Learning Unit Qu 3.3_2008 v01

8/13/2019 Learning Unit Qu 3.3_2008 v01

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LEAR UNIT 1

Designing QMS ISO 9001:2000

LearningUnit

QU-3.3

Module 3, first semester

Developing approaches to quality


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D EV EL O P I N G A PPR O A CH ES TO Q U A L I TY S TU D EN TS MA TER I A L S S EMES TER 3

L EA R N I N G U N I T Q U -3.3 D ES I G N I N G Q MS I S O 9001:20002

International Training Centre of the ILO Turin (Italy)

First edition, 2008

This publication has been developed under the component of the ESDP The

Indonesian Entrepreneurial Skills Development Programme implemented byASPI The Association of Polytechnics in Indonesia financed by the Governmentof the Netherlands. Excerpts of this publication may be reproduced withoutauthorisation, on condition that the source is mentioned. Any request foradaptation or translation of the material other than Indonesian Bahasa, must

be addressed to the International Training Centre of the ILO, Viale Maestri delLavoro, 10 10127 Turin (Italy).

QUALITY MANAGEMENT SYSTEMS PROGRAMME

SEMESTER 3. MODULE 3 : DEVELOPING APPROACHES TO QUALITY

LEARNING UNIT 3 Designing QMS ISO 9001:2000

Author:Barbara Marcelis (CINOP), Sara Colonna (DELTA Programme)

The designation employed in publications of the International Training Centreof the ILO, which are in conformity with the United Nations practice, and the

presentation of material therein, do not imply the expression of any opinionwhatsoever on the part of the Centre concerning the legal status of anycountry, area or territory of its authorities, or concerning the delimitation ofits frontiers.

The responsibility for opinions expressed in signed articles, studies and othercontributions rests solely with their authors, and the publication does not

constitute an endorsement by the Centre of the opinions expressed in them.

Reference to names of firms and commercial products and processes does notimply their endorsement by the International Labour Office, and any failure tomention a particular firm, commercial product or process is not a sign of

disapproval.

DELTA (Distance Education and Learning Technology Applications)

International Training Centre of the ILO

Viale Maestri del Lavoro, 10 10127 Turin, Italy

Tel.: +39-011-6936-523; +390-011-6936-111

Fax.: +39-011-6936-469; +39-011-6638-842

E-mail: [email protected]


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LEARNING UNIT QU-3.3

Designing QMS

Specific learning objectives

1. Introduction2. Designing QMS ISO 9001:2000

2.1. Historical background of ISO2.2. Making the Decision: ISO 9001:2000 Registration2.3. Documentation requirements2.4. Implementation steps

3. Project Plan3.1. ,The ISO Steering Team Meeting3.2. Holding Task Group Team Meeting

4. List of AssignmentAnnexes

Bibliography and Webography


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Specific Learning Objectives

By the end of this learning unit you will be able to:

Outline the historical background of ISO

Justify the benefits of ISO certification

Identify the vision and mission of an organisation

Make organisational charts

Describe the procedure of ISO Implementation


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1 IntroductionIn the first chapter we will explore the ISO historical background. The original

ISO 9000 series were born out of the defence industry where there was a long

tradition of command and control. As a consequence, ISO 9000 followed the

same pattern of imposing requirements to prevent failures despite the fact

that experience has shown this method to be unsuccessful in ensuring good

product quality.

The ISO 9000:2000 series represent a fundamental change in intent,

directionand approach.

By looking at ISO 9000 as a framework upon which can be built a successful

organisation, rather then as a narrow set of minimum requirements,significant benefits will be gained. By using an implementation approach,

well follow a proven path for successful registration.

There are those who believe that standards introduced more bureaucracy and

constraints-coercing organisations into doing things that add no real value.

There are those who believe it is a necessary evil to have the ISO 9000 badge

on the wall and are unlikely to have the inclination or devote the time to

understand and learn.

But If you continue to do the things that you have always done, you will

continue to get what you always got!


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2 Designing QMS ISO 9001:20002.1 Historical background of ISO

ISO was born from the union of two organisations - the

ISA (International Federation of the National

Standardising Associations), established in New York in

1926, and the UNSCC (United Nations Standards

Coordinating Committee), established in 1944.

In October 1946, delegates from 25 countries, meeting

at the Institute of Civil Engineers in London, decided to

create a new international organisation, of which the

object would be "to facilitate the international

coordination and unification of industrial standards".

The new organisation, ISO, officially began operations

on 23 February 1947.

The ISO 9000 and ISO 14000 families are among ISO's

best known standards ever. ISO 9001:2000 and ISO 14001 (1996 and 2004

versions) are implemented by over a million organisations in 161 countries.

The ISO 9000 family addresses "quality management". This means what the

organisation does to fulfil:

customer's quality requirements

applicable regulatory requirements

customer satisfaction

continual performance improvement

What ISO 9000 Requires

ISO 9001:2000 is the standard that provides a set of standardised requirements for

a quality management system, regardless of what the user organisation does, its

size, or whether it is in the private, or public sector. It is the only standard in the

family against which organisations can be certified although certification is not a

compulsory requirement of the standard.


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The other standards in the family cover specific aspects such as fundamentals and

vocabulary, performance improvements, documentation, training, and financial and

economic aspects.

Why an organisation should implement ISO 9001:2000

Without satisfied customers, an organisation is in peril! To keep customers

satisfied, the organisation needs to meet their requirements. The ISO 9001:2000

standard provides a tried and tested framework for taking a systematic approach to

managing the organisation's processes so that they consistently turn out product

that satisfies customers' expectations.

How the ISO 9001:2000 model works

The requirements for a quality system have been standardised - but manyorganisations like to think of themselves as unique. So how does ISO 9001:2000

allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on

the other, to a multinational manufacturing company with service components, or a

public utility, or a government administration?

The answer is that ISO 9001:2000 lays down what requirements your quality

system must meet, but does not dictate how they should be met in any particular

organisation. This leaves great scope and flexibility for implementation in different

business sectors and business cultures, as well as in different national cultures.

