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Quality Manual

CONTROLLED/UNCONTROLLED copy (delete as applicable)

Controlled Copy No: .................................................

Issued to: .................................................

Authorised for Issue :

Date:

This document may not be copied or reproduced in any way without the prior written permission of XXX

XXX Quality Manual Page 1 of 14 Issue: 1


Table of Contents
Page Section Title
Number Number
3 - Amendment record
4 1 Introduction
5 2 Scope and exclusions
5 3 Quality policy
6 4 Quality management system
8 5 Management responsibility
9 6 Resource management
9 7 Product realisation
11 8 Measurement, analysis and improvement

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Amendment Record

Issue Section/Page Brief Description of Change Date


No. No.

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Section 1 Introduction

Goes in here

Contact Information

Offices:

Goes in here

Telephone:
Fax:

Web site:

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Section 2 Scope & Exclusions

The scope of our quality management system is:

The design and delivery of tunnelling solutions for the water, road, rail and utilities
industries, plus research and development of tunnelling techniques and materials.

Due to the nature of our business, there are no exclusions from ISO 9001:2008.

Section 3 Quality Policy

It is the quality policy of XXX to:

 Establish itself as a Centre of Excellence for the design of tunnelled solutions to


the construction industry in the UK.

 Undertake research for new and innovative design solutions incorporating the
development of materials, design and construction methods.

 Offer technical guidance and management services to underground construction


schemes with select clients in chosen markets.

 Implement our management system in accordance with ISO 9001:2008 and


provide adequate resources for its maintenance.

 Invest in and involve all personnel in order to ensure that they develop within the
company in order to achieve their strategic targets.

 Ensure that our contractual and regulatory objectives are fulfilled, promote
collaborative working with our clients and effect continual improvement of our
management system.

This policy will be reviewed periodically in order to ensure that it remains effective and
realises our strategic targets.

Authorised by:

Engineering Director

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Section 4 Quality Management System

4.1 General Requirements

XXX’s quality management system has been developed around the processes of its
business activities – the diagram below shows the main processes and their
interrelationships.

These processes will be implemented and maintained in order to achieve our objectives
and we will actively seek to continually improve the system.

Core Processes Organisational


System Processes
Processes
Enquiry received

No
Can XXX
Internal Audit and conduct the Reject
Management work?
Review
Yes

Conduct site Select tender Site


Nonconforming visit team investigation Human Resources
Product and
Customer
Complaints

Produce outline
tender design

Corrective Action IT

Issue bid/tender

Preventive Action
Business
Development

No
Bid accepted? End

Control of
Documents
Yes

Finance
Calculations,
drawings, Conduct detail Research and
specifications design development

Control of Records
Testing

Contractor
Support
performs work
Calibration of
Equipment

Commissioning,
testing and
validation

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4.2 Documentation Requirements

XXX’s quality management system is structured in 4 main tiers as shown below:

Quality Manual

Procedures

Method Statements

Forms etc.

The quality manual (this document) outlines our approach to quality and is designed to
help the reader to understand how we meet the requirements of ISO 9001 at policy level
and to point the reader in the direction where further information can be found.

Our procedures take these policies and turn them into practical information on how to
operate our processes in a defined manner. Some of these procedures are unique to
XXX and will be identified by the prefix XXX, whilst others are common to the parent
body’s quality system and will be identified by the prefix ZZ. A list of our procedures is
contained in appendix 1 of this manual.

Method statements, where they are required, provide further detail of how to perform a
particular task.

The lowest layer contains all of our standard forms which are used to record and control
our activities and also contains other documents such as standards, codes of practice,
etc.

4.2.3 Control of Documents

Ensuring that our employees have ready access to correctly authorised, up to date
documents is fundamental to our ability to meet requirements. This applies to paper and
electronic documents, whether they have been created by ourselves or supplied by an
external source. As such, we have developed and implemented documented
procedures to control these activities and satisfy this clause.

See procedure XXX 09 & XXX 10

4.2.4 Control of Records

Records are created during the operation of most of our processes. These may be
paper and/or electronic records and they will be managed in such a manner as to
ensure that they are legible, identified, stored, protected and retrievable. Timescales for
their retention will be established and a suitable method of disposal employed at the
end of this period. Where records are retained electronically, appropriate back-up
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systems will be used to achieve the above. In order to achieve the above requirements
we have developed and implemented a documented procedure to control these
activities and satisfy this clause.

See procedure XXX 11

Section 5 Management Responsibility


The head of XXX is the Engineering Director whose ultimate responsibility it is to ensure
that quality and customer satisfaction are, as a minimum, achieved and wherever
possible, exceeded through the use of our QMS. His duties include ensuring that all
staff understand their role in achieving quality and meeting customer, statutory and
regulatory requirements.

