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UNDERSTANDING INTERNATIONAL QUALITY MANAGEMENT STANDARDS

K NUST SUMMER SCHOOL 2

Presented b y: A B ENA SAFOA OSEI, M.Phil IRCA Regis tered Qu al i ty Au di to r Food Safe ty Exper t

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P RESENTATION OUTLINE

History and Introduction to Quality ManagementSystems and StandardsThe PDCA Cycle

The Process Approach to ManagementThe Eight Quality Management PrinciplesBenefits of Quality Management SystemsOverview of Quality Management Standards and

their ImplementationISO 9001: 2008 Summary of Requirements

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S ESSION 1

QUALITY MANAGEMENT

SYSTEMS STANDARDSHis tory and In t roduc t ion

PDCA and the Eight Pr inciples

Benef i ts of Qual i ty Managem ent Systems Standards

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HISTORY OF QUALITY MANAGEMENT SYSTEMS (QMS)

MIDDLE AGES:The Guilds regulated various trades the craftsman was hisown quality inspector and maintained direct relations with theclient

LATE 18 TH CENTURY:The Guilds disappeared, the industrialization age began withvague or no rules on quality

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HISTORY 19 TH CENTURY:

Fraud became more widespread and some sort of inspections took hold

EARLY 20TH

CENTURYVarious laws on inspection activities were producedStatistical methods and monitoring systems began between1940 1955

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HISTORY Quality assurance systems were defined in varioussystems:

1954 in the American Military Systems1969 American Nuclear Systems

1984 British System, NATO Programme and AFNORstandards in France1987 the first ISO International Standard for QualityManagement System

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INTRODUCTION TOMANAGEMENT SYSTEMS

A management system is a Set of interrelated or interacting elements to establish policy and objectivesand to achieve those objectives

To ensure capability and consistency of the organizationto meet customer as well as statutory/ regulatoryrequirements

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A Management System can also be described as a set of activities an organisation carries out to manage itsprocesses in order to meet set objectives such as:

Satisfying customer requirementComplying with regulations or Meeting environmental requirements

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Organisations have recognised the costs of poor quality(rework & frequent complaints) and the need to havecontrol over their processes

Organisations gradually opted for the Quality Approach tomanagement

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Quality is achieved through planning andcommunication to prevent problems

It is cheaper and more effective to run preventivesystems than to run inspection based systems

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QUALITY MISCONCEPTIONS

The Quality approach has gradually dismissed thegeneral misconceptions of quality. Themisconceptions include:

Quality means expensiveQuality systems are expensive nice to haves Good quality is high specificationsQuality control is testing and checkingQuality comes from inspection only

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QUALITY APPROACH

Preventive measures include planning activities andprocesses, analysing inputs and outputs, training,writing and implementing procedures or plans andauditing the activities

The Quality Approach also includes monitoring andcontinual improvement

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Management System standards set up the model tofollow in setting up and operating a management system

The ISO 9001 is an example of a management systemstandard

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ISO M ANAGEMENT S TANDARDS Quality management systems (QMS) (ISO 9001)Environmental management systems (EMS) (ISO14001)Informational security management systems (ISM)

(ISO/IEC 27001)

Food safety management systems (FSMS) (ISO 22000)

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QMS Ensures quality of products and services

EMS To ensure organization complying to legal &

statutory requirements for environment

FSMS To ensure organization complying with foodsafety requirements

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OHSMS - To ensure organization complying to legal &statutory requirements for safety & health of theemployees

The ISO 9001 is an integral part of all the other management standards

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ISO 9001 S TANDARD FOR QMS

ISO first published the standard on Quality ManagementSystems in 1987

The latest edition was revised in 2008

ISO 9001 is a generic standard and can be implemented byany type of organization, manufacturing, service providers, etc

In 2007, and International Working Agreement developed andGuidance for the implementation of ISO 9001 in EducationalOrganizations ( IWA 2: 2007)

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THE ISO 9000 SERIES ISO 9000:2005 - Quality Management Systems Fundamentals and Vocabulary

ISO 9001:2008 Quality Management Systems

Requirements

ISO 9004:2009 - Managing for the sustained success of an organisation A Quality Management Approach

ISO 19011:2011 Guidelines for Auditing ManagementSystems

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The PDCA CYCLE

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The major operating principle underlying the ISOManagement Standards is the PDCA Cycle

Cycle also known as Deming Cycle was first introduced

by Deming

PDCA is a pro-active approach to management

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Proact ive appro ach all problems are anticipated andmeasures are taken to prevent them in order to ensure acontinually improving system.