History and applications

Quality standards have their roots in the 12thcentury practice of hallmarking silver.

To protect customers, an item was

tested at an assay office, and if it

met minimum standards of silver

content, it was stamped with a

hallmark.

Starting in 1959, the US and UK

defence departments issued

standards for quality control to

ensure that materials, parts, and

equipment provided by suppliers

were of suitable quality. No one

wanted bombs that wouldnt

explode-or exploded prematurely!

Government inspectors visited

suppliers to ensure compliance to


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the standards. Other standards proliferated through the 1960s: by NASAs space

program, NATO, Canadian and British electrical utilities, the UKs Ministry of

Defence. All these standards were based on a philosophy of inspecting the product

for quality after production and required auditing by the customers inspectors. In

Britain alone, 17,000 inspectors were employed by the government.

During the 1970s, the approach changed from customers inspection of their

suppliers to independent, third-party inspectors performing this function. The term

Quality assurancealso became prevalent, rather than Quality control.

In 1979, the British standards office issued BS 5750, covering quality assurance in

non-military applications. Other countries followed suit. Finally, in 1987, the

International Organisation for Standardisation (known as ISO, from the Greek word

meaning equal), an alliance of the standards bodies of 91 countries worldwide,

issued the ISO 9000 series of standards to facilitate international trade. It was

essentially identical to BS 5750.

Use of ISO 9000 spread rapidly, as customers required it of their suppliers in order

to be assured of a minimum level of quality practice. In 1994, ISO issued minor

revisions to the standard. However, concern was widespread about whether the

standards promoted quality approaches that reflected post- World War II

knowledge about managing quality. In 2000, ISO issued a major revision of the

standards, reducing the number of documents in the series and placing more

emphasis on concepts such as work processes and customer satisfaction. Transition

to the new standard was required by December 2003.

For suppliers to the automotive industry, ISO/TS 16949:2002 follows the format of

ISO 9001:2000 but adds additional requirements. This standard will supplant QS-

9000, a standard published by Ford, General Motors, and DaimplerChrysler. ISO

14001, a standard for environmental management system, is aligned with ISO

9001:2000 for easy integration of environmental and quality management systems.

Problems and Potential

The first (1987 and 1994) version of ISO 9000 was criticised for its emphasis on

inspection, control of nonconforming product, and documentation. It reflected a

traditional quality control approach of inspect-in quality. It would work with

modern total quality management concepts, especially if used within the final

standardisation step of an improvement process, but it had to be creatively applied

by people who had learned elsewhere the principles of TQM. By itself, it led to an

outmoded management system.

ISO 9001:2000 was intended to incorporate current quality management principles,

as well as to be more user-friendly. It changes included greater emphasis on

processes, customer satisfaction, the role of top management, data analysis, and

continual improvement. The Eight quality Management principles are included


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(LU3.1.2), although their use is not required for certification: customer focus,

leadership, involvement of people, process approach, system approach to

management, continual improvement, factual approach to decision making, and

mutually beneficial supplier relationships.

One major criticism of any standard-based approach is that it guarantees only

minimum level of quality to customers. Proponents argue that the recent changes

will lead an organisation through cycles of improvement that will take it beyond

minimum requirements.

Past experience has shown that when applied well, ISO 9000 standards can benefit

the organisation by ensuring consistency and sustainability of its quality

management system. As of this writing, the changes to ISO 9000 are too new to

assess whether the standard alone can form the foundation of an effective quality

management system.

Now undertake Assignment QU-3.3 AS1/4 BENEFITS OF ISOCERTIFICATION that you will find under the Section Assignment

at the end of this Learning Unit. Please remember to follow the

guidance note related to the Learning Journal and Portfolio of

Evidence

Vision and mission of an organisation

Definitions:

- a vision statement defines what the organisation wants to be where theorganisation wants to be in the near future (1 3 years) and what theorganisation carries out.

- a missionstatement defines what an organisation is, why it exists, its reasonfor being. At a minimum, a mission statement should define the organisations

primary customers, the products and services it produces and a description of

the geographical location in which it operates (what do I have to do to get

there?).

Visioning the future

The vision concept and statement should be seen to embody two components:

a guiding philosophy a tangible image.


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What should an effective vision be like? (i.e. in a school)

Challenging- always in sight but not out of reach

Clear-not open to conflicting interpretations

Memorable- a statement that is no longer than 20-25

words is ideal.

Involving- a statement that enables and empowers

Value-driven- there should be a strong tie to the

values of the school

Visual- it should be something that can be represented or pictured visually

Mobilizing- it should demand a response from all.

A guideline- it should be something by which all engaged with the school can

measure their actions against daily.

Linked to the needs of student- the ultimate test of a vision will relate to the

actions and achievements of students.

Commitment - the real challenge of vision

The organisation is locked into a strategy

The organisation has so delimited its options that it is locked-out of alternatives

because of prior decisions

Because of time legs between starting a strategy and its effects, the

organisation has to hold to its strategy so as to reap the benefits of its

investments in people, equipment, marketing and buildings

Inertia- the organisation is unable and unwilling to respond to changes in

circumstances and, in any case, sees itself as insulated against them because of

historic factors

Now undertake Assignment QU3.3-AS2/4 VISION AND

MISSIONthat you will find under the Section Assignment at the

end of this Learning Unit. Please remember to follow the guidance

note related to the Learning Journal and Portfolio of Evidence

Organisational chart

The next step to undertaken is find out how the organisational is organized. In yearone you already learned what a organisational chart is. This is a reversal.


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Director

UNIT 1 UNIT 2 UNIT 3

Administration

Or

BOARD

DIRECTOR

UNITUNIT UNIT

TEAMTEAM TEAM TEAM TEAM TEAM

An organisational chart is a chart which represents the structure of an

organisational in terms of rank. The chart usually shows the managers and sub-

workers who make up an organisational. The chart also shows relationships

between staff in the organisational which can be:

Line- direct relationship between superior and subordinate.


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Lateral- relationship between different departments on the same hierarchicallevel.

Staff - relationship between a managerial assistant and other areas. Theassistant will be able to offer advice to a line manager. However, they have no

authority over the line manager actions.

