iso 9001:2000 implementation demonstration software · iso 9001:2000 implementation demonstration...

olutionseneration

ISO 9001:2000 ImplementationDemonstration Software

Developed and produced bySolutions Generation Co. Limited and

Edinburgh Chamber of Commerce and Enterprise

You may distribute this product. Use "F5" to view contents.

www.iso90012000.co.uk

ISO 9001:2000

Implementation

Please contact Bien Consultants Limited

directly with any product or ISO 9001 queries,

or if you like to find out more about our services.

Bien Consultants Limited, Merriton House

8 Larch Road, Glasgow, G41 5DA, Scotland

Tel: ++44 (0) 141 427 9595

Mobile: ++44 (0) 7802 719 658

E-Mail: [email protected]

Web Site: zzwww.iso90012000.co.uk

Product Overview

© Solutions Generation Company Limited. All Rights Reserved

Introduction This demo shows the structure, features, contents and application of the ISO 9001:2000 product. Due to size limitations, only 5% of the product can be shown. Sample screens from the 11 product sections can be viewed from the home page. Navigational tools are explained in the User Guide.To view the full product contents press function key “F5”. These will convey the breadth and detail of the product materials which are sequenced to help you implement ISO 9001:2000 in easy stages. User Benefits

• describes ISO 9001:2000 clause requirements in simple terms and translates these into meaningful action plans with relevant references to key quality system documents.

• helps you quickly and easily develop a structured quality system to suit your needs • provides comprehensive quality manual, procedures, project plans, guides, flowcharts,

questionnaires and forms which can be quickly incorporated into your quality system • provides good value for money and reduces the need for external consultants • allows you develop your quality system at your own pace knowing you have help at hand. The product comes with free help line support from Solutions Generation’s consultants

Product Key features with Adobe Acrobat

• Product software platform is reliable, robust and stable to use. • Search facilities enable you to easily locate and cross-reference the information you need. • Index linking and navigation tools allow access to complete contents and sub topics. • You are able to quickly identify where you are in the application and view pages. • Menu and interactive features allow quick finger tip access to relevant details • Interactive hotlinks on screens take you to the next piece of information • Print function enables you to generate printed outputs you require

Product Realisation

Imp

rovem

en

t

Input OutputProcess

Responses

Needs

Feedback

CustomerProduct

Customer

Customer

1.0 Purpose1 Purpose of Software Organisations as a basis for establishing their quality management systems have for many years used the international ISO 9000 family of standards. The standards were revised and published 15 December 2000 by ISO (International Standardisation Organisation). The purpose of this software is to introduce you to the current ISO 9000 family of standards with emphasis on their features. It also presents an overview of the standards and illustrates how, collectively, they establish a basis for continual improvement and excellence for your organisation. Moreover, you will see through sample illustrations how the standards may be applied and utilised to your maximum benefit. 2 Aims of Software We have simple aims. This software has been developed to ensure that current, consistent and clear messages are made available to all users. This will facilitate their efforts towards the successful implementation of a quality management systems to meet the requirements of the ISO 9001:2000 standard. We aim to do this with maximum transparency and minimum effort. It also introduces ISO 9001:2000 and ISO 9004:2000 as a "consistent pair" of Quality Management System Standards.


3 Using this Software This software has been designed to help organisations introduce process management and develop their systems to meet the requirements of ISO 9001: 2000.

It will enable them to: - • access information relating to the requirements

of the new ISO 9000 2000 standards

• prepare your action plan for the implementation of a quality management system to address the new standard

Numerous sample documents, such as quality manual, procedures, process documents and forms are designed for your use with your needs in mind. These illustrate how the requirements may be implemented.

4 Who can benefit for this Software? This software has been specifically designed to give guidance to users intending to develop and implement their ISO 9001:2000 quality management system and who are in the process of implementing. Those new users looking at ISO 9001:2000 for the first time will find this software a helpful tool.


ISO90012000

1.0 Purpose

5 ISO 9001:2000 - contents To understand the requirements of ISO 9001:2000, this software explains the application and the ISO 9001:2000 standard, comprising of the following main sections: -

Section Overview 1 Purpose Presents aims and use of software. 2 ISO 9001:2000 Introduces its background and structure as well as a process approach. Explains

general and specific clause requirements and their application. Describes the Quality Principles - the rules or belief upon which ISO 9000:2000 is based.