The measures put in place are constantly monitored. Youplan, do, act and check with your results you planagain..

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THE P-D-C- A C YCLE

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Plan establishobjectives andmake plansDo implementplansCheck measureresults

Act correct andimprove plans &how they are putinto practice

Act Plan

Check Do

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THE PDCA AND ISO 9001

This operating principle runs through all the clausesof the ISO 9001 standard

They must characterize all your activities in order toachieve your set objectives

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The Process

Approach ToManagement

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THE P ROCESS APPROACH

Process a set of interrelated or interacting activitieswhich transforms inputs into outputs

Product Result of process (service) - The Educational

Service

Output of one process may the input of another process

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THE P ROCESS APPROACH

The systematic identification and management of theprocesses and interactions between such processes isreferred to as the Process Approach.

Control of process inputs ensures that outputs meetsspecified requirements

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CONTROL OF PROCESSES

Processes are controlled by controlling the inputsinto the processes rather than inspecting theoutput: People - by training Materials control of suppliers and specifications Methods - by procedures and standards Machines - by maintenance systems Environment by organisation and care

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P ROCESS APPROACH

consistent inputs produce consistent outputsQuality must be built in as a chain of event bylinking the processes this is referred to as thesystem approach to managementThe smoother the materials and information flowthrough the system the greater the efficiency

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P ROCESS APPROACH

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P ROCESS APPROACH CONTINUAL IMPROVEMENTS OF P ROCESS

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PDCACycle

Processes in termsOf Added Value

DO

Continual improvementsof Processes based onobjective measurements

ACTION

Measure results of processPerformance and effectiveness

- Objective Measurements

CHECK

Understanding andmeeting requirements

PLAN

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S IMPLE PROCESS MAP

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Processinputs:MenMachinesMaterialsMethodsMeasurement

Processes Administration Allocating teaching loadsDeveloping coursecatalogues etc.

ProcessoutputsTeaching modulesQualified students

Customer satisfaction survey

Monitoring

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EXERCISE - 1

Identify three key processes inyour department and map themtogether

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The Eight QualityManagement

Principles

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THE EIGHT QUALITY PRINCIPLES

A functional / effective quality system is based onfunctional principles these are the eight qualitymanagement principles.

These principles make the management systemfunctional

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ISO 9001 AND QUALITY S YSTEMS

The ISO 9001: 2008 is based on the processapproach and the eight quality principles

Effective implementation of ISO 9001 ensure asound quality system based on with all the qualityprinciples maintained

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THE E IGHT QUALITY P RINCIPLES

Principle 1 Customer focus

Principle 2 Leadership

Principle 3 Involvement of people

Principle 4 Process ApproachPrinciple 5 System Approach to Management

Principle 6 Continual Improvement

Principle7 Factual Approach to Decision MakingPrinciple 8 Mutually Beneficial Supplier

Relationships

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1. CUSTOMER FOCUS

understand current and future customer needs

meet customer requirements

strive to exceed customer expectations.

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CUSTOMER FOCUS (2)

Organisations must identify their customers

Communicate their needs throughout theorganisation

Measure customer satisfaction

In educational institutions the learner is thecustomer!

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2. LEADERSHIP

Leaders must establish unity of purpose anddirection

create and maintain the internal environment wherepeople become involved in achieving theorganisations goal.

Leaders must lead by example, demonstrate visiblecommitment

Leaders must identify the vision and mission of theinstitution and drive everyone along

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LEADERSHIP (2)

Management / Leaders should

Consider the needs of all interested parties

Establish clear visions for the future

Establish trust and eliminate fear

Provide resources, training etc.

freedom to act & recognizing people'scontributions (wisdom and skill) and use allfor the organization

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3. INVOLVEMENT OF PEOPLE

Quality is everybodys business

People at all levels are the essence of an

organization and their full involvement enables their abilities to be used for the organization's benefit.

