QUALITY SYSTEM DOCUMENTATION

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

QUALITY SYSTEM DOCUMENTATION

DOCUMENTATION STRUCTURE
The Standard defines five types of documentation within a quality management system:
a quality policy and quality objectives;
a quality manual;
documented procedures as required by the Standard;
documents required by the organization to ensure effective planning, operation and control
of processes;
records required by the Standard.
However, the amount of documentation will depend on:
the size of the organization and types of activities;
the complexity of processes and their interaction;
the competence of personnel.
A document is virtually anything that provides information. It may be a record, procedure, specification,
drawing or report. The information may be presented on paper, magnetic tape, electronic, computer disc,
photograph, master samples or a combination of these.
In those areas where the Standards call for documented procedures, one would expect to find
information set out in formally, meeting the criteria set out in paragraph 5.2.
The flexible approach of the Standard is intended to enhance the implementation, maintenance and
improvement of the system. This being the case, management should decide upon structure and format of
the documentation that is needed to support the quality management system. The nature and extent of the
documentation should depend upon, and meet, the needs of the organization.
GUIDANCE ON DOCUMENTATION
Organization wishing to adapt an existing QMS
An organization with an existing quality management system should not need to rewrite all of its
documentation in order to meet the requirements of ISO 9001:2000. This is particularly true if an
organization has structured its system in the way it operates effectively, using a process approach. In this
case, the existing documentation may be adequate and can be simply referenced in the revised quality
manual.
An organization that has not used a process approach in the past will need to define its processes, their
sequence and interaction as required by the Standard.
Because ISO 9001:2000 is less prescriptive than the 1994 versions, an organization may be able to carry
out some streamlining and/or consolidation of existing documents, in order to simplify its system.
Organizations preparing to implement a QMS
Since ISO 9001:2000 emphasizes a process approach to quality management, organizations that are in the
process of implementing or have yet to implement a quality management system should adopt this
methodology.
These processes include the management, resources, product realisation and measurement processes that
are needed for the effective operation of the system.

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

The processes should be the driving force for deciding the amount of documentation needed for the
system, talking into account the requirements of ISO 9001:2000; it should not be the documentation that
drives the processes.
Demonstrating compliance with ISO 9001:2000
In order to claim conformity with ISO 9001:2000, the organization must provide evidence of the
effectiveness of the processes and quality management system. As noted above, this may not necessarily
depend on documented procedures or records, except where these are specifically required by ISO
9001:2000. Organizations, particularly small organizations, may be able to demonstrate compliance
without the need for extensive documentation.
THE QUALITY POLICY AND OBJECTIVES
Quality policy
The Quality Policy should define top managements commitment to comply with requirements and to
continually improve the effectiveness of the quality management system.
An effectively formulated quality policy should:
Demonstrate top management commitment to quality and the provision of adequate resources for its
achievement;
promote a commitment to quality at all levels in the organization;
be consistent with the organizations overall business policies;
be consistent with the vision of the organizations future;
enable quality objectives to be understood throughout the organization;
address continual improvement and customer satisfaction;
provide a framework for establishing and reviewing quality objectives.
In establishing the quality policy, top management should consider.
The expected level of customer satisfaction;
The needs of other interested parties;
Opportunities and needs for continual improvement;
Resources needed and;
Contributions of suppliers and partners.
Quality objectives
Quality objectives are a link between the policy and the commitment to continual improvement.
The organizations objectives should be:
established during the planning process;
set at each relevant function and levels;
measurable and consistent with the quality policy.
In establishing quality objectives, management should consider:
the current and future needs of the organization and the markets served;
current product and process performance;
the levels of satisfaction of all interested parties;
actions arising from management review.

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

Once decided, the objectives need to be communicated to the appropriate people in a way that they are
able to translate these objectives into their individual contributions.
Objectives should be reviewed periodically and revised as necessary in order to provide current objectives
for continual improvement of the quality management system.
QUALITY MANUAL
Contents
The Quality Manual provides an overview of the quality system. Each Manual will be unique to the
organization but should contain :
title page;
table of contents;
introduction to the organization;
Quality Policy;
The scope of the system, including the details and justification for any
exclusions;
Organization structure (for example charts and scopes of responsibility)
A description of the interaction of the processes of the system;
the documented procedures or reference to them;
amendment record (if appropriate);
a cross-reference between the organizations system and the
requirements of the Standard.
Exclusion from any requirements of ISO 9001 must be justified and limited to Clause 7, but the key
words from Clause 1.2 must be heeded. The exclusions must neither affect the organizations ability, nor
absolve it from its responsibility o provide product that meets customer requirements.
Role
As well as meeting the requirements of the Standard, many organizations use the Quality Manual to:
promote awareness of quality throughout the organization;
demonstrate the organizations ability to operate a quality assurance system;
impress customer or to meet customer demands;
define and clarify the quality function;
facilitate change;
improve communications;
meet international business requirements;
act as a training aid
provide a system of audits;
act as a guide for suppliers;
meet ISO 9001: Clause 4.2.4
The Quality Manual must clearly define the scope of the quality system; for
example;
This Manual describes the quality system established for the manufacture of plastic
injection mouldings at the Heathcote Works of T.E. Tilley and Sons Ltd of Newton Abbot,
Devon.
The Standard requires that responsibilities and authorities and the interrelation between them are defined
and communicated within the organization (5.5.1).