3 Business Requirements

Develops your quality strategy. Explains the business process. Helps you to review and define your quality requirements.

4 Resources Helps you to build and prepare your project team and source a consultant. 5 Project Plan Explains issues relating to project planning. Provides sample project and

documentation plans that support requirements of ISO 9001:2000. 6 Staff

Development Develops quality awareness of staff. Raises training issues for ISO 9001:2000.Presents useful operational tools and techniques to support their work.

7 Implementation Helps you develop an effective process-based quality system using flow charts and measurement techniques that support ISO 9001:2000 requirements.

8 Auditing Explains need for audits. Introduces important techniques for planning and performing audits as well as raising and closing of audit reports.

9 Certification Provides insight to issues relating to preparation, assessment, common non conformances and successful certification and surveillance.

10 Continual Improvement

Illustrates how continual improvement of business process can be achieved in incremental and significant steps.

11 Materials Provides useful sample documents necessary for ISO 9001:2000 implementation. This includes manuals, procedures, process documents, forms, plans etc.


1.0 Purpose

1 Main Sections of ISO 9001:2000 and Requirements The structure of ISO 9001:2000 supports the continual improvement of a process-based quality management system and includes the following main sections:

- Quality Management System - Management Responsibility - Resource Management - Product Realisation - Measurement Analysis and Improvement

2 General Requirements - Quality Management System Your organisation needs to establish, document, implement and maintain a quality management system and continually improve its effectiveness. This includes: - • Identifying the processes and their interaction with each other • Ensuring that the required resources to produce the product and support processes are

available • Determining how process performance is monitored, controlled and improved. In addition to these, we identify all quality management system documents needed to ensure the effective planning, operation and management of your operating processes as well as methods for controlling quality management system documents including the quality manual, procedures and records.


2.2 ISO 9001:2000 – General Requirements

2.3 ISO 9001:2000 Clauses: Introduction


Introduction (1 of 2) This is a substantial section which deals with the understanding of the ISO 9001:2000 standard. Any set of standards needs to be clearly defined and understood otherwise implementation may become costly and ineffective. For users introducing a quality system for the first time, they may find that parts of this standard is couched in terms which they may find difficult to interpret and apply to their own situation. This section therefore seeks to remove such confusion and any resulting ambiguity, which may be experienced by such users.

Each clause of the standard is examined in some depth and good practical advice is given on how its requirements should be interpreted. This section also gives practical examples of how the standard could be applied. The eight main clauses of the standard are: Please note, numbers in this section follow the ISO 9001:2000 clause numbers.

Clause Title 1.0 Scope

2.0 Normative Reference

3.0 Terms and Definitions

4.0 Quality management system

5.0 Management Responsibility

6.0 Resource Management

7.0 Product Realisation

8.0 Measurement, analysis and improvement

4.2 Documentation Requirements 4.2.1 General (1 of 4) This clause describes the type of documents you must include in your quality management system. These are: - 1. documents covering quality policy and quality objectives 2. quality manual 3. quality procedures required by the ISO 9001:2000 standard 4. documents required for effective planning, operation

and control of the processes within your organisation

5. quality records required by the ISO 9001:2000 standard As the standard does not impose rules on the format, structure, type, number, details and delivery of quality management system documents, they can be designed to suit the requirements of your organisation. An organisation can therefore develop their own type and style of quality system documents, as long as they address the needs of the standard and reflect the way it effectively plans, operates and controls its processes.


Quality

System

Files

2.3 ISO 9001:2000 Cause: 4.0 Quality Management System

4.2 Documentation Requirements 4.2.1 General (2 of 4) Organisations need to produce six documented quality procedures. These may be in electronic or hard copy form. They should relate to: -

1. the control of documents, 2. internal audit, 3. control of non conforming product, 4. control of quality records, 5. corrective action and 6. preventive action.

Organisations are also required to produce a documented statement, how the business processes are planned, controlled and implemented. These documents may however be a series of flow charts, with references to detailed instructions, guides and forms. It is likely that most organisations, for operational, training and practical considerations, choose to provide easy-to-use descriptive documents.

