quality manual-template-guidance-example

ISO 9001:2008

Quality Manual

Template Guidance

GD001

www.iso-9001-checklist.co.uk ISO 9001:2008 Quality Manual Template Guidance

Document: GD001 of 37

Disclaimer

The material presented in this guidance document 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 document 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.



Table of Contents

Introduction ................................................................................................................................................................. 5

Navigating the Quality Manual ........................................................................................................................................ 5 Styles ................................................................................................................................................................................ 6 Headings and numbering ................................................................................................................................................. 7 What content do I need to amend? ................................................................................................................................. 8 Procedures ....................................................................................................................................................................... 8

1. Scope ....................................................................................................................................................................... 9

2. References ............................................................................................................................................................... 9

3. Terms & Definitions ................................................................................................................................................. 9

4. Quality Management System ................................................................................................................................. 10

4.1 General Requirements ............................................................................................................................................. 10 4.2 Documentation Requirements................................................................................................................................. 10

4.2.1 General.............................................................................................................................................................. 10 4.2.2 Quality Manual ................................................................................................................................................. 10 4.2.3 Document Control ............................................................................................................................................ 11 4.2.4 Control of Records ............................................................................................................................................ 12

Records Required By ISO 9001 ................................................................................................................................................. 12

5. Management Responsibilities ................................................................................................................................ 14

5.1 Management Commitment ..................................................................................................................................... 14 5.2 Customer Focus ....................................................................................................................................................... 14 5.3 Quality Policy ........................................................................................................................................................... 15 5.4 Planning ................................................................................................................................................................... 15

5.4.1 Quality Objectives ............................................................................................................................................. 15 5.4.2 Quality Management System Planning ............................................................................................................. 16

5.5 Responsibility, Authority and Communication ........................................................................................................ 16 5.5.1 Responsibility and Authority ............................................................................................................................. 16 5.5.2 Management representative ............................................................................................................................ 16 5.5.3 Internal Communication ................................................................................................................................... 16

5.6 Management Review ............................................................................................................................................... 16 5.6.1 General.............................................................................................................................................................. 16 5.6.2 Review Input ..................................................................................................................................................... 17 5.6.3 Review Output .................................................................................................................................................. 17

6. Resource Management .......................................................................................................................................... 18

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 Realization ................................................................................................................................................ 20

7.1 Planning ................................................................................................................................................................... 20 7.2 Customer Related Processes .................................................................................................................................... 20

7.2.1 Determination of Requirements Related to Product ........................................................................................ 20 7.2.2 Review of Requirements Related to Product .................................................................................................... 20 7.2.3 Customer Communication ................................................................................................................................ 20

7.3 Design & Development ............................................................................................................................................ 20 7.3.1 Planning ............................................................................................................................................................ 20



7.3.2 Input .................................................................................................................................................................. 21 7.3.3 Output ............................................................................................................................................................... 21 7.3.4 Review ............................................................................................................................................................... 21 7.3.5 Verification ........................................................................................................................................................ 21 7.3.6 Validation .......................................................................................................................................................... 21 7.3.7 Change Control ................................................................................................................................................. 21

7.4 Purchasing ................................................................................................................................................................ 21 7.4.1 Purchase Orders ................................................................................................................................................ 21 7.4.2 Purchasing Information .................................................................................................................................... 22 7.4.3 Verification of Purchased Product .................................................................................................................... 22

7.5 Production & Service Provision ................................................................................................................................ 22 7.5.1 Control of Production & Service Provision ........................................................................................................ 22 7.5.2 Validation of Processes for Production & Service Provision ............................................................................. 22 7.5.3 Identification & Traceability.............................................................................................................................. 22 7.5.4 Customer Property ............................................................................................................................................ 22 7.5.5 Preservation of Product .................................................................................................................................... 23

7.6 Calibration ................................................................................................................................................................ 23

8. Measurement, Analysis & Improvement ................................................................................................................ 24

8.1 General..................................................................................................................................................................... 24 8.2 Monitoring & Measurement .................................................................................................................................... 24

8.2.1 Customer Satisfaction ....................................................................................................................................... 24 8.2.2 Internal Audit .................................................................................................................................................... 24

The Human Aspect of Auditing ................................................................................................................................................. 25 Preparing for the Audit ............................................................................................................................................................. 25 Elementary Audit Questions ..................................................................................................................................................... 26 How to Audit a Process ............................................................................................................................................................. 26 How to Measure a Process ....................................................................................................................................................... 27 How to Audit without Procedures ............................................................................................................................................ 27 Getting the Most from the Audit Schedule .............................................................................................................................. 28

