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Introduction
The standard
requires documentation in areas where its absence would have
an adverse effect on quality. There is no need to make it
cumbersome and bureaucratic.
The following briefly indicates the type of documentation
and its uses:
The
Quality Manual
The purpose of the quality manual is to provide an adequate
description of the quality system for the implementation and
maintenance thereof.
It also serves to:
1. Improve communication
2. Provide a training aid
3. Provide role clarity
4. Provide a basis for periodic audit and review
5. Demonstrate to customers, certification body and shareholders
systematic planning
Structure of
quality system documentation
There are generally three levels of documentation:
1. The Quality Manual
2. Quality System Procedures
3. Work instructions and Formats
In larger organisations and where confidentiality is involved
it is advantageous to have these separated with cross-references:
in small organisations it is permissible to have these in
a single volume to simplify the approach.
Steps in writing a quality
manual
1. Coordinator
to list all existing quality-related documents and obtain
one copy each.
2. Study each process and prepare flowcharts of activities
3. Examine the interfaces or lack of interfaces between processes
4. Review flowcharts and identify duplications or disconnects
in the information or process flow
5. Map out what is to be written for each area
6. Verify the presence of all the required ISO quality elements
and set priorities for filling the gaps,
if any
7. Allocate responsibilities for preparing drafts to the people
actually concerned with specific operations.
Guide them to write or suggest the relevant parts of the manual.
8. Deal with documentation covering critical areas first.
9. Handle documents that can be prepared easily next, so that
a large part of the manual can be put together
quickly.
10. Circulate the completed drafts to all staff concerned
for comments.
11. Edit the documents ruthlessly, check for reliability and
keep as simple as possible.
12. Incorporate corrections based on comments and prepare
final script.
13. Monitor the use of the manual and fine tune.
14. Print and distribute according to established document
control procedures.
The contents
of a quality manual
The ISO standard does not specify a specific, rigid structure
and the company has the flexibility to design its manual provided
all the elements of the standard are addressed. If any particular
clause does not apply to the company, the reason for this
should be given in the manual.
The content structure is itemised
below:
1. Name of the company
2. Table of contents
3. Scope and field of application
4. Introductory text on the company
5. The manual's issue number and date of issue
6. Status of amendments with amendment record sheet
7. Designation of the person authorised to issue copies of
the manual and subsequent changes
8. Definition of standard forms
9. Quality policy and objectives of the company
10. Description of the company's organisational structure,
and statement of responsibilities and authorities
11. Description of applicable elements of the quality system
12. Appendix showing quality records and supportive data if
appropriate
13. Abbreviations, if any
Two approaches
to writing a quality manual
There are two approaches to writing a quality manual,
each with its own advantages. The first approach is to write
the manual according to the layout and sequence of the standard.
This has the advantage of making it easy for an outsider (customer,
auditor etc.) to verify concordance with the standard. Its
disadvantage is that it may not fit the individual company's
actual workflow. However, as it is easier of the two approaches
to follow and ensures that no quality element is left out,
it is generally recommended for small companies. Under the
second approach, the manual is designed to follow the company
workflow and cross-references are given in a schedule of conformity
to the relevant elements of the standard. This approach is
practical for large companies.
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uality
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