ISO 9001:2000 Clause Module Demonstration SoftwareISO 9001:2000 Clause Module Demonstration Software...

olutionsenerationISO 9001:2000 Clause Module

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ISO 9001:2000

Clause Requirements Module

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ISO 9001:2000 Clauses: Introduction

© Solutions Generation Company Limited. All Rights Reserved

1 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 clauses of thestandard are shown below. 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

Understanding ISO 9001:2000

1 Introduction (2 of 2) The cornerstone of quality management is the concept of the customer and supplier working together to satisfy each other’s needs. To achieve this, your organisation must have arrangements to ensure that all of its functions which affect quality are effectively controlled. This will inevitably lead to developing a quality management system. The ISO 9001:2000 standard provides a framework that is recognised throughout the world. It allows an organisation to organise its quality system such that consistency in materials, methods and equipment can be achieved. The International Standards Organisation has established a model that will allow a company to incorporate its activities within a quality system suited to its own operating structure and business needs. The ISO 9001:2000 standard requires that you demonstrate capability by:

• defining your quality system processes such that they satisfy the requirements of the ISO 9001:2000 standard and • showing that you conform to your documented quality system by:

maintaining appropriate records as well as conducting internal quality audits

The standard consists of four main sections which your organisation must address in order to demonstrate that its systems and processes are capable of meeting customer needs. Only sub-clauses within section seven of the standard may be excluded from the scope of your quality system. This is more fully explained under product realisation.

What is

ISO 9000?


ISO 9001:2000 Clauses: Introduction

ISO 9001:2000 Clause: 1.0 Scope

Content

1.0 Scope

1.1 General

1.2 Application


ISO 9001:2000 Clause: 1.0 Scope

1.1 General The scope of this standard includes many important requirements. These are primarily aimed at: • Increased management accountability • Evidence of a systematic approach to achieving customer satisfaction, • Measurement of the effectiveness of the quality management system as it is applied • Application of continual improvements to key processes and the prevention of non conformance. Demonstrating your organisation's ability to consistently provide conforming product that meets customer requirements is at the heart of the standard. There are however stringent requirements with regard to performance improvement through continual quality improvement processes and efforts to achieve customer satisfaction. Throughout this software product the term product is used. It should be noted that this also relates to services. Details of these and other necessary actions are explained later in this section.


ISO 90012000

CertificateScope…..

ISO 9001:2000 Clause: 2.0 Normative Reference

Normative reference For the implementation of this standard, this clause refers the user of the body of the ISO 9001:2000 standard document for information relating to its provisions, requirements, application, revision issue and controls. For clarification, users are encouraged to refer to the latest revision of the ISO 9000:2000, Quality management systems - fundamentals and vocabulary. Alternatively, for terms and definitions, you may look at our list of commonly used words.


ISO 9001

2000

ISO 9001:2000 Clause: 3.0 Terms and Definitions

Terms and definitions (1 of 1) The terms and conditions which apply to the ISO 9001:2000 standard are defined in document entitled "ISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary". This standard introduces useful vocabulary which is currently in common use and to reflect the terminology used in the supply chain, as indicated below: ISO 9000: 2000 terms: supplier -- > organisation ---> customer

The term "supplier" describes the body from which supplies are received which includes sub-contractors. The term "organisation" describes the body in which the ISO 9000-quality management system is applied. The term "customer" describes the person or company which receives the product Note also that wherever the term "product" occurs, it can also mean "service".

Recommended Actions 1 Refer to ISO 9000:2000 Quality Management

Systems - Fundamentals and Vocabulary for definitions and explanations of other terms used or summary list provided.


ISO 9001:2000 Clause: 4.0 Quality Management System

Content 4.0 Quality Management System

4.1 General Requirement

4.2 Documentation Requirements

4.2.1 General Requirement

4.2.2 Quality Manual

4.2.3 Control of Documents

4.2.4 Control of Quality Records


ISO 9001:2000 Clause: 4.0 Quality Management System

4.1 General Requirements ( 1 of 2) Emphasis is placed on management to establish and demonstrate a customer-oriented organisation by implementing and maintaining a quality management system that is designed to continually improve the effectiveness and efficiency of the organisation and its ability to satisfy customer's needs. We suggest you review your current management and operating processes using the following guidelines. 1. Identify your processes

Using our assessment checklist, determine the operating processes to be included in your quality management system as it will be applied throughout the organisation

2. Understand your operating processes and interactions

Working with your staff, map out the sequence flow and interactions of your operating processes. See sample company flow chart.

3. Operate and control your processes. Determine suitable working methods and measurement

criteria that are necessary to ensure that the operating processes are effective and controlled. See sample performance reporting process.


Your Project Plan

Content

5.0 Management Responsibility

5.1 Management Commitment

5.2 Customer Focus

5.3 Quality Policy

5.4 Planning

5.4.1 Quality Objectives

5.4.2 Quality Management System Planning

5.5 Responsibility, authority and communication

5.5.1 Responsibility and Authority

5.5.2 Management representative

5.5.3 Internal communication

5.6 Management Review

5.6.1 General

5.6.2 Review Input

5.6.3 Review Output


ISO 9001:2000 Clause: 5.0 Management Responsibility

5.1 Management Commitment Top management (those who direct and control the organisation) need to demonstrate their commitment to the process of development, implementation and improvement of the quality management system, as well the achievement of customer satisfaction. These require management to: • communicate to all employees the importance of meeting customer • and regulatory requirements. See sample internal communications process. • develop, document and approve the quality policy and quality objectives. • conduct quality management review meetings. • provide necessary personnel, material and financial resources. Recommended Actions To provide evidence of this commitment, senior management should: • decide how their communication with employees is to be addressed. This may

be through workshops, presentations, notice board memo and letters. • review and approve its quality policy and objectives. • put in place working methods for assessing organisational performance to ensure

that quality objectives are achieved. For practical reasons, we would recommend that such methods are documented.