Functional - relationships between specialist positions and other areas. Thespecialist will normally have authority to insist that a line manager implements

any of their instructions.

In many large companies the organisational chart can be large and incredibly

complicated and is therefore sometimes dissected into smaller charts for each

individual department within the organisational.

There are several limitations with organisational charts:

It only shows 'formal relationships' and tells nothing of the pattern of human(social) relationships which develop.

It shows nothing about the managerial style adopted (e.g. autocratic ordemocratic)

It very quickly becomes out-of-date, especially in large organisationals whichchange their staff regularly.

NOTE: In order to make a proper organisational chart you need to know the

organisational. Whenever you make an organisational chart of on organisational

you do not know, you have to ask for information first. A good relationship with the

organisational is therefore necessary.

The dynamic nature of organisations

Organisations are dynamic in nature and change and evolve continuously.

Management has the ability to change job duties and responsibilities at any time to

meet legitimate organisational needs. As a result, changes in duties and

responsibilities or the restructuring of the organisation do not always warrant a

change in role title and/or pay band. Additionally, exceptional performance of an

employee does not warrant a change in role title and/or pay band. However, when

a position's duties and responsibilities change significantly and appear to be for an

indefinite period, managers have an obligation to their employees to submit a

request for a position review. Examples of significant changes may include achange in reporting relationship; the addition/change or removal of a primary

responsibility; and a substantial change in the percentage of time spent in a

primary duty. Management should direct all questions regarding whether the

changes in the duties and responsibilities are significant to UHR Compensation

Management.


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If there are significant changes in the duties and responsibilities assigned a

position, management may initiate a formal review of the position by submitting a

role change. A role change is a management-initiated, non-competitive movement

to a different role in a higher, lower or the same pay band for classified staff and

university staff positions only. There are three types of role changes:

An upward role changeis movement to a different role in a higher pay

band. It may result in a 0-10% increase in the employee's salary as

subject to management's discretion.

A lateral role change is movement to a different role in the same pay

band. It may result in a 0-10% increase in the employee's salary as

subject to management's discretion.

A downward role changeis movement to a different role in a lower pay

band. It does not result in a salary change unless the employee's salary

exceeds the maximum pay for the new pay band. If pay is above the

maximum, salary is frozen for 6-months and then reduced to maximum of

the new pay band. A downward role change does not result in a salary

increase under any circumstance.

To request an upward, downward or lateral role change, a department must submit

a completed Position Action Form, Employee Work Profile and Organisational Chart.

An organisational chart must include the position under review, its supervisor(s),

subordinate(s) and all other positions (faculty, staff and students) within its

organisational unit (department, division, center, section, institute, etc).

Now undertake Assignment QU3.3AS 3/4 ORGANISATIONAL

CHART that you will find under the Section Assignment at the

end of this Learning Unit. Please remember to follow the guidance

note related to the Learning Journal and Portfolio of Evidence

2.2 Making the Decision: ISO 9001:2000 Registration

Now undertake the following Readings that you will find underthe section readings at the end of this learning unit.

- ISO 9001: The Standard Interpretation: ( 6-17 = 11 pp.)- ISO 9001:2000 for SME (Bahasa Indonesia): (8-43= 35 pp.)


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What an organisation or enterprise can really expect in return for investing in

an ISO 9001:2000 Quality Management System? What happens when you

have your QMS in place and working for you? Feedback from ISO 9001:2000

registered companies shows what you can expect as the payoff from all your

hard work.

Because of the responsibilities called out in the ISO9001:2000 Standard,

organisations often see an increased involvement of top management with

regards to the Quality management System. This starts with the setting of the

Quality Policy and Quality Goals and objectives. It continue with

Management Review looking at data from the QMS, and taking actions to

make sure that Quality Goals are met, new Goals are set, and continual

improvement is achieved.

With the QMS in place and working

for you, the organisation is

focused towards the Quality Goals.

Management is provided with data

on a continual basis and able to

see progress or a lack of progress

toward goals and take appropriate

action. The organised, scheduled process of conducting Management Review

ensures that this evaluation takes place. It provides the mechanism of

reviewing goals and performance against goals on a scheduled basis, and for

taking action based on the evaluation.

Increased productivity results form the initial evaluation and improvement

of processes that occurs during the implementation process and fromimproved training and qualification of employees. Better documentation or

control of processes leads to consistency in performance, and less scrap and

rework. Managers experience less late night troubleshooting calls; employees

have more information for troubleshooting problems on their own.

Customer satisfactionincreases are seen as Goals and objectives take the

customer needs into account. Customer needs are better understood as

customer feedback is sought, received and analysed. Goals and objectives are

adjusted based on the information and the organisation becomes more

customer driven. As goals focus on the customer, the organisation spends

less time focusing on individual goals of departments and more time working

together to meet customer needs.

All of this leads to financial rewards, your reward for your hard work

and investment in the Quality management System.


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So work with enthusiasm and optimism, knowing that your organisation will

be significantly improved by this ISO 9001:2000 implementation project. You

are contributing to the future success and profitability of your School, and

later on, possibly, of you own company!

2.3 Documentation Requirements

Guidance on the Documentation Requirements of ISO 9001:2000

Two of the most important objectives in the revision of the ISO 9000 series of

standards have been

to develop a simplified set of standards that will be equally applicable to

smallas well as mediumand large organisations, and

for the amount and detail of documentation required to be more relevant

to the desired results of the organisations process activities.

ISO 9001:2000 Quality management systems Requirements has achieved these

objectives, and the purpose of this additional guidance is to explain the intent of

the new standard with specific regard to documentation.

ISO 9001:2000 has significantly reduced the documentation requirements and is

much less prescriptive than the 1994 version of the standard. It allows an

organisation more flexibility in the way it chooses to document its quality

management system (QMS). This enables each individual organisation to develop

the minimum amount of documentation needed in order to demonstrate the

effective planning, operation and control of its processes and the implementation

and continual improvement of the effectiveness of its QMS.