8.2.3 Process Monitoring & Measurement ................................................................................................................ 28 8.2.4 Product Monitoring & Measurement ............................................................................................................... 28

8.3 Control of Non-conforming Products ...................................................................................................................... 28 8.4 Analysis of Data ........................................................................................................................................................ 29 8.5 Improvement ........................................................................................................................................................... 30

8.5.1 Continual Improvement .................................................................................................................................... 30 8.5.2 Corrective Action .............................................................................................................................................. 30

Practical Problem Solving (8D Emphasis) .................................................................................................................................. 31 Prepare the Problem Solving Process ....................................................................................................................................... 31 Describe the Problem ............................................................................................................................................................... 32 Initiate Interim Containment Action ......................................................................................................................................... 32

STEP 1 – Select an Interim Containment Action ................................................................................................................... 32 STEP 2 – Verify an ICA .......................................................................................................................................................... 32 STEP 3 – Implement an ICA .................................................................................................................................................. 32

Identify the Root-Cause ............................................................................................................................................................ 33 STEP 1 – Review the Problem Description ........................................................................................................................... 33 STEP 2 – Complete a Comparative Analysis ......................................................................................................................... 33 STEP 3 – Develop Root-cause Theories ................................................................................................................................ 33 STEP 4 – Test the Theories ................................................................................................................................................... 34 STEP 5 – Verify the Root-Cause ............................................................................................................................................ 34 STEP 6 – Determine and Verify the Escape Point ................................................................................................................. 34

Implement & Validate Permanent Corrective Actions .............................................................................................................. 35 Prevent Recurrence .................................................................................................................................................................. 35

8.5.3 Preventative Action .......................................................................................................................................... 36 Auditing Preventive Action ....................................................................................................................................................... 36 How to Audit Preventive Action ............................................................................................................................................... 37 Follow-up & Verification ........................................................................................................................................................... 37



Introduction

Navigating the Quality Manual

We recommend you enable the ‘Document Map’ feature of MS Word. This is done in different ways depending on your version of MS Word – please see your MS Word Help to enable this feature. In MS Word 2007 use the ‘View’ tab, and tick the checkbox ‘Document Map’ (just under the ‘Mailings’ tab).

Alternatively you can navigate the quality manual using the ‘Contents’; the headings shown in the contents pages are hyperlinked to the relevant sections of the quality manual:

Open the ‘Quality Manual Template’

Go to page 4 ‘Contents’

Place your mouse cursor over the heading you wish to navigate to

Press and hold ‘CTRL’

‘left click’ your mouse



Styles

Styles are used throughout the document for your convenience:

Normal

Heading 1

Heading 2

Heading 3

Heading 4

Tables

Styles save considerable time formatting documents. Please change the styles to your house style/branding - font, size, weight, line-spacing, line-height, etc.

Style management differs in different versions of MS Word, for more information we recommend you search and view ‘how to’ videos on YouTube specific to your MS Word version, e.g. http://www.youtube.com/watch?v=eURMxdhCC94

http://www.youtube.com/watch?v=eURMxdhCC94



Headings and numbering

We have used the same headings and numbering (e.g. 5.4.1 Quality Objectives) as the ISO 9001 standard. This is to aid reference for Quality professionals using the Quality Manual; external auditors and certification bodies are accustomed to seeing Quality Manuals using this numbering system.

We don’t recommend changing the main headings or numbering system – but this is not a requirement of the standard - you can change the numbering system if it better suits your existing documentation.

For more information, please read section 4.b on the ISO website:

http://www.iso.org/iso/iso_catalogue/management_standards/quality_management/iso_9001_2008/guidance_on_the_documentation_requirements_of_iso_9001_2008.htm

Adding sections and numbers

If you wish to add more headings please use MS Word styles. This will enable you to update the ‘Contents’ dynamically and will save you time. This is done differently in different versions of MS Word, for more information we recommend you search and view ‘how to’ videos on YouTube specific to your MS Word version, e.g. http://www.youtube.com/watch?v=6BqHH-zkzEw

If you wish to add sections and new content we recommend you leave the heading 1 numbering the same (for reason, see above) and add subsections using styles - heading 2, heading 3, etc.