Recommended Actions 1. Produce high level flow charts depicting key functions and interactions of the

company and its departments. 2. Cross-refer these key functions to documents that describe their processes in terms

of required resources, inputs, activities and outputs. For auditing purposes, it may also be useful to cross-refer these to clauses of the standard.

3. Decide which documents are required for incorporation in the quality system and produce a documentation plan. This plan may list flow charts, procedures, work instructions, guides and forms.


2.3 ISO 9001:2000 Cause: 4.0 Quality Management System

Flow Chart

See QI 18 work instruction

See OP 32 Operational Process

1 Introduction Understanding your business process is fundamental to establishing effective control of your product or service quality. Most people see an organisation as made up of separate departments and the people within those departments see themselves as forming part of a department team. This section examines the elements of the processes that make the business what it is and also demonstrates how products, materials and services flow within and across departments. These flows form an internal customer supply chain, which provide seamless links throughout the organisation all the way to the external customer. It looks at the functional and cross-functional nature of the processes that are necessary to produce the goods and services that the customer desires. It examines how the inputs and outputs from processes develop into an internal customer supply chain and the techniques for examining these transactions with a view to improving them. Finally it demonstrates how people have a major part to play in the effective operation of theseprocesses and the continuous effort to improve them.

The business process is necessary to produce quality products and services and embraces every function in the organisation such as, design, manufacturing, engineering, maintenance, sales, accounting, distribution and personnel. Every activity in an organisation has inputs and outputs. Normally some work is done to add value to the input thus creating the output and this is the Business Process. Where no value is added to input then the need for the activity should be questioned. Examples of business process outputs could include:

• paper (a report, an invoice, a design drawing, etc) • hardware (a tool, a part, an assembly, etc) • service (car repair, aircraft servicing, • television repair, travel booking, etc)


M.D.

Sales Production

StoresAdmin

Purchasing

3.2 Business Requirements – Business Process

1 Build Your Project Team (1 of 2) A project such as the implementation of a quality management system requires careful management and for most companies, this will mean the establishment of a quality managementcommittee or team. For those companies who have a large number of employees from which to make the choice of team members, this section will give you some guidance with regard to the criteria for selection. Most small companies however will find that they do not have much choice and in fact the management team almost selects itself. For these companies training and development of the relevant staff will be a key activity. This section deals with the skills required by those involved in the quality project to effectively discharge their responsibilities. These skills generally fall under the headings of:

• management skills • leadership skills

• team skills

• using quality teams

• conducting effective meetings,

Each of these topics is developed in this section.

S

K IL

L

S


4.1 Resources – Build Your Project Team

1 Produce Your Project Plan The project plan section introduces the user to typical project stages for the transition of their quality management system to ISO 9001:2000 certification. Refer to samle project plan.

This plan is presented in five stages, namely: -

• planning, • assessment, • development and training • Implementation and certification

In addition to this, important issues relating to planning are addressed, such as, project management, project time-scales, project stages, the success criteria and the effort required to achieve the deliverables. It also deals with the initial interactions with customers and how this opportunity should be used to gain their support and commitment. The subject of the culture change requirement for the organisation is dealt with in some depth as is the degree of commitment required from staff and management. Finally the structure of the whole project is considered together with the requirement for appropriate measures to be in place to determine if objectives have been achieved.

Your Project Plan


5.0 Project Plan

1 Develop Quality Awareness Those companies that are embarking on a formal approach to quality management for the first time will almost certainly find that their staff will require to be sold on the benefits of the process in order to gain their commitment. You should be aware that every single member of staff should be involved in this process. No one should feel that his or her contribution to quality is too small to be considered.

This section will guide you through the steps required to raise quality awareness throughout thewhole organisation with timing that matches events on the ground. This will include guidance on how to plan for this activity, how to educate management and staff and the effective use of quality teams. Guidance is also given on how to conduct the required workshops. The use and selection of internal trainers is examined and well as the results you might expect from this activity. Effective communications will be an essential part of spreading of the quality message and the remainder of this section deals with these issues.