It is stressed that ISO 9001 requires (and always has required) a "Documented

quality management system", and not a "system of documents".

What is a "document"? - Definitions and references

The following are some of the main objectives of an organisations documentation,

independent of whether or not it has implemented a formal QMS;

Communication of Information s a tool for information transmissionand communication. The type and extent of the documentation will

depend on the nature of the organisations products and processes, the

degree of formality of communication systems and the level of

communication skills within the organisation, and the organisational

culture.


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Evidence of conformity provision of evidence that what was planned,has actually been done.

Knowledge sharing in order to disseminate and preserve the

organisations experiences. A typical example would be a technical

specification, which can be used as a base for design and development of

a new product.

A list of commonly used terms relating to documentation is presented in Annex A

(taken from ISO 9000:2000). It must be stressed that, according to ISO 9001:2000

clause 4.2 Documentation requirements documents may be in any form or type of

medium, and the definition of "document" in ISO 9000:2000 clause 3.7.2 gives the

following examples:

paper

magnetic

electronic or optical computer disc

photograph

master sample

Users are also referred to ISO/TR 10013 Guidelines for quality management

systems documentation for further guidance.

ISO 9001:2000 Documentation Requirements

The organisation shall establish, document, implement and maintain a quality

management system and continually improve its effectiveness in accordance withthe requirements of this lnternational Standard. The organisation shall

identify the processes needed for the quality management system and

their application throughout the organisation (see 1.2)

determine the sequence and interaction of these processes,

determine criteria and methods needed to ensure that both the operation

and control of these processes are effective,

ensure the availability of resources and information necessary to support

the operation and monitoring of these processes,

monitor, measure and analyse these processes, and

implement actions necessary to achieve planned results and continual

improvement of these processes.

These processes shall be managed by the organisation in accordance with the

requirements of this international Standard. Where an organisation chooses to

outsource any process that affects product conformity with requirements, the


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organisation shall ensure control over such processes. Control of such outsourced

processes shall be identified within the quality management system.

NOTE Processes needed for the quality management system referred to above

should include processes for management activities, provision of resources, product

realization and measurement.

To increase the effectiveness of processes and customer satisfaction a systematic

and visible way of how the organisation is organized and managed is necessary.

One method is introducing, maintaining and improving a quality management

system (QMS). The processes needed for a QMS are shown in above requirement: a

to f. Also the determination and control of out-contracted or out-sourced processes

are emphasised.

In the NOTEis explained to which processes is referred when in the standard a

reference is made to processes of the quality management system.

Now undertake Assignment QU3.3-AS4/7 QMS that you will

find under the Section Assignment at the end of this Learning Unit.

Please remember to follow the guidance note related to the

Learning Journal and Portfolio of Evidence

The Documentation requirements focuse on, as it is in the name, documents: QMS

documents ensure effective planning, operation and control of the company

processes, with the interaction of these processes shown, allowing insight.

Documentation, written procedures, is needed for:

Control: all QMS data and documents, from both internal and external

sources. It includes methods for approval, updates and change, and

identifying a documents current revision. Documents must be legible and

available when needed.

Traceability: control of quality records including identification, retention

times, protection, storage and easy retrieval of records.

General requirement

The quality management system documentation shall include:

documented statements of a quality policy and quality objectives;

a quality manual;

documented procedures required by this International Standard;

documents needed by the organisation to ensure the effective planning,

operation and control of its processes, and

records required by this International Standard (see 4.2.4).


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NOTE 1 Where the term procedure appears within this International Standard,

this means that the procedure is established, documented, implemented and

maintained.

NOTE 2The extent of the quality management system documentation can differ

from one organisation to another due to:

the size of organisation and type of activities,

the complexity of processes and their interactions, and

the competence of personnel.

NOTE 3 The documentation can be in any form or type of medium.

Documentation supports communication and a consistent manner of work within

organisations. It promotes an effective implementation of processes.

Documentation contributes to meet the requirements, improvement, it provides the

organisation with objective evidence, validity, traceability and assessing

effectiveness and adequacy of the system. Drawing up documentation is no end in

itself, but a tool for the functioning and improvement of the quality management

system.

Quality manual

The organisation shall establish and maintain a quality manual that includes

the scope of the quality management system, including details of and

justification for any exclusions (see 1.2)

the documented procedures established for the quality management

system, or reference to them, and c) a description of the interaction

between the processes of the quality management system.

Quality manuals (QM) provide consistent information on the QMS of the

organisation. The QM provides the organisation with an overview of the QMS for

usage both internally (for own employees) and externally (for customers, auditors).

The QM indicates the agreed work procedure within the organisation.

A QM is:

A means to communicate the vision, values, mission, policies and

objectives of the organisation;

A means of showing how the system has been designed;A means of showing linkages between processes;

A means of showing who does what

An aid to training new people;

A tool in the analysis of potential improvements;

A means of demonstrating compliance with external standards and

regulations.


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Documents control

Documents required by the quality management system shall be controlled.

Records are a special type of

document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed:

to approve documents for adequacy prior to issue,

to review and update as necessary and re-approve documents,

to ensure that changes and the current revision status of documents are

identified,

to ensure that relevant versions of applicable documents are available at

points of use,

to ensure that documents remain legible and readily identifiable,

to ensure that documents of external origin are identified and their

distribution controlled, and

to prevent the unintended use of obsolete documents, and to apply

suitable identification to them if they are retained for any purpose.

The standard requires that documents used to define, direct and control activities

that affect your quality management system be controlled. The purpose of

document control is to ensure that the necessary, accurate and up-to-date

documents are available to those who need them.

Documents support the execution of processes of the QMS. For effective support it

is necessary to establish what documents need to be controlled and the type of

control is required. The following documents are distinguished: The QMS itself

(procedures, instructions, process descriptions etc.), documents such as records

(process performances, complains etc.), product information (drawings), and all

other documents (standards and laws).

The document control procedure, which is required by the standard, should

describe how the following are controlled;

Creation, review, updating and change of documents, together with

associated approval processes appropriate for each of these stages;

Identification of documents (i.e. issue number, revision status, issue

date);

Distribution.