• Chair or participate in the quality management review process with a defined agenda. The issue of resource availability may be addressed here.

• ensure that the statement of responsibilities for personnel including themselves address the requirements of this sub-clause.


ISO Plan

ISO 9001:2000 Clause: 5.0 Management Responsibility

ISO 9001:2000 Clause: 6.0 Resource Management

Content

6.0 Resource Management

6.1 Provision of Resources

6.2 Human Resources

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work Environment


6.1 Provision of resources This is a general clause that clarifies the need for the organisation to identify and provide the necessary resources as and when required to: • effectively implement and maintain the quality management system • improve the performance of the quality management system processes • enhance customer satisfaction by fulfilling customer requirements. There is also emphasis for provision of resources to support continual quality improvement effort. The level and type of resources required by organisations will vary, and may include staff, infrastructure, work environment, information, suppliers, natural resources and financial resources. Recommended Actions.

1. The need for resources may be identified during the quality management review process, assessment audits or operational meetings.

The required resources may be defined and allocated during the quality planning process.

2. Determine how required resources are

planned and documented.


Resource Plan

ISO 9001:2000 Clause: 6.0 Resource Management

ISO 9001:2000 Clause: 7.0 Product Realisation

Content

7.0 Product Realisation7.1 Planning of Product Realisation7.2 Customer -Related Processes

7.2.1 Determination of requirements related to the product7.2.2 Review of Requirements related to the Product.7.2.3 Customer Communication

7.3 Design and Development7.3.1 Design and Development Planning7.3.2-3 Design and Development Inputs - Outputs7.3.4 Design and Development Review7.3.5 Design and Development Verification7.3.6 Design and Development Validation7.3.7 Control of Design and Development Changes

7.4 Purchasing7.4.1 Purchasing Process

7.4.2 Purchasing Information7.4.3 Verification of Purchased Product

7.5 Production and Service Provision7.5.1 Control of Production and Service Provision

7.5.2 Validation of Processes for Production and Service Provision7.5.3 Identification and Traceability7.5.4 Customer Property7.5.5 Preservation of product

7.6 Control of monitoring and measuring devices


7.1 Planning of product realisation (1 of 2) This is an all-encompassing clause that requires your organisation to plan and define how its products and services are processed, monitored and delivered to your customers. Therefore you may need to describe what these processes are, how they operate and interact with one another, and what management and staff checks are in place to ensure their effective implementation. In your planning you may need to consider the following issues as appropriate: - • the operating processes and how these are documented within the quality system • measurable quality objectives used and product requirements to be met • resources allocated to the processes and product, such as materials and staff • suitable in-process and final inspections or checks • the criteria used to assess the product performance • how results of the product checks are recorded and the type of records used Document your Plan ISO 9001:2000 does not prescribe how you structure and document your plan. This would be determined by your business needs as well as the type of products and services you deliver to your customers. For repeat product orders, it is possible that the original realisation plan for this product may still be used for subsequent orders. However, for different product orders, such as project services, unique plans would be required. When important changes are made to processes and resources, which affect the provision of products, these need to be incorporated in an update plan in the quality system. © Solutions Generation Company Limited. All Rights Reserved

ISO 9001:2000 Clause: 7.0 Product Realisation

Content

8 Measurement, Analysis and Improvement

8.1 General

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

8.2.2 Internal Audit

8.2.3 Monitoring and Measurement Processes

8.2.4 Monitoring and Measurement of Product

8.3 Control of Non-conforming Product

8.4 Analysis of Data

8.5 Improvement

8.5.1 Continual Improvement

8.5.2 Corrective Action

8.5.3 Preventive Action


ISO 9001:2000 Clause: 8.0 Measurement, Analysis and Improvement

8.1 General

This clause requires you plan and establish measurement, analysis and improvementprocesses within your quality system which have the following objectives;-

• to demonstrate that your products and services satisfyyour customer’s perceived and real requirements

• to ensure your products and activities fulfil therequirements of ISO 9001:2000, your quality system,client and regulatory bodies.

• to continually improve (8.5) the effectiveness of thequality system as well as your capability to meet clientneeds.

To meet these aims you will need to examine your productcharacteristics (8.2.4), determine customer satisfaction (8.2.1),measure control of key processes (8.2.3) and performs internalaudits of your quality system (8.2.2).

When these processes are implemented they will produce data thatneeds to be analysed (8.4), using appropriate statistical tools andtechniques. Relevant output data from such analysis is fed into yourimprovement and management review process for consideration.

You may choose to document how these processesoperate in your company, either by policy,procedures, guides, instructions, tables, forms, flowcharts etc. See sample documents for internalauditing, statistical techniques and inspection.


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ISO 9001:2000 Clause: 8.0 Measurement, Analysis and Improvement

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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:

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)

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 1 to 13, use the "full screen" option (Ctrl and L) • 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.


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