Management of ISO Quality

SUMITTED BY:. SHAILESH SINGH MBA, Marketing and Operations S.G.S.I.T.S, Indore

Management of Quality

Quality Management Systems

ISO 9001 and ISO 14001 in brief

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

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

ISO 9001 helps organizations to implement quality management.

ISO 14001 helps organizations to implement environmental management.

Quality management

ISO 9001 is for quality management. Quality refers to all those features of a product (or

service) which are required by the customer.Quality management means what the organization

does to ensure that its products or services satisfy the

customer's quality requirements andcomply with any regulations applicable to those

products or services.

Quality management (cont.)

Quality management also means what the organization does to

enhance customer satisfaction, andachieve continual improvement of its

performance.

Environmental management

ISO 14001 is for environmental management. This means what the organization does to:

minimize harmful effects on the environment caused by its activities,

to conform to applicable regulatory requirements, and to

achieve continual improvement of its environmental performance.

Generic standards

ISO 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, andwhether it is a business enterprise, a

public administration, or a government department.

Generic standards (cont.)

Generic also signifies that no matter what the organization's scope of

activityif it wants to establish a quality

management system, ISO 9001 gives the essential features

or if it wants to establish an environmental management system, ISO 14001 gives the essential features.

Management systems

Management system means what the organization does to manage its processes, or activities in order that

its products or services meet the organization’s objectives, such as

satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives

Management systems

To be really efficient and effective, the organization can manage its way of doing things by systemizing it.

Nothing important is left out. Everyone is clear about who is responsible for doing

what, when, how, why and where.Management system standards provide the organization

with an international, state-of-the-art model to follow.

Management systems (cont.)

Large organizations, or ones with complicated processes, could not function well without management systems.

Companies in such fields as aerospace, automobiles, defence, or health care devices have been operating management systems for years.

The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations.

Processes, not products

Both ISO 9001 and ISO 14001 concern the way an organization goes about its 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.

Processes, not products (cont.)

Processes affect final products or services.

ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services.

ISO 14001 gives the requirements for what the organization must do to manage processes affecting the impact of its activities on the environment.

Certification and registration

Certification is known in some countries as registration.

It means that an independent, external body has 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 certification body. It means the formal approval by a specialized body - an

accreditation body - that a certification body is competent to carry out ISO 9001:2000 or ISO 14001:2004 certification in specified business sectors.

Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived 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 benefit from an ISO 9001 or ISO 14001 system without having it certified.

The organization can implement them for the internal benefits without spending money on a certification programme.

Certification is a business decision

Certification is a decision to be taken for business reasons:

if it is a contractual, regulatory, or market requirement,

If it meets customer preferencesit 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 to

encourage good practice in accreditation and certification.

OVERVIEW OF ISO 9001:2000

>

Consolidation of ISO 9000 family - Current 20 standards to be replaced by four:

ISO 9000: Quality management systems- Fundamentals & vocabulary

ISO 9001: Quality management systems - Requirements ISO 9004: Quality management systems - Guidance for

performance improvement*ISO 19011: Guidelines for auditing quality & environmental

management systems

To be supported by technical reports

Overview Of ISO 9001 : 2000

Sector Specific Standards

AS9100: Aerospace IndustryISO TS 16949: Automotive SuppliersTL 9000: Telecommunications

ISO 9001 : 2000

Some basics

Applicability : Universal

Aim : Enhancing customer satisfaction

Scope : As per the requirements of the organization

01 GeneralStrategic decision - adoption of QMSQMS design & implementation is

organisation specificStandard can be used by internal & external

parties to assess the ability to meet customer, regulatory and organisation’s own requirements

QMS requirements are complementary to technical requirements for product

ISO 9001:2000

The Process Approach . Process approach to quality management encouraged

. Introduces & explains the process model as conceptual presentation

of QMS requirements specified

ISO 9001:2000

Processes

ProcessActivities

+Resources

Input Output

Controls

(e.g.procedure)

