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ISO Handbook 02

ISO Handbook 02

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F

QUALITY HANDBOOK
A Practical Guide to the Documentation of ISO 9001:2000

info@isom.co.uk

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ISOM QUALITY HANDBOOK

First edition 1992 (to BS 5750 Part 2) Second edition 1993 (revised to include Parts 1 and 3 of BS 5750) Third edition 1995 (revised to updated standards EN ISO 9001:1994 and 9002:1994) Fourth edition 2001 (revised to updated standard EN ISO 9001:2000)

Copyright 2001 Isom Ltd

This document may be reproduced by the purchaser for the sole purpose of implementing the purchaser's own quality system. Requests for reproduction for other purposes should be sent to Isom Ltd at the address below. Isom Ltd 9 Patford Street Calne Wiltshire Tel: 01249 812343 Fax: 01249 816963 website: www.isom.co.uk e-mail: info@Isom.co.uk

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ISOM QUALITY HANDBOOK

CONTENTS
Page No HANDBOOK CONTENTS ISO 9001:2000 CROSS REFERENCE GUIDE SECTION 1 INTRODUCTION 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Purpose of Handbook BS EN ISO 9001:200 Investing in Quality Assurance Route to Registration Documentation Requirements Aims and Objectives Use of Handbook Presentation of Information in the Handbook Feedback 3 6 10 10 12 13 14 15 17 17 18 18

SECTION 2 DOCUMENTATION REQUIREMENTS OF ISO 9001:2000 2.1 2.2 2.2.1 2.2.2 General Quality Management System: General Requirements Documentation Requirements General Quality Manual Control of Documents Revisions Distribution List Control of Records Management Responsibility

19 19 19 19 21 21 22 23 24 24 25 26

2.3

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Page No SECTION 2 DOCUMENTATION REQUIREMENTS OF ISO 9001:2000 (Continued) 2.3.1 2.3.2 2.3.3 2.3.4 2.4 2.5 2.5.1 2.5.2 2.5.3 2.5.4 2.5.5 General Customer Focus Quality Policy Management Review Resource Management Product Realization Planning of Product Realization Customer-Related Processes Design and Development: Purchasing Production and Service Provision: Control of Production and Service Provision/ Validation of Processes for Production and Service Provision Identification and Traceability Customer Property Preservation of Product Control of Monitoring And Measuring Devices Measurement, Analysis and Improvement General Monitoring and Measurement: Control of Non-Conforming Product Analysis of Data Improvement Overview 26 28 28 29 30 32 32 33 34 36 37

2.5.6 2.6 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.7

37 39 40 41 42 43 43 43 46 47 48 49

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ISOM QUALITY HANDBOOK

Page No SECTION 3 QUALITY MANUAL 3.1 3.2 3.3 3.4 3.5 Requirements Contents Format Appendices Distribution 51 51 52 53 54 55

SECTION 4 DOCUMENTED PROCEDURES AND WORK INSTRUCTIONS 4.1 4.2 4.3 4.4 4.5 General Distribution Format Examples Work Instructions

56 56 57 58 58 60

APPENDICES A CONTROL OF MONITORING, MEASURING AND TEST EQUIPMENT B C D CONTROL PROCEDURES FOR WORKSHOP PRACTICES DESIGN AND PRODUCTION CONTROL PROCEDURES FOR BATCH PRACTICES WORK INSTRUCTION

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ISOM QUALITY HANDBOOK

ISO 9001:2000 CROSS REFERENCE GUIDE
Requirement ISO 9001:2000 Clause No(s). 4 Quality Management System: 4.1 General requirements 4.2 Documentation requirements: 4.2.1 General 4.2.2 Quality Manual 4.2.3 Control of documents 4.2.4 Control of records 5. 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: Handbook Page No(s). 19 19 21 21 22, 51 23 25 26 26 28 28, 51 26 26 26 26 26 26 26 29

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Requirement ISO 9001:2000 Clause No(s). 5.6.1 General 5.6.2 Review input 5.6.3 Review output 6 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 7 Product realization 7.1 Planning of product realization 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product 7.2.2 Review of requirements related to the product 7.2.3 Customer communication 7.3 Design and development: 7.3.1 Design and development planning 7.3.2 Design and development inputs 7.3.3 Design and development outputs

Handbook Page No(s). 29 29 29 30 30 30 30 30 30 30 32 32 33 33 33 33

34 34 34 34

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Requirement ISO 9001:2000 Clause No(s).