QualityIdeas


6.1 Staff Development – Quality Awareness


Staff Training Workshop

1 Purpose (1 of 3) This section deals with the essential activity of staff training. It is unlikely that all members of staff will have the necessary skills and knowledge to handle the multiplicity of activities which will be required of them in the journey towards certification to ISO9001:2000. Key to the success of achieving and sustaining certification to the standard will be the effort to ensure that everyone has the skills required of them. This section looks at the assessment of training needs and the development of a training plan to deal with the likely shortfall which may exist. Effective training and the need for quality improvement are synonymous, and this should form a major part of your quality policy. At the start of the implementation process ask yourself the following questions:

• Who needs to be trained? • What type of training they require?

• To what level they need to be trained?

• When the training needs to take place?

• How the training should be carried out?

6.2 Staff Development – Train your team on ISO 9001:2000

1 Introduction This section deals with the practical issues of applying the quality standards through an implementation process. It deals with the various stages of implementing the ISO 9001:2000 project plan

during which you can:

• assess your current position

• review your current practices

• identify your strengths and weaknesses

It then demonstrates how to flowchart your processes and explains how this will help you to develop appropriate procedures and correct any deficiencies in current practices. It examines the process for creating procedures, conducting a gap analysis to identify areas for improvement and using failure mode and effect analysis to prioritise those areas for action. The role of the customer in the process is examined and customer satisfaction is placed high on the agenda together with measures of performance, which will ensure that standards are maintained. The section concludes with useful guidance on document control.


Flow Chart

7.1 Implementation– Assessment

1 Introduction Producing flowcharts of critical processes will allow you to identify and agree the events, activities, stages and decisions that affect the quality your products and services. This process also allows you to review your current work practices and consider how these may be revised to improve quality and performance. 2 Purpose of Flowcharts A person may need to rely on one of several methods to develop an understanding of how a process performs. This may be a verbal instruction, demonstration or written document. The difficulties with these may be that the attention span or recall of the person may be limiting or the written documents provided are too technical or too brief for the person to develop a good understanding. In our experiences developing your staff effectively in their understanding of working methods and procedures is best achieved through the use of flowcharting. Producing flow charts help staff to quickly describe and agree their existing processes as they currently exist, identify their shortcomings and highlight areas for improvement.

3 Benefits

Generating a flowchart helps staff build a shared picture of the steps in a process. It can clarify what work needs to be done and by whom as well as expose obvious problems such as delayed actions and missing, excessive or inappropriate actions. This also allows the person to explain the current state of the process as compared with the preferred methods of working. Once developed, the flowchart can be used as an effective tool to quickly explain the existing or new processes to established staff or new employees.


Flow Chart

7.2 Implementation – Flowcharting

1 Introduction There is one good reason for measuring performance; what gets measured gets done. Measurement plays a key role in quality and productivity improvement because it:

• tells you if customer requirements have been met • allows sensible objectives to be set • provides standards for establishing comparisons • provides visibility and a scoreboard for people to

monitor their own performance • highlights quality problems and determines which

areas require priority attention • gives an indication of the costs of poor quality • justifies the use of resources • monitors progress in your ISO 9000 programme

and quality improvement

2 Designing A Performance Measurement System When you implement your performance measurement system you should consider the following points: • measure what the customer perceives to be important • relate your process performance to customer needs • determine appropriate measures for different parts of the organisation • compare the value of a measure with the cost of producing it • measure all critical parts of the process • start with simple measures and progress to more complex ones • distinguish between measures for different purposes • measure only the core activities and question the

accuracy and timeliness of measures


Select

Measures

7.4 Implementation – Performance Measurement

1 Develop Quality Manual and Procedures Your quality procedures may describe a sequence of tasks that implement the policies of the quality manual. They specify how quality is controlled, define what activities need to be performed and what checks or verifications are carried out. The quality procedures may also cross reference other documents which describe in more detail the specific tasks to be carried out or standards to be met. These may include:

• Process documents, such as flow charts • work instructions • operating guides • codes of practice • regulations and • quality records

The type of documents used in companies varies significantly. Careful thought should be given to the type of documents that would be effective and avoid unnecessary duplication and bureaucracy.

To determine which procedural and process documents to write, you need to consider the needs of your business as well as the requirements of the ISO 9001:2000 standard. Refer to section 2.3 for further details on documentation requirements. It is important to identify which process documents are necessary to support operational performance as well as your business objectives.


