Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
MANUAL
QM1
BS EN ISO 9001:2008
Your Company
The signatures below certify that this Quality Manual has been reviewed and accepted, and demonstrates that the
signatories are aware of all the requirements contained here in and are committed to ensuring their provision.
Prepared By
Reviewed By
Approved By
This document is an uncontrolled copy of a controlled document held by the Quality Management System. Prior to
use, ensure this document is the most recent revision by checking the Master Document List. To request changes,
submit a Document Change Request to the Document Control Representative.
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
GUIDANCE
The ISO standard requires a minimum of six quality procedures, a quality manual and a
quality policy. You’ll probably want to have more procedures which are necessary to
operate your specific business, but only six are mandatory.
1. Control of documents
2. Control of records
3. Internal audit
4. Control of nonconforming product or service
5. Corrective actions
6. Preventive actions
You might want to document other procedures, such as how to approve vendors, how to
process sales orders, shipping and receiving inspection, things like that. But that’s
optional.
Also optional are work instructions. Work instructions might be procedures on how to
operate machinery, how to mix chemicals for a certain process, how to process a
purchase order, or anything else you feel is important enough to document. You want to
make sure everyone is doing things the way you want them to be done. Documented
procedures also make it easier to train future employees.
Various guidance paragraphs are provided within this document and should be deleted as
the Quality Manual is compiled.
To aid in the navigation of this document; the headings in the contents page are
hyperlinked to the relevant sections. Further to this, it is suggested that you choose ‘view’
from the main menu and then ‘document map’, the section headings are now displayed
as bookmarks on the left hand side.
It is also useful to display the text boundaries of each page, choose ‘tools’ then ‘options’,
click the ‘view’ tab, select ‘text boundaries’.
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
Disclaimer
The material presented in this manual and its accompanying instructions, suggestions and comments are
based on the requirements of ISO 9001:2008 and our experiences gained through its successful
application. Every company is different, however, in terms of its needs, its culture, and its level of
management system development. These differences often require that the generalised guidelines in this
manual be applied with special approaches. Readers are advised and cautioned that Endeavour
Technical Ltd will accept no responsibility for the way in which these guidelines are interpreted and
applied, or the problems which may arise henceforth.
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
Amendment Record
This Quality Manual is reviewed annually to ensure relevance to the systems and process that it defines.
A record of contextual additions or omissions is given below.
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
Table of Contents
INTRODUCTION ......................................................................................................................................... 7
1. SCOPE .................................................................................................................................................... 8
2. REFERENCES ........................................................................................................................................ 8
5. MANAGEMENT RESPONSIBILITIES................................................................................................... 12
6. RESOURCE MANAGEMENT................................................................................................................ 17
7.1 PLANNING.......................................................................................................................................... 20
7.2 CUSTOMER RELATED PROCESSES ....................................................................................................... 21
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
APPENDICES............................................................................................................................................ 32
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
Introduction
Your Company has developed and implemented a Quality Management System in order to document the
company’s best business practices, better satisfy the requirements and expectations of its customers and
to improve the overall management of the company.
The Quality Management System of Your Company meets the requirements of the international standard
ISO 9001:2008. This system addresses the design, development, production, installation, and servicing of
the company’s products.
This manual describes the Quality Management System, delineates authorities, inter relationships and
responsibilities of the personnel responsible for performing within the system. The manual also provides
procedures or references for all activities comprising the Quality Management System to ensure
compliance to the necessary requirements of the standard.
This manual is used internally to guide the company’s employees through the various requirements of the
ISO standard that must be met and maintained in order to ensure customer satisfaction, continuous
improvement and provide the necessary instructions that create an empowered work force.
This manual is used externally to introduce our Quality Management System to our customers and other
external organizations or individuals. The manual is used to familiarise them with the controls that have
been implemented and to assure them that the integrity of the Quality Management System is maintained
and focused on customer satisfaction and continuous improvement.
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
1. Scope
The International Organization Standard ISO 9001:2008 describes the requirements for a Quality
Management System by addressing the principles and processes surrounding the design development
and delivery of a general product or service. The activity covered by Your Company is for the provision of
and/or [delete as appropriate] supply of [Specify business/industry/sector].
The Quality Management System complies with all applicable requirements contained in ISO 9001:2008,
covers the design and provision of all products and/or services, and encompasses all operations at our
facility located at [insert address of your facilities here]. The following table identifies ISO 9001:2008
requirements not applicable to Your Company and provides a brief narrative justifying their exclusion from
the scope of the Quality Management System. Exclusions are limited to Clause 7, Product Realisation
where such processes are not performed or managed by the organization.
2. References
In addition to ISO 9001:2008 standard the company will also make reference to relevant British and or
International Standards as well as customer specifications appropriate to the product and its market.
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
Your Company operates and maintains a Quality Management System in accordance with the
requirements of ISO 9001:2008 and through its application will ensure that both the operation and control
of relevant processes is effective; by ensuring the availability of resources and information needed to
support the QMS. Your Company monitors, measures and analyses relevant processes and takes action
to achieve planned results and the continual improvement of our QMS. Any outsourced process or activity
is controlled as per applicable ISO 9001 requirements.
Outsourced processes may be controlled in any number of ways, e.g. by providing the
supplier/subcontractor with product specifications or by requesting inspection and test
results or certificates of compliance or by conducting product and QMS audits of your
supplier/subcontractor.
The expectation here is that your QMS flows down to your supplier/subcontractor, the
relevant ISO 9001 requirements that you would have to implement had the process been
performed in-house under your QMS control.
4.2.1 General
In order to maintain this assurance a documented quality system has been developed to ensure
and demonstrate that all work undertaken conforms to specification requirements. The system is
structured in five levels.
This Quality Manual has been prepared to describe Your Company’s Quality Management
System. The scope and permissible exclusions of the QMS are described in section one of this
manual. Each section of the manual references mandatory procedures, forms, and process
diagrams relating to the requirements outlined in that section.
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
Controls applied concerning the attainment of quality and the overall process is described in a
process map (Appendix 9.1). In addition, the following procedures are implemented:
If, for instance, your company operates a training procedure or a procedure to evaluate
suppliers, they should be listed here and then referenced in the relevant section of the
quality manual. Remember, only six procedures are mandatory.
All of the Quality Management System documents are controlled according to the Document
Control Procedure (QP1). This procedure defines the process for:
The company uses standard forms and a local area network computer system with an electronic
document management system which are updated as required. Documents which must be
controlled but are not limited to:
Controlled documents are identified with a document name and document number
www.iso-9001-checklist.co.uk
[Your Company] Quality Manual
ISO 9001:2008
The records established to provide evidence of conformity to the requirements specified by the
standard and of the effective operation of the quality management system is formally controlled
through the effective application of the Control of Records Procedure (QP2).
Related Documents
As part of your document control process, you must also devise a way to withdraw the
obsolete documents and prevent their accidental use, and also issue the new updated
documents to the necessary personnel in your organization. Whatever process you use to
make sure you have the latest revisions, you must document this in your quality manual.
www.iso-9001-checklist.co.uk