Handbook Page No(s).

7.3.4 Design and development review 7.3.5 Design and development verification 7.3.6 Design and development validation 7.3.7 Control of design and development changes 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product 7.5 Production and service provision: 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification and traceability 7.5.4 Customer property 7.5.5 Preservation of product 7.6 Control of monitoring and measurement devices 8 Measurement, analysis and improvement: 8.1 General 8.2 Monitoring and measurement: 8.2.1 Customer satisfaction 8.2.2 Internal audit

35 35 35 35 36 36 36 36 37 37

37 39 40 41 42 43 43 43 43 43

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ISOM QUALITY HANDBOOK

Requirement ISO 9001:2000 Clause No(s).

Handbook Page No(s).

8.2.3 Monitoring and measurement of 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

44 44 46 47 48 48 48 48

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SECTION 1 INTRODUCTION 1.1 Purpose of Handbook

Organizations already operating an effective Quality Management System (QMS) should have no major difficulty in adapting that system to the requirements of ISO 9001:2000. As a rule of thumb, providing you are concerned about meeting your customers’ needs and if your current system and associated procedures are effective, then all that is required is that they are defined, documented, implemented and recorded. In essence:

• • • • •

You prove that you know and meet your customers’ needs. You define and document your quality assurance policies, practices and procedures. You do what your QMS documentation says you should do. You record what you have done to provide documentary evidence that you have done it. You organize a method to ensure continual improvement of the QMS.

We believe that the preparation of the required QMS documentation is seen by many organizations as the most difficult aspect of achieving registration to the standard. The purpose of this Handbook is to assist and guide in the preparation of QMS documentation so that a QMS, according to ISO 9001:2000, may be achieved with the minimum of expenditure.

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ISOM QUALITY HANDBOOK

The information provided is based upon our experience as a small technical writing company awarded registration to BS 5750 (the British standard for quality systems at that time) on first assessment. Isom achieved the award by using its professional technical writing skills to prepare all the necessary QMS documentation for registration, seeking assistance from a consultant only when necessary. In taking this course of action, the outlay in gaining registration was considerably reduced. Subsequently, Isom’s QMS has been successfully updated in-house to meet the requirements of ISO 9000:1994 and, more recently, ISO 9001:2000. This Handbook interprets the QMS documentation requirements of ISO 9001:2000 into user friendly terminology and also provides examples of approved content and format for QMS documentation. Isom consider that it is essential that a copy of the standard is available as a source of reference. When obtained from BSI, BS EN ISO 9001:2000 is delivered complete with complementary standards BS EN ISO 9000:2000 and 9004:2000. ISO 9000:2000 contains fundamentals and a vocabulary for a QMS; ISO 9004:2000 contains guidelines for performance improvements of a QMS. ISO 9004:2000 is intended as a guide to organizations wishing to expand and improve their QMS beyond the basic requirements of ISO 9001:2000; however, it can be useful in that it provides some further insights into the requirements of ISO 9001:2000.

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1.2

BS EN ISO 9001:2000

The new ISO 9001:2000 standard, in addition to reiterating that ‘Top Management’ must be fully committed to quality, introduces a major new requirement which is to focus on the customer’s needs in order to ensure customer satisfaction and to meet, and where possible exceed, customer expectations. The general requirements of the four main elements of the standard are as follows: 1 Management Responsibility: Management commitment to planning, administration, control and periodic review of the QMS to ensure its continuing effectiveness. In addition management should be committed to continual improvement of the QMS. Resource Management: The requirement of the organization to provide the human, material and environmental resources to implement and improve the QMS. Product Realization: The requirement for the organization to plan, develop and implement the processes needed for realization of the product from identification of customer requirements through to delivery and support of the product. Measuring, Analysis and Improvement: The requirement to ensure that the product goes through a system of inspection and testing to ensure product conformity and that results are periodically audited to ensure continued effectiveness of the QMS and identify areas for improvement.

