ISO9001 Quality Manual
Quantum Risk Management Ltd
t/a Quantum Compliance
Registered Head Office Address
34 Greenbox
Westonhall Road
Stoke Prior
B60 4AL
Copyright © 2014. This Manual and the information contained herein are the property of Quantum Risk Management Ltd. It must not be reproduced or otherwise disclosed without prior consent in writing from Quantum Risk Management Ltd.
MANUAL IDENTIFICATION
Copy Number: 1 of 1
Issued to: Philip Jones
Title: Technical Director
Signed:
Quality Manager
REVISION AND AMENDMENT REGISTER
DATE / PAGENUMBER / PROCEDURE
NUMBER / REVISION DETAILS / ISSUE NUMBER
27.8.09 / Amendments
following visit by QMS
Aug 2011 / 7.5.1.11
7.5.1.12 / Amendments following Aug 2011 Audit
19.7.12 / 8.2.1 / Amendments following July 2012 Audit
5.6.1.2 / Management review meetings changed to not greater than 12 monthly intervals
26.09.13 / 9 / Quality structure chart included / 1
26.09.13 / 54 / 7.6 / Standard changed to include calibration of thermometers
26.09.13 / 56 / 8.2.1 / Amended to remove customer satisfaction questionnaires and replaced with range of alternative measurements.
12.01.14 / 1 / New address updated.
23.06.14 / 9 / New organogram included.
29.10.14 / 8 / Quality policy checked and confirmed no changes. Updated date to reflect current.
5.11.14 / 44 / 7.5.1 / Update to reflect change in proof review process
5.11.14 / 38 / 7.1 / Changed references to spreadsheet to Tracker system.
5.11.14 / 40 / 7.2 / Added in Business development team
5.11.14 / 50 / 7.6 / Add in requirement to maintain a calibration record centrally.
4/2/2015 / 51 / 8.2.1 / Add in more information regarding client meetings, customer feedback and work audits.
4/2/2015 / 52 / 8.2.2 / Updated the internal quality audit information.
4/2/2015 / 30 / 5.6.2 / Updated to reflect management review meeting format.
4/2/2015 / 19 / 4.2.3 / Amended wording as report templates on website and data-station.
4/2/2015 / 20 / 4.2.4 / Removed reference to management information records, organisation spread-sheet and planning schedule – not relevant.
3/3/2015 / 19 / 4.2 / Added reference to internal procedures
3/3/2015 / 20 / 4.2.4 / Added reference to internal procedures
3/3/2015 / 21 / 4.2.4 / Added reference to Appendix A – Record Control Schedule.
12/5/2015 / 44 / 7.5.1 / Changed spread-sheet to computer system and amended wording to reflect more environmentally friendly approach of emailing and only printing hard copy if requested
5/6/2015 / 55 / 8.2.3 / Amended documents used to facility monitoring to include work quality audits, appraisal records and induction training records.
11/12/2015 / Amended quality policy to 2016 review date after confirmation that no changes were required.
29/2/2016 / 19 / 4.2 / Amended reference to British Standards on-line from Barbour Index / 2.3
19/5/2016 / Appendix A / n/a / Updated record control schedule and added revised version to manual. / 2.4
10/11/2016 / 30 / 5.6.1 / Removed management information and trend analysis from management review list and amended management system to changes in operational environment. / 2.5
16/11/2016 / 59 / 8.4 / Updated to remove two points that are not relevant. / 2.5
ISO 9001:2000November 2016 Issue 2.5
CONTENTS
ISO 9001 REFERENCEForeword
Organisation Profile
Quality Policy
Quality Structure
1 / Scope
2 / Normative references
3 / Terms and definitions
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
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 realisation
7.1 / Planning of product realisation
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
CONTENTS
(continued)
ISO 9001 REFERENCE7.3 / Design and development
7.3.1 / Design and development planning
7.3.2 / Design and development inputs
7.3.3 / Design and development outputs
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 measuring devices
8 / Measurement, analysis and improvement
8.1 / General
8.2 / Monitoring and measurement
8.2.1 / Customer satisfaction
8.2.2 / Internal Quality Audits
8.2.3 / Monitoring and measuring of processes
8.2.4 / Monitoring and measuring 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
FOREWORD
This Quality Manual is the means by which Quantum Risk Management Ltd (the ‘Organisation’) satisfies the requirements of its customers, particularly with regard to management responsibility.