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

One way of doing this is through organization charts and scopes of responsibility and these may well be
presented in the Manual. The lines of reporting of the Management Representative, especially in terms of
quality related decisions, should be clearly defined in the organization structure.
DOCUMENTED PROCEDURES
ISO 9001:2000 calls for documented procedures in only six areas :
control of documents (4.2.3);
control of records (4.2.4);
internal audit (8.2.2);
control of nonconformity (8.3);
corrective action (8.5.2);
preventive action (8.5.3);
However, some organizations may need documented procedures in other areas covering particular
departments, functions, or processes.
Procedures should be written in an agreed format and the following are typical sections or headings;
purpose
The objective or intention of the procedure.
Scope
Applicability, boundaries.
Procedure/method
Who is responsible for the action/control?
What is actioned/controlled and how, including:
information is processed;
methods and equipment used;
records to be completed / processed
Where: location.
When: timing, frequency
References
Other documents quoted and those that may need to be read to understand the procedure.
The Documented Procedures may be contained within the Quality Manual or in a separate Procedures
Manual.
OTHER DOCUMENTS
These are documents required by the organization to ensure the effective planning, operation and control
of its processes.
Such documents may include:
product flow charts;
process flow charts;
organization charts;
production schedules;
work instructions;
operating instructions;
job cards;
user manuals;

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

inspection plans;
test methods and instructions;
drawings;
approved supplier lists;
technical manuals;
manufacturers recommendations;
performance standards.
QUALITY PLANS
ISO 9000 defines a Quality Plan as:
A document specifying which procedures and associated resources shall be applied by whom and when to
a specific product, project, process or contract.
A quality plan focuses on an area of work relevant to a particular contract or project. The plan is usually a
control document:
providing a statement of the operations to be carried out;
identifying the procedures and reference documents controlling the
operations;
defining hold points;
indicating the means of monitoring process;
indicating the way by which records are generated and maintained.
Hold points are the key or critical stages and activities in the Plan beyond which work must not proceed
until that activity has been completed and verified. The evidence of such a review should be shown on the
Plan at that time. The Plan may then continue to completion and be reviewed for adequacy against the
contract or other documents.
RECORDS
ISO 9001 recognizes records as a special type of document. The organization needs to maintain records to
demonstrate compliance with customer requirements ad for determining the effectiveness of the quality
management system.
Records should be simple, effective and accurate, and provide information for staff to access as they work
towards continuous improvement.
Records should provide top management with useful information for continual improvement and should
provide data for improving processes.
Records may appear in any form which means that in many organizations,
records will be held electronically.
ELECTRONIC DATA SYSTEM
The introduction and use of electronic based systems can provide online access to information,
communication and the elimination of obsolete documentation.
However, auditors will need to consider the implications of such systems for;
Security;
Change control;
Authorization;
Access controls;
Document approvals;

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

Signatories;
Virus checking;
Record keeping;
Back-up controls;
Restore testing;
Control in the event of computer system failure.
CONTROL OF DOCUMENTS AND RECORDS
All quality system documents have to be controlled. There must be a documented procedure to ensure
this.
The following information is essential to control a document:
Title;
number;
issue status;
page number and total number of pages;
approval authority;
issuing authority;
issue date.
In some organizations the issuing and approval authorities may be the same person.
A quality document and record should be:
Identifiable title, number;
Up-to-date(documents);
Legible;
Understandable;
Logically laid out;
Clear in meaning;
Adequate;
Complete;
Self consistent within the purpose and scope of the system or process;
Consistent with other documents;
Available (documents);
Retrievable (records).
DOCUMENT EVALUATION
A review of the documentation (desk study) should identify the key elements of the quality
management system. The following technique is useful when initially drafting or examining a
complicated document or process:
Produce a sequence of events in tabular form
Turn this into a flow diagram
check the interfaces between the people, processes, departments and so on, referred to in the
procedure.
RECORDS REQUIRED BY ISO 9001 Clause No.
Record required
5.6.1
Management reviews
6.2.2(e)
Education, training, skills and experience
7.1(d)
Evidence that the realisation processes and
resulting product fulfill
requirements
7.2.2
Results of the review of requirements
relating to the product and
Actions arising from the review

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

7.3.2
7.3.4
7.3.5
7.3.6
7.3.7
7.4.1
7.5.2(d)

7.5.3
7.5.4
7.6(a)

7.6
7.6
8.2.2
8.2.4

8.3
8.5.2
8.5.3

By: G. R. P. K. Perera, Lecturer, CoT, Kandy

Design and development inputs

Results of design and development reviews
and any necessary actions
Results of design and development
verification and any necessary actions
Results of design and development
validation and any necessary actions
Results of the review of design and
development changes and any necessary
actions
Results of supplier evaluations and actions
arising from the evaluations
As required by the organization to
demonstrate the validation of processes
where the resulting output cannot be verified
by subsequent monitoring or measurement
The unique identification of the product,
where traceability is a requirement
Customer property that is lost, damaged or
otherwise found to be unsuitable for use
Standards used for calibration or verification
of measuring equipment
where no international or national
measurement standards exist
Validity of previous results when measuring
equipment is found not to conform with its
requirements
Results of calibration and verification of
measuring equipment
Internal audit results
Evidence of product conformity with the
acceptance criteria and indication of the
authority responsible for the release of the
product
Nature of the product nonconformities and
any subsequent actions taken, including
concessions obtained
Results of corrective action
Results of preventive action