We have established a quality policy (see section 3) and quality objectives are set to
enable us to manage and improve our processes. Reviews of the system will be
integrated into regular business meetings and the need for resources considered and
provided as necessary.

Quality objectives are set on a ‘project by project’ basis and include such elements as
completion on time, completion to cost and number of nonconformities raised. These
are contained in the project documentation and reviewed as the project progresses.
Also included will be the planned methods of achieving these objectives which will be
used as key tool for the improvement of our services to customers.

XXX operate a ‘flat’ management system which relies on selecting team members for
projects based on their competence and availability. As such, there is no formal
organisation chart but project based responsibilities and authorities are defined within
each project’s documentation.

The Engineering Director fulfils the role of the management representative and as such,
takes responsibility for managing the QMS, reporting on its performance and ensuring
that customer’s needs and expectations are fully understood by all staff.

Regular project meetings take place to ensure that customer’s stated and changing
requirements are fully communicated within XXX and with the customer. These
meetings are supplemented by other communication methods such as email, letters,
memo’s and design briefs to provide up to date information within the organisation.

Management review of the QMS takes place in a number of ways. As regular project
meetings are held, many items are discussed and addressed at these meetings. In
addition, an overview of the outcomes of these meetings will also be conducted at least
annually.

See procedure XXX 06

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Section 6 Resource Management

Resources will be considered on 2 levels – a general business level and a project level.
General business resources are reviewed on an ongoing basis and provided as
required whereas project resources are determined and provided on a project by project
basis and because our projects can last for a number of years, resources are
continually reviewed throughout the life of the project.

People will only be assigned to tasks for which they have a demonstrated competence.
However, the development of our people is also one of our objectives so people will be
encouraged to enhance their competence through training and other development
activities.

We will identify the competence requirements for tasks and wherever a ‘skills gap’
occurs, we will identify and implement a suitable method of bridging the gap and verify
the effectiveness of the solution provided. In addition to specific technical competences,
we will also ensure that all of our people are familiar with our QMS and the role it plays
in achieving customer satisfaction.

Records of training and reviews of training needs will be maintained.

See procedure XXX 12

Our work is completed in both an office environment and outside, ‘on site’. In the office
we will provide a suitable infrastructure and working environment which is appropriate to
the work we perform and also the necessary hardware such as computers, software
and supporting services such as communications.

Controlling the infrastructure and work environment for on site work is more difficult to
manage but we will provide all the necessary equipment to ensure that we mitigate
against the possibility of outside factors impacting negatively on our services.

Section 7 Product Realisation


7.1 Planning

Every project is subject to a planning phase, the outputs from which are project and
design plans, which ensures that project requirements are clearly defined and
communicated to all necessary parties. Where applicable, this will also include a risk
assessment of the project. These plans are used to monitor and control the project and
are reviewed and updated as the project progresses. They also contain or reference
acceptance criteria for validation and acceptance testing and the records to be retained
to demonstrate results obtained.

See procedure XXX 04

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7.2 Customer related processes

Enquiries for work are received and reviewed to establish the customer’s requirements.
If XXX decide to tender for the work a formal process is entered into which is described
in procedure XXX 01. This includes the appointment of a project manager and suitable
team and may entail a site investigation which ensures that all requirements can be
identified and evaluated, be they stated, implied or statutory/regulatory.

From this information an outline design is produced (see procedure XXX 02) and
reviewed to ensure that the project is adequately defined, XXX can perform the work
and any changes from the initial enquiry have been considered and addressed. The
tender is then prepared and submitted to the customer for acceptance (see procedure
XXX 01).

Once the tender has been accepted, regular contact is maintained with the customer
throughout all stages. This includes project meetings and an end of project review which
also provide opportunities for customers to give feedback, including any problems
encountered.

7.3 Design and Development

Design of the project is conducted in 2 stages – outline design and detail design - and
would include any required temporary works. Design work is conducted in accordance
with documented procedures (see procedure XXX 02 & Design Office Method
Statement MS/01/T) and takes into account all applicable current codes and practices.
The outputs from the design process are in the form of a design plan which includes
drawings, calculations, specifications, etc., these outputs are reviewed and verified by
an independent designer and the final design is issued.

Due to the nature of our work, validation of the design cannot be conducted until the
finished design is implemented. Validation takes the form of a post project review plus
measuring and testing activities such as leak testing. The results of these activities are
recorded and may be used as inputs for future, similar designs.

Design changes may be initiated by the customer or XXX and are controlled via a
design change application system which ensures that any changes are adequately
reviewed, controlled and implemented.

