UNDERSTANDING INTERNATIONAL QUALITY MANAGEMENT STANDARDS

KNUST SUMMER SCHOOL 2

Presented by: ABENA SAFOA OSEI, M.Phil IRCA Registered Quality Auditor

Food Safety Expert

PRESENTATION OUTLINE

History and Introduction to Quality Management Systems and Standards

The PDCA Cycle The Process Approach to Management The Eight Quality Management Principles Benefits of Quality Management Systems Overview of Quality Management Standards

and their Implementation ISO 9001: 2008 – Summary of Requirements

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SESSION 1

QUALITY MANAGEMENT SYSTEMS STANDARDS

History and Introduction PDCA and the Eight Principles Benefits of Quality Management Systems Standards

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HISTORY OF QUALITY MANAGEMENT SYSTEMS (QMS)

MIDDLE AGES: The Guilds regulated various trades – the craftsman

was his own quality inspector and maintained direct relations with the client

LATE 18TH CENTURY: The Guilds disappeared, the industrialization age

began with vague or no rules on quality

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HISTORY 19TH CENTURY:

Fraud became more widespread – and some sort of inspections took hold

EARLY 20TH CENTURY Various laws on inspection activities were produced Statistical methods and monitoring systems began

between 1940 – 1955

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HISTORY Quality assurance systems were defined in

various systems: 1954 – in the American Military Systems 1969 – American Nuclear Systems 1984 – British System, NATO Programme and AFNOR

standards in France 1987 – the first ISO International Standard for Quality

Management System

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INTRODUCTION TO MANAGEMENT SYSTEMS

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

To ensure capability and consistency of the organization to meet customer as well as statutory/ regulatory requirements

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INTRODUCTION TO MANAGEMENT SYSTEMS

A Management System can also be described as a set of activities an organisation carries out to manage its processes in order to meet set objectives such as: Satisfying customer requirement Complying with regulations or Meeting environmental requirements

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INTRODUCTION TO MANAGEMENT SYSTEMS

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

Organisations gradually opted for the Quality Approach to management

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INTRODUCTION TO MANAGEMENT SYSTEMS

Quality is achieved through planning and communication to prevent problems

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

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QUALITY MISCONCEPTIONS

The Quality approach has gradually dismissed the general misconceptions of quality. The misconceptions include: Quality means expensive Quality systems are expensive “nice to haves” Good quality is high specifications Quality control is testing and checking Quality comes from inspection only

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QUALITY APPROACH

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

The Quality Approach also includes monitoring and continual improvement

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INTRODUCTION TO MANAGEMENT SYSTEMS

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

The ISO 9001 is an example of a management system standard

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ISO MANAGEMENT STANDARDS Quality management systems (QMS) (ISO 9001) Environmental management systems (EMS) (ISO

14001) 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 food safety requirements

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

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

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ISO 9001 STANDARD FOR QMS

ISO first published the standard on Quality Management Systems in 1987

The latest edition was revised in 2008

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

In 2007, and International Working Agreement developed and Guidance for the implementation of ISO 9001 in Educational Organizations (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 Management Systems

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The PDCA CYCLE

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The major operating principle underlying the ISO Management 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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Proactive approach – all problems are anticipated and measures are taken to prevent them in order to ensure a continually improving system.

The measures put in place are constantly monitored. You plan, do, act and check – with your results you plan again…..

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THE “P-D-C-A” CYCLE

Plan – establish objectives and make plans

Do – implement plans

Check – measure results

Act – correct and improve plans & how they are put into practice

ActPlan

Check Do

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THE PDCA AND ISO 9001

This operating principle runs through all the clauses of the ISO 9001 standard

They must characterize all your activities in order to achieve your set objectives

The Process Approach To

Management

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THE PROCESS APPROACH Process – a set of interrelated or interacting

activities which 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 PROCESS APPROACH

The systematic identification and management of the processes and interactions between such processes is referred to as the “Process Approach”.

Control of process inputs ensures that outputs meets specified requirements

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CONTROL OF PROCESSES

• Processes are controlled by controlling the inputs into the processes rather than inspecting the output:– 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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PROCESS APPROACH

consistent inputs produce consistent outputs Quality must be built in as a chain of event

by linking the processes – this is referred to as the system approach to management

The smoother the materials and information flow through the system the greater the efficiency

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PROCESS APPROACH – CONTINUAL IMPROVEMENTS OF PROCESS

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PDCA Cycle

Processes in terms

Of Added Value

DO

Continual improvements

of Processes based on

objective measurements

ACTION

Measure results of process

Performance and effectiveness

- Objective Measurements

CHECK

Understanding and

meeting requirements

PLAN

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SIMPLE PROCESS MAP

Process inputs:

•Men•Machines •Materials•Methods •Measurement

Processes•Administration •Allocating teaching loads •Developing course catalogues etc.