Communication is essential (training is a means of communication)

Involvement of people is the most effective way for an educational organisation to achieve itsobjectives

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INVOLVEMENT OF PEOPLE (2)

Organisations should help its people understand theimportance of their contribution and role

identify constraints to their performance

accept ownership of problemsshare knowledge and experience

Openly discuss problems and issues.

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4. PROCESS APPRAOCH

A desired result is achieved moreefficiently when activities and relatedresources are managed as a process.

The systematic identification andmanagement of the processes isreferred to as Process Approach

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PROCESS APPROACH (2)

Identify processes, control process inputs andmonitor the characteristics for variation andpossible improvement

People, machines, methods, materials andenvironment are classic inputs

Identified processes must relate to the objectives of the organisation

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PROCESS APPROACH (3)

Systematically define the activities necessary toobtain a desired result

Establish clear responsibilities and accountabilityfor managing key activities

Analyse and measuring of the capability of keyactivities

Identify the interfaces of key activities

Focus on resources, methods, & materials.

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SYSTEM APPROACH TOMANAGEMENT (2)

Understand the interdependencies between theprocesses - one process output is another processinput.

Reduce cross-functional barriers this causes

repetitions

Materials and information flow through the systems mustbe smooth

Systems approach allows total optimization of operational processes to achieve objectives for theadministrative standpoint.

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6. CONTINUAL IMPROVEMENT

Continual improvement of the organization's overallperformance should be a permanent objective of the organization.

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CONTINUAL IMPROVEMENT (2)

The organisation should continually improve products,processes and systems this should be an objective for every one in the organisation

Establish goals to guide and measures to track continualimprovement

Providing training in the methods and tools of continualimprovement.

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CONTINUAL IMPROVEMENT

Continual improvement:Organizations are more efficient & effective when they continually tryto improve.Organizations must make a permanent commitment to continuallyimprove their overall performance

C

B

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TIME (YEARS)

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A

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7 . FACTUAL APPROACH TODECISION MAKING

Effective decisions are based on theanalysis of data and information.

(no one man decisions; avoid grapevines)

Data needs to be gathered factuallyindependently and without bias

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FACTUAL APPROACH TODECISION MAKING (2)

We should:

take decisions and actions based on factualanalysis facts not feelings

Make data accessible to those who need it

Ensure it is in a usable format to decision makers

Ensure data is accurate and reliable.

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8. MUTUALLY BENEFICIALSUPPLIER RELATIONSHIPS

An organization and its suppliers areinterdependent and a mutuallybeneficial relationship enhances theability of both to create value.Collaboration with partners isimportant to obtain optimal skill andcreativity to achieve learner value

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MUTUALLY BENEFICIALSUPPLIER RELATIONASHIPS

Identify and select key suppliers / partners

Establish clear and open communication

Pool expertise and resources

Establish joint development and improvementactivities with partners

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MUTUALLY BENEFICIALSUPPLIER RELATIONASHIPS

Long term relationships enable the future to be planned it gives confidence

Performance may be reviewed for improvements -

review the performance of your partners and allow themto review yours as well (2 nd party audits)

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IWA 1) CREATING LEARNER VALUE

Encourage learners to be satisfied with the valuesthey are receiving

Leaner satisfaction must be measured

Measurement must determine the degree to whichvalues received meet the learners needs andexpectations

It is key to improve processes for creatinglearner value

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IWA 2) FOCUSING ON SOCIAL VALUE Assess how / what learners and other interestedparties feel about ethics, safety and environmentalconservations

Educational organizations can ensuresustainable growth only when the larger societyappreciates value-added output of learners

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IWA 3) AGILITY Sustaining growth in a drastically changingenvironment is important

This agility turns and ever changing educationenvironment into an opportunity for success

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IWA 4) AUTONOMY

An educational organization must be free fromstereotyping

Self analysis helps the educational analysis tomake its own value decisions and keep it free fromstereotyping

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S UMMARY

With the IWA Guidance, there are a 12management principles for and educationorganization (EO)

In the EO, the learner is the customer and theproduct / service provided is the education serviceoffered.