The Organisation is obliged to ensure that its Quality Policy is fully and completely understood by its employees, and that its procedures are implemented and maintained at all times. This Quality Manual is in accordance with the requirements of BS EN ISO 9001 : 2000. All of the components of the Quality Management System shall be periodically and systematically reviewed by both internal and external Quality Audit procedures.
The Quality Manager, appointed by the Organisation’s Chairman, is responsible for the control of all matters relating to the implementation of these procedures.
The assurance of quality is fundamental to all the work undertaken by the Organisation. All personnel at every level in the Organisation’s structure shall practise the procedures established.
PROFILE
Quantum Risk Management Ltd was founded in 2002 by the present management, to provide high-quality compliance services.
The Company established a reputation throughout the United Kingdom, undertaking contracts for several major companies. The Company’s success was, and remains, attributable to a firm commitment to quality.
QUALITY POLICY
Quantum Risk Management Ltd. (the ‘Organisation’) aims to provide defect free products to its customers on time and within budget.
The Organisation operates a Quality Management System that has gained BS EN ISO 9001: 2008 certification, including aspects specific to the provision of risk management consultancy services.
The management is committed to:
- Develop and improve the Quality Management System.
- Continually improve the effectiveness of the Quality Management System.
- The enhancement of customer satisfaction.
The management has a continuing commitment to:
- Ensure that customer needs and expectations are determined and fulfilled with the aim of achieving customer satisfaction.
- Communicate throughout the Organisation the importance of meeting customer needs and all relevant statutory and regulatory requirements.
- Establish the Quality Policy and its objectives.
- Ensure that the Management Reviews set and review the quality objectives, and reports on the Internal Audit results as a means of monitoring and measuring the processes and the effectiveness of the Quality Management System.
- Ensure the availability of resources.
The structure of the Quality Management System is defined in this Quality Manual.
All personnel understand the requirements of this Quality Policy and abide with the contents of the Quality Manual.
The Organisation complies with all relevant statutory and regulatory requirements.
The Organisation constantly monitors its quality performance and implements improvements when appropriate.
This Quality Policy is regularly reviewed in order to ensure its continuing suitability.
Copies of the Quality Policy are made available to all members of staff. Copies of the minutes of Management Reviews, or extracts thereof, are provided to individual members of staff in accordance with their role and responsibilities as a means of communicating the effectiveness of the Quality Management System.
Mark Ball Chairman November 2016
ISO 9001:2000November 2016 Issue 2.5
QUALITY STRUCTURE CHART
This chart establishes responsibilities and lines of internal communication within the Quality Management System and does not necessarily portray other management structures.
1 - SCOPE
This Quality Manual demonstrates the Organisation’s:
- Ability to consistently provide products and/or services that meet customer and applicable regulatory requirements, and
- Aims to enhance customer satisfaction through the effective application of the Quality Management System, including processes for continual improvement of the System and the assurance of conformity to customer and applicable regulatory requirements.
Whenever any requirement(s) of this International Standard cannot be applied they are excluded. The rationale for all such exclusions is clearly set out in this Quality Manual.
Such exclusions do not affect the Organisation's ability, or responsibility, to provide products that meet customer and applicable regulatory requirements.
ISO 9001:2000November 2016 Issue 2.5
2 - NORMATIVE REFERENCES
At the time that this Quality Manual was prepared the entire fundamentals and vocabulary relating and applied to the International Standard are set out in the document titled:
ISO 9000:2008, Quality Management Systems, Fundamentals and Vocabulary.