Process outputs

•Teaching modules •Qualified students

Customer satisfaction survey

Monitoring

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EXERCISE - 1

Identify three key processes in your department and map them together

The Eight Quality

Management Principles

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THE EIGHT QUALITY PRINCIPLES

A functional / effective quality system is based on functional principles – these are the eight quality management principles.

These principles make the management system functional

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ISO 9001 AND QUALITY SYSTEMS

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

Effective implementation of ISO 9001 ensure a sound quality system based on with all the quality principles maintained

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THE EIGHT QUALITY PRINCIPLES

Principle 1 Customer focus Principle 2 Leadership Principle 3 Involvement of people Principle 4 Process Approach Principle 5 System Approach to Management Principle 6 Continual Improvement Principle7 Factual Approach to Decision

Making Principle 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 the organisation

Measure customer satisfaction

In educational institutions the learner is the customer!

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2. LEADERSHIP

Leaders must establish unity of purpose and direction

create and maintain the internal environment where people become involved in achieving the organisation’s goal.

Leaders must lead by example, demonstrate visible commitment

Leaders must identify the vision and mission of the institution 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's

contributions (wisdom and skill) and use all for the organization

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3. INVOLVEMENT OF PEOPLE

Quality is everybody’s 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 its objectives

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INVOLVEMENT OF PEOPLE (2)

Organisations should help its people understand the importance of their contribution and role

identify constraints to their performance accept ownership of problems share knowledge and experience Openly discuss problems and issues.

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4. PROCESS APPRAOCH

A desired result is achieved more efficiently when activities and related resources are managed as a process.

The systematic identification and management of the processes is referred to as Process Approach

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PROCESS APPROACH (2)

Identify processes, control process inputs and monitor the characteristics for variation and possible improvement

People, machines, methods, materials and environment 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 to obtain a desired result

• Establish clear responsibilities and accountability for managing key activities

• Analyse and measuring of the capability of key activities

• Identify the interfaces of key activities

• Focus on resources, methods, & materials.

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5. SYSTEM APPROACH TO MANAGEMENT

Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency in achieving its objectives.

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SYSTEM APPROACH TO MANAGEMENT (2)

Understand the interdependencies between the processes - one process output is another process input.

Reduce cross-functional barriers – this causes repetitions

Materials and information flow through the systems must be smooth

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6. CONTINUAL IMPROVEMENT

Continual improvement of the organization's overall performance 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 continual improvement

Providing training in the methods and tools of continual improvement.

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Continual improvement: Organizations are more efficient & effective when they continually

try to improve. Organizations must make a permanent commitment to

continually improve their overall performance

C

B A

TIME (YEARS)

PERFORMANCE

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DECISION MAKING

Effective decisions are based on the analysis of data and information.

(no one man decisions; avoid grapevines)

Data needs to be gathered factually independently and without bias

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FACTUAL APPROACH TO DECISION MAKING (2)

We should: take decisions and actions based on factual

analysis – 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.

8. MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS

An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Collaboration with partners is important to obtain optimal skill and creativity to achieve learner value

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MUTUALLY BENEFICIAL SUPPLIER RELATIONASHIPS

Identify and select key suppliers / partners Establish clear and open communication Pool expertise and resources

Establish joint development and improvement activities with partners

MUTUALLY BENEFICIAL SUPPLIER 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 them to review yours as well (2nd party audits)

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FOUR ADDITIONAL PRINCIPLES

FOR ESTABLISHING EDUCATIONAL SUCCESS

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IWA 1) CREATING LEARNER VALUE

Encourage learners to be satisfied with the values they are receiving

Leaner satisfaction must be measured

Measurement must determine the degree to which values received meet the learner’s needs and expectations

It is key to improve processes for creating learner value

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IWA 2) FOCUSING ON SOCIAL VALUE

Assess how / what learners and other interested parties feel about ethics, safety and environmental conservations

Educational organizations can ensure sustainable growth only when the larger society appreciates value-added output of learners

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IWA 3) AGILITY Sustaining growth in a drastically changing

environment is important

This agility turns and ever changing education environment into an opportunity for success

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IWA 4) AUTONOMY

An educational organization must be free from stereotyping

Self analysis helps the educational analysis to make its own value decisions and keep it free from stereotyping

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SUMMARY

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

In the EO, the learner is the customer and the product / service provided is the education service offered.