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EXERCISE - 21. List the 12 quality management principles for

an EO

2. Explain the principle factual approach todecision making

3. Identify three key collaborators / partners thatKNUST needs to establish mutually beneficialrelationships with.

4. What is PDCA?

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EXERCISE - 2

5. Identify which of the 12 principles falls under plan, which comes under do, check andact?

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Benefits of a QualityManagement System

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BENEFITS OF A QMS STANDARD

The ISO QMS standard i.e. ISO 9001, outlines aprocess approach to implementing and supportinga QMS.

A key benefit is the increased involvement of topmanagement in all aspects of the companysactivities.

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BENEFITS INCLUDE .

Increased organisational image

Increased customer satisfaction

Increased competitive power - increased marketshare

Better relationship with supplier / partners

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BENEFITS INCLUDE .

Gives room for continual improvement

Systematic and efficient operations cost saving -orderliness in the organization - removes processesand activities which do not add value repetition/duplication of work reduced

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BENEFITS INCLUDE .

increases employee motivation and participation ownership of system each is responsible for hisactivitiesSpeedy complaint redress thus enhancingcustomer satisfactionmakes company managers and other employeesbecome more aware and conscious of "qualitymanagement

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BENEFITS INCLUDE .

Finally the QMS standards gives one QualityManagement System standard used all over theworld

Like all standards, it gives us one language for Quality Management implementation and puts thecompany on the International platform (speakingthe international language!)

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ISO 9001:2008

QUA L ITY MA NA GEMENT SYSTEMS

REQUIREMENTS

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GENERAL

Eight ClausesClauses 1,2 & 3 are not auditableClauses 4 8 are the auditable requirements.1-Scope, 2-References , 3 Definitions

4 Quality Management System5- Management Responsibility6 Resource Management7 Product Realisation8 Measurement, Analysis, Improvement

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CLAUSE 1 - SCOPE

ISO 9001 specifies requirements for a QMSwhen an organization needs to demonstrateability to consistently provide services that meet

customer and statutory requirementsAnd for organisations aiming at enhancingcustomer satisfaction

Exclusions are limited to clauses withinclause 7

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CLAUSE 2 NORMATIVE REFERENCES

Normative references are other standardsneeded for the complete implementation of ISO 9001:2008

ISO 9000: 2005 Quality Management Systems Fundamentals And Vocabulary

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CLAUSE 3 TERMS AND DEFINITIONS

This clause usually defines keyterms and words used in thestandards

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CLAUSE 4 REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM

4.1 General RequirementsEstablish - document - implement - maintain -continually improve effectivenessManagement of processes

identify the processes and their application

determine their sequence and interaction,

ensure availability of resources and information

Ensure control on outsourcing of any processaffecting product conformity

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CLAUSE 4 REQUIREMENTS OF THE QUALITY

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CLAUSE 4 REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM

4.2 Documentation RequirementsDocumented statements of Quality Policy & QualityObjectives

Quality Manual

Documented procedures required by the Standard

Documents needed by the organization to ensure the effectiveplanning, operation and control of its processes

Records required records provide information about activitiescarried out

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DOCUMENTS REQUIRED CONT .

Quality manualEstablish and maintain a Quality Manual

Quality Manual shall include:Scope and justification for exclusionsDocumented procedures or reference

Description of interaction between processes

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4.2.3 D OCUMENT CONTROL

Standard requires a document control procedure todefine..

How to control documentWhat to control

When to controlEncompass preparation, handling, issue and

recording of changes

Control must cover Internal and external documents

Approval prior to document issue Identify revision status Review, update & re-approve

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Establish and maintain records toprovide evidence of conformity&effective operation of QMSLegible, identifiable & retrievable

Documented procedure to definecontrols needed:IdentificationStorageProtectionRetrievalRetention timeDisposition

4.2.4 C ONTROL OF RECORDS

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Top management shall demonstratecommitment to the development,implementation and improvement of theQMS

Communicate the importance of meetingcustomer and legal requirements

Conduct management reviews

Ensure availability of resources

5 M ANAGEMENT RESPONSIBILITY

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5.1 M ANAGEMENT COMMITMENT

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5.1 M ANAGEMENT COMMITMENT

Evidence of commitment of development andimplementation of QMSContinually improve its effectiveness by:

Communicating customer requirements

Establishing quality policyEstablishing quality objectivesConducting management reviewsEnsuring availability of resources

5 2 C F

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5.2 C USTOMER F OCUS

Ensure that customer requirements aredetermined and are met for enhancing customer satisfaction. For this:

Identify customer needs & expectationsTranslate them into requirementsCommunicate requirements through out the

organizationFocus on improvement to ensure value for customers

For details see 7.2.1 ( customer relatedprocesses) & 8.2.1 ( customer satisfaction)

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C USTOMER F OCUS

Need to stop and think:Who are my customers ?What do they really want ? customer requirementsWhat are my key processes to ensure thatthey get what they want?

More emphasis on defining objectives

Providing leadership to enhance customer satisfaction

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5.3 Q UALITY P OLICY

Top management shall ensure AppropriateCommitment to meet requirements andcontinually improveFramework for quality objectivesCommunicated

UnderstoodReviewed

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5.4 PLANNING

Quality Objectives must be established ,communicated and worked at.These must be reviewed as system is continuallymonitored

The Quality Objectives should cover relevantfunctions and should be consistent with the QualityPolicy

These should be SMART: - Specific, Measurable, Acceptable, Realistic and Time-bound

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5.5.2 M ANAGEMENT REPRESENTATIVE

Top management to appoint aManagement Representative withResponsibility and authority for:ensuring processes are established, implementedand maintained for QMSreporting to top management on the performance

5.6 Top management must organize periodicManagement Review Meetings

6 R ESOURCE M ANAGEMENT

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6 R ESOURCE M ANAGEMENT

6.1 Provide resources toImprove effectivenessEnhance customer satisfaction

6.2 Human resourcesCompetence, awareness and trainingEvaluate effectivenessMaintain records

6.3 InfrastructureWorkspaceEquipment, hardware and softwareSupporting services

6.4 Work environment

7 1 P LANNING OF P RODUCT REALIZATION

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7.1 P LANNING OF P RODUCT REALIZATION

Plan and develop processesQuality objectives &requirements for productEstablish processes, documentation and provideresources.

Verification, validation, monitoring, inspection andtest activitiesRecords for evidence

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7.2 CUSTOMER RELATED P ROCESSES Determine the product requirements

Customer specifications including delivery and postdelivery requirementsRequirements not specified by customers but necessary

for intended useStatutory and regulatory requirementsOthers

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WHAT DOYOU WANT? 7.3.1 Planning

Stages of development

Review, verification & validation Responsibilities& authorities Interfaces

7.3.2 Inputs7.3.3 Outputs

7.3.4 Review7.3.5 Verification7.3.6 Validation7.3.7 Change Control

7.3 D ESIGN AND DEVELOPMENT

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Purchasing process

Meeting purchase requirements Extent of Control on suppliers Evaluation and select Criteria for selection,evaluation & re-evaluation Maintain records

Purchasing Information Product, procedures, processes and equipment Qualification of personnel Adequacy of specified requirements Verification of purchased product

Determine conformity to requirements By Organization By Customer

7.4 P URCHASING

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7.5 P RODUCTION & S ERVICE P ROVISION 7.5.1 Control of production and service provision7.5.2 Validation of processes

7.5.3 Identification and trace-ability

7.5.4 Customer property

7.5.5 Preservation of product7.6 Control of monitoring and measuring devices

7.5.1 C ONTROL OF P RODUCTION AND SERVICE

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Controlled Conditions Availability of informationWork Instructions as necessarySuitable equipmentMonitoring and measuring devicesMonitoring and measurement activitiesImplementation of release , delivery,and post-delivery activities

CONSISTENCYCONFORMITY TO REQUIREMENTS

7.5.1 C ONTROL OF P RODUCTION AND SERVICE P ROVISION

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P RODUCTION AND SERVICE P ROVISION

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Validate processesDefine criteria for review and Approval,

Approval of equipment and

qualification of personnelUse specific Methods & ProceduresRecordsRe-validation

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7.5.3 I DENTIFICATION AND T RACE -ABILITY

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Identified by suitable meansIdentify product status