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Control of records

Records shall be established and maintained to provide evidence of conformity to

requirements and of the effective operation of the quality management system.

Records shall remain legible, readily identifiable and retrievable. A documented

procedure shall be established to define the controls needed for the identification,

storage, protection, retrieval, retention time and disposition of records.

Records can provide you with information to manage your activities. An

organisation must keep up records in order to meet the requirements of ISO 9001

or to establish the effective functioning of the QMS. Records can also be useful as

evidence in case of legal responsibility. Recordings are no end in itself, but a

means for reviewing, analysing data and improvements.

Now undertake Assignment QU3.3-AS6/7 REGISTRATION OF

EXAMINATION MARKS that you will find under the Section

Assignment at the end of this Learning Unit. Please remember tofollow the guidance note related to the Learning Journal and

Portfolio of EvidenceIn the last week of the second years semester you will visit an organisation that

is ISO certified. This field trips aim is to provide you with a good example of how

ISO works in practice. Make good use of this opportunity. You are already familiar

with the concept and the principles. Also you have discussed and explored in class

the requirements around documentation, management responsibility and resource

management. The next two requirements, product realization and measurement,

analysis & improvement, are yet to come.

Especially the product realization process is interesting. This probably is the core

business of the organisation. This is where the food is cooked and served. Take

the ISO process Approach and the supplier-input-process-output-customer figures

with you and explore them during the field trip.

The programme of the field trip consist roughly of an introduction, a conducted tour

through the organisation and a plenary discussion / time for questions were you will

be able to interview your host.

2.4 Implementation steps1 The Project manager prepares a Project Plan

2 Management and the Project manager identify an ISO 9001:2000 Steering Team

3 The Project Manager and others conduct a Gap Analysis with a Gap Analysis

Checklist


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4 The ISO 9000 Steering team assign responsibilities for customizing or developing

each Quality System Procedure and the Quality manual to a Task Team or

individual.

5 The Project manager trains employees on ISO 9001:2000

6 Team leaders hold team meetings to revise processes and procedures based on

the results of the Gap Analysis and the prepared Quality System Procedure

Templates

7 The ISO 9001:2000 Steering Team reviews the procedures as they are

completed.

8 The Project manager trains internal auditor

9 The system is used for several months while records are collected and

improvements are made.

10 The registrar comes to audit

This is a recommended plan, you may change it to suit your organisation or

enterprise. You will make this system your own by reviewing and editing the

procedures, manual and forms. You will also be making changes to your existing

processes so you meet the requirements of the ISO 9001:2000 standards.

This Project Plan will help you in manage these changes.


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3 Project Plan

A. Determine the project goals (Use the project Plan Template inAppendix A)

In order to start planning, you will need to determine what your goals are for

the project. Answer these questions:

1 When will you start your project?

Consider the start of your project as the date of the Gap Analysis. When will you

be ready to conduct the Gap Analysis?

Recommended steps to be completed before conducting the Gap Analysis:

Identify one or more people to conduct the Gap Analysis; it is

helpful if they have some quality system experience or audit

experience

print the Gap Analysis Checklist

schedule the Gap Analysis, and communicate to all employees

what is being done, and why. You will want to be able to make

the employees comfortable with answering your auditors

questions.

(The auditor is the person conducting the gap analysis. It maybe an audit team or one individual)

2 When does your company want to have an ISO9001:2000 certificate in hand?

The answer to this question will determine your timeline.

The shorter time frame allowed for the project, the more resources the

project will demand during implementation.

It is important to know what your goal is because other dates will be

determined by this information

Find out if there are company goals, are there clients that are

requesting certification or other circumstances that will determine thedate? If you are transitioning from 1994 talk to your registrar. Find out

what goals they have for their clients to transition.

Your date may be revised later. You will use this as a target date, and

as we move along to the gap analysis and creating the task list you will

be able to determine if the date is realistic. It will depend on what you


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That way you can decide if some people that will be involved in theproject need more detailed training, and you can let employees know

who will be working on the project.

Plan training before the tasks team meetings so individuals involved in

the task groups are trained before the first meeting.

Read handout, QUALITY MANUAL 1, AND 2that you will find

under the Section handouts for Semester 3

Scheduling and conducting the Gap Analysis

A Schedule the Gap

1 Review the project plan:

Who did you identify to conduct the gap?

Schedule the Gap Analysis, and communicate to all employees what is

being done, and why. You will want to be able to make the employees

comfortable with answering your auditors questions.

You may want to consider sending out a newsletter to inform employees

that the Gap will be performed, by whom, when and why the Gap is being

performed.

2 The audit schedule

Determine if you will audit by process/procedure or by area of the facility.

Our approach is usually to audit by area of the facility.

Divide the facility into manageable areas. Schedule time to audit each

section of the standard that applies to the area.

If you are using an audit team, assign the team to cover the various areas

of the facility

Arrange the Gap Analysis checklists so each auditor will have the sections

of the standard that are applicable in the areas they will cover.

Arrange your checklists so each auditor will have the sections of the

standard that are applicable in the areas they will cover.


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B Conducting the audit

Follow the schedule that you have prepared. Go into each area of the facility to

evaluate the current quality system. Focus on what is in place, and what is not in

place. Remind auditors that you are not focusing on compliance or not compliance

to the current system, and how it matches the ISO 9001:2000 requirements.

Take notes on what is in place, and what will need to be developed and changed,.

Take complete notes, reference documents and examples.

C Reporting

Summarize the audit findings in the form of a task list. You will usually identify

several categories of tasks.

Processes that comply with the standard and are documented

Processes that comply with the standards and must be documented

Processes that do not comply with the standard and must be redesigned

Processes requires by the standard that are not currently in place.

For each requirement of the standard you will want to identify the status of the

current system. The ISO 9001:2000 Steering Team will use this information as they

assign responsibility for development of a procedure.

3.1 The ISO Steering Team MeetingA. Planning your ISO Steering Team meeting

1. Determine who should attend. Include top management. Answer these

questions:

Who will be able to decide which employees will be assigned tasks?