Updating the contents pages dynamically

If you add new sections using heading Styles, you can automatically update the ‘Contents’ pages using the ‘Update Table’ feature of MS Word (this will save you time). This is done in different ways depending on your version of MS Word – please see your MS Word Help for more information about this feature.



http://www.youtube.com/watch?v=6BqHH-zkzEw



What content do I need to amend?

This document should be used as guidance when developing or upgrading your ISO 9001:2008 quality manual. To begin:

Open the ‘Quality Manual Template’

Review and amend the quality manual

Review and amend the quality policy

Review and amend the procedures

Review and amend the forms

Replace the text to match your quality system requirements

At a minimum, blue text should be replaced with your information

Your Company indicates that you should use your company’s name in that location

Procedures

The 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:

QSP4.2.3 Document Control

QSP4.2.4 Control of Records

QSP8.2.2 Internal Audit

QSP8.3 Control of Non-conformances

QSP8.5.2 Corrective Actions

QSP8.5.3 Preventive Actions

You might want to document more procedures for other processes such as management reviews, how to approve vendors, how to process sales orders or shipping and receiving inspection, etc., but that’s optional.

Work instructions are also optional. Work instructions might describe how to operate machinery, how to mix chemicals for a certain process, how to process a purchase order, or anything else that you feel is important enough to document.

It is important to maintain a clear distinction between the contents of the quality manual and the purpose and scope of the procedures. The quality manual should define Top Management’s intention to operate an effective quality management system, while the procedures define how those intentions will be implemented at an operational level.

The approach taken many companies to avoid over-burdening their quality manual is by allowing lower-level documents, such as procedures and work instructions to contain the operational detail. Then, simple reference is made to the procedures and work instructions from within the quality manual itself. In other words, let the procedures take the strain of controlling day-to-day activities.



1. Scope Identify any ISO 9001:2008 requirements not applicable to your organization and provide a brief narrative justifying their exclusion from the scope of the Quality Management System. Any excluded requirements must only come from Section 7 of ISO 9001.

The quality manual must clearly define which requirements have been excluded with detailed justification for their exclusion. Excluded requirements must not:

Affect the ability of the organization to meet customer and regulatory requirements

Affect the ability of the organization to provide conforming products or services

An example of a justifiable exclusion might relate to design and development; if a company does not undertake design and development activities then Clause 7.3 would not be applicable.

In order to exempt your company from a requirement; a statement such as the following would suffice:

‘Your Company does not engage in designing, developing or changing the design of the products we manufacture. Therefore, our QMS does not encompass product design and development processes and therefore, paragraph 7.3 is not applicable to our business and has been excluded.’

2. References In addition to ISO 9001:2008 standard the organization should make reference in this section to other relevant British and or International Standards as well as customer specifications appropriate to the product and its market.

ISO 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 Define your organization’s terms and definitions; include any industry specific acronyms in Appendix A.4 of the quality manual.



4. Quality Management System

4.1 General Requirements

Your organization’s quality management system is that part of your overall management system which establishes, documents and implements your quality policy, and related processes for providing products and services which meet or exceed customer requirements, and which satisfies quality management system requirements of ISO 9001:2008.

Your organization should adopt the process approach advocated by ISO 9000:2005, by defining and managing:

Process inputs, controls, and outputs to ensure desired results are achieved, and

Interfaces between interrelated processes to ensure system effectiveness is achieved

If your organization outsources processes, you must be able to demonstrate sufficient control over each outsourced process. This is 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; either by providing suppliers or subcontractors with product specifications or by requesting inspection and test results or certificates of compliance or by conducting product and quality management system audits of your supplier/subcontractor.

The expectation here is that your quality management system 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 quality management system control.

4.2 Documentation Requirements

Define and document your quality management system.

4.2.1 General

Develop the quality policy document (5.3)

Develop and establish the quality objectives (5.4.1)

Develop and establish the quality manual (4.2.2)

Develop procedures to implement your quality system (4.2.3. 4.2.4, 8.3, 8.2.2, 8.5.2, 8.5.3)

Develop documents that reflect what your organization does

Use this documentation hierarchy:

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

The quality manual is the cornerstone of your organization’s quality management system. It manifests and communicates top management’s commitment to providing and operating an effective quality management system.

Prepare the quality management system manual

Define the scope of your quality management system



Document your procedures

Describe how your processes interact

Like any high level document, the quality manual must be written in such a way that it provides employees, customers, auditors and other interested parties with a sound overview of how your organization satisfies customer requirements. People throughout your organization will refer to it when they want to see the big picture of the system, or what policies have been established.