2

3

4

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1.3

Investing in Quality Assurance

Although investing in quality assurance will realize long term benefits, the initial investment can be expensive. Registration may necessitate involvement with a consultant at some stage and though consultancy fees vary considerably, they will undoubtedly prove costly. At one end of the scale is the option to pay a consultant to do most of the work for you. This is probably the most expensive option as consultants do not come cheap. This option may also result in your workforce considering the resulting QMS to have been imposed on them, which could result in problems with implementation in the future. Another point to remember is that the people who know your organization and processes best are, of course, you and your fellow workers. At the other end of the scale is the option to develop and document your own QMS, apply for certification and use your assessor’s comments to ‘fine tune’ your system. Since part of the certification process involves a bench assessment of the system, you will be paying your assessor for this work in any case. There is no need to be overawed by the apparent complexity of the ISO 9001:2000 standard. Though you may not realize it, your organization is probably already operating an adequate quality system. Therefore, with this Handbook to guide you, there is no reason why you should not be able to understand the contents and implications of ISO 9001:2000 and to organize and document your system in accordance with the requirements of the standard. Why pay a consultant to do it all for you?

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ISOM QUALITY HANDBOOK

1.4

Route to Registration

To gain registration you must: Demonstrate you know your customers’ needs and meet them. Write down the applicable processes, providing a documented QMS. Operate these processes. We show how Isom do this later in the handbook.

Applicable processes are listed in ISO 9001:2000 and clarified throughout the handbook No problems should arise as this is probably something you already do. ISO 9001:2000 gives guidance about record keeping. Isom’s methods are shown in our Quality Manual and Quality Procedures Manual. Isom has devised a process which has been approved by independent auditors.

Prove that your organization is working to the system, therefore applicable records must be kept.

Take steps to enable continuous improvement of the system.

Any questions about interpretation are dealt with later in the handbook and a clause-by-clause explanation is given, illustrated with excerpts from Isom’s own QMS documentation. The route to registration must be considered in two parts. 1 The first part concerns the organization of the QMS and the preparation of QMS documentation detailing the policies and

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ISOM QUALITY HANDBOOK

quality procedures necessary to implement the system. provides you with two options: a) b) You seek consultancy help only when necessary.

This

You use an independent quality consultant to lead you through the process.

No matter which option you choose, you will do most of the work yourself. It will be necessary for management and senior members of staff to spend time discussing, developing and organising the QMS, either among themselves or with the quality consultant. This tends to be overlooked, especially when choosing Option b), but it is an expenditure which cannot be discounted. With this in mind, it is evident that Option a) should still prove to be the cheapest. Also, a quality system organized from within your organization is likely to be better accepted by your staff. 2 The second part concerns the application to a certification body for registration to the standard and the resultant assessment and surveillance fee. This fee is generally for a fixed price over a three year period, the cost of which very much depends upon the certification body chosen and the size of the organization. Therefore, quotations should be sought from a selection of certification bodies having appropriate experience in the activities of your organization.

1.5

Documentation Requirements

In order to meet the requirements of the standard (Clause 4.2.1), the minimum documentation needed will comprise a Quality Manual, documented procedures and a Quality Records system. The Quality

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Manual describes the organization’s QMS and sets out its general policies and practices. The documented procedures are the procedures which the workforce must follow to comply with the requirements of the QMS as described in the Quality Manual. These procedures may be presented separately or included in a Quality Procedures Manual; they may even be included as part of the Quality Manual. There is no set format for presenting this documentation. Organizations using few procedures may choose to include them in their Quality Manual. Organizations using a large number of procedures may choose to present them separately, or in sets issued to appropriate departments. Isom chose to present these in a separate Quality Procedures Manual, mainly to keep the Quality Manual from seeming ‘cluttered’. Choose what best suits your organization. It may also be necessary to compile work instructions (see the examples presented in Appendices B thru D) and set agendas for management review and internal audit as a means of communicating more detailed requirements for a given task. The management of the quality system will be based on the practical working of your organization, therefore quality procedures and work instructions should be documented and expressed in terminology appropriate to your business. Policies, procedures and work instructions must be comprehensive and accurate, yet simple to follow.

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1.6

Aims and Objectives

An effective QMS is a valuable asset in winning and keeping business. By making reference to the text and example pages in following sections of this handbook you should be able develop your own QMS documentation to satisfy the requirements of ISO 9001:2000. To ensure your QMS is implemented efficiently and its effectiveness maintained, it is essential that: • There is real and visible 'commitment from the top'. No amount of enthusiasm from below can fully counter a lack of commitment from senior management. Your procedures are available at the work place, can be understood by your staff and are applied diligently. This will necessitate an ongoing training effort. The procedures are regularly reviewed and updated as circumstances in your organization change.