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EXERCISE - 21. List the 12 quality management

principles for an EO

2. Explain the principle “factual approach to decision making”

3. Identify three key collaborators / partners that KNUST needs to establish mutually beneficial relationships with.

4. What is PDCA?Sky Portal Consults

EXERCISE - 2

5. Identify which of the 12 principles falls under “plan”, which comes under “do”, “check” and “act”?

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Benefits of a Quality Management

System

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BENEFITS OF A QMS STANDARD

The ISO QMS standard i.e. ISO 9001, outlines a process approach to implementing and supporting a QMS.

A key benefit is the increased involvement of top management in all aspects of the company’s activities.

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BENEFITS INCLUDE ….

• Well defined and documented procedures which increases the consistency of output

• Procedures ensure corrective actions are taken whenever defects occur – the result is a decrease in rework

• Helps to achieve quality control/ quality assurance;

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BENEFITS INCLUDE ….

• Increased organisational image

• Increased customer satisfaction

• Increased competitive power - increased market share

• 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 processes and 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 his activities

Speedy complaint redress – thus enhancing customer satisfaction

makes company managers and other employees become more aware and conscious of "quality management”

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BENEFITS INCLUDE ….

Finally the QMS standards gives one Quality Management System standard used all over the world

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

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ISO 9001:2008 QUALITY MANAGEMENT

SYSTEMS – REQUIREMENTS

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GENERAL Eight Clauses Clauses 1,2 & 3 are not auditable Clauses 4 – 8 are the auditable requirements. 1-Scope, 2-References , 3 – Definitions 4 – Quality Management System 5- Management Responsibility 6 – Resource Management 7 – Product Realisation 8 – Measurement, Analysis, Improvement

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CLAUSE 1 - SCOPE

ISO 9001 specifies requirements for a QMS when an organization needs to demonstrate ability to consistently provide services that meet customer and statutory requirements

And for organisations aiming at enhancing customer satisfaction

Exclusions are limited to clauses within clause 7

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CLAUSE 2 NORMATIVE REFERENCES

Normative references are other standards needed 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 key terms and words used in the standards

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CLAUSE 4 – REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM

4.1 – General Requirements Establish - document - implement - maintain

- continually improve effectiveness Management 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 process affecting product conformity

CLAUSE 4 – REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM

4.2 – Documentation Requirements

Documented statements of Quality Policy & Quality Objectives

Quality Manual

Documented procedures required by the Standard

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

Records required – records provide information about activities carried out

DOCUMENTS REQUIRED CONT.

Quality manual Establish and maintain a Quality

Manual

Quality Manual shall include:Scope and justification for exclusions Documented procedures or reference Description of interaction between

processes

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4.2.3 DOCUMENT CONTROL

Standard requires a document control procedure to define..

How to control document What to control When to control

Encompass 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 to provide evidence of conformity& effective operation of QMS

Legible, identifiable & retrievable

Documented procedure to define controls needed:

IdentificationStorageProtectionRetrievalRetention timeDisposition

4.2.4 CONTROL OF RECORDS

Reco

rd

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Top management shall demonstrate commitment to the development, implementation and improvement of the QMS

Communicate the importance of meeting customer and legal requirements

Conduct management reviews

Ensure availability of resources

5 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT

Evidence of commitment of development and implementation of QMS

Continually improve its effectiveness by:

Communicating customer

requirements Establishing quality policy Establishing quality objectives Conducting management reviews Ensuring availability of resources

5.2 CUSTOMER FOCUS

Ensure that customer requirements are determined 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 related processes) & 8.2.1 ( customer satisfaction)

CUSTOMER FOCUS

Need to stop and think:Who are my customers?What do they really want? customer requirements

What are my key processes to ensure that they get what they want?

More emphasis on defining objectives Providing leadership to enhance customer

satisfaction

5.3 QUALITY POLICY

Top management shall ensure Appropriate Commitment to meet requirements and

continually improve Framework for quality objectives Communicated Understood Reviewed

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5.4 PLANNING Quality Objectives must be established ,

communicated and worked at. These must be reviewed as system is

continually monitored

The Quality Objectives should cover relevant functions and should be consistent with the Quality Policy

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

5.5.2 MANAGEMENT REPRESENTATIVE

Top management to appoint a �Management Representative with Responsibility and authority for:

ensuring processes are established, implemented and maintained for QMS

reporting to top management on the performance

5.6 Top management must organize periodic Management Review Meetings

6 RESOURCE MANAGEMENT

6.1 Provide resources to Improve effectiveness Enhance customer satisfaction

6.2 Human resources Competence, awareness and training Evaluate effectiveness Maintain records

6.3 Infrastructure Workspace Equipment, hardware and software Supporting services

6.4 Work environment

7.1 PLANNING OF PRODUCT REALIZATION

Plan and develop processes Quality objectives &requirements for product Establish processes, documentation and

provide resources. Verification, validation, monitoring,

inspection and test activities Records for evidence

7.2 CUSTOMER RELATED PROCESSESDetermine the product requirements Customer specifications including delivery and

post delivery requirements Requirements not specified by customers but

necessary for intended use Statutory and regulatory requirements Others

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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 Outputs7.3.4 Review7.3.5 Verification7.3.6 Validation7.3.7 Change Control

7.3 DESIGN 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 PURCHASING

7.5 PRODUCTION & SERVICE PROVISION

7.5.1 Control of production and service provision

7.5.2 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

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Controlled Conditions Availability of information Work Instructions as necessary Suitable equipment Monitoring and measuring devices Monitoring and measurement activities

Implementation of release , delivery, and post-delivery activities

CONSISTENCYCONFORMITY TO REQUIREMENTS

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

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Validate processes Define criteria for review and Approval,Approval of equipment and qualification of personnelUse specific Methods & ProceduresRecordsRe-validation

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7.5.3 IDENTIFICATION AND TRACE-ABILITY

Identified by suitable means

Identify product status

Trace-ability if required

Record unique

identification

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7.5.4 CUSTOMER PROPERTY

Identified Verified Protected Safeguard Recorded and reported if Lost, damaged or unsuitable

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Preserve conformity during:

Internal processing Delivery Identification

Handling

Storage ProtectionPackaging

7.5.5 PRESERVATION OF PRODUCT

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Determine measurements required Devices identified and calibrated Defined traceable standards Calibration status be determined Safeguard from adjustments Assessed & record if out of calibration

Protected from damage & deterioration

Software confirmed Records maintained

7.6 CONTROL OF MONITORING AND MEASURING DEVICES (MAY BE EXCLUDED)

8 MEASUREMENT ANALYSIS AND CONTROL

8.1 General Plan and implement monitoring,

measurement analysis and improvement processes needed to: demonstrate conformity of the product ensure conformity of the QMS continually improve effectiveness of the QMS• Determine applicable methods including statistical techniques, and the extent of

their use

8.2 MEASUREMENT AND MONITORING

• Measurement and monitoring is the first step that leads to control and eventually 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 CUSTOMER SATISFACTION

Monitor information

Customer perception

Methods determined

One of the parameters of quality is the gap between customer’s expectation and supplier’s capability. The narrower this gap the better is the meeting of minds of the customer and supplier

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CUSTOMER SATISFACTION MEASURES

Periodic customer surveys Customer focus groups Customer aftercare calls Client meetings Customer churn rate Golf course approach - informal chats Market research Complaints

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Documented Procedure Actual = Plan ?

Periodic Audits

Effective, Objective, Impartial

Independent Auditors

Recorded Results

Follow-up

8.2.2 INTERNAL AUDIT

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PROCESSES SUITABLE METHODS PLANNED RESULTS CORRECTION AND

CORRECTIVE ACTION

8.2.3

8.2.4

8.2.3

8.2.3 MONITORING AND MEASUREMENT OF PROCESSES

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MONITOR AND MEASURE FOLLOW PLANNED ARRANGEMENTS

EVIDENCE OF CONFORMITY

RECORDS FOR AUTHORITY FOR RELEASE APPROVED BY RELEVANT AUTHORITY OR THE CUSTOMER

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What happens when things go wrong?

Documented Procedure Identified And Controlled Authority Defined Eliminate The Nonconformity Authorize, Release Or Acceptance Under Concession After Delivery Or Use Has Started, Appropriate Action Records Maintained Re-verified After Correction

8.3 CONTROL OF NONCONFORMING PRODUCT

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Determine, collect And Analyse Data Identify Areas Of Continual Improvements Provide Information Relating To:Customer Satisfaction Conformance To Requirements Process Trends And Product Characteristics Suppliers

8.4 ANALYSIS OF DATA

Graphical methods Pareto, Cause and effect, Scatter plots

Process Capability Establishing of limitsControl charts Monitoring & controlling

production & measurementSampling & acceptance - Inspection and testing plans

8.5 IMPROVEMENT

8.5.1 Continual improvement

8.5.2 Corrective action

8.5.3 Preventive action

8.5.1 CONTINUAL IMPROVEMENT Continually improve effectiveness through:

Quality policy Quality objectives Audit results Analysis of data Corrective and preventive actions Management review

8.5.2 CORRECTIVE ACTION

A documented procedure must be established

Procedure must review nonconformities

Identify the causes Review the effectiveness of the

corrective action Records shall be maintained

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8.5.3 PREVENTIVE ACTION Documented procedure must be

established

Procedure to evaluate need for action to prevent occurrence of nonconformities

Review the effectiveness of preventive action taken

Records shall be maintained

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GOD BLESS YOU

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