Processes - understand interactions

ProcessA

ProcessD

ProcessB

ProcessC

InputOutputControls

CUSTOMER

CUSTOMER

Management responsibility

Resourcemanagement

Measurement, analysis,improvement

ProductProductrealisation

Quality Management SystemContinual Improvement

Requirements

Satisfaction

InputOutput

The QMS Model

Process and System Approach

Identify and manage processesDetermine the sequence and interaction of processesDetermine the criteria and methods to ensure effective

operation of the processesMeasure, monitor, analyse the processes and implement

actions necessary to achieve planned results and continual improvement

Ensure availability of information necessary to operate processes

(ISO 9001:2000 clause 4.1)

Plan

Do

Verify

Correct

The Demming Cycle

The recognition process

Understanding the standard requirements

Establishment of a quality management

system

Certification

Accrual of benefits

The requirements :Quality Management SystemManagement ResponsibilityResources ManagementProduct RealizationMeasurement, Analysis & Improvement

ISO 9001:2000

Clauses 0 - 3

Introduction

Scope

Normative references

Terms and definitions

ISO 9001:2000

Clause 4QMS requirements

Process approach

Documentation requirements

ISO 9001:2000

Clause 5Management responsibility

Commitment, Customer focus

Policy, Objectives, Planning, Communication

ISO 9001:2000

ISO 9001:2000

Clause 6

Resource Management

Human resources

Infrastructure

Work Environment

ISO 9001:2000

Clause 7Product Realization

Planning

Marketing, selling, design, production, purchase…

ISO 9001:2000

Clause 8Measurement, Analysis & Improvement

Measure, Analyse and improve…

Myths

8 “ISO is only documentation”

8 “ISO is expensive”

8 “ISO is for the auditor”

8 “ISO is the responsibility of MR”

8 “ISO will drastically improve results immediately”

8 “ISO is TQM”

BENEFITS OF CERTIFICATION

>

Benefits of certification

Commercial

Non-commercial

Enhanced customer satisfaction and loyalty

Reduced quality costs

Increased competitiveness

Improved internal transfer of know how

Improved morale and motivation of staff


Benefits : Commercial

Competitiveness

Customer confidence

Exports

Governmental recognition

Benefits : Non-commercial

Quality, an essential requirement todayContinual improvement, another

necessity Effect on costs –

Higher quality costs lessQuality has one of the highest ROIAlmost the entire standard is preventative in

nature !

Benefits : Non commercialOpportunity to integrate systems Inspiring confidence to the management and people

of the organizationTransparency Identification of non conformitiesReduced errors Internal quality auditsPrestige Improved morale of staff Improvements becoming a way of lifeA stepping stone to TQM

To SummariseGenericGoes beyond quality assurance to include

customer satisfactionBased on 8 quality management principlesProcess approachAllows tailoring to business but does not loose

sight of customer focusLow on documentation and high on effectiveness

(performance)Focuses on continual improvements through: Quality objectives

Corrective and Preventive actions

Certification of quality system to ISO 9001 as a “bonus”:

Tangible proof that the company’s quality system complies with internationally recognised standard.

Avoidance of multiple second party audits.

Marketing edge.

Certificate

ISO 9001



An opportunity to eliminate any excessive documentation requirements


•THE CERTIFICATION PROCESS

Top managementcommitment

Formation of Steering committee

Understanding The standard

Review of theExisting system

Gap AnalysisTime bound

Action plan toFill gaps

Internal AuditsAnd

ManagementReviews

Pre-assessmentreview

CertificationAudit

THE CERTIFICATION PROCESS

Continual Improvement

Problem Solving Techniques Cause & effect diagram Pareto analysis Flowcharting Brain storming

How to effectively approach the project?