7.5 Implementation – Quality System Development

ISO 9001Standard

ISO

ProcessDocuments

QualityManual

1 Purpose 1 Why Audit Auditing is a central function of achieving and maintaining an effective quality management system. It is an essential element in ensuring that procedures and work instructions are being followed and consistent standards are being maintained. Auditing requires auditors and those auditors require the skills necessary to carry out their task effectively. Audits are required to ensure that your quality system policies, procedures and processes comply with the requirements of the standard and are effectively implemented. For example:-

• your documented quality manual and procedures are in place and adhered to • there is objective evidence that procedures and controls are operating • records are being completed satisfactorily • you are complying with your own documented system • personnel at all levels understand their responsibilities and are committed to quality • non-conformance with procedures, controls and records is

identified, recorded and the necessary corrective action taken • company suppliers comply with your quality system requirements • you are complying with the customer and regulatory requirements • training needs for company personnel are identified • managers are advised of all non-conformance within their department • there is a process for correcting non-conformities identified during the audit

Having established a quality system to ISO 9001:2000 it is essential to maintain its effectiveness. Internal audits are a mandatory part of standard, which provides the mechanism for doing this. The audits are designed to highlight training needs and system non-conformance and provide an opportunity for system improvement. They should cover every component of your quality system such as policy, training, operating procedures and documentation.


8.0 Auditing

1 Introduction Establishing an effective quality system, which suits your requirements, is one thing, but achieving certification is something else. This section offers advice, based upon our experience on the most common deficiencies found by certification bodies. This advice, together with good auditing techniques, should help you avoid most of the common pitfalls. We also explain the stages in the certification process which includes advice on the formal assessment and how to deal with any non-conformances found. 2 Purpose of Certification Your ISO 9000 certificate tells customers and suppliers that yours is a quality company. It demonstrates that you have the capability to deliver quality products and services, and that your business is committed to improving its quality system continuously for the benefit of its customers. Your purpose of achieving ISO9000 may be to generate:

• External confidence in your -

company products and services quality systems commitment to customers and

• Internal commitment to –

quality management systems business performance and profits


9.0 Certification


1 Introduction

This section introduces important strategies for organisations to adopt for cintinual improvement of their processes. There are two basic ways in which organisational improvement can be achieved and sustained. 2 Stepped Improvements

This involves gradual process improvements within the operation of the quality management system or the business. These improvements are usually the result of work groups or improvement teams. To ensure that they are effective in their assigned tasks, management should provide their staff with sufficient resources, adequate methods and training. 3 Marked Improvements

This requires marked improvements that usually result from the re-engineering of critical processes out-with the normal business operations. Such changes to the operating processes can have dramatic effects, not only to the operations but staff work practices. Project of this type can be managed over 5 distinct phases: - Example of Improvement Plan over 4 Phases

Phase 1 Determine Goals and Strategies for improvement Phase 2 Determine Current State - Review of existing processes and performance Phase 3 Analysis: Future State (Target) - planned improvement Phase 4 Implementation of planned actions and confirmation of improvements Phase 5 Continuous Improvement Culture /Establish next project

Details of these phases are dealt with later.

10.0 Continual Improvement

olutions eneration

Thank you

www.iso90012000.co.uk

11 Material Content

© Solutions Generation Limited Page 1 of 3

Quality System and Support Documents:

1.0 Quality Manual 1 QM - Quality Manual

2.0 Quality Procedures 1 QP 01 - Control of Non Conformance 4 QP 04 - Document Change Control 2 QP 02 - Control of Quality Records 5 QP 05 - Internal Auditing 3 QP 03 - Corrective and Preventive Action

