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QUALITY HANDBOOK
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ISOM QUALITY HANDBOOK
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 3
ISO 9001:2000 CROSS REFERENCE GUIDE 6
SECTION 1 INTRODUCTION 10
1.1 Purpose of Handbook 10
1.2 BS EN ISO 9001:200 12
1.3 Investing in Quality Assurance 13
1.4 Route to Registration 14
1.5 Documentation Requirements 15
1.6 Aims and Objectives 17
1.7 Use of Handbook 17
1.8 Presentation of Information in the Handbook 18
1.9 Feedback 18
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Page No
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Page No
APPENDICES
A CONTROL OF MONITORING, MEASURING AND
TEST EQUIPMENT
B CONTROL PROCEDURES FOR WORKSHOP
PRACTICES
C DESIGN AND PRODUCTION CONTROL
PROCEDURES FOR BATCH PRACTICES
D WORK INSTRUCTION
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Requirement - Handbook
ISO 9001:2000 Clause No(s). Page No(s).
5. Management Responsibility: 26
5.1 Management commitment 26
5.2 Customer focus 28
5.3 Quality Policy 28, 51
5.4 Planning: 26
5.4.1 Quality objectives 26
5.4.2 Quality management system planning 26
5.5 Responsibility, authority and communication: 26
5.5.1 Responsibility and Authority 26
5.5.2 Management Representative 26
5.5.3 Internal communication 26
5.6 Management Review: 29
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Requirement - Handbook
ISO 9001:2000 Clause No(s). Page No(s).
5.6.1 General 29
5.6.2 Review input 29
5.6.3 Review output 29
6 Resource Management: 30
6.1 Provision of resources 30
6.2 Human resources: 30
6.2.1 General 30
6.2.2 Competence, awareness and training 30
6.3 Infrastructure 30
6.4 Work environment 30
7 Product realization 32
7.1 Planning of product realization 32
7.2 Customer-related processes 33
7.2.1 Determination of requirements related to the 33
product 33
7.2.2 Review of requirements related to the product 33
7.2.3 Customer communication
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ISOM QUALITY HANDBOOK
Requirement - Handbook
ISO 9001:2000 Clause No(s). Page No(s).
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ISOM QUALITY HANDBOOK
Requirement - Handbook
ISO 9001:2000 Clause No(s). Page No(s).
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ISOM QUALITY HANDBOOK
SECTION 1
INTRODUCTION
• 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.
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ISOM QUALITY HANDBOOK
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.
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ISOM QUALITY HANDBOOK
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.
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ISOM QUALITY HANDBOOK
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ISOM QUALITY HANDBOOK
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.
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ISOM QUALITY HANDBOOK
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ISOM QUALITY 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-by-
side with Section 2.
1.9 Feedback
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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
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ISOM QUALITY HANDBOOK
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.
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• How the customer will agree the product meets the specification
and how that will be recorded.
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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.
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