Steering committee and task forceDiagnosis of an existing systemExecution planTrainingPlanning, Re- engineering,

Documenting ImplementationAudits and reviewPossible changes

Identification and control of processes, their sequence and interaction is critical for effective quality management

IMPLEMENTING THE STANDARD

STEP 1

TOP MANAGEMENT COMMITMENT

A basic requirement for any quality initiative

Direction,monitoring and motivational aspects


STEP 2

FORMATION OF A STEERING COMMITTEE

To ‘legitimise’ the issueShould include top/middle/junior

management personnelRegular review of progress


STEP 3UNDERSTANDING THE STANDARDAttend training programmesOrganise ‘Awareness’ programmes for allInterpretation to the organisational

practiceAppointment of a external expert if

necessary


STEP 4 REVIEW OF THE EXISTING SYSTEM Review of all current practices, written or

otherwise Review for1. Adequacy2. Suitability3. Effectiveness


STEP 5 GAP ANALYSIS» Gap between the current

practices and ISO 9001 requirements

» A checklist could be useful


STEP 6TIME BOUND ACTION PLAN TO FILL

THE GAPSFor documentationFor complianceFor suitabilityFor adequacyFor effectiveness


STEP 7INTERNAL AUDITS & MANAGEMENT

REVIEWSTo evaluate adequacy of documentationTo evaluate complianceTo evaluate effectiveness


STEP 8PRE-ASSESMENTBy an external agency – usually the

certification bodyIn good time before the certification audit


STEP 9

CERTIFICATION AUDITBy the certification body


STEP 10

CONTINUED COMPLIANCEBy reviewsBy audits – internalBy audits -- external

Quality system is for the organisation, and not organisation for the system.

Unnecessary changes should not be imposed.

Always consider:

company culture;operating philosophy;nature of business;market environment.

Flaws to avoid:System that is not tailored to suit the

organization’s mode of operation

Flaws to avoid:Insufficient training, communication &

awareness

Certification ProcessContract Review

Initial Audit

Certification

Surveillance

Re-certification audit

CertificateISO 9001

Scope of certificationStandard

Products covered

Locations covered

Elements of organisation covered

Accreditation

To ensure uniform standard of certification

To ensure recognition of certificates

The ISO 14000 family

ISO 14001 is the standard that gives the requirements for an environmental management system.

ISO 14001:2004 is the latest, improved version. It is the only standard in the ISO 14000 family that can

be used for certification.The ISO 14000 family includes 21 other standards that

can help an organization specific aspects such as auditing, environmental labelling, life cycle analysis…

What is an EMS?

Systematic way of managing an organization’s environmental affairs

Based on Plan-Do-Check-Act Model (PDCA)Focused on Continual Improvement of systemAddresses immediate and long-term impact of

an organization’s products, services and processes on the environment.

A tool to improve environmental performance

EMS ModelPolicy

Planning

Implementation

CheckingCorrective Action

ManagementReview

Based on the P-D-C-A Model, Plan-Do-Check-Act

Why Implement an EMS?To get your environmental ducks in a row!Struggling to stay in compliance and keep track

of regulations/lawsEnvironmental management just one of many

responsibilitiesEstablish a framework to move beyond

complianceVehicle for positive change; improved employee

morale, enhanced public imageEmployee turnover

Why Implement an EMS ?More reasons:

Helps to identify the causes of environmental problems.better to make a product right the first timecheaper to prevent a spill or other accidentcost effective to prevent pollution

Trade and competitive issuesInconsistency in environmental regulation and

enforcementMany individual parts may already

be in place – just need to unify under the EMS umbrella!

ISO 14000: A series of standards

Created by the International Organization of Standardization, a non-governmental organization (NGO) established in 1947, located in Switzerland (see handout for more info)ISO is not an acronym - from the Greek iso, meaning

equal (as in isothermal)

ISO is a worldwide federation of national standards bodies from over 100 countries; American National Standards Institute (ANSI) is US representativeThey have created many standards: ISO 9000, film

speeds

ISO 14000 FamilyA series of guidance documents and

standards to help organizations address environmental issues. Ones below deal with EMS.14001: Environmental Management Systems14004: EMS general guidelines14010: Guidelines for Environmental Auditing14011: Guidelines for Auditing of an EMS14012: Auditing - Qualification criteria