3.0 Operational Processes

1 OP 01 - Calibration of Measuring Equipment 13 OP 13 - Maintenance of Plant and Equipment 2 OP 02 - Internal Communication 14 OP 14 - Order Review 3 OP 03 - Computer Back - Up 15 OP 15 - Preservation of Product 4 OP 04 - Control of External Documents 16 OP 16 - Performance Reporting 5 OP 05 - Customer Focus 17 OP 17 - Plant Infrastructure & Work Environment 6 OP 06 - Design Control 18 OP 18 - Supplier Assessment and Approval 7 OP 07 - Stock Control 19 OP 19 - Planning Product Realisation 8 OP 08 - Stock Inspections 20 OP 20 - Purchase Order Processing 9 OP 09 - Inspection of Incoming Material 21 OP 21 - Quality Management Review 10 OP 10 - Training 22 OP 22 - Review of Quality Objectives 11 OP 11 - Inspection of Product 23 OP 23 - Quality Planning 12 OP 12 - Job Descriptions 24 OP 24 - Application of Statistical Techniques

11 Material Content



4.0 Flowcharts 1 Administration 4 Goods Receiving Process 2 Document Control 5 Order Review 3 Design Process 6 Quality Planning

5.0 Useful Guides

1 Cost of Quality and Case Studies 8 Quality Policy 2 Infrastructure and Environment 9 Requirements for procedures & records 3 Internal Communications 10 Statistical Techniques 4 ISO 9001 Structures 11 Management Skills Questionnaire 5 Lost Profit & Case Studies 12 Team Building Skills 6 Performance Reporting 13 Staff Training Needs Analysis 7 Quality Objectives

6.0 Plans 1 Calibration Schedule 7 Management Review Agenda 2 ISO 9001:2000 Project Plan 8 Production Meeting Agenda 3 ISO 9001: Documentation Plan 9 Sales Review Meeting Agenda 4 Product Realisation Plan 10 Staff Training Plan and Matrix 5 Internal Audits Plan 11 Quality Plan 6 Equipment Maintenance Schedule

11 Material Content



7.0 Questionnaires 1 Customer Satisfaction Questionnaire 3 Supplier Assessment Questionnaire 2 ISO 9001 Assessment Questionnaire

8.0 Records 1 Calibration - Test Record 9 Corrective Action - Form 2 Training - Staff Record 10 Purchasing - Order Form 3 Suppliers - Approved List 11 Document Control - Master Register for Controlled Documents 4 Quality Records - Register 12 Document Control - Master Register for External Documents 5 Stock Control - Inspection Form 13 Document Control - Change Note Register for Controlled Documents 6 Audits - Internal Audit Report 14 Document Control - Change Note Form for Controlled Documents 7 Audits - Internal Audit Checklist 8 Corrective Action - Register

9.0 General 1 End User Licence Agreement 3 FAQs - Frequently Asked Questions 2 User guide - Navigational aids

Organisation Limited Procedure No: QP 03 Issue: 01 Title: Corrective and Preventive Action Page: 1 of 3

© Solutions Generation Limited

ManageConsult

1.0 Overall Process Flowchart This overall process for this process is shown across.

2.0 Detailed Process Flowchart: Process: Control of Non Conformance

Persons Responsible Process Activity for Control of Quality Records Staff Operations

Manager Quality

Manager 1 Raise a Corrective Action Form (CAF) with details of non conformance e.g. (description, location etc) ( Inputs - Non conformance report. Ref - Corrective Action Form QF 01. Output - CAF completed with non–conformance details )

2 Non conformance reviewed and corrective actions agreed. ( Inputs - Raised CAF. Ref - Corrective Action Form. Outputs - CAF completed with defined actions ).

3 CAF approved and CAF number given. CAF register updated. CAF assigned for action? (Inputs - CAF for approval. Ref – CAF & CAF Register. Outputs - Approved CAF. Updated CAF register.)

4 Remove CAF. Dispose of non-conformance as required. ( Inputs - Verbal instruction from quality manager. Ref: 3.5. Outputs - Non-conformance disposed off. CAF destroyed)

5 Implement corrective and preventive actions. Update CAF with progress and results. ( Inputs - Approved CAF with actions. Ref - CAF-QF 01. Outputs - Actions implemented and CAF updated.

6 Confirm that actions taken are effective. Close off actions on CAF. Update CAF register. (Inputs - CAF with results of actions taken. Ref: - CAF. Outputs: CAF closed off. CAF register completed.