Will they know whether the employees workload will be able to

accommodate the assigned tasks?

Who is responsible for resources and can make resources available to the

ISO 9001:2000 project?

This group should continue meeting as the ISO 9001:2000 Steering

team

2. Create an Agenda, items to include:

Explain the Implementation Steps to the group using the Power point

presentation ISO 9001:2000 Implementation

Use the meeting handout in Appendix B


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Assign the tasks to individuals or teams (Use tables from Appendix B)Review the responsibilities to make sure that they are well dispersed, not

assigned heavily to one group or one individual

For each team identify a team leader. It works very well to have amember of the ISO Steering team as a leader for each of the Task Group

teams. It provides good communication between the teams and the ISO

Steering Team throughout the project.

Determine resources required for completion of the task.

Will teams or individuals need assistance with other responsibilitiesduring the ISO 9001:2000 project?

What kind of technical guidance will be needed to allow these teamsor individuals to complete the tasks efficiently and effectively?

Assistance form the management representative Prepared material Special training

Assign dates to tasks (use table form Appendix B)

Stagger start dates according to resource available Determine which tasks you need to complete in the beginning to

allow others to build on, e.g.:

Management Responsibility. Complete the Quality Policy and QualityGoals as well as identifying key processes and their interrelation early

on in the project.

Estimate the amount of time needed to complete each task based onthe amount of resources available to the task.

3.2 Holding task Group Team MeetingThe team leader is responsible for scheduling the first team meeting according to

the plan on the Gantt chart.

1. An agenda is provided in Appendix C:

Discuss Responsibilities of the ISO 9001:2000 Steering Team and

Implementation steps using the PowerPoint presentation Implementation

of ISO 9001:2000

Use the Task Group Team Handout in Appendix C

Hand out the Quality System Procedure that the team will be responsible

for. ( If using the prepared procedures)


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Hand out the section of the Gap Analysis that applies to the team.Determine resources required for completion of the tasks.

Will teams or individuals need assistance with other responsibilitiesduring the ISO 9001:2000 project?

What kind of technical guidance will be needed to allow these teamsor individuals to complete the tasks efficiently and effectively?

Assistance from the management representative? Prepared materials? Special Training?

2. Assign dates to tasks from the Gap Analysis using the start and finish date on

the Gantt chart. The team leader should print copies of the section of the Gap

Analysis that are relevant to the team.

Explain to the team that the Procedure and your process must match. Some

of your processes (the way you do things) will need to be changed to meet

requirements of the standard, and parts of the procedure will need to be

edited to accurately describe what you do.

If you are not using the prepared procedures this team will be responsiblefor developing and documenting the new procedure for a section of the

standard.

List the requirements from the Gap Analysis Checklist that you are not

currently meeting. These will need to be evaluated to determine if you will

change your process to match the procedure, or alter your process to meet

the standard and edit the procedure.

List the requirements from the Gap Analysis Checklist that you are meeting.

Evaluate these against the procedure to see if edits are needed to the

Procedure, or if the process documented in the procedure will work better

for you.

Or if not using the prepared procedures, identify therequirements of the standard that you will need to address to

be incompliance.

Schedule next meeting. During the next meetings you will work on the tasks

that you have listed above.

Once the process has been determined the procedure will need to be

finalized and sent for approval by the ISO 9001:2000 Steering Team.

3. Discuss the Next agenda:


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Read The 9000 Store Procedure (Or for the team responsible for thequality manual read The 9000 Store Quality Manual and compare to

current processes.

If not using The 9000 Store procedures, outline a new process to meet the

requirements of the standard.

Assign tasks for implementing changes in your processes and editing

prepared procedure.

Set next agenda

Schedule next meeting


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Appendix AThe Project Plan

Project Plan: ISO 9001:2000

Project goals:_____________________________________

Start Date:_________________________________________Target Registration Date:______________________________

Responsibilities:Project Manager:________________________________________________

Management Representative:___________________________________________Top Management:____________________________________________ISO 9001:2000 Steering

Team___________________________________________________

Project timeline:

Step Schedule Completion Date

1. Project Manger

completes Online

Training 2. Conduct Gap Analysis 3. Hold ISO

Steering

Team Meeting 4. Introductory


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Appendix BISO 9001:2000 Planning Meeting

ISO Steering Team Meeting HandoutsAgenda:

1. Review the Implementation Steps

2. PowerPoint presentation Implementation of ISO 9001:2000

3. Assign individuals to teams for each task group. Determine resources requiredfor completion of the tasks.

Will teams or individuals need assistance with other responsibilities duringthe ISO 9001:2000 project?What kind of technical guidance will be needed to allow these teams orindividuals to complete the tasks efficiently and effectively? Assistance from the management representative? Prepared materials?

Special Training?

4. Assign dates to tasksStagger start dates according to resources available.Determine which tasks you need to complete in the beginning to allowothers to build on, for example: Management Responsibility and DocumentControl should start early in the project. Complete the Quality Policy andQuality Goals as well as identifying key processes and their interrelationearly on in the project.Estimate the amount of time needed to complete each task based on theamount of resources available to the task. Refer to the Gap Analysisresults to determine how much work each team has to complete.

5. Schedule employee training sessions using the Training Materials Package

All employees need training on the ISO 9001:2000 Standard. Providingthe training early on in the project makes everyone aware of the projectsand its goals.*Keep minutes of all of the ISO 9001:2000 Planning and Steering Teammeetings. This helps demonstrate top management involvement in thedevelopment of the ISO 9001:2000 Quality Management System. Recordattendees.


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Appendix BISO 9001:2000 Planning Meeting

Implementation Steps

1. The team of people assigned responsibility will use The 9000 Store

Procedures, Quality Manual and Forms as a foundation for the process toaddress the requirements of the standard. The team will use the task list toidentify what areas need changes to processes.

2. Each responsible team will evaluate the process presented in the procedure,determine if any changes are necessary for your organisation, and make editsto the procedure and forms.