1.7 Use of Handbook
The documentation requirements of the clauses listed in ISO 9001:2000 are explained in Section 2 of this handbook. Additionally, Isom’s complete Quality Manual and Quality Procedures Manual provide examples of QMS documentation. We consider that the usefulness of the handbook is centred on the use of these examples of actual approved documentation for a QMS assessed and registered as meeting the requirements of ISO 9001:2000. The examples may be used as the basis for your own QMS documentation.

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ISOM QUALITY HANDBOOK

The explanatory text describes the documentation requirements of the particular clause(s) of the standard. This text describes particular points regarding the presentation of the required information, although the example text is generally self-explanatory. It may also include added information which the reader may find useful in implementing the standard and, where applicable, describes those items in the Isom example that, although not specified, enhance the value of the QMS documentation.

1.8

Presentation of Information in the Handbook

This latest edition of the handbook has been prepared primarily for use as a PDF file, viewed on screen, with links from the explanatory text in Section 2 to the appropriate page(s) in the example documentation. Alternatively, if used in hard copy format it is recommended that the Quality Manual and Quality Procedures Manual are printed as separate documents that can be used side-byside with Section 2. Isom’s Quality Manual and Quality Procedures Manual are also available as Word (6.0 or ‘97) files to be used as a basis for your own manuals. For further information refer to our QMS documentation website: ‘www.qualitymanual.co.uk’ or contact Isom Ltd (details are on page 2.

1.9

Feedback

In order to assist with our own quality assurance programme, any comment regarding the use and value of this handbook would be gratefully received. Contact details for Isom Ltd are on page 2.

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ISOM QUALITY HANDBOOK

Pages 19 to 30 are not available in this free sample

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ISOM QUALITY HANDBOOK

The standard emphasises the need for a systematic approach to the determination and provision of resources required to provide a product that meets with customer requirements. The requirement to provide suitable resources also covers human resources to the extent that only suitably qualified personnel should be used for specific tasks which are controlled by QMS procedures. Records of the education, formal qualifications, experience, skills, experience and training should be maintained for these personnel. The procedures for determining levels of required competency, training needs and for the training itself should be carefully considered. Our experience is that this is one of the aspects of the QMS where it is easy to over document and prepare more than is necessary. For example, if the training needs for a particular task can be adequately determined by informal assessment by the appropriate supervisor/manager then make a statement to that effect in the Quality Manual or relevant documented procedures. Do not be tempted to develop a more complicated assessment procedure that may be impractical or excessively time consuming and will therefore probably be ignored or not used correctly. Remember that at external assessment/ audit, an assessor may comment on your procedures, but they are your procedures. If they work for you, and your product quality supports this, then you should be able to make a case to retain them. However, an assessor will pick up on a procedure not used, or used incorrectly, and will almost certainly record this as a non-compliance. Depending on the nature and/or number of non-compliances recorded, at best this will require to be rectified before the next audit; at worst, the organizations registration will be suspended until rectification of the non-compliance(s) has been confirmed by a further audit. Refer to pages 16 and 17 in the Quality Manual.

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2.5

PRODUCT REALIZATION (ISO 9001:2000, Clause 7)

Note that for clause 7 requirements only, the organization can exclude any requirement that cannot be applied due to the nature of the organization or product. Any such exclusions should be justified in the Quality Manual. For example, Isom does not use any physical measuring or monitoring equipment, all ‘measuring and monitoring’ is carried out using a series of QMS forms. Therefore, clause 7.6 Control of Monitoring and Measuring Devices is not applicable to Isom and appropriate text has been prepared to justify this as an exclusion. Refer to page 21 in the Quality Manual.

2.5.1

PLANNING OF PRODUCT REALIZATION - Clause 7.1

Product realization is the term used in the standard to cover the complete range of processes required from customer enquiry (or identification of customer needs) up to delivery of the product or service and including any post-delivery support or servicing. The text should describe the methods the organization’s management will use to plan and develop QMS processes required to achieve product realization. The planning and development should identify: • • • • A specification for the product or service. Any special processes, documentation or resources needed. Methods to ensure that the specification for the service will be fully met and proved. How you will demonstrate the product meets the specification.