Trace-ability if required

Record unique identification

7 5 4 C USTOMER P ROPERTY

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7.5.4 C USTOMER P ROPERTY

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Identified Verified

Protected Safeguard Recorded and reported if

Lost, damaged or unsuitable

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Preserve conformity during:

Internal processingDelivery

Identification

Handling

StorageProtection

Packaging

7.5.5 P RESERVATION OF P RODUCT

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Determine measurements requiredDevices identified and calibratedDefined traceable standardsCalibration status be determinedSafeguard from adjustmentsAssessed & record if out of calibrationProtected from damage & deteriorationSoftware confirmedRecords maintained

M EASURING DEVICES (MAY BE EXCLUDED )

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8 MEASUREMENT ANALYSIS AND CONTROL 8.1 General

Plan and implement monitoring, measurementanalysis and improvementprocesses needed to: demonstrate conformity of the productensure conformity of the QMScontinually improve effectiveness of theQMS

Determine applicable methods includingstatistical techniques, and the extent of their use

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8.2 M EASUREMENT AND M ONITORING

Measurement and monitoring is thefirst step that leads to control andeventually to improvement

If you can not measure something,

you can not understand it.

If you can not understand it,

you can not control it.If you can not control it,

you can not improve it.

8.2.1 C USTOMER SATISFACTION

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8.2.1 C USTOMER SATISFACTION

Monitor information

Customer perception

Methods determined

One of the parameters of quality is the gap betweencustomers expectation and suppliers capability. Thenarrower this gap the better is the meeting of minds of the customer and supplier

C USTOMER SATISFACTION M EASURES

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C US O S S C O M SU S

Periodic customer surveys

Customer focus groupsCustomer aftercare callsClient meetingsCustomer churn rateGolf course approach - informal chatsMarket researchComplaints

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8.2.2 I NTERNAL AUDIT

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Documented ProcedureActual = Plan ?

Periodic Audits

Effective, Objective, Impartial

Independent Auditors

Recorded Results

Follow-up

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8.2.3 M ONITORING AND M EASUREMENT OF P ROCESSES

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PROCESSESSUITABLE METHODS

PLANNED RESULTSCORRECTION ANDCORRECTIVE ACTION

8.2.3

8.2.4

8.2.3

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8.2.4 M ONITORING AND M EASUREMENT OF P RODUCT

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M SU O P ODUC

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MONITOR AND MEASURE

FOLLOW PLANNED ARRANGEMENTSEVIDENCE OF CONFORMITY

RECORDS FOR AUTHORITY FOR RELEASEAPPROVED BY RELEVANT AUTHORITY

OR THE CUSTOMER

8.3 C ONTROL OF NONCONFORMING P ROD UCT

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What happens when things go wrong?

Documented ProcedureIdentified And ControlledAuthority DefinedEliminate The NonconformityAuthorize, Release Or AcceptanceUnder Concession

After Delivery Or Use HasStarted, Appropriate ActionRecords MaintainedRe-verified After Correction

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8.4 A NALYSIS OF DATA

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Determine, collect And

Analyse DataIdentify Areas Of ContinualImprovementsProvide Information Relating To:

Customer SatisfactionConformance To RequirementsProcess Trends And ProductCharacteristics

Suppliers

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Graphical methods Pareto, Cause and effect,Scatter plotsProcess Capability Establishing of limitsControl charts Monitoring & controlling

production & measurementSampling & acceptance - Inspection and testing plans

8 5 I MPROVEMENT

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8.5 I MPROVEMENT

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

8 5 1 C ONTINUAL IMPROVEMENT

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8.5.1 C ONTINUAL IMPROVEMENT Continually improve effectivenessthrough:

Quality policy Quality objectivesAudit results

Analysis of dataCorrective and preventive actionsManagement review

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8.5.2 C ORRECTIVE ACTION

A documented procedure must beestablishedProcedure must review nonconformitiesIdentify the causesReview the effectiveness of the correctiveactionRecords shall be maintained

Sky Portal Consults

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8.5.3 P REVENTIVE ACTION

Documented procedure must be established

Procedure to evaluate need for action to preventoccurrence of nonconformitiesReview the effectiveness of preventive actiontakenRecords shall be maintained

Sky Portal Consults

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GOD B L ESS YOU