Consultation Responsibility DecisionActivity: R C Key: -

Raise corrective action form (CAF)

CAF reviewed and assigned to personnel

Actions confirmed and CAF closed

Agreed actions implemented

yes

no

R

C R

R

R CR C

R R

Cost of Quality and Case Studies

3 of 18

Scale of the problem? In manufacturing companies, the costs of conformance and non-conformance can be as high as 20-25% of turnover. This can rise to 25-40% of operating costs in service companies. It should be remembered that administrative and support functions in your company are in effect mini “service” companies, and should therefore be included in your cost of quality calculations. With a cost of quality of between 20% and 40% of turnover, it is easy to see how a quality improvement programme could make a substantial contribution to a company’s profits. Even a modest improvement in quality could contribute substantially to the bottom line. Reducing the Quality Related Costs

When the quality costs are determined these will be investigated and reduced through appropriate investigative and corrective actions. The diagram across generally depicts how the total quality related costs diminish as quality awareness and improvements increase over time with contributions from the appraisal and preventive activities. The total quality costs vary between companies, as do the contributions from appraisal, prevention and failure costs. The rate at which quality costs fall is dependent upon the efforts and success of management and staff to resolve the quality problems.

The efforts required to identify and reduce the failure costs should be estimated so that the likely attainable "benefits" can be assessed and it can be shown that these outweigh the ‘cost’ of implementing any changes

Quality Awareness and Improvement through Corrective and Preventive Actions

Quality Related Costs

Total Quality Related Costs

Failure

Appraisal

Prevention

Structure of ISO 9001:2000

1 of 2

ISO 9001:2000 Clauses

1 Scope 5.4.1 Quality objectives 1.1 General 5.4.2 Quality management system planning 1.2 Application 5.5 Responsibility, authority and communication - (title only) 2 Normative references 5.5.1 Responsibility and authority 3 Terms and definitions 5.5.2 Management representative 4 Quality management system - (title only) 5.5.3 Internal communication 4.1 General requirements 5.6 Management review - (title only) 4.2 Documentation requirements - (title only) 5.6.1 General 4.2.1 General 5.6.2 Review input 4.2.2 Quality Manual 5.6.3 Review output 4.2.3 Control of documents 6 Resource management - (title only) 4.2.4 Control of quality records 6.1 Provision of resources 5 Management responsibility - (title only) 6.2.1 General 5.1 Management commitment 6.2.2 Competence, awareness and training 5.2 Customer focus 6.3 Infrastructure 5.3 Quality policy 6.4 Work environment 5.4 Planning - (title only)

Gap Analysis : ISO9001:2000 Assessment Questionnaire

Clauses and Checklist QMS

ReferenceNotes and Actions

4.0 Quality Management System 4.1 General Requirement

- Has the organisation established, implemented and maintained a Quality Management System? - Does the organization continually improve the effectiveness of the QMS?

a) Have processes needed for the QMS been identified and applied throughout the organisation? b) Have the interaction and sequence of processes been determined? c) Have the criteria and methods necessary for the effective operation and control of these processes been

determined? d) Are resources and information needed to support the operation and monitoring of these processes available? e) Are the QMS processes measured, monitored and analysed to achieve planned results? f) Are actions implemented necessary to achieve planned results and continual improvement of these processes?

- Are QMS processes managed in accordance with the requirementsof ISO9000:2000? - Are any outsourced processes identified for control?

4.2 Documentation Requirements 4.2.1 General Requirement

- Does the QMS documentation include the following:

a) Statements of quality policy and quality objectives? b) Quality manual? c) Documented quality procedures required by ISO9001:2000? d) Documents needed for the effective planning, operation and control of QMS processes? e) Quality records required by ISO 9001:2000?

Note 1: Are all QMS documented procedures established, implemented and maintained? Note 2: Does the format and extent of the QMS reflect the organization, its processes and competence of personnel? 4.2.2 Quality Manual

- Does the QMS quality manual include the following:

a) Scope of the QMS as well as any details of and justifications for exclusions? b) Specified documented procedures or reference to them? c) Description of the interaction between the processes of the QMS?

