Learning Unit QU-3.

3
Module 3, first semester Developing approaches to quality
LEAR UNIT 1

Designing QMS ISO 9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 by ASPI The Association of Polytechnics in Indonesia financed by the Government of the Netherlands. Excerpts of this publication may be reproduced without authorisation, on condition that the source is mentioned. Any request for adaptation or translation of the material other than Indonesian Bahasa, must be addressed to the International Training Centre of the ILO, Viale Maestri del Lavoro, 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 Centre of the ILO, which are in conformity with the United Nations practice, and the presentation of material therein, do not imply the expression of any opinion whatsoever on the part of the Centre concerning the legal status of any country, area or territory of its authorities, or concerning the delimitation of its frontiers. The responsibility for opinions expressed in signed articles, studies and other contributions 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 not imply their endorsement by the International Labour Office, and any failure to mention 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: delta@itcilo.org

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

LEARNING UNIT QU-3.3 Designing QMS Specific learning objectives 1. Introduction 2. Designing QMS ISO 9001:2000 2.1. 2.2. 2.3. 2.4. Historical background of ISO Making the Decision: ISO 9001:2000 Registration Documentation requirements Implementation steps

3. Project Plan 3.1. 3.2. ,The ISO Steering Team Meeting Holding Task Group Team Meeting

4. List of Assignment Annexes Bibliography and Webography

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Introduction
In 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, direction and 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!

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Designing QMS ISO 9001:2000

2.1 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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 many organisations 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 12th century 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
LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 assurance also 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 QS9000, 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
LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

(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 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

Vision and mission of an organisation Definitions: - a vision statement defines what the organisation wants to be where the organisation wants to be in the near future (1 3 years) and what the organisation carries out. - a mission statement defines what an organisation is, why it exists, its reason for 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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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

MISSION 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

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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

10

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Director

Administration

UNIT 1

UNIT 2

UNIT 3

Or

BOARD

DIRECTOR

UNIT

UNIT

UNIT

TEAM

TEAM

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 subworkers 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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

11

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Lateral - relationship between different departments on the same hierarchical level. Staff - relationship between a managerial assistant and other areas. The assistant 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. The specialist 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 or democratic) It very quickly becomes out-of-date, especially in large organisationals which change 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 a change 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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

12

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 change is 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 change is 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 under the 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.)

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

13

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 from improved 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 satisfaction increases 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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

14

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 small as well as medium and 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 transmission and 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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

15

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 with the 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
LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

16

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 NOTE is 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).

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

17

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

NOTE 1 Where the term procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The 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.
LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

18

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

A QM should contain: Introduction Purpose (of the manual) Scope (of the manual) Applicability (of the manual) Definitions ( of terms used inn the manual) Business overview Nature of business/organisation its scope of activity, its products and services, The organisations interested parties 9customers, employees, regulations, shareholders, suppliers, owners), The context diagram showing the organisation relative to its external environment, Vision an values Mission Organisation Function description, Organisation chart, Locations with scope of activity Business processes The system model showing the key business processes and how they are interconnected System performance indicators and method of measurement Mission management process description Resource management process description Demand creation process description Demand fulfilment process description Function matrix (relationship of functions to processes) Location matrix (relationship of locations to processes). Now undertake Assignment QU3.3-AS5/7 QUALITY MANUAL 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 Read handout, QUALITY MANUAL 1, AND 2 that you will find under the Section handouts for Semester 3

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

19

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

20

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 to follow the guidance note related to the Learning Journal and Portfolio of Evidence In 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 steps

1 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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

21

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

22

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Project Plan

A. Determine the project goals (Use the project Plan Template in Appendix 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 may be 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 the date? 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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

23

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

currently have in place for your quality system, and how many resources you have available for the project.