To Whom Do the Standards Apply?Standard is VoluntaryLarge and Small Business & IndustryService Sectors (hospitals, hotels, etc.)City and County GovernmentApplicable to all types of organizations, of

all sizes anywhere in the world

Becoming ISO 14001 certified

ISO 14001 is the only certification standardRegistration body examines EMS for

conformity to the ISO 14001 standardNot a compliance audit, an EMS auditFacility awarded registrationDoes NOT mean that products are more

environmentally friendlyDoes mean have a documented EMS that is

fully implemented and consistently followed

External Drivers for ISO 14001?Suppliers encouraged to consider an EMS

by:IBM Xerox (30,000)Bristol-Myers Squibb (15,000)Ford and GMToyota- choice of 3MP&M, Others??

Approx. 271,000 ISO 9000 certifications worldwide (est. 380 NC certifications)

World Picture

30,303 ISO 14001 cert. in world as of 6/011,480 ISO 14001 cert. in US as of 6/01 54 companies known certified in NC, and one

municipalityUS is 5th in number of certifications behind

Japan (6,648), the UK (2,500), Germany (2,400), and Sweden (1,911)

What does ISO 14001 Say?

17 Requirements in ISO 14001

Env. Policy 4.2 Document control 4.4.5

Env. Aspects 4.3.1 Operational control 4.4.6

Legal and other req. 4.3.2 Emergency preparedness and response 4.4.7

Obj. and targets 4.3.3 Monitoring and measurement 4.5.1

Env. Mgmt. Program 4.3.4 Corrective/preventive action 4.5.2

Structure and Responsibility 4.4.1 Records 4.5.3

Training, awareness, and competence 4.4.2

EMS audit 4.5.4

Communication 4.4.3 Management Review 4.6

EMS documentation 4.4.4

ISO 14001 Key Elements

Policy Statement Identification of Significant Environmental

ImpactsDevelopment of Objectives and TargetsImplementation Plan to Meet Obj. and TargetsTrainingManagement Review

How you meet the elements is up to you

EMS ModelPolicy

Planning

Implementation


ManagementReview

Based on the P-D-C-A Model, Plan-Do-Check-Act

ISO 14001 Policy Statement (4.2)

Management’s declaration of commitment to the environment.

Policy Statement 3 Main Elements (Big 3)

Commitment to ComplianceCommitment to Prevention of Pollution, and Commitment to Continual Improvement

Broader definition of pollution preventionAvailable to Interested Parties

EMS Policy StatementMust be appropriate to the nature, scale and

environmental impacts of the organization’s activities, products or services

Provides a framework for setting and reviewing objectives and targets

Way of communicating environmental mission internally and externally

Broader definition of pollution prevention than EPA’s: not just source reduction,but also recycling, treatment, disposal, and material substitution

EMS ModelPolicy

Planning

Implementation


ManagementReview

Aspects and Impacts (4.3.1)

An organization evaluates and addresses its own significant aspects, including non-regulated aspects

May be positive or negativeThink from the fenceline:

Aspect: Cause or Input: Element of an organization’s activities, products, or services which can interact with the environment

Impact: Effect or Output: Any change to the environment, whether adverse or beneficial, resulting from an organization’s activities, products, or services

Aspects and ImpactsConsider:

Air emissionsSolid/hazardous wasteWater effluentsContamination of landNoise, vibration and odorLand use, energy use, water useRaw material and resource usePositive environmental issues

Example:Aspect - Radioactive materialImpact – Transportation and storage issues;

Environmental contamination

Not just regulated issues!

Ranking (4.3.1)

The organization shall establish and maintain procedures to identify its environmental aspects in order to determine those which can have a significant impact on the environment.