Assessor’s Notes:

Supplier Records

2 of 3

Sample of Approved Supplier List

Supplier Rating Register Grade Approval Status Supplier Name Contact Name Before Now By Date CAF

Assessment Method(s) Reason

ABC Supplier Limited

C. Hanlon, Operations Manager 1 4 WB 24-Jan 1 OK

Roll Shutters J Edmunds, Quality Manager N/a 1 WB 24-Jan 8 2, 3, 4 Do not use, too costly

and unreliable Metal Fabrication Products Ltd

T Hughes, Technical Director N/a 1 WB 24-Jan 1, 2 OK

Approved by: - W. Bienkowski Date 26/01/01

Note: CAF is a corrective action form that is raised to address identified problems.

USER GUIDE 1 System Requirements for Windows

• An Intel i486 or Pentium processor-based personal computer (Pentium recommended) • Microsoft Windows 95, Windows 98, or Windows NT 4.0 with Service Pack 3 or later • 16 MB RAM for on Windows 95 and Windows 98, 24 MB RAM for Acrobat on Windows NT (32 MB recommended) • A hard drive with at least 75 MB of available space • Adobe Acrobat 4.0 Reader or later

2 To display useful navigation tools

F5 To hide and show the Bookmarks (contents listing) F8 To hide and show the Command Bar F6 To hide and show the Thumbnails F9 To hide and show the Tool Bar F7 To hide and show the Menu Bar

3 To alter page view

Full Screen depress Ctrl and L Fit in Window depress Ctrl and 0 Zoom In depress Ctrl and + Actual Size depress Ctrl and 1 Zoom Out depress Ctrl and - Fit Width depress Ctrl and 2 Zoom To... depress Ctrl and M Fit Visible depress Ctrl and 3

4 Suggested Viewing

• To obtain full view of sections, use the "full screen" option (Ctrl and L). To view menu keys press "Esc" key on keyboard.• To read support documents in portrait layout, use the "fit to window" option and the zoom control (Ctrl + or -) and arrow

keys to scroll viewed documents as necessary. 5 Using Hyper-linked text

• Throughout the product, text highlighted in light blue provides a useful hyperlink to supporting information.

Frequently Asked Questions

© Solutions Generation Limited

Introduction

This section provides the users with numerous and frequently asked questions with answers and is intended to develop a better understanding of the background and requirements of the ISO 9001:2000 standard. This list of Frequently Asked Questions (FAQs) is structured in a logical sequence. Input has been obtained from consultants and practitioners of the ISO 9000 standards. This section is regularly reviewed and updated with new or amended questions to ensure that it remains accurate and helpful. The intention is to provide users with a useful point of reference for additional information. These questions have been grouped into six main categories, namely:

1. Background 2. Main features of the ISO 9001:2000 Standard 3. Benefits and Implications 4. Certification 5. Impact

1.0 The background 1.1 Why is the purpose of continually revising the ISO standards?

To ensure that the standards remain current and address the needs of organisations world-wide, to do this, they are usually considered for review and revision every five years. The revision prior to this was in 1994. The emergence of the ISO 9000:2000 series of standards provide users with an exciting opportunity to add value to their business and continually improve the performance of their organisation's quality management system by focusing management activities on the key business processes. During the development stages of this revision, surveys were conducted to take account of the experiences and the needs of users. This confirmed that users favoured a closer alignment of quality management systems with their organisational needs. It also identified the growing need to reduce the wide range of standards in favour of a structured, Coherent process driven approach. Other main features of the ISO9001:2000 standards is the need to place more emphasis on measuring customer satisfaction, establishing the effectiveness of the quality management system and the adoption of a set of generic quality management principles.


How to purchase

Methods Credit/Debit Card Purchase Order Bank Transfer

WebsiteVisit our website and submit your order and

credit card details

Telephone or e-mail

You may provide your order and credit card

details directly by e-mail or phone.

When you send us your purchase order details we

will forward you a pro-forma invoice for payment.

Pay into BCL account: Bank: Clydesdale plcSort Code: 82 64 17A/c No: 70131391

Product Despatch On receipt of confirmed payment, we will quickly despatch your product or e-mail

you a URL that enables product download.

Contact Details You may contact us using the following: -

Questions Should you have any questions about the product or our purchasing arrangements, please feel free to contacts us.

Telephone: ++ 44 (0) 141 427 9595 Mobile: ++44 (0) 7802 719 658: E-Mail: [email protected] Web site: www.iso90012000.co.uk

http://www.iso90012000.co.uk