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How the customer will agree the product meets the specification and how that will be recorded.

Refer to page 18 in the Quality Manual.

2.5.2

CUSTOMER RELATED PROCESSES - Clause 7.2

The text should define how the organization identifies requirements related to the product including at least what the customer wants, legal requirements, identified user needs. These requirements should be reviewed by the organization and agreed with the customer prior to any commitment to supply the product. The review, which should be recorded, should ensure that: • • • All the requirements related to the product or service are fully defined. You have the necessary resources and capabilities to fulfil all requirements. There are no present or foreseeable conflicts with your customer.

You have to ensure that effective means of communication are in place with your customer that must include for product, contractual and customer feedback matters. The review of requirements relating to a new product or service is the starting point for quality planning. It is essential that your organization understands every aspect of those requirements and has confirmed its ability to meet them before the contract is signed. The standard implies that customer needs, requirements and expectations are paramount.

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ISOM QUALITY HANDBOOK

Isom have introduced additional paragraphs in this section under the heading of Customer Review. They are not a requirement of the standard but define a customer related process which is relevant to Isom’s product. These paragraphs are included on page 19 in the Quality Manual. Refer to pages 18 and 19 in the Quality Manual. Refer to page 5 in the Quality Procedures Manual.

2.5.3

DESIGN AND DEVELOPMENT - Clause 7.3

The text should define the organization’s procedures which control and verify the design and development of products and services in order to ensure that requirements will be met. The standard divides the design process into the following seven specific parts: Clause 7.3.1 Design and Development Planning • • • • Responsibilities and authorities must be defined. The stages involved in the design and development phase must be defined. How fulfilment of each stage is demonstrated must be defined. The process must be capable of change as work progresses.

Clause 7.3.2 Design and Development Input. Records must be kept about all matters considered during design and development of the product. They must be reviewed to ensure there are no conflicts, there is no ambiguity and all known relevant items have been considered, which should include:

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ISOM QUALITY HANDBOOK

• • •

Legal requirements. Performance requirements Similar designs.

Clause 7.3.3 Design and Development Output. Requires the preparation of a specification to enable the completion of the task identified in the Design Input. Clause 7.3.4 Design and Development Review. During planning, how progress and performance of the work undertaken during design and development is determined will have to be identified. Reviews of that performance, as planned, will be undertaken, and records kept. Clause 7.3.5 Design and Development Verification. Proves that the Design and Development Output meets the requirements of the Design and Development Input and is an ongoing activity which should operate throughout the design process and should be recorded. Clause 7.3.6 Design and Development Validation. This is normally performed on the final product/service and is a demonstration the product/service is suitable for the use for which it was intended and should be recorded. Clause 7.3.7 Design and Development Changes. Procedures should be established for the identification, documentation, approval and control of all Design and Development changes and modifications required due to Design and Development Verification activities. The design function should be capable of assessing customer requirements and translating these, in a systematic and controlled way, into a specification which enables the provision of the required product or service.

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Isom’s product is normally prepared to a precise specification supplied by their customers. Where no customer specification is available and Isom develop a documentation specification (design) to meet the customer’s needs, then the requirements of this clause must be satisfied. Text in the example Quality Manual is a brief outline only; full Design and Development related QMS procedures are included in the Quality Procedures Manual. Refer to page 19 in the Quality Manual. Refer to pages 6 and 7 in the Quality Procedures Manual.

2.5.4

PURCHASING - CLAUSE 7.4

This text should define the organization’s controls to ensure that purchased product (components or materials) meet the specified requirements. The extent of the controls depends upon how the purchased items affect the final product. • Where appropriate, the purchasing information could include product specification, QMS requirements, personnel requirements and/or approval procedures as necessary. In order to establish that purchased product meets the specified requirements, suitable verification activities should be established and implemented. Where appropriate, these activities can be carried out either at the organization’s premises or the supplier’s premises and should be defined in the purchase orders. The intent of this clause is to ensure that any components or materials purchased by your organization for use in the final product meet the specified requirements for that product. This will entail the following:

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Pages 37 to 61 and Appendices A to D are not available in this free sample

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