Parties to agreements based on this International Standard are encouraged to adopt the amendments contained in any subsequent editions of the International Standard that may be published. Members of ISO and IEC maintain registers of currently valid International Standards.
3 - TERMS AND DEFINITIONS
The International Organisation for Standardisation (ISO) has specified the following definitions for use in Quality Management Systems:
A product is defined as the “result of a process” and may include any services or advice, provided to a client as well as physical goods.
A customer is an “organisation or person that receives a product” and may include clients, purchasers, partners, stakeholders, or any other party having a quality related relationship with you and your Organisation.
A supplier is an “organisation or person that provides a product”. A supplier can be internal or external to the Organisation. In a contractual situation a supplier may be referred to as a contractor.
A process is “a set of interrelated or interacting activities, that transforms inputs into outputs.” In simple terms, what you do to get something.
A document is “information and its supporting medium”. The medium can be paper, magnetic, electronic or optical computer disk, photograph or master sample, or a combination thereof.
A record is a “document stating the results achieved or providing evidence of activities performed”.
Quotation marks on this page denote direct quotations from the Standard.
4 - QUALITY MANAGEMENT SYSTEM
4.1 / General requirementsSummary
Of
Requirements / The ISO 9001 Standard requires that the Organisation establishes and maintains a Quality Management System. In addition to its conventional management disciplines the Organisation must recognise and address quality management.
The Quality Management System must provide:
a)Management with a reference for the administration of the Organisation
b)A benchmark for the performance of management
c)A reference against which the performance of the Organisation can be measured
The Quality Management System must establish the goals on which the quality management is based. Amongst other things goals must be established for ensuring that the Organisation’s processes are clearly identified, regularly monitored and recorded, and remain effective.
The Organisation’s management must establish and implement a policy of on-going improvement in the quality of all of its activities.
The requirements set out above must, if possible, be recognised, adhered to and controlled whenever the Organisation outsources any of its quality-related requirements.
STATEMENT/PROCEDURE
As part of the implementation of this Quality Management System the Organisation has identified and documented in this Manual:
- The processes needed for the Quality Management System
- The sequence and interaction of these processes
- The criteria and methods used to ensure the effective operation and control of these processes
- The means to ensure the availability of the resources and the information necessary to support the operation and monitoring of these processes
- The processes used to measure, monitor and analyse these processes and implement action necessary to achieve planned results and monitor continual improvement
4 - QUALITY MANAGEMENT SYSTEM
4.1 / General requirements (continued)/ The Quality Management System is based on the following process model:
As part of the Management Review process, the Organisation reviews the Quality Management System and, when required, makes changes in order to ensure that it continues to meet management requirements and market conditions.
4 - QUALITY MANAGEMENT SYSTEM
4.2 / Documentation requirements4.2 1 / General
Summary
Of
Requirements / The International Standard recognises that the extent of the requirements for documented procedures differs according to the characteristics of the individual organisation. However as a minimum, in order to satisfy the requirements of the International Standard a formal written Quality Policy and a Quality Manual are generally considered essential.
STATEMENT/PROCEDURE
The following documents together define the Organisation’s Quality Management System and ensure the effective operation and control of its procedures:
- The Quality Policy
- This Quality Manual
- The Health & Safety Manual
- Specifications
- Client Instructions
4 - QUALITY MANAGEMENT SYSTEM
4.2 / Documentation requirements (continued)4.2.2 / Quality Manual
Summary
Of
Requirements / The Quality Manual contains a description of all of the components and requirements of the Quality Management System. It also identifies and justifies all exclusions from the requirements of the International Standard. It must also provide a description of how, within the Organisation’s activities, the sequence and interaction of processes takes place.
STATEMENT/PROCEDURE
Management ensures that this Quality Manual includes:
- The defined scope of the Quality Management System with any exclusions identified and justified
- Documented procedures or reference to them within other documents
- A description of the interaction of processes
Effective implementation of the Quality Management System is monitored on an informal basis, as part of the Organisation’s day to day operations.
