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

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Act

Plan

Check

Do

THE PDCA AND ISO 9001

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

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People - by training Materials control of suppliers and specifications Methods - by procedures and standards Machines - by maintenance systems Environment by organisation and care

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
Understanding and meeting requirements

PLAN

Processes in terms Of Added Value

DO

PDCA Cycle
Measure results of process Performance and effectiveness - Objective Measurements

Continual improvements of Processes based on objective measurements

ACTION

CHECK
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SIMPLE PROCESS MAP

Monitoring
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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

EXERCISE - 1
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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 organisations 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 Establish Provide

clear visions for the future trust and eliminate fear

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

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

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P E R F O R M A N C E

TIME (YEARS)

7. FACTUAL APPROACH TO
DECISION MAKING
Effective

decisions are based on the analysis of data and information.

(no one man decisions; avoid grapevines)

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Data

needs to be gathered factually independently and without bias

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

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

MUTUALLY BENEFICIAL SUPPLIER RELATIONASHIPS

Identify and select key suppliers / partners

Establish clear and open communication

Pool expertise and resources

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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 learners 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 - 2
1.

List the 12 quality management principles for an EO Explain the principle factual approach to decision making Identify three key collaborators / partners that KNUST needs to establish mutually beneficial relationships with. What is PDCA?

2.

3.

4.

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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 companys activities.

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BENEFITS INCLUDE .

Well defined and documented procedures which increases the consistency of output
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Procedures ensure corrective actions are taken whenever defects occur the result is a decrease in rework Helps to achieve quality control/ quality assurance;

BENEFITS INCLUDE .

Increased organisational image

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Increased customer satisfaction

Increased competitive power - increased market share

Better relationship with supplier / partners

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 ISO

SCOPE

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

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ISO 9000: 2005 Quality Management Systems Fundamentals And Vocabulary

CLAUSE 3
This

TERMS AND DEFINITIONS

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
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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..

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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

4.2.4 CONTROL OF RECORDS

Establish and maintain records to
provide evidence of conformity& effective operation of QMS Legible, identifiable & retrievable Documented procedure to define controls needed: Identification Storage Protection Retrieval Retention time Disposition
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MANAGEMENT RESPONSIBILITY

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

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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 & expectations Translate them into requirements Communicate requirements through out the organization Focus on improvement to ensure value for customers details see 7.2.1 ( customer related processes) & 8.2.1 ( customer satisfaction)

For

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

5.4 PLANNING
Quality Objectives must be established , communicated and worked at. These must be reviewed as system is continually monitored

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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 Competence, awareness and training Evaluate effectiveness Maintain records Workspace Equipment, hardware and software Supporting services

6.2 Human resources

6.3 Infrastructure

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 PROCESSES

Determine 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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7.3 DESIGN AND DEVELOPMENT

WHAT DO YOU WANT?

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7.3.1 Planning
Stages of development Review, verification & validation Responsibilities& authorities Interfaces

7.3.2 Inputs 7.3.3 Outputs 7.3.4 Review 7.3.5 Verification 7.3.6 Validation 7.3.7 Change Control

7.4 PURCHASING
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

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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 product 7.6 Control of monitoring and measuring devices

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION

Controlled

Conditions
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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
CONSISTENCY CONFORMITY TO REQUIREMENTS

7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION

Validate processes Define criteria for review and Approval, Approval of equipment and qualification of personnel Use specific Methods & Procedures Records Re-validation

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7.5.3 IDENTIFICATION AND TRACE-ABILITY

Identified by suitable means

Identify product status

Trace-ability if required

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Record unique identification

7.5.4 CUSTOMER PROPERTY

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

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7.5.5 PRESERVATION OF PRODUCT

Preserve conformity during: Internal processing Delivery Identification Handling Storage Protection Packaging

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

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

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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 customers expectation and suppliers capability. The narrower this gap the better is the meeting of minds of the customer and supplier

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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8.2.2 INTERNAL AUDIT

Documented Procedure Actual = Plan ?

Periodic Audits
Effective, Objective, Impartial Independent Auditors Recorded Results Follow-up

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8.2.3 MONITORING AND MEASUREMENT OF PROCESSES

8.2.3

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8.2.3

PROCESSES SUITABLE METHODS PLANNED RESULTS CORRECTION AND CORRECTIVE ACTION

8.2.4

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT

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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

8.3 CONTROL OF NONCONFORMING PRODUCT

What happens when things go wrong?

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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

8.4 ANALYSIS OF DATA

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 Graphical methods Pareto, Cause and effect,
Scatter plots Process Capability Establishing of limits Control charts Monitoring & controlling production & measurement Sampling & acceptance - Inspection and testing plans

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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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