You are on page 1of 15

Quality Manual CONTROLLED/UNCONTROLLED copy (delete as applicable) Controlled Copy No: Issued t o: Authorised for Issue : Date: ................................................

. ................................................. This document may not be copied or reproduced in any way without the prior writt en permission of XXX XXX Quality Manual Page 1 of 14 Issue: 1

Table of Contents Page Number 3 4 5 5 6 8 9 9 11 Section Number 1 2 3 4 5 6 7 8 Title Amendment re cord Introduction Scope and exclusions Quality policy Quality management system Management responsibility Resource management Product realisation Measurement, a nalysis and improvement XXX Quality Manual Page 2 of 14 Issue: 1

Amendment Record Issue No. Section/Page No. Brief Description of Change Date XXX Quality Manual Page 3 of 14 Issue: 1

Section 1 Introduction Goes in here Contact Information Offices: Goes in here Telephone: Fax: Web site: XXX Quality Manual Page 4 of 14 Issue: 1

Section 2 Scope & Exclusions The scope of our quality management system is: The design and delivery of tunnel ling solutions for the water, road, rail and utilities industries, plus research and development of tunnelling techniques and materials. Due to the nature of ou r 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 f or the design of tunnelled solutions to the construction industry in the UK. Und ertake research for new and innovative design solutions incorporating the develo pment of materials, design and construction methods. Offer technical guidance an d management services to underground construction schemes with select clients in chosen markets. Implement our management system in accordance with ISO 9001:200 8 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 ac hieve their strategic targets. Ensure that our contractual and regulatory object ives are fulfilled, promote collaborative working with our clients and effect co ntinual improvement of our management system. This policy will be reviewed perio dically in order to ensure that it remains effective and realises our strategic targets. Authorised by: Engineering Director XXX Quality Manual Page 5 of 14 Issue: 1

Section 4 Quality Management System 4.1 General Requirements XXXs quality management system has been developed around the processes of its bus iness activities the diagram below shows the main processes and their interrelat ionships. These processes will be implemented and maintained in order to achieve our objectives and we will actively seek to continually improve the system. System Processes Core Processes Enquiry received Organisational Processes Internal Audit and Management Review Can XXX conduct the work? Yes No Reject Nonconforming Product and Customer Complaints Conduct site visit Select tender team Site investigation Human Resources Produce outline tender design Corrective Action IT Issue bid/tender Preventive Action Business Development No Bid accepted? Control of Documents End Yes Calculations, drawings, specifications Finance Conduct detail design Researc h and development Control of Records Testing Contractor performs work Calibration of Equipment Support Commissioning, testing and validation XXX Quality Manual Page 6 of 14 Issue: 1

4.2 Documentation Requirements XXXs 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 desig ned 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 i nformation on how to operate our processes in a defined manner. Some of these pr ocedures are unique to XXX and will be identified by the prefix XXX, whilst othe rs are common to the parent bodys quality system and will be identified by the pr efix ZZ. A list of our procedures is contained in appendix 1 of this manual. Met hod statements, where they are required, provide further detail of how to perfor m a particular task. The lowest layer contains all of our standard forms which a re used to record and control our activities and also contains other documents s uch as standards, codes of practice, etc. 4.2.3 Control of Documents Ensuring th at 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 e lectronic documents, whether they have been created by ourselves or supplied by an external source. As such, we have developed and implemented documented proced ures 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 mos t of our processes. These may be paper and/or electronic records and they will b e managed in such a manner as to ensure that they are legible, identified, store d, protected and retrievable. Timescales for their retention will be established and a suitable method of disposal employed at the end of this period. Where rec ords are retained electronically, appropriate back-up XXX Quality Manual Page 7 of 14 Issue: 1

systems will be used to achieve the above. In order to achieve the above require ments 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 ensu ring that all staff understand their role in achieving quality and meeting custo mer, statutory and regulatory requirements. We have established a quality policy (see section 3) and quality objectives are set to enable us to manage and impro ve our processes. Reviews of the system will be integrated into regular business meetings and the need for resources considered and provided as necessary. Quali ty objectives are set on a project by project basis and include such elements as c ompletion on time, completion to cost and number of nonconformities raised. Thes e are contained in the project documentation and reviewed as the project progres ses. Also included will be the planned methods of achieving these objectives whi ch will be used as key tool for the improvement of our services to customers. XX X operate a flat management system which relies on selecting team members for proj ects based on their competence and availability. As such, there is no formal org anisation chart but project based responsibilities and authorities are defined w ithin each projects documentation. The Engineering Director fulfils the role of t he management representative and as such, takes responsibility for managing the QMS, reporting on its performance and ensuring that customers needs and expectati ons are fully understood by all staff. Regular project meetings take place to en sure that customers stated and changing requirements are fully communicated withi n XXX and with the customer. These meetings are supplemented by other communicat ion methods such as email, letters, memos and design briefs to provide up to date information within the organisation. Management review of the QMS takes place i n a number of ways. As regular project meetings are held, many items are discuss ed 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 XXX Quality Manual Page 8 of 14 Issue: 1