3. The team will finalize the procedure and send it to the ISO 9001:2000Steering Team for review and approval.

4. The team will train employees that are affected by or have responsibility forthe procedure.

5. The employees will start following the documented process and maintainingrecords.

ISO 9001:2000 Steering Team Responsibilities

1. Identify team members for each procedure.

2. Assign target start date and completion date for each team.

3. Identify training needs for employees and schedule training sessions forISO 9001:2000

4. Meet on a regular basis to evaluate progress, answer questions for theteams and evaluate resource needs for the implementation.

5. Review and approve procedures as they are finalized.

6. Evaluate and choose a Registrar

Now undertake FIELD VISIT QU3.3-AS7/7 ISO

CERTIFICATION that you will find under the Section Assignment

at the end of this Learning Unit. Please remember to follow the

guidance note related to the Learning Journal and Portfolio of

Evidence


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Task Assignments

Task Group

Quality ManualDocument ControlControl of Quality RecordsManagement ResponsibilityCompetence, Awareness andTrainingInfrastructure

Planning of Product RealizationProcessesCustomer Related ProcessesDesign and DevelopmentPurchasingControl of Production and ServiceProvision

Team Members Team Leader


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Task Assignments

Task Group

Identification and TraceabilityCustomer Property

Preservation of Product

Control of Measuring andMonitoring Devices

Monitoring, Measuring and

Analysis of Customer Satisfaction

Internal AuditsMonitoring, Measuring andAnalysis of Product and

Realization Processes

Control of Nonconforming Product

Corrective Action and Preventive

Action

Team Members Team Leader


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Project Gantt Chart

(Change headings to the Months you expect your project to run- identify when each team will start and stop, shade th

Task group Month 1 Month2 Month3 Month4 Month5 Month6

Document Control

Control of Quality Records

Management Responsibility

Competence, Awareness and

Training

Infrastructure

Planning of Product Realization

Processes

Customer Related Processes

Design and Development

Purchasing

Control of Production and Service


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Task group Month 1 Month2 Month3 Month4 Month5 Month6

Preservation of Product

Control of Measuring and

Monitoring Devices


Analysis

of Customer Satisfaction

Internal Audits


Analysis


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Appendix BTask Team Meeting

Task Team MeetingAgenda:1. Review the Implementation Steps and Responsibilities of the ISO9001:2000 Steering Team. Use the PowerPoint presentation ISO 9001:2000

Implementation

2. Review procedure that the team will be responsible for.

3. Review the section of the Gap Analysis that applies to the team.

4. Determine resources required for completion of the tasks.Will the team need assistance with other responsibilities during the ISO9001:2000 project?What kind of technical guidance will be needed to allow the team tocomplete the tasks efficiently and effectively? Assistance from the management representative? Prepared materials? Special Training?

5. Assign dates to tasks from Gap Analysis using the start and finish date on theGantt chart.

6. Schedule next meeting.

7. Next agenda:1. Read The 9000 Store Procedure and compare to current processes.2. Assign tasks for implementing changes in your processes and editing preparedprocedure.

Implementation Steps

1. The team assigned responsibility for each procedure will use the The 9000Store Procedure as a foundation for the process to address the requirements ofthe standard. The team will use the task list to identify what areas need changes toprocesses.

2. Each responsible team will evaluate the process presented in the procedure,determine if any changes are necessary for your organisation, and make edits tothe procedure and forms.

3. The team will finalize the procedure and send it to the ISO 9001:2000Steering Team for review and approval.

4. The team will train employees that are affected by or have responsibility for the

procedure.

5. The employees will start following the documented process and maintainingrecords.


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Appendix BTask Team Meeting

ISO 9001:2000 Steering Team Responsibilities

1. Identify team members for each procedure.

2. Assign target start date and completion date for each team.

3. Identify training needs for employees and schedule training sessions:Employee Introduction to ISO 9001:2000 using the Training MaterialsPackageInternal Auditor Training using the Internal Auditor Training MaterialsPackage

4. Meet on a regular basis to evaluate progress, answer questions for the teamsand evaluate resource needs for the implementation.

5. Review and approve procedures as they are finalized.


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4 LIST OF ASSIGNMENTSAssignment Title Estimated

Learning

time

QU 3-3 AS 1/7 LEARNING EXERCISE BENEFITS OF ISO

CERTIFICATION

15

QU 3-3. AS 2/7 LEARNING EXERCISE VISION ANDMISSION

15

QU 3-3. AS 3/7 LEARNING EXERCISE ORGANISATIONAL

CHART30

QU 3-3. AS 4/7 LEARNING ASSIGNEMENT QMS 30

QU 3-3. AS 5/7 LEARNING EXERCISE QUALITY MANUALAND PROCEDURE BOOK

30

QU3-3. AS 6/7 LEARNING EXERCISE EXAMINATIONMARKS FOR DIPLOMA

30

QU 3-3 AS 7/7 FIELD TRIP ISO CERTIFICATION 240


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QU 3-3. AS 1/7 LEARNING EXERCISE BENEFITS OF ISO

CERTIFICATION

ESTIMATED LEARNING TIME: 15 MINUTES

Learning objective: Understanding the advantages for organisations of a

good working quality management system and certification in ISO 9001.

What does ISO 9001 certification mean to an organisation?

Think of advantages of certification. Write down at least five advantages.

Can you think of a disadvantage too?

Notes

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

In class discussion about the following questions.

What can you do yourself and what do you have to board out? When do you need an advisor? What is an auditor?


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QU 3-3. AS 2/7 LEARNING EXERCISE VISION AND MISSION


Your teacher will hand out to you the mission and vision of your school. Discuss in

groups whether or not you recognize the definitions. Can you tell the difference

between mission and vision just by reading them? Explain.

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

Do you recognize the vision and mission of your school in your day to day

schoolwork?

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

Find on the internet or library the vision and mission of several companies. Compare

them and write down the similarities and differences.

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................


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QU 3-3. AS 3/7 LEARNING EXERCISE ORGANISATIONALCHART


Make in groups the organisational chart of your school and of another

company. Prepare on Flip over. Present in class.

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................


