , 519-726-9669

Branko D imitrijevic

bran kod @aqsr.com , 519-726-9669

Harold Jean

hjean @aqsr.com, 519-726-9669

Questions

integrating q ms and ems

Documents