One of best ways to understand and implement ISO 9001:2008 is the actual task of compiling the quality manual. By reading through each of the requirements one-by-one and assigning each requirement a relevant document, process or procedure that exists within your organization, you’ll find that more than half of the requirements have already been addressed. The quality manual just needs formalise the relationship between the processes and the documents.

4.2.3 Document Control

A robust document control process invariably lies at the heart of any compliant quality management system; almost every aspect of auditing and compliance verification is determined through the scrutiny of documented evidence. With this in mind, it becomes apparent that the ongoing maintenance of an efficient document management system must not be overlooked.

Clause 4.2.3 tells us that an organization must control the documentation required by the quality management system and that a suitable document control procedure must be implemented to define the controls needed to; approve, review, update, identify changes, identify revision status and provide access. The document control procedure must clearly define the scope, purpose, method and responsibilities required to implement these parameters.

In order to comply with the document control clause, it is essential that all personnel understand what type of documents should be controlled and more importantly, how this control should be exercised. To get the most out of your document control procedure, it must communicate the steps necessary to ensure that staff and other users of the organization’s documentation understand what they must do in order to manage that information effectively and efficiently.

Departmental managers should always be responsible for promoting good document and record management practices in their area whilst supporting overall compliance to the document control procedure.

Individuals and their line managers should be responsible for the documents and records that they create, as well as being responsible for their retention and disposal in line with legislative requirements and organizational procedures and practices.

The document control procedure (QSP4.2.3) defines how the following controls will be achieved:

Approve documents before your distribute them

Provide the correct version of documents at points of use

Review and re-approve documents whenever you update them

Specify the current revision status of your documents

Monitor documents that come from external sources

Prevent the accidental use of obsolete documents

Preserve the usability of your quality documents

If you don’t want to control external documents, you must specifically state this in your quality manual, and on the documents themselves, that they are “For Reference Only” and are not updated.

Related documents:

Ref Definition

QSP4.2.3 Document Control Procedure



QF4.2.3-1 Master Document Index

QF4.2.3-2 Document Issue Sheet

QF4.2.3-3 Document Change Request

4.2.4 Control of Records

Similarly; Clause 4.2.4 demands that an organization must implement a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records and that these records must remain legible and identifiable throughout their retention period.

This because records are an important organizational asset; they provide the primary route for evidence based verification and traceability, and are able to demonstrate compliance with customer requirements. Records also prove the efficacy of the quality management system.

Use your records to prove that requirements have been met

Develop a procedure to control your records (QSP4.2.4)

Ensure that your records are useable

Records Required By ISO 9001

Implementing a compliant document management system could mean keeping certain records that your organization might not be already keeping. Some of these records may seem a little confusing until you become more familiar with the quality standard.

Of course, you might decide to keep more records than those listed below, if you feel your organization needs them, but as we always preach; keep your system simple. The fewer documents and records you keep, the fewer things that will be audited, and the more time you will have to actually run your business.

Ref Definition

5.6.1 Management review minutes, &c

6.2.2 (e) Education, training, skills and experience

7.1 (d) Evidence that realization process and resulting products fulfil requirements

7.2.2 Results of review of requirements relating to the product and actions arising

7.3.2 Design and development inputs

7.3.4 Results of design and development reviews and any necessary actions

7.3.5 Results of design and development verification and any necessary actions

7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design & development changes and any necessary actions

7.4.1 Results of supplier evaluations and actions arising from the evaluations

7.5.2 (d) Validation of processes where the output cannot be verified by 8.2

7.5.3 The unique identification of the product, where traceability is a requirement.



7.5.4 Customer property is lost, damaged or otherwise found to be unsuitable for use

7.6 (a) Basis for calibration of measuring equipment where no standards exist

7.6 Validity of previous results when measuring equipment does not conform

7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results

8.2.4 Proof of conformity with acceptance criteria/authority for release of product

8.3 Type of non-conformities and subsequent actions taken, including concessions

8.5.2 Results of corrective actions

8.5.3 Results of preventive actions

Keep in mind that you are free to combine some of these records where it makes sense, for example, you could combine the corrective action request and preventive action request records with a simple checkbox to note which one it is. You could also combine both corrective action and preventive action requests onto one form, again with a check box to designate if it is a corrective or preventive action request.

Please note this is a list of the records you will be required to keep. This does not deal with the mandatory documents, comprising of the quality manual, policy and procedures.

Related documents:

Ref Definition

QSP4.2.4 Control of Records Procedure

QF4.2.4-1 Master Quality Record Index

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