The Quality Manager deals with instances when the Quality Management System is not correctly implemented.
Persistent breaches of the Quality Management System are dealt with in accordance with the Organisation’s disciplinary procedures.
Such breaches are taken into account when reviewing:
- The overall operation of the Organisation’s Quality Management System
- The Quality Manual, to ensure that it is up to date and accurately reflects the working practices of the Organisation
- Staff training requirements
4 - QUALITY MANAGEMENT SYSTEM
4.2 / Documentation requirements (continued)4.2.3 / Control of documents
Summary
Of
Requirements / There must be documented procedures for:
- Document approval
- Review and update of documents,
- Identifying a document’s status
- Ensuring document availability
- Ensuring document legibility and identification
- Identifying and distributing documents of external origin
- Preventing the unintended use of obsolete documents
STATEMENT/PROCEDURE
QUALITY MANUAL
The Technical Director has approved this Quality Manual and will approve all subsequent issues.
The only controlled copy of the Quality Manual is that held on the Organisation’s computer system and is maintained by the Quality Manager.
All hard and any other electronic copies are by definition un-controlled.
Proposed changes to the Quality Manual are identified during the day to day activities as well as more formally during the Management Review process described in Section 5.6.
Proposed changes are reviewed and, if appropriate, adopted by the Quality Manager after taking into account all of the relevant information.
When adopted, changes are made to the controlled copy of the Quality Manual and the appropriate personnel are notified of the change.
4 - QUALITY MANAGEMENT SYSTEM
4.2 / Documentation requirements (continued)OTHER CONTROLLED DOCUMENTS
- The Health & Safety Manual
- Specifications
- Report templates
- Client Instructions
- Internal Procedures
Consultants are provided with access to an online technical library (British Standard on-line), which comprises standards, trade literature and other relevant documents.
As updates are received, they are communicated to consultants by the Technical Director.
GENERAL CONTROLS
The Organisation’s computer system is regularly backed-up with a copy securely stored.
The integrity of the computer system and the data held on it is maintained by running background virus protection software and the maintenance of effective and regularly updated Firewalls.
4 - QUALITY MANAGEMENT SYSTEM
4.2 / Documentation requirements (continued)4.2.4 / Control of records
Summary
Of
Requirements / A schedule of records addressed within the Quality Management System must be prepared and maintained.
The schedule must include minimum periods of retention and establish standards for their identification, storage and disposition.
STATEMENT/PROCEDURE
The Quality Manager is responsible for keeping the following records and similar documents for a minimum period of 12 months or as required by legal, regulatory and/or contractual requirements, whichever is the longer, in order to demonstrate conformity to the requirements and effective operation of the Quality Management System:
- Previous Management Review records
- Quality Audit Reports
- Staff suggestions
- Staff training records
- Non-conformance records including customer complaints
- Customer satisfaction records
- The Health & Safety Manual
- Specifications
- Fee Proposals/Tender Responses
- Reports
- Internal Procedures
4 - QUALITY MANAGEMENT SYSTEM
4.2 / Documentation requirements (continued)The Quality Manager is responsible for:
- Identifying and specifying the records that are subject to control
- Nominating individuals responsible and accountable for every record
- Specifying the contents of records (through procedures)
- Record disposal
The Organisation’s storage system, both in electronic and hard copy, ensures that all quality records and similar documents are adequately protected, remain legible and identifiable. Records are stored and maintained in a manner to make them readily retrievable, in facilities that provide an environment to minimise deterioration or damage and to prevent loss.
The Quality Manager maintains a Record Control Schedule with document specific requirements as appropriate for the identification, collating, indexing, filing, storage and maintenance of records. See Appendix A (page 61).
Quality records are reviewed annually by the Quality Manager and those retained in excess of the specified retention period are disposed of.
5 - MANAGEMENT RESPONSIBILITY