Rank aspects and impacts in order to assess their significance

Company-specific

Ranking/Significance ScoringConsider:Environmental Concerns

Regulatory/legal exposure; health/env. risks; conservation

Business Concerns:Effect on the public image; community concernsCost savings; cost recovery period; equipment/facility

Other issues:Scale, duration, and zone of impactProbability of occurrence - frequent, likely, possible,

rarely, unlikelySeverity of impact - catastrophic, severe, moderate,

minor

Example Significance MatrixActivity, Product, Service

Aspect Impact Legal Liability

Public Concern

Frequency Severity OSR Significance(OSR>2.5)

Dissolve MineralOre

Water use

Resource depletion

1 3 2 1 1.75 No

Natural GasUse

Resource depletion

1 1 2 2 1.50 No

Natural GasUse

Air pollution (Nox)

1 2 2 1 1.50 No

Use of Strong Acids

Spills to land or water

3 2 3 3 2.75 Yes

Legal and Other Environmental Requirements (4.3.2)

Setting legal framework for the EMShave a procedure to identify and access the legal

requirements: state, federal, local

have a documented system for keeping up-to-datecommunicate to the right people

Industry-specific requirements CMA Responsible Care Int’l.Chamber of Commerce (ICC) Charter

Other voluntary requirements EPA ClimateWise, WasteWise, 33/50 Program Green Seal

Planning (4.3)

Establishobj./target

Review policy

Determine significant impacts

Determine legal/other rqmts.

Objectives &Targets (4.3.3)The organization shall establish and maintain

documented environmental objectives and targets.

Can include commitment to:reduce waste reduce or eliminate release of pollutantdesign product to minimize environmental

impact in production, use, and disposal.

Be realistic. Keep objectives simple, flexible, and measurable.

OBJECTIVES & TARGETSReduce generation of hazardous wasteImprove indoor air quality by reducing

solvent odorsPrevent spills Reduce electrical use

Reduce spent solvent by 80% by 01/2002Reduce emissions by 90% by 05/2002

Max. of 2 /yr. by 2003Reduce electricity use by 10% by 08/2002

Planning

Establishobj./target

Review policy

Determine significant impacts

Determine legal/other rqmts.

Develop Env. Mgmt. program

Env. Mgmt. ProgramPlan: Switch to aqueous cleaning process Action- Substitute water based cleaning process

for vapor degreasing processResponsibilities - Process EngineeringSchedule -

Bench top trials - 2 months (date)Full scale pilot - 3 months (date)Implementation period - 1 month (date)

Resources needed - 1 FTE for 4 months - Est. Budget $12,000

EMS ModelPolicy

Planning

Implementation


ManagementReview

Implementation (4.4) Structure/responsibility (4.4.1)

Training, awareness, & competence (4.4.2)

Communication (internal/external) (4.4.3)

Env. Mgmt. System Documentation (4.4.4)

Document control (4.4.5)

Operational control (4.4.6)

Emergency preparedness and response (4.4.7)

Sections overlap: For example, 4.4.2 and 4.4.6 require that employees have info. on EMS as well as knowledge of environmental impacts from operations and activities

(4.4.2) Training: Ex. Training Matrix

Document Title Document # Rev

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Awareness Training N/A N/A 5/9/00 5/9/00 8/11/00 8/29/00 NR 5/9/00 5/12/00 9/11/00 5/12/00 5/12/00 5/9/00 5/11/00

Environment Management System Manual EMS-0100.000 0 NR 2/14/00 NR 3/8/00

EMS Review Procedure EMS-0100.001 08/30/00 2/14/00 NR 4/10/00 5/8/00 3/8/00

Document Control Procedure EMS-0100.002 0 2/14/00 NR 4/10/00 5/8/00 3/8/00

Aspects and Impacts Procedure EMS-0100.003 0 5/15/00 2/14/00 NR 5/10/00 5/8/00 3/8/00