B. Identify Project Responsibilities It is important to determine who will be leading this project. Are you the person leading the charge? If so, you would be the project manager. You do not need to identify the management representative at this point. You will need to clarify who makes up Top Management. The standard has requirements to be fulfilled by Top management, and the sooner they are involved in this project, the better. Who is your project manager? Who makes up Top Management at your organisation? Who should be on the ISO 9001:2000 Steering Team? (This team will play an important role in planning, coordinating and providing resources for the ISO 9001:2000 project. See Appendix B for team responsibilities).

C. Begin to fill in the Project Timeline 1 When will you conduct your Gap Analysis and how long will it take to complete? Gap Analysis can typically take anywhere from 2 days to 5 days to perform. It will depend on the size of your organisation, the number of auditors, the state of you current quality system and the experience of your auditors. 2 Planning meetings to assign Task Teams This will take one or two meetings. He project manager and top management should be involved. 3 Target a date for introductory training for all employees. You will want your employees to be aware of the project, what will need to be done, who will be involved, and why you are implementing ISO 9001:2000. Choose a date tat is after the meeting discussed above.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

24

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

That way you can decide if some people that will be involved in the project 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 2 that 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.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

25

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 Meeting

A. 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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

26

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 a member 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 responsibilities during the ISO 9001:2000 project? What kind of technical guidance will be needed to allow these teams or 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 Quality Goals 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 on the amount of resources available to the task.

3.2 Holding task Group Team Meeting

The 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)
LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

27

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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 responsibilities during the ISO 9001:2000 project? What kind of technical guidance will be needed to allow these teams or 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 responsible for 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 the requirements 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:

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

28

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Read The 9000 Store Procedure (Or for the team responsible for the quality 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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

29

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Appendix A The 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 Steering Team Meeting 4. Introductory ISO

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

30

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Appendix B ISO 9001:2000 Planning Meeting ISO Steering Team Meeting Handouts Agenda: 1. Review the Implementation Steps 2. PowerPoint presentation Implementation of ISO 9001:2000 3. Assign individuals to teams for each task group. Determine resources required for completion of the tasks. Will teams or individuals need assistance with other responsibilities during the ISO 9001:2000 project? What kind of technical guidance will be needed to allow these teams or individuals to complete the tasks efficiently and effectively? Assistance from the management representative? Prepared materials? Special Training? 4. Assign dates to tasks Stagger start dates according to resources available. Determine which tasks you need to complete in the beginning to allow others to build on, for example: Management Responsibility and Document Control should start early in the project. Complete the Quality Policy and Quality Goals 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 on the amount of resources available to the task. Refer to the Gap Analysis results 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. Providing the training early on in the project makes everyone aware of the projects and its goals. *Keep minutes of all of the ISO 9001:2000 Planning and Steering Team meetings. This helps demonstrate top management involvement in the development of the ISO 9001:2000 Quality Management System. Record attendees.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

31

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Implementation Steps

Appendix B ISO 9001:2000 Planning Meeting

1. The team of people assigned responsibility will use The 9000 Store Procedures, Quality Manual and Forms as a foundation for the process to address the requirements of the standard. The team will use the task list to identify 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 edits to the procedure and forms. 3. The team will finalize the procedure and send it to the ISO 9001:2000 Steering 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 maintaining records. 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 for ISO 9001:2000 4. Meet on a regular basis to evaluate progress, answer questions for the teams 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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

32

Task Assignments Task Group Team Members Team Leader

Quality Manual 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 Provision

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Task Assignments Task Group Team Members Team Leader

Identification and Traceability Customer Property Preservation of Product Control of Measuring and Monitoring Devices Monitoring, Measuring and Analysis of Customer Satisfaction Internal Audits Monitoring, Measuring and Analysis of Product and Realization Processes Control of Nonconforming Product Corrective Action and Preventive Action

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Project Gantt Chart (Change headings to the Months you expect your project to run- identify when each team will start and stop, shade the time that each team will run) Task group 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 Month 1 Month2 Month3 Month4 Month5 Month6 Month7 Month8 Month9

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

Task group Preservation of Product Control of Measuring and Monitoring Devices Monitoring, Analysis of Customer Satisfaction Internal Audits Monitoring, Analysis Measuring and Measuring and