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QU 3-3. AS 4/7 LEARNING EXERCISE QMS


Assignment: QMS

After going through the Learning Units 3.1 to know you have learned many

principles, tools, insights of Quality. At the beginning of this LU you have read

chapter 4.1 of The Standard interpretation. Now reading the Requirement above:

could give your own explanation of this requirement?

Discuss this requirement in a group. Write down your findings in a joint report.

Make sure you addressed all the above requirements. Use the PP-P sheet of your

teacher or the sheet in your book ( its the same).

Make sure you reflect on the following concepts:

QMS

Organisation

Quality

Requirement.

Assignment Result: 2 A4 report of the meaning of these requirements. You can use

the school or an other company of interest as an example or case.

Tip Use the Deming circle: Plan - Do Check - Act

Notes

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................


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QU 3-3. AS 5/7 LEARNING ASSIGNMENT QUALITY MANUALAND PROCEDURE BOOK


Learning Exercise

Your teacher will hand out the Quality Manual and Procedure book of your school

and work replacement organisations. Work in groups. Explore the QM and Procedure

book. Do you recognize the above requirements? Which do you find, which you

dont.

Write down on a flip over your group findings. Present this in class.

...............................................................................................................

...............................................................................................................

...............................................................................................................

...............................................................................................................

Could you explain why documentation is not part of The Process Approach

mentioned before?

...............................................................................................................

...............................................................................................................

...............................................................................................................

Which activities and products are within the scope of QM? This should be recordedin the QM.Any exclusion should be obtained recorded.Make a flowchart of the processes ( the sequence and interaction relation).


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QU 3-3. AS 6/7 LEARNING ASSIGNMENT EXAMINATIONMARKS FOR DIPLOMA


Assignment: registration of examination marks for diploma

After you have read chapter 4.1 General requirements for the QMS; ISO 9001, The

Standard Interpretation make the following assignment in a group of four. Make

sure you discuss this requirement properly and ask assistance of your teacher when

necessary.

Each semester you have to take per course a mid-term and final examination.

Besides these exams you make assignments. Your examination marks and

assignments marks together form your final mark. If this mark is equal or above the

passing standard, you have passed the course. Than you will receive an

examination note as evidence. All these notes together are proof you successfully

attend your education and will give you a diploma.

How do you think the registration is organised? Describe the registration process

from student assignment mark to passing the first year of your education ( you can

take your own first year as an example). Take one of your group members as an

example. Write down his name, the name of the education and the year he is

attending.

Try to answer the following questions when writing down the registration process.

Check

What happens to all the marks the student is receiving?

What s the role of the teacher in register the marks?

Which department of the school is concerned of student progress

registration?

How does a student keep track of his progress?

How can a student prove he has successfully attended the first year?

Which people are involved by registration form assignment tot diploma?

Which materials are needed?

Use the 4.1 General Requirements for QMS overall page (pp.18) to make sure you

meet requirements.

Discuss your group result in class and adjust if necessary. This assignment isportfolio material!


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QU 3-3 AS 7/7 LEARNING EXERCISE ISO CERTIFICATIONESTIMATED LEARNING TIME: 240

Preparation:

Firstly, prepare in groups an topic list you would like to explore during your

field trip.

Discuss in class the topic list: one group present its list. The other groups add

their topics. Prioritise the topics (in case of time pressure during the trip).

Assign two interviewers who will represent the class during the interview.

Assign reporters/note takers during the interview ( each group takes 1 cluster

of topics).

The reporters write the reports together with their group.

Exchange your group report with the other groups.

Put together one final report with all the discussed topics of the interview.

Put this report after it is signed by your teacher in your portfolio of evidence.

Use the example topic list below! This one is not complete but is meant as an

starter.

Suggested topics:

ISO and suppliers

ISO and processes

ISO and people (human resources0

ISO and customers

Process Approach in your company

Product realization process in your company

Measurement of quality

Suggested questions:

How come QMS is that important to a company, to your company?

What was the reason to start with QMS, with ISO?

What is the surplus value of QMS and ISO

On what point is the surplus value of QMS / ISO not a surplus value


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anymore?

What does quality means to you?

What would you do differently if you could do the implementation all

over again?

What is the financial benefit to the organisation?

How do the people in the organisation respond on the QMS?


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BIBLIOGRAPHY and WEBOGRAPHY

Beaumant, L., R. ISO 9001: the standard interpretation. The international standard

fot Quality Management Systems, Simply Quality, Middletown, 2000, third revision.

Bergenhenegouwen, L.,B. (2001). Change over to the new ISO 9000- series

(Overstappen op de nieuwe ISO 900-serie). KAM management, 3, Delft.

Claessen, J.,J.,H., Gobbels, M., W., Hortensius, D. (2003). Auditing. Kam-

management 4.

Dorr. D., C. (2006). Perform with processes.(Presteren met processen), Kluwer,

Deventer.

Gerritsen, R., Van den Berg, O., (2005). KAM- managment in practice (de

praktijk). Kluwer, Deventer.

Hoyle, D. (2007). ISO 9000 Quality systems handbook. Butterwirth-Heinemann.

http://www.entrepreneur.com

KAM management 5, ISO 9001 for SME , 2003, Delft.

McConnell, J. ( 1986). The seven tolls of TQC. Delaware books.

Ool, van, p.,h.,j.,m. (2001). Quality pocketbook. Elsevier.

Quality management systems, fundamentals and vocabulary. (2005) International

standard, Switzerland.

ReVelle, J.,B. (2004) Quality Essentials, a reference guide from A to Z. ASQ Quality

press, Milwaukee, Wisconsin.

Tague, N., R. (2005). Quality Toolbox. ASQ Quality press, Milwaukee, Wisconsin.

Van Dam, N.,H.,M., Marcus, J.,A. (2000). Organisation and Management, a practice

oriented apprach (een praktijkgerichte benadering), EPN, Houten.

Vries, de, H.,J. (2002). KAM-management 2, Procedures for ISO 9000:2000,Delft.

Learning Unit Qu 3.3_2008 v01

Documents

Transcript of Learning Unit Qu 3.3_2008 v01