QUALITY SYSTEM 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. Signature
Position
Date
Prepared By
Reviewed By
Approved By
COMPANY PROPRIETARY INFORMATION 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.
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Quality Manual
[Your Company]
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. The six required procedures are: 1. 2. 3. 4. 5. 6.
Control of documents Control of records Internal audit Control of nonconforming product or service Corrective actions 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. ISO 9001:2008 is intended to be generic and therefore applicable to all organizations, regardless of type, size and product category. However, not all requirements in the Standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may exclude some specific requirements, such as Product Realisation. This document is to be used as a template in developing or upgrading your ISO 9001:2008 Quality Management System. Review the text in the quality manual, quality policy, procedures and forms; replace the text to match your quality system requirements. At a minimum, the blue text should be replaced with your information. Your Company indicates that you should use your Company’s name in that location. 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’.
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Quality Manual
[Your Company]
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.
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Quality Manual
[Your Company]
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.
Amendment Date
Guide Page (Numbers)
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Context
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Initial
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Quality Manual
[Your Company]
ISO 9001:2008
Table of Contents INTRODUCTION ......................................................................................................................................... 7 1. SCOPE .................................................................................................................................................... 8 2. REFERENCES ........................................................................................................................................ 8 3. TERMS & DEFINITIONS ......................................................................................................................... 8 4. QUALITY MANAGEMENT SYSTEM....................................................................................................... 9 4.1 INTRODUCTION ..................................................................................................................................... 9 4.2 DOCUMENTATION REQUIREMENTS.......................................................................................................... 9 4.2.1
General ................................................................................................................................ 9
4.2.2
Quality Manual ..................................................................................................................... 9
4.2.3
Control of Documents ........................................................................................................ 10
4.2.4
Control of Records ............................................................................................................. 11
5. MANAGEMENT RESPONSIBILITIES................................................................................................... 12 5.1 MANAGEMENT COMMITMENT ............................................................................................................... 12 5.2 CUSTOMER FOCUS ............................................................................................................................. 13 5.3 QUALITY POLICY ................................................................................................................................ 14 5.4 PLANNING.......................................................................................................................................... 15 5.4.1 Quality Objectives.................................................................................................................... 15 5.4.2 Quality Management System Planning.................................................................................... 15 5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION............................................................................... 15 5.5.1 Responsibility and Authority .................................................................................................... 15 5.5.2 Management representative .................................................................................................... 15 5.5.3 Internal Communication........................................................................................................... 15 5.6 MANAGEMENT REVIEW ....................................................................................................................... 16 5.6.1 General.................................................................................................................................... 16 5.6.2 Review Input............................................................................................................................ 16 5.6.3 Review Output ......................................................................................................................... 16 6. RESOURCE MANAGEMENT................................................................................................................ 17 6.1 PROVISION OF RESOURCES ................................................................................................................. 18 6.2 HUMAN RESOURCES ........................................................................................................................... 18 6.2.1
General .............................................................................................................................. 18
6.2.2
Competence, Awareness & Training .................................................................................. 18
6.3 INFRASTRUCTURE ............................................................................................................................... 19 6.4 WORK ENVIRONMENT ......................................................................................................................... 19 7. PRODUCT REALISATION .................................................................................................................... 20 7.1 PLANNING.......................................................................................................................................... 20 7.2 CUSTOMER RELATED PROCESSES ....................................................................................................... 21
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Quality Manual
[Your Company]
ISO 9001:2008
7.2.1
Determination of Requirements Related to Product ........................................................... 21
7.2.2
Review of Requirements Related to Product...................................................................... 21
7.2.3
Customer Communication.................................................................................................. 21
7.3 DESIGN & DEVELOPMENT .................................................................................................................... 22 7.3.1
Planning ............................................................................................................................. 22
7.3.2
Input ................................................................................................................................... 22
7.3.3
Output ................................................................................................................................ 22
7.3.4
Review ............................................................................................................................... 22
7.3.5
Verification ......................................................................................................................... 22
7.3.6
Validation ........................................................................................................................... 23
7.3.7
Change Control .................................................................................................................. 23
7.4 PURCHASING ..................................................................................................................................... 23 7.4.1