7.4 Purchasing

Purchasing activities are limited to items such as software, laboratory equipment and
the use of sub-contract services such as consulting engineers and electrical and
mechanical contractors.

A formal process exists within the parent body for selecting and evaluating suppliers
and for placing purchase orders. This system will be adopted by XXX but we will be
responsible for verifying that purchasing requirements have been satisfactorily met.

See ZZ 06 & XXX 03


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7.5 Service Provision

The service provided by XXX is largely that of design so this element is mostly
addressed within clause 7.3. However, other activities do exist such as research and
development activities and on site support.

The control of these activities is mostly achieved by the fact that they are conducted by
competent people but this may be supplemented by method statements as required.

Projects are identified by a project reference which is used on all documentation relating
to the project. Documentation is controlled via a design issue sheet and signature
blocks indicate the acceptance or not of each document.

Customers supply documents, data and other information to XXX before and during a
project. XXX verify the validity of this information, to the extent possible, and control it to
ensure that confidentiality is maintained. Should problems occur with this information,
XXX will formally report the fact to the customer.

Design documents and data form the product produced by XXX. These may be
distributed in paper and/or electronic format with care being exercised at all stages to
ensure that they are not lost, damaged or corrupted.

All equipment used for monitoring and measuring purposes will be controlled to ensure
that it is adequate for the purpose and is calibrated. A documented procedure exists to
control the calibration of equipment (see procedure XXX 13). Where appropriate,
software used for calculation purposes, such as finite element analysis packages, will
be verified to ensure its adequacy and accuracy.

Section 8 Measurement, Analysis and Improvement


Monitoring and measuring activities will be conducted at various stages of a project to
verify that the design meets requirements, that the quality management system is
adequate and to seek improvements. The methods used to conduct these activities vary
according to the circumstances and may include the use of statistical data where it
would be beneficial.

Customer satisfaction will be determined throughout the life of a project and is


conducted through project meetings, including post project reviews. The information
gathered will be reviewed and used to identify potential improvements to our services
wherever possible.

Regular internal audits will be conducted on the QMS and projects to identify
conformance with the system and ISO 9001 as well as looking at the effectiveness of
our processes.

See procedure XXX 06

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Projects and the processes used to design and implement them are measured
throughout their lifecycles in order to determine conformance with requirements and the
effectiveness and efficiency of achieving them. Each finished design is subjected to a
rigorous, pre-planned validation process which enables us to verify its effective
implementation. Indicators such as nonconformities, complaints, project/budget
overruns, internal audits and management review will also be used as a guide to the
effectiveness of our processes.

The tunnelling contractor is required to produce ‘as built’ drawings to confirm the final
implementation of the design. The final validation of the project will be used as a
method of final release and a handover certificate issued. Results of these testing
activities will be retained and made available for future reference.

See procedure XXX 05

Nonconforming Product

Where a project, or part of a project, does not meet specified requirements, it will be
identified as nonconforming. Nonconformities will be dealt with in accordance with a
documented procedure. This includes responsibilities and authorities, actions to be
taken and reporting mechanisms. It also addresses how nonconformities will be dealt
with when they are identified after installation has been completed.

See procedure XXX 07

Analysis of Data

Data will be collected and analysed from many sources to enable us to determine the
effectiveness and conformity of our systems, processes and projects with the aim of
improving them where possible. These include, but are not limited to the results from
our monitoring and measuring activities and supplier performance.

Improvement

Improvement of our products/services, systems and processes is one of our main


objectives. We aim to enhance our performance for the benefit of our customers,
ourselves and our people. We will use all means possible to achieve this including our
quality policy, objectives, audits, management reviews, analysis of data, corrective and
preventive actions.

Corrective Action

Where nonconformities and customer complaints occur, we will take appropriate


corrective action to resolve the situation and to prevent it from recurring. The method of
conducting and recording corrective action is contained in a documented procedure.

See procedure XXX 08

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Preventive Action

We acknowledge that prevention is better than cure and as such, we will consider
preventive action at all stages of our processes as appropriate. These may include
planning activities and techniques such risk assessments and the use of statistics to
help identify where potential problems may occur. The method of conducting and
recording preventive action is contained in a documented procedure.

See procedure XXX 08

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Index to Procedures
Procedure Procedure Title
Number
XXX 01 Tendering
XXX 02 Design
XXX 03 Vendor Assessment
XXX 04 Risk Assessment
XXX 05 Monitoring & Measurement
XXX 06 Internal Audits & Management Review
XXX 07 Non-Conformance & Customer Complaints
XXX 08 Corrective & Preventive Action
XXX 09 Document Control - General
XXX 10 Document Control - QMS
XXX 11 Control of Records and Archives
XXX 12 Training
XXX 13 Measuring and Test Equipment

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