Month 1

Month2

Month3

Month4

Month5

Month6

Month7

Month8

Month9

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

Task Team Meeting Agenda: 1. Review the Implementation Steps and Responsibilities of the ISO 9001:2000 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 ISO 9001:2000 project? What kind of technical guidance will be needed to allow the team to complete 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 the Gantt 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 prepared procedure. Implementation Steps

Appendix B Task Team Meeting

1. The team assigned responsibility for each procedure will use the The 9000 Store Procedure as a foundation for the process to address the requirements of the standard. The team will use the task list to identify 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 edits to the procedure and forms. 3. The team will finalize the procedure and send it to the ISO 9001:2000 Steering 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 maintaining records.

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

ISO 9001:2000 Steering Team Responsibilities 1. Identify team members for each procedure. 2. Assign target start date and completion date for each team.

Appendix B Task Team Meeting

3. Identify training needs for employees and schedule training sessions: Employee Introduction to ISO 9001:2000 using the Training Materials Package Internal Auditor Training using the Internal Auditor Training Materials Package 4. Meet on a regular basis to evaluate progress, answer questions for the teams and evaluate resource needs for the implementation. 5. Review and approve procedures as they are finalized.

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

LIST OF ASSIGNMENTS
Assignment Title Estimated Learning time 15

QU 3-3 AS 1/7

LEARNING EXERCISE BENEFITS OF ISO CERTIFICATION LEARNING MISSION EXERCISE VISION AND

QU 3-3. AS 2/7 QU 3-3. AS 3/7 QU 3-3. AS 4/7 QU 3-3. AS 5/7 QU3-3. AS 6/7 QU 3-3 AS 7/7

15 30 30 30 30 240

LEARNING EXERCISE ORGANISATIONAL CHART LEARNING ASSIGNEMENT QMS LEARNING EXERCISE QUALITY MANUAL AND PROCEDURE BOOK LEARNING EXERCISE MARKS FOR DIPLOMA EXAMINATION

FIELD TRIP ISO CERTIFICATION

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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?

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

QU 3-3. AS 2/7 LEARNING EXERCISE VISION AND MISSION ESTIMATED LEARNING TIME: 15 MINUTES

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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

QU 3-3. AS 3/7 LEARNING EXERCISE ORGANISATIONAL CHART ESTIMATED LEARNING TIME: 30 MINUTES

Make in groups the organisational chart of your school and of another company. Prepare on Flip over. Present in class. ............................................................................................................... ............................................................................................................... ............................................................................................................... ...............................................................................................................

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

QU 3-3. AS 4/7 LEARNING EXERCISE QMS ESTIMATED LEARNING TIME: 30 MINUTES

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

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

QU 3-3. AS 5/7 LEARNING ASSIGNMENT QUALITY MANUAL AND PROCEDURE BOOK ESTIMATED LEARNING TIME: 30 MINUTES

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 recorded in the QM. Any exclusion should be obtained recorded. Make a flowchart of the processes ( the sequence and interaction relation).

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

QU 3-3. AS 6/7 LEARNING ASSIGNMENT EXAMINATION MARKS FOR DIPLOMA ESTIMATED LEARNING TIME: 30 MINUTES

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 is portfolio material!

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

QU 3-3 AS 7/7 LEARNING EXERCISE ISO CERTIFICATION ESTIMATED 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
LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

10

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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?

LEARNING UNIT QU-3.3 DESIGNING QMS ISO

9001:2000

11

DEVELOPING APPROACHES TO QUALITY

STUDENTS MATERIALS

SEMESTER 3

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. Kammanagement 4. Dorr. D., C. (2006). Perform with processes.(Presteren met processen), Kluwer, Deventer. Gerritsen, R., Van den Berg, O., (2005). 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. www.the 9000store.com
LEARNING UNIT QU-3.3 DESIGNING QMS ISO

KAM- managment in practice (de

9001:2000

12