Purchase Orders ................................................................................................................ 23
7.4.2
Purchasing Information ...................................................................................................... 23
7.4.3
Verification of Purchased Product ...................................................................................... 24
7.5 PRODUCTION & SERVICE PROVISION .................................................................................................... 24 7.5.1
Control of Production & Service Provision.......................................................................... 24
7.5.2
Validation of Processes for Production & Service Provision............................................... 24
7.5.3
Identification & Traceability ................................................................................................ 24
7.5.4
Customer Property ............................................................................................................. 24
7.5.5
Preservation of Product...................................................................................................... 25
7.6 CALIBRATION ..................................................................................................................................... 25 8. MEASUREMENT, ANALYSIS & IMPROVEMENT................................................................................ 26 8.1 GENERAL .......................................................................................................................................... 26 8.2 MONITORING & MEASUREMENT ........................................................................................................... 27 8.2.1
Customer Satisfaction ........................................................................................................ 27
8.2.2
Internal Audit ...................................................................................................................... 27
8.2.3
Process Monitoring & Measurement .................................................................................. 28
8.2.4
Product Monitoring & Measurement................................................................................... 28
8.3 CONTROL OF NONCONFORMING PRODUCTS .......................................................................................... 28 8.4 ANALYSIS OF DATA ............................................................................................................................. 29 8.5 IMPROVEMENT ................................................................................................................................... 30 8.5.1
Continual Improvement ...................................................................................................... 30
8.5.2
Corrective Action................................................................................................................ 30
8.5.3
Preventative Action ............................................................................................................ 31
APPENDICES............................................................................................................................................ 32 9.1
EXAMPLE PROCESS MAP ............................................................................................................ 32
9.2
QUALITY GLOSSARY ................................................................................................................... 33
9.3
ABBREVIATIONS & DEFINITIONS ................................................................................................... 37
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Quality Manual
[Your Company]
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. Quality Management System (QMS) Process Map
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Quality Manual
[Your Company]
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. Exclusion
Clause
Justification
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. Standard
Title
Description
ISO 9000:2005
Quality management systems
Fundamentals and vocabulary
ISO 9001:2008
Quality management systems
Requirements
ISO 9004:2000
Quality management systems
Guidelines for performance improvements
3. Terms & Definitions Our Quality Management System uses the same internationally recognised terms, vocabulary and definitions given in ISO 9000:2005. Acronyms, terms, vocabulary and definitions unique to our organization, customers, industry and region and referenced throughout our Quality Management System are contained in Appendix 9.3. [Define your unique terms/definitions, if any, in Appendix 9.3] The following terms and definitions are taken from ISO 9000:2005: Term
Clause
Definition
Document
3.7.2
Information and its supporting medium
Procedure
3.4.5
Specified way to carry out an activity or a process
Quality Manual
3.7.4
Document specifying the quality management system of an organization
Quality Plan
3.7.5
Document specifying how procedures and resources shall be applied
Record
3.7.6
Document stating results achieved or evidence of activities performed
Specification
3.7.3
Document stating requirements
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Quality Manual
[Your Company]
ISO 9001:2008
4. Quality Management System 4.1 Introduction 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.
GUIDANCE: Outsourced Processes You must be able to demonstrate sufficient controls over outsourced processes to ensure that those processes are performed according to the relevant requirements of ISO 9001:2008. 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 Documentation Requirements 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.
Level 1: Policies – key system objectives Level 2: Quality Manual – approach & responsibility Level 3: Procedures – methods (Who, What, Where & When) Level 4: Work Instructions – description of processes (How) Level 5: Forms, Data & Records – evidence of conformance
4.2.2
Quality Manual
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.
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Quality Manual
[Your Company]
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:
Ref.
ISO Clause
Definition
QP1
4.2.3
Document Control
QP2
4.2.4
Control of Records
QP3
8.2.2
Internal Audits
QP4
8.3
Control of Non-conformances
QP5
8.5.2
Corrective Action
QP6
8.5.3
Preventive Action
GUIDANCE: Quality Procedures Your company may well require more procedures to operate effectively than the six mandatory procedures listed above.
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.
4.2.3
Control of Documents
All of the Quality Management System documents are controlled according to the Document Control Procedure (QP1). This procedure defines the process for:
Approving documents for adequacy prior to issue Reviewing and revising as necessary and re-approving documents Ensuring that changes and current revision status of documents are identified Ensuring that relevant versions of applicable documents are available at points of use Ensuring that documents remain legible and readily identifiable Ensuring that documents of external origin are identified and their distribution controlled Preventing the unintended use of obsolete documents Ensuring that documents of external origin are identified and their distribution controlled
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:
Specifications and drawings Process work instructions Quality manual, mandatory procedures and associated forms External documents
Controlled documents are identified with a document name and document number
Procedures are referenced according to the ISO 9001:2008 element number Procedures are prefixed QP Forms are prefixed with F
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Quality Manual
[Your Company]
ISO 9001:2008
4.2.4
Control of Records
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).
Final Inspection Records Training Records Process Instructions Calibration Records Corrective Action Reports Management Review Results
Related Documents Control of Documents Procedure
QP1
Master Document Index
F101.1
Document Issue Sheet
F101.2
Document Change Request
F101.3
Control of Records Procedure
QP2
Master Quality Record Index
F102.1
GUIDANCE: Document Control If you don’t want to control external documents, you must specifically state in your quality manual, and on the documents themselves, that they are “For Reference Only” and are not updated.
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.
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