Corrective/Preventative Action Report Procedure

EMS-0100.004 25/9/00 5/9/00 8/30/00 8/29/00 NR 5/9/00 8/28/00 9/11/00 8/30/00 8/30/00 5/9/00 5/9/00

Training Procedure EMS-0100.005 1 12/18/00 NR 4/10/00 12/18/00 12/18/00

Roles and Responsibilities Listing EMS-0100.006 0 8/30/00 2/14/00 8/30/00 8/29/00 NR 4/10/00 1/27/00 5/8/00 3/8/00

Objective and Targets - Improvement Plan Summary

EMS-0100.007 1 NR 8/29/00 NR

External Communications Procedure EMS-0100.008 1 6/28/00 6/28/00 8/11/00 8/29/00 NR 6/28/00 6/29/00 9/11/00 8/30/00 8/30/00 8/4/00 6/28/00

Environmental Management System Audit EMS-0100.011 0 NR 5/8/00

Sewer Overflow / Reporting Procedure (Press Release);Media List; Distribution list; Emergency Phone list

EMS-0100.012 3NR 9/1/00 NR 9/1/00

Monitoring and Measuring Procedure EMS-0100.013 0 NR NRLegal and Other Requirements EMS-0101.001 1 NR

EMS Management Procedures

Document Title Document # Revision Retain Frequency Controlled Copy Locations

Environment Management System Manual

EMS-0100.000 0 As Needed

As Needed w U: Drive 1. Long Creek Operations 2. Crowders Conf. Room 3. PW Director’s Office 4. Pretreatment Office 5. Superintendent's Office

EMS Review Procedure EMS-0100.001 0 As Needed


Document Control Procedure EMS-0100.002 0 As Needed


ENVIRONMENTAL MANAGEMENT SYSTEM DOCUMENTS

Procedures for Environmental Management System

(4.4.5) Document Control – Ex. Matrix

Checking/Corrective Action (4.5)

Monitoring andMeasuring (4.5.1)

Records (4.5.3)

Non-conformance andCorrective/Preventive Action

(4.5.2)EMS Auditing (4.5.4)

(4.5.1) Monitoring and Measuring

The organization shall establish and maintain documented procedures to monitor and measure ... the key characteristics of its operations that can have a significant impact on the environment.

Track how well the system is workingMeasure the key characteristics of those

activities that can have significant impactsAnalyze the root causes of problems

(4.5.2) Non Conformance and Corrective and Preventive Action

Develop procedure for investigating, correcting, and preventing system deficiencies

Set up process for assigning responsibilities for and tracking completion of corrective action

Set up process to revise EMS procedures based on corrective actions

(4.5.3) Records

The organization shall establish and maintain procedures for the identification, maintenance and disposition of environmental records

Include - training records, audits, management reviews

(4.5.4) EMS Auditing

Develop internal EMS audit programAre all EMS requirements met?

(Are we meeting the standard?)Is the system working?

(Are we doing what we said we would?)

Determine audit frequency and procedures; train auditors; keep records of audits, findings, and follow up actions

EMS Model (Plan-Do-Check-Act)Policy

Planning

Implementation


ManagementReview

(4.6) Management Review

Reviews EMS to ensure its continuing suitability, adequacy and effectiveness

Reviews process to ensure necessary information is collected for evaluation

Review must be documentedConsider changes to:

policyobjectivesother EMS elements

Thoughts on Going for ISO 14001 Attend an overview class (need a champion,

know what’s coming)Start with gap analysis or “road map”6-18 months to design and fully implementWork in teams or task groupsStaff resourcesIncorporate Health and Safety?Level of Involvement of Suppliers/ContractorsTraining (internal/lead auditor, overview)Using an accredited trainer/registrar

The ISO Survey

The ISO Survey (cont.)

Benefits of ISO 9001 and ISO 14001

International, expert consensus on state-of-the-art practices for quality and environmental management.

Common language for dealing with customers and suppliers worldwide in B2B.

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.


Sustainable businessUnifying base for industry sectorsQualify suppliers for global supply

chainsTechnical support for regulations


Transfer of good practice to developing countries

Tools for new economic playersRegional integrationFacilitate rise of services

Management of ISO Quality

Engineering

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