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 b y project basis and because our projects can last for a number of years, resourc es are continually reviewed throughout the life of the project. People will only be assigned to tasks for which they have a demonstrated competence. However, th e development of our people is also one of our objectives so people will be enco uraged to enhance their competence through training and other development activi ties. We will identify the competence requirements for tasks and wherever a skill s gap occurs, we will identify and implement a suitable method of bridging the ga p 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 o f training and reviews of training needs will be maintained. See procedure XXX 1 2 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 co mputers, software and supporting services such as communications. Controlling th e infrastructure and work environment for on site work is more difficult to mana ge but we will provide all the necessary equipment to ensure that we mitigate ag ainst 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 a nd communicated to all necessary parties. Where applicable, this will also inclu de 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 c ontain or reference acceptance criteria for validation and acceptance testing an d the records to be retained to demonstrate results obtained. See procedure XXX 04 XXX Quality Manual Page 9 of 14 Issue: 1

7.2 Customer related processes Enquiries for work are received and reviewed to establish the customers requireme nts. 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 ma nager and suitable team and may entail a site investigation which ensures that a ll requirements can be identified and evaluated, be they stated, implied or stat utory/regulatory. From this information an outline design is produced (see proce dure 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 consider ed 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 co ntact is maintained with the customer throughout all stages. This includes proje ct meetings and an end of project review which also provide opportunities for cu stomers to give feedback, including any problems encountered. 7.3 Design and Dev elopment 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 ac cordance with documented procedures (see procedure XXX 02 & Design Office Method Statement MS/01/T) and takes into account all applicable current codes and prac tices. The outputs from the design process are in the form of a design plan whic h includes drawings, calculations, specifications, etc., these outputs are revie wed 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 th e finished design is implemented. Validation takes the form of a post project re view 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 desi gns. Design changes may be initiated by the customer or XXX and are controlled v ia a design change application system which ensures that any changes are adequat ely reviewed, controlled and implemented. 7.4 Purchasing Purchasing activities are limited to items such as software, laboratory equipmen t and the use of sub-contract services such as consulting engineers and electric al and mechanical contractors. A formal process exists within the parent body fo r selecting and evaluating suppliers and for placing purchase orders. This syste m will be adopted by XXX but we will be responsible for verifying that purchasin g requirements have been satisfactorily met. See ZZ 06 & XXX 03 XXX Quality Manual Page 10 of 14 Issue: 1

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 identifi ed by a project reference which is used on all documentation relating to the pro ject. Documentation is controlled via a design issue sheet and signature blocks indicate the acceptance or not of each document. Customers supply documents, dat a and other information to XXX before and during a project. XXX verify the valid ity of this information, to the extent possible, and control it to ensure that c onfidentiality is maintained. Should problems occur with this information, XXX w ill 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 fo rmat with care being exercised at all stages to ensure that they are not lost, d amaged or corrupted. All equipment used for monitoring and measuring purposes wi ll 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 pro cedure 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 pro ject to verify that the design meets requirements, that the quality management s ystem is adequate and to seek improvements. The methods used to conduct these ac tivities vary according to the circumstances and may include the use of statisti cal data where it would be beneficial. Customer satisfaction will be determined throughout the life of a project and is conducted through project meetings, incl uding post project reviews. The information gathered will be reviewed and used t o identify potential improvements to our services wherever possible. Regular int ernal audits will be conducted on the QMS and projects to identify conformance w ith the system and ISO 9001 as well as looking at the effectiveness of our proce sses. See procedure XXX 06 XXX Quality Manual Page 11 of 14 Issue: 1

Projects and the processes used to design and implement them are measured throug hout their lifecycles in order to determine conformance with requirements and th e effectiveness and efficiency of achieving them. Each finished design is subjec ted to a rigorous, pre-planned validation process which enables us to verify its effective implementation. Indicators such as nonconformities, complaints, proje ct/budget overruns, internal audits and management review will also be used as a guide to the effectiveness of our processes. The tunnelling contractor is requi red 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 r etained and made available for future reference. See procedure XXX 05 Nonconform ing Product Where a project, or part of a project, does not meet specified requi rements, it will be identified as nonconforming. Nonconformities will be dealt w ith in accordance with a documented procedure. This includes responsibilities an d authorities, actions to be taken and reporting mechanisms. It also addresses h ow nonconformities will be dealt with when they are identified after installatio n has been completed. See procedure XXX 07 Analysis of Data Data will be collect ed and analysed from many sources to enable us to determine the effectiveness an d conformity of our systems, processes and projects with the aim of improving th em where possible. These include, but are not limited to the results from our mo nitoring and measuring activities and supplier performance. Improvement Improvem ent of our products/services, systems and processes is one of our main objective s. 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 qu ality policy, objectives, audits, management reviews, analysis of data, correcti ve and preventive actions. Corrective Action Where nonconformities and customer complaints occur, we will take appropriate corrective action to resolve the situ ation and to prevent it from recurring. The method of conducting and recording c orrective action is contained in a documented procedure. See procedure XXX 08 XXX Quality Manual Page 12 of 14 Issue: 1

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 appropria te. These may include planning activities and techniques such risk assessments a nd the use of statistics to help identify where potential problems may occur. Th e method of conducting and recording preventive action is contained in a documen ted procedure. See procedure XXX 08 XXX Quality Manual Page 13 of 14 Issue: 1

Index to Procedures Procedure Number XXX 01 XXX 02 XXX 03 XXX 04 XXX 05 XXX 06 XXX 07 XXX 08 XXX 09 XXX 10 XXX 11 XXX 12 XXX 13 Procedure Title Tendering Design Vendor Assessment R isk Assessment Monitoring & Measurement Internal Audits & Management Review NonConformance & Customer Complaints Corrective & Preventive Action Document Contro l - General Document Control - QMS Control of Records and Archives Training Meas uring and Test Equipment XXX Quality Manual Page 14 of